PDDS Manuf Juris Toxicology Pacop

1.
The most famous surviving memorials of early drugs with more than 800 formulas or prescriptions is
a. De Materia Medica
b. Galen’s Formula
c. Papyrus Ebers
d. Pharmacopeia
2. One of the Galen’s famous formula is known as:
a. Galen’s ointment
b. Galen’s cream
c. Galen’s suppository
d. Galen’s cerate
3. The label of OTC drugs contain
I. Pharmacologic category
II. Rx symbol
III. Dosage form
a. I, II and III
b. II and III
c. I and III
d. I only
4. A _____ is defined as any agent intended for use in the diagnosis, mitigation, cure, treatment, or prevention of
disease in man or in other animals.
a. Substance
b. Article
c. Dosage form
d. Drug
5. Amount administered to a patient after exposure or contraction of the illness
a. Prophylactic dose
b. Therapeutic dose
c. Maintenance dose
d. Minimum effective concentration
6. The following are parts of the monograph EXCEPT
a. Pharmacologic category
b. Statement of chemical purity
c. Official title
d. CAS registry number
7. The following are drugs from plant sources EXCEPT
a. Reserpine
b. Paclitaxel
c. Insulin
d. Vincristine
8. Information found in the package insert include all the following EXCEPT
a. Contraindication
b. Warning
c. Clinical protocol
d. How supplied
9. The purpose of Phase 3 clinical trial is
a. Mainly for safety
b. For short term safety, but mainly effectiveness
c. For safety, effectiveness and dosage
d. Post-marketing surveillance
10. A chemical compound that has a fundamental desired biologic or pharmacologic activity is referred to as
a. Prodrug
b. Lead compound
c. Goal drug
d. All of these
11. Which of the following is NOT a product of genetic engineering?
a. Human insulin
b. Home pregnancy testing kit
c. Interferon
d. Paclitaxel
12. It is used to gain approval to market a duplicate product to one that had been approved previously and marketed
by the pioneer
a. Supplemental New Drug Application
b. Abbreviated New Drug Abbreviation
c. “Treatment Investigational New Drug Application”
d. New Animal Drug Application
13. Which of the following statements is correct?
I. A drug product label includes package inserts
II. Phases I, II and III of clinical trials are conducted using animal subjects
III. Revision of USP/NF is every 5 years
a. I, II and III
b. II and III
c. I and III
d. I and II
e. III only
14. These substances are used to prevent the drying out of preparations due to the agent’s ability to retain moisture
a. Levigating agent
b. Humectants
c. Plasticizer
d. Antioxidant
e. Occluding agent
15. Cocoa butter is used as a base in the manufacture of
a. Capsule
b. Suppositories
c. Pills
d. Tablets
16. Parabens are used in syrups as:
a. Buffer
b. Thickener
c. Preservative
d. Sweetener
17. The bitter taste of drugs is best concealed by
a. Citrus flavor
b. Cocoa flavor
c. Raspberry flavor
d. Mint flavor
18. The disadvantage of Sodium saccharin as a sweetening agent is:
a. Less sweet than sucrose
b. It has carcinogenic potential
c. Contraindicated to phenylketonurics
d. Bitter after-taste
19. Characteristics of Stevia powder include
I. A natural, non-toxic sweetener
II. Contraindicated to phenylketonurics
III. About 30 times sweeter than sucrose
a. Only I
b. I and II
c. I and III
d. II and III
20. Which of the following dosage forms are designed to conceal the bitter, salty or offensive taste or odor of a drug
substance?
I. Capsules
II. Coated tablets
III. Flavored syrups
a. Only I
b. I and II
c. I and III
d. I, II and III
21. This chemical agent is used to render capsules opaque
a. Titanium dioxide
b. Sorbitol
c. Magnesium oxide
d. Silica
e. Lactose
22. FD&C yellow no. 5
I. Also known as tartrazine
II. Can cause hypersensitivity reaction
III. Now permitted as colorant for externally applied products
a. I and III
b. I and II
c. II and III
d. I, II and III
23. Products requiring colorants include
I. Ointments
II. Compressed tablets
III. Capsules
a. I only
b. III only
c. I and II
d. II and III
e. I, II and III
24. Which of the following is NOT an antioxidant?
a. Alphatocopherol
b. Butylhydroxyanisole
c. Benzoic acid
d. Ascorbic acid
25. Self-sterilizing preparations include
I. Tinctures
II. Spirits
III. Elixirs
a. I only
b. III only
c. I and II
d. II and III
e. I, II and III
26. The following are examples of single dose parenteral containers EXCEPT
a. Fusion-sealed ampuls
b. Pre-filled syringes
c. Cartridges
d. 30ml capacity vials
27. The release of an ingredient from the packaging component into the contents is best described by the term:
a. Sorption
b. Leaching
c. Permeation
d. Diffusion
28. Type II glass container is
I. Highly resistant borosilicate
II. Can be used as container for parenterals
III. Treated soda lime glass
a. I and III
b. I and II
c. II and III
d. I, II and III
29. Photodegradation can be prevented by packaging drugs in a light resistant container. Which of the following
containers is NOT light resistant?
a. Colorless bottle covered with aluminum foil
b. Plastic container
c. Amber colored bottle
d. Bottle covered with carbon paper
30. This plastic material is rigid and has good clarity thus, is used in blister packaging of capsules and tablets is
a. PET
b. PVC
c. PETG
d. APET
31. Single dose parenteral container
I. Is a hermetic container
II. Ampul
III. Permits withdrawal of successive portions of the contents
a. I and III
b. I and II
c. II and III
d. I, II and III
32. The temperature of a cold place is
a. 8°C-15°C
b. Not exceeding 8°C
c. 15°C-30°C
d. 25°C
33. Based on USP guidelines the stability of extemporaneously compounded aqueous liquids (reconstituted
formulation) is
a. A beyond use date of not later than 25% of the time remaining until the products’ expiration date or 6
months, whichever is earlier
b. Not later than 14 days when stored at cold temperatures
c. Not less than the intended duration of therapy or 30 days, whichever is earlier
d. Maximum beyond use date is 6 months or 25% of the remaining time between the compounding date and
the shortest expiration date of the ingredients, whichever is earlier
34. ______ stability is important for selecting storage condition, proper container and for anticipating interactions
when mixing drugs.
a. Physical
b. Chemical
c. Microbiological
d. Therapeutic
35. An approach to stabilize preparations against hydrolytic decomposition EXCEPT
a. Removal of water
b. Use of buffering agent
c. Use of anti-oxidant
d. Supplying the drug in dry form for reconstitution
36. Geometric dilution:
I. Is employed in comminuting powders
II. Is employed in mixing small amount of potent drug with a large amount of diluents
III. Can be performed when trituration method of mixing powder is used
a. I, II and III are correct
b. I and III are correct
c. II and III are correct
d. Only I is correct
37. A comminution process where a suitable agent, usually a non-solvent, is added to the powder to form a paste
then rubbing or grinding the paste in a mortar.
a. Trituration
b. Pulverization with intervention
c. Levigation
d. Sieving
38. Powders disperse and dissolve more readily than compacted dosage forms because
a. They contain disintegrants
b. Are better lubricated
c. Have a greater surface area
d. Flow better
39. Divided powders are also known as
a. Parvules
b. Boluses
c. Chartula
d. Cachets
40. Statements concerning bulk powders
I. Oral powders are mixed with water or other beverages before swallowing
II. Douche powders are dissolved in warm water for vaginal use
III. Dusting powders include topical anti-infectives, antifungals and antiperspirants
d. Only II is correct
41. Finely divided powders introduced into the body cavities such as ears, nose, throat, tooth sockets and vagina.
I. Dusting powder
II. Douche powder
III. Insufflation
a. I only
b. III only
c. I and II
d. II and III
e. I, II and III
42. Effervescent granulated salts usually contain
a. Sodium bicarbonate, potassium citrate and sodium tartrate
b. Sodium bicarbonate, citric acid and tartaric acid
c. Sodium carbonate, sodium citrate and tartaric acid
d. Carbonic acid, potassium citrate and potassium tartrate
43. The gas evolved when effervescent powders dissolve in water is
a. Oxygen
b. Carbon dioxide
c. Carbon monoxide
d. Water vapor
44. Which of the following products are not classified as dispensed powder and granules?
a. Dentrifices
b. Douches
c. Insufflations
d. Lozenges
45. Which is a major advantage of powders and granules?
a. Bulk powder is easily carried by patients
b. They are more stable than liquid preparations
c. They can mask unpleasant tastes
d. They are good for dispensing hygroscopic and deliquescent drugs
46. Efflorescent powders when triturated or stored in low humidity release
a. Carbon dioxide
b. Water
c. Dust
d. Bad smells
47. Triturations are dilutions of potent powdered drugs prepared by intimately mixing them with a suitable diluent in a
definite proportion by weight. The proportion of the potent drug to the diluent is
a. 1:20
b. 1:2
c. 1:10
d. 1:100
48. Soft gelatin capsules
I. Are used to hermetically seal and encapsulate liquids, suspensions, and pasty materials
II. Render elastic and plastic-like by adding titanium dioxide
III. Contain more moisture than hard gelatin capsule
d. Only III is correct
49. This substance is added to soft gelatin capsule to render it elastic or plastic-like
a. Glycerin
b. Gelatin
c. Sugar
d. Water
50. Hard gelatin capsules are
I. Commonly employed in clinical trials
II. In small scale compounding, pharmacist uses “punch method”
III. Can be prepared by rotary die process
b. I and II are correct
51. Characteristics of added substances to capsule formulation
I. Harmless in quantities used
II. Do not interfere with requisite compendial assays and tests
III. Do not impair product’s bioavailability, therapeutic efficacy or safety
52. TRUE statements regarding capsule excipients include
I. Lactose is a common diluent
II. Sodium lauryl sulfate is used as surface-active agent
III. Magnesium stearate is used as a disintegrant
53. When preparing hard gelatin capsules, the formulator is not generally concerned with
a. Powder blending and homogeneity
b. Powder flow
c. Powder lubrication
d. Powder compaction
54. Flavoring agents are usually added to
I. Buccal tablets
II. Film-coated tablets
III. Chewable tablets
55. A tablet which is 50% larger and heavier than the original uncoated one is
a. Sugar-coated tablet
b. Film-coated tablet
c. Enteric-coated tablet
d. Chocolate-coated tablet
56. Which of the following is NOT correctly matched?
a. Claritin Reditabs – Instant disintegrating tablet
b. Minidiab-OD – Extended-release tablet
c. Nitrostat – Tablet for oral ingestion
d. Neozep – Multiple-compressed tablet
e. Bonamine – Chewable tablet
57. Disc-shaped solid dosage form containing a hard candy base to be dissolved slowly in the mouth
a. Cachet
b. Parvules
c. Pills
d. Lozenges
58. Which of the following is a troche?
a. Fentanyl Actiq
b. Dequadin
c. Alaxan-FR
d. Clusivol
e. Zantac-150
59. True statements about the function of excipients used in tablet formulation EXCEPT
a. Binders promote granulation
b. Glidants promote the flow of the tablet granulation
c. Lubricants help the patient to swallow the tablet
d. Diluents make up the desired bulk of the tablet formulation
60. Dulcolax™ tablet is
a. Sugar-coated
b. Enteric-coated
c. Film-coated
d. Multiple-compressed
61. An excipient used in sugar-free chewable tablet is
a. Sucrose
b. Mannitol
c. Glycerin
d. Xylitol
62. Tablet for oral ingestion
I. Acetaminophen tablet
II. Alkaselter
III. Poten-cee
63. Advantages of film-coating over sugar-coating include:
I. More durable
II. Less bulky
III. Less time consuming to apply
64. This tablet is originally used by physician in extemporaneous preparation of parenteral solutions
a. Molded tablet
b. Hypodermic tablet
c. Dispensing tablet
d. Tablet triturate
65. Uncoated, bullet or ovoid-shaped tablets intended for localized effect
a. Sugar-coated tablet
b. Multiple-compressed tablet
c. Effervescent tablet
d. Vaginal tablet
66. Which method of tablet manufacture can be used to combine two incompatible substance in the same tablet
a. Sugar-coating
b. Film-coating
c. Enteric-coating
d. Multilayer compression
67. Increase amount of this capsule/tablet excipient reduces wetting of particles thus slowing dissolution
a. Surface-active agent
b. Disintegrant
c. Lubricant
d. Diluent
68. True statements for pills include:
I. Small, round, solid dosage forms containing medicinal agents and are orally administered
II. Replaced today by compressed tablets and capsules
III. Placed in the mouth, where they dissolve slowly for local effect
a. I, II and III
b. I and III
c. I and III
d. I and II
e. Only I
69. Solid dosage administered other than oral route
I. Pellets
II. Troches
III. Lollipops
a. Only I is correct
c. I and II are correct
d. I, II and III are correct
70. Lozenges usually do not contain the following tableting excipient
a. Sucrose
b. Cross-linked povidone
c. Lactose
d. Gelatin
71. Complete mixing of magnesium stearate with tablet granules will
a. Decrease the crushing strength of tablets
b. Increase tablet hardness
c. Increase tablet dissolution
d. Increase tablet disintegration
72. Which of the following factors does not influence the speed of drug dissolution from tablets?
a. Particle size of the drug
b. Solubility of the drug
c. Tablet hardness
d. Weight uniformity
73. The rate of drug bioavailability is most rapid when the drug is formulated as a
a. Controlled-release product
b. Hard gelatin capsule
c. Solution
d. Suspension
e. Compressed tablet
74. To what type of modified release formulation enteric coated tablet belongs?
a. Delayed-action
b. Controlled-release
c. Sustained-action
d. Extended-action
75. Dose dumping is
I. A problem in the formulation of modified release products
II. The abrupt, uncontrolled release of a large dose of drug from a controlled-release product
III. Prevented by chewing or cutting a controlled release tablet
76. Characteristic of drug substances best suited for incorporation into an extended-release product include:
I. Uniformly absorbed from the GIT
II. Possess a good margin of safety
III. Used in the treatment of acute rather than chronic condition
77. Microencapsulation is
I. A process by which solids, liquids, or even gases maybe encapsulated into microscopic size
II. The technology employed in Micro-K Extencaps
III. Formed by applying a thin coating of “wall” material around the substance being encapsulated
78. Correct statements about repeat-action tablets include
I. The tablet may be prepared with immediate-release dose in the tablet’s outer shell
II. The tablet’s second dose is in the inner core
III. An example of this type of product is the GITS
79. Which of the following is NOT an oral osmotic pump delivery system?
a. Oramorph SR
b. Glucotrol XL
c. Procardia XL
d. Covera-HS
80. Spansule capsule is
I. An example of extended-release product prepared by embedding drug in a slowly eroding hydrophilic
matrix system
II. A capsule containing beads of different coating thickness
III. A half-colored, half-transparent hard gelatin capsule containing colored beads or granules
a. Only III is correct
81. Which of the following extended-release dosage form is prepared by embedding the drug in an inert plastic
matrix?
a. Ferro-Gradumet
b. Tussionex Pennkinetic Suspension
c. Diamox Sequels
d. Oramorph SR tablet
82. Lacrisert is
I. An extended-release ocular insert
II. Used for the treatment of dry eyes
III. Release medication over a 7-day period
a. I and II are correct
83. Osmotically controlled system include
I. Glucotrol XL
II. Feosol Spansule
III. Adalat GITS
a. I only
b. III only
c. I and III
d. II and III
e. I, II, III
84. Transdermal drug delivery systems (TDDS)
I. Facilitate the passage of therapeutic quantities of drug substances through the skin into the systemic
circulation
II. Often called “transdermal patches”
III. Avoid first-pass effect
85. Transderm-Nitro Therapeutic System
I. Is an example of monolithic system
II. Is used to treat and prevent angina
III. Delivers nitroglycerin for 24 hours after application
a. Only II is correct
b. II and III are correct
c. I and III are correct
86. A TDDS used to prevent travel related motion sickness is
a. Transdermal Scopolamine
b. Transdermal Clonidine
c. Transdermal Nicotine
d. Transdermal Estradiol
87. Nicotine transdermal delivery system
a. Testoderm
b. Deponit
c. Habitrol
d. Transderm-Scop
88. Correct statement about Catapres TTs include
I. The first transdermal patch to receive FDA approval
II. Worn in a hairless area behind the ear
III. Provides controlled release of clonidine for 7 days
a. I, II and III
b. I and III
c. I and II
d. III only
89. The following statements are correct EXCEPT
a. Only potent drugs are suitable candidate for transdermal activity
b. Transdermal patches are controlled-release products
c. Repetab is a delayed-release tablet
d. Sustained-release parenteral systems are commonly administered by intramuscular injection
90. Drug readily absorbed in the skin and administered via transdermal route include
I. Nitroglycerin
II. Clonidine
III. Scopolamine
91. A drug delivery system for the treatment of advanced prostatic cancer is
a. Depo-Provera
b. Zoladex implant
c. Physostigmine TDDS
d. Estring
e. Crinone gel
92. Clinical considerations in the use of TDDS include
I. Should be placed at a site that will subject it to being rubbed off by clothing or movement
II. Wet or moist skin can accelerate drug permeation beyond the intended rate
III. Use of skin lotions should be avoided at the application site because they affect skin hydration and can
also alter the partition coefficient between the drug in the TDDS and the skin
a. I only
b. III only
c. I and III
d. II and III
e. I, II and III
93. Which of the following is a correct statement regarding TDDS?
a. Ortho Evra is a testosterone transdermal system
b. Skin lotion may be used at the application site of transdermal patches to avoid irritation
c. Physical exercise and extreme ambient temperature (e.g. sauna) may increase the absorption of drug from
nitroglycerin patch
d. Absorption of drug from TDDS is greater if the patch is applied to a site with a thick horny layer
94. Ointment base classified as hydrocarbon base include
I. Petrolatum
II. White ointment
III. Polyethylene Glycol Ointment
a. I only
b. I and II
c. I and III
d. III only
e. I, II and III
95. Ointment bases that resemble cream in appearance
a. Hydrocarbon bases
b. Water soluble base
c. Absorption base
d. Water removable base
e. Oleaginous base
96. True statements about levigation includes
I. Allows both particle size reduction and dispersion of the substance in vehicle
II. Glycerin is the levigating agent for bases where water is the external phase
III. The amount of the levigating agent should be about equal in volume to the solid material
a. I only
b. I and II
c. I and III
d. II only
e. I, II and III
97. Which of the following statements is true?
I. Vanishing cream is a without emulsion containing small amounts of water
II. Creams find primary application in topical skin products and in products used rectally and vaginally
III. Ointments are preferred more by patients due to ease of spreadability
a. I only
b. I and II
c. II only
d. I and III
e. I, II and III
98. Zinc oxide paste is
I. A very firm product used to protect the skin and absorbs serous secretions
II. Prepared by levigating and mixing 25% each of zinc oxide and starch with white petrolatum
III. Also known as Lassar’s Plain Zinc Paste
a. I only
b. III only
c. I and III
d. II and III
e. I, II and III
99. These are solid or semi-solid adhesive masses spread upon a backing material of paper, fabric, moleskin or
plastic
a. Creams
b. Paste
c. Plasters
d. Lotion
100. Cold cream is
I. An O/W type cream
II. Petrolatum rose water ointment
III. An emulsion
101. How many percent of ZnO is contained in Zinc glycerogelatin?
a. 15%
b. 35%
c. 40%
d. 5%
e. 10%
102. The following are advantages of pastes over ointments EXCEPT
a. More absorptive
b. Easier to spread and remove
c. Less greasy
d. Preferred for oozing lesions
103. Medicated plasters include all of the following EXCEPT
a. Corn plaster
b. Chili plaster
c. Salonpas
d. Micropore
e. Band-aid
104. All of the following statements are correct EXCEPT
a. Cataplasms should be warmed before application and applied with a piece of cloth
b. Liquid petrolatum is used as levigating agent if solid substances are to be incorporated into hydrocarbon
bases
c. Corn plaster is also known as Chili plaster
d. Paraffin dressing is an air-excluding, soft, pliable, analgesic, splint-like covering for surfaces denuded by
wound
105. Referred to as “greaseless” base
a. Hydrocarbon base
b. Water-soluble base
c. Absorption base
d. Water-removable base
106. Medicated gels may be administered into the
a. Skin
b. Eye
c. Nose
d. Vagina and rectum
e. All of these
107. Based on the compendial requirement for ointments, what particular microbes should be absent from
dermatological products?
I. S. aureus
II. P. aureginosa
III. E. coli
a. I, II and III
b. I and II
c. II and III
d. III only
108. Classes of dressings include
I. Primary wound dressing
II. Absorbents
III. Bandages and adhesive plasters
a. I only
b. II and III
c. I and II
d. I, II and III
109. Type of ointment that must meet sterility test and requirements for metal particles
a. Ophthalmic ointment
b. Nasal ointment
c. Vaginal ointment
d. Rectal ointment
110. What type of dermatological preparations Procto-foam HC belongs?
a. Vaginal cream and foam
b. Nasal gel
c. Aura gel
d. Rectal foam
111. Cements are dental preparations employed as
I. Temporary protective coverings for exposed pulps
II. For holding medicinal agents in tooth cavities
III. Rebasing of dentures
a. I, II and III
b. II and III
c. I and III
d. III only
112. Numotizine is a medicated application classified as
a. Plaster
b. Glycerogelatin
c. Dressing
d. Cataplasm
113. Which of the following products is classified as dressing?
a. Salonpas
b. Zinc Gelatin Boot
c. KY Jelly
d. Sofra-Tulle
114. Ophthalmic ointments and jells
I. Must be package in collapsible ointment tubes having elongated narrow tip
II. Sterile preparation
III. Ointment bases should have a softening point close to body temperature, both for comfort and for drug
release
a. I, II and III
b. I and II
c. I and III
d. II and III
115. Dermatologic products used to treat local conditions of anorectal pruritus, inflammation, and the pain and
discomfort associated with hemorrhoids
a. Nasal ointments and gels
b. Aural ointments and creams
c. Rectal ointments and creams
d. Vaginal ointments, creams and gels
116. Suppositories
I. Are solid dosage forms of various weights and shapes, usually medicated, for insertion into the rectum,
vagina or urethra
II. Soften, melt, or dissolve in the cavity fluids after insertion
III. Provide local and systematic action
a. I only
b. III only
c. I and II
d. II and III
e. I, II and III
117. Rectal suppositories
I. Pediatric suppositories are more narrow and pencil-shaped than the typical bullet-shaped adult
suppository
II. Suppositories intended for females are about half the length and weight of the male counterpart
III. Examples include glycerin suppositories and Bisacodyl suppositories
a. I only
b. III only
c. I and II
d. I and III
e. I, II and III
118. Cocoa butter
I. Exhibits marked polymorphism
II. Phenol and chloral hydrate have a tendency to lower its melting point
III. Is a water-soluble or water-miscible base
a. I only
b. III only
c. I and II
d. II and III
e. I, II and III
119. MUSE
I. Indicated for the treatment of erectile dysfunction
II. Contains alprostadil
III. A urethral suppository
a. I, II and III
b. I and II
c. I and III
d. III only
120. Wecobee bases are derived from
a. Mineral oil
b. Coconut oil
c. Almond oil
d. Olive oil
e. Theobroma oil
121. TRUE statements about PEG-based suppositories include
I. Stored at room temperature
II. Leaks from the orifice
III. It dissolves in the body fluid to release the active drug
a. I, II and III
b. I and III
c. II and III
d. I and II
e. I only
122. Cocoa butter is softened due to the addition of certain drugs, which of the following can be added as a solidifying
agent?
a. Gelatin
b. White petrolatum
c. Paraffin
d. Beeswax
123. When the word alcohol is used in pharmacy, it refers specially to
a. Isopropyl alcohol
b. Ethanol-water mixture 50% v/v
c. Ethyl alcohol
d. Methyl alcohol
124. Which of the following phrases describe the solution dosage form?
I. A homogenous system
II. The solute is in a monomolecular dispersion
III. The product contains at least two components
a. I, II and III
b. II and III
c. I and III
d. I only
125. Purified water USP
I. Can be prepared by ion-exchange treatment
II. Used to manufacture parenterals solution
III. Sterile and pyrogen free
a. I, II and III
b. II and III
c. I and II
126. The process of redistilling one or more fresh delicate drugs with small quantities of volatile products
a. Cohobation
b. Steam distillation
c. Maceration
d. Reflux distillation
127. Use of aromatic waters:
I. Flavored vehicle
II. Perfumed vehicle
III. Disinfectant
a. I, II and III
b. I and II
c. II and III
d. I and III
128. Aromatic water should be free from empyreumatic odor. Empyreumatic odor means
a. Foul-smelling
b. Rancid odor
c. Smoke-like odor
d. Sweet odor
129. Which of the following is for external use only?
a. Lugol’s solution
b. Boric acid solution 2%
c. Magnesium citrate solution
d. Diphenhydramine elixir
130. The following solutions are administered topically EXCEPT
a. Hydrogen Peroxide solution
b. Aluminum Subacetate solution
c. Povidone-Iodine solution
d. Magnesium Citrate solution
131. All of the preparations contain alcohol EXCEPT
a. Syrup NF
b. Phenobarbital Elixir
c. Aromatic Spirit of Ammonia
d. Eriodictyon Fluidextract USP
132. Magnesium citrate solution is used as
a. Fungicide
b. Component of Calamine lotion
c. Saline laxative
d. Carminative
133. Strong Iodine solution is commonly known as
a. Lime water
b. Lemonada purgante
c. Lugol’s solution
d. Lysol
134. Lemonada purgante is prepared by
a. Simple solution
b. Distillation
c. Chemical reaction
d. Percolation
135. Which solution is used as an astringent?
a. Strong Iodine solution USP
b. Aluminum Acetate Topical solution USP
c. Acetic acid NF
d. Aromatic Ammonia Spirit USP
e. Benzalkonium Chloride solution USP
136. A colorless to slightly yellow, clear, effervescent liquid having a sweet, acidulous taste and a lemon flavor
a. Citric Acid syrup
b. Magnesium Citrate solution
c. Simple Syrup
d. Calcium Hydroxide solution
137. Which of the following statements is correct about Simple Syrup?
I. It is a highly viscous vehicle
II. It is 85% w/w
III. A sucrose-based syrup
138. Medicated syrups have 3 or more component. Which of the following could be present?
I. A pharmacologically active chemical
II. Sucrose or artificial sweeteners
III. Flavoring agents
a. I only
b. II and III
c. I and III
d. I, II and III
139. Characteristics of sugar-based syrup include all of the following EXCEPT
a. Cap-locking is a problem in manufacture of syrup
b. Non-glycogenetic
c. Imparts a characteristic “body” to the preparation
d. Self-preserving at 85% w/v concentration
140. Oxymel is a preparation classified as
a. Mucilage
b. Juices
c. Dilute acid
d. Honey
141. Thick, viscid, adhesive liquid made by dispersing gums in water
a. Honeys
b. Mucilages
c. Syrup
d. Jellies
142. Acacia mucilage can produce colors with some organic compounds due to the presence of ____ in acacia
a. Bassorin
b. Peroxidase
c. Benzoic acid
d. Alcohol
143. True statements about acacia mucilage include
I. Used as demulcent and an excipient in making pills and troches
II. Prepared by solution with the aid of heat
III. A sweet vehicle for many flavored and medicated syrups
a. I only
b. I and III
c. II and III
d. I, II and III
144. Dilute acids have strength of
a. 10% w/w
b. 10% w/v
c. 12% w/v
d. 6% w/w
145. Evacuation enemas are used to
I. Promote evacuation of bowel
II. Cleanse the colon
III. Diagnose the GIT
a. I and III
b. I and II
c. II and III
d. I, II and III
146. 70% alcohol is
I. A disinfectant
II. A hydroalcoholic solvent
III. Antigoiterogenic
a. I, II and III
b. I and II
c. II and III
d. III only
147. The label “Not to be swallowed” or “Do not swallow” is to be affixed to
I. Phenol Gargle
II. Magnesium Citrate solution
III. Alkaline mouthwash
a. I, II and III
b. I and III
c. II and III
d. Only III
148. Fleet® is a/an
a. Gargle
b. Enema
c. Douche
d. Liniment
e. Mouthwash
149. Which of the following statements is CORRECT?
a. Diapid nasal spray is used for the prevention and treatment of perennial allergic rhinitis
b. Lugol’s Solution is prepared by simple solution method
c. A bulb syringe is used to administer an enema
d. Calcium hydroxide topical solution is also known as Liquor Carbonis Detergens
150. Compared with syrups, elixirs are
I. Less sweet
II. Less effective in masking the taste of medicinal substances
III. More viscous
a. I, II and III
b. II and III
c. I and II
d. II only
e. I only
151. Which of the following phrases describe the elixir dosage form?
I. A homogenous one-phase system
II. The solute is ethyl alcohol
III. The product contains isopropyl alcohol as preservative
a. I only
b. II and III
c. I and III
d. I, II and III
152. Phenobarbital Elixir is used as
a. Cardiotonic
b. Nasal decongestant
c. Antihistamine
d. Sedative/Hypnotic
153. Spirits are similar to elixirs as to
a. Solvent mixture
b. Solute
c. Sweetness
d. Suspending agent
154. Spirits can be prepared by
I. Solution with heat
II. Solution with Maceration
III. Distillation
155. Type of distilled spirit derived from cereal grains
a. Peppermint spirit
b. Brandy
c. Whisky
d. Aromatic Spirit of Ammonia
156. Aromatic Spirit of Ammonia is
I. A distilled spirit
II. Administered by inhalation
III. A reflex stimulant
157. Which of the following spirits is NOT administered orally?
a. Peppermint Spirit
b. Spiritus frumentis
c. Compound Orange Spirit
d. Aromatic Spirit of Ammonia
158. Liniments are products generally applied with rubbing, so are called
a. Ethereal solution
b. Embrocations
c. Glycerite
d. Balsams
159. TRUE statements about White Liniment include
I. A solution
II. Used as a rubefacient and counterirritant
III. Intended for external application to the skin with rubbing
a. I, II and III
b. I and II
c. II and III
d. Only III
160. Collodions are prepared by dissolving pyroxillin in ____ solvent mixture
a. Propanol-chloroform
b. Alcohol-ether
c. Alcohol-glycerin
d. Ether-water
161. Salicylic acid collodion contains how many % of salicylic acid in Flexible Collodion USP?
a. 3%
b. 5%
c. 10%
d. 15%
e. 1%
162. Flexible Collodion is prepared by adding castor oil and camphor to Collodion USP. How many % of castor oil is
required in this preparation?
a. 3%
b. 5%
c. 2%
d. 0.5%
e. 1%
163. Which is NOT a component of toothache drops?
a. Clove oil
b. Iodine
c. Phenol
d. Creosote
164. Oleovitamins generally consist of
a. Vit. A & D
b. Vit. B
c. Vit. A & B
d. Vit. A
165. Glycerites contain NLT ____ of glycerin
a. 50%
b. 25%
c. 10%
d. 1%
e. 0.5%
166. This preparation is a topical protectant
a. Essence of peppermint
b. Starch Glycerite
c. White Embrocation
d. Fluidextract of Bittermelon
167. The following preparations can be used as flavored vehicle EXCEPT
a. Aromatic elixir
b. Compound orange syrup
c. Sweet orange peel tincture
d. Starch glycerite
168. Which of the following is a hydroalcoholic solution?
a. Aromatic elixir
b. Syrup of lemon
c. White liniment
d. Tragacanth mucilage
169. A tincture of non-potent drugs contains ____ of the crude drug per 100ml of the tincture
a. 50g
b. 10g
c. 20g
d. 1g
170. Tinctura Aurantii Dulcis is
a. Applied with rubbing as rubefacient
b. Lowers blood sugar level
c. Flavor for elixirs
d. Carminative in flatulence
171. Which of the following is NOT a flavoring tincture?
a. Vanilla tincture
b. Tolu balsam tincture
c. Belladonna tincture
d. Sweet orange peel tincture
172. Alcohol in fluidextract is used as
I. Solvent
II. Rubefacient
III. Preservative
a. I, II and III
b. I and II
c. I and III
d. Only I
173. Fluidextracts are often referred to as ____ % tinctures
a. 10
b. 100
c. 20
d. 50
174. This method of extraction is a process in which the soluble constituent of a comminuted drug is extracted by a
slow passage of a suitable solvent through a column of the drug
a. Percolation
b. Infusion
c. Decoction
d. Maceration
175. In percolation, the rate of flow described as “percolate slowly” is
a. 5-10 ml/min
b. 1-3 ml/min
c. NMT 1ml/min
d. 3-5 ml/min
176. This is a form of extract which is of plastic consistency, prepared with nearly all of the menstruum removed
a. Pilular
b. Syrupy
c. Dry
d. Semiliquid
177. Correct statements include
I. An extractive referred to as 100% tincture is a fluidextract
II. Glycerites contains NLT 6% w/v of glycerin
III. Collodions are ethereal solution
a. I, II and III
b. I and II
c. I and III
d. I only
e. III only
178. Ideal suspension
I. Particles are perfect spherical
II. No collision of particles
III. Settling of particles obey Stokes’ Law
a. I, II and III
b. II and III
c. I and II
d. III only
e. I and III
179. A technique of reducing particles size producing 10-50um particle diameter is
a. Dry milling
b. Micropulverization
c. Micronization
d. Spray drying
180. A 5% preparation of native, colloidal hydrated aluminum silicate, in purified water is
a. starch glycerite
b. Bentonite magma
c. Chalk mixture
d. Calamine lotion
181. The following are oral suspensions EXCEPT
a. Maalox suspension
b. Combantrin suspension
c. Mesalamine suspension
d. Amoxicillin suspension
182. Magnesium aluminum silicate is also known as
a. Kaolin
b. Acacia
c. Veegum
d. Bentonite
183. Which of the following properties is undesirable in pharmaceutical suspension?
a. Thixotropy
b. Caking
c. Cracking
d. Bleeding
184. TRUE statements regarding packaging, labeling and storage of suspensions include
I. Packaged in an oversize container to facilitate thorough mixing
II. A “Shake well” label must be affixed
III. Must be protected from freezing, excessive heat and light
a. I, II and III
b. II and III
c. I and II
d. III only
e. I and III
185. Correct statements about Bentonite magma include
I. Exhibits sol-gel reversible transformation
II. Prepared by Simple Solution method
III. Used as suspending agent in Chalk Mixture
a. II and III
b. I and II
c. I and III
d. Only III
186. Acacia, as ____ % dispersion in water, is used as a suspending agent
a. 35
b. 10
c. 25
d. 50
187. The vehicle used in Calamine lotion is
a. Aluminum acetate solution
b. Lead acetate solution
c. Calcium hydroxide solution
d. Magnesium hydroxide solution
188. Which of the following can exhibit a reversible sol-to-gel or gel-to-sol transformation?
I. Gels
II. Magmas
III. Lotions
a. I and II
b. II and III
c. I, II and III
d. I and III
189. Benzalkonium chloride is
a. A non-ionic surfactant
b. A cationic surfactant
c. Anionic surfactant
d. Chelating agent
190. Single phase gels
I. Are made up of small inorganic particles
II. Exhibit thixotropy
III. Are those in which no apparent boundaries exist between the desired phase and the dispersion medium
a. I, II and III
b. II and III
c. I and II
d. III only
e. I and III
191. A “Shake well before use” label should be affixed to
I. Bentonite magma
II. Calamine lotion
III. Cod liver oil emulsion
192. Aluminum hydroxide gel is
I. Prepared by chemical reaction method
II. An antacid
III. Applied externally
a. I and II
b. II and III
c. I and III
d. III only
e. I, II and III
193. It is the taking up of a certain amount of liquid without a measurable increase in the size of a gel
a. Syneresis
b. Swelling
c. Imbibition
d. Thixotropy
194. A system consisting of at least one immiscible liquid intimately dispersed in another in the form of droplets
a. Emulsion
b. Suspension
c. Glycerites
d. Gels
195. Cod liver oil emulsion is used as
a. Carminative
b. Laxative
c. Source of Vitamins A and D
d. Lubricating cathartic
196. In preparing the primary nucleus of an emulsion, a 4:2:1 proportion of O:W:G is used in
I. Cod liver oil emulsion
II. Liquid petrolatum emulsion
III. Turpentine oil emulsion
a. I, II and III
b. I and II
c. II and III
d. Only III
197. Forbes-Bottle method is used in preparing
I. Mineral oil emulsion
II. Cod liver oil emulsion
III. Turpentine oil emulsion
a. I, II and III
b. I and II
c. II and III
d. Only III
198. Surfactants of HLB value 3 to 6 are employed as
a. O/W emulsifiers
b. W/O emulsifiers
c. Antifoaming agents
d. Wetting agents
199. This theory of emulsification assumes monomolecular layers of emulsifying agent curved around a droplet of the
internal phase
a. Surface tension theory
b. Plastic-film theory
c. Oriented-wedge theory
d. Interfacial film theory
200. Which of the following preparations has a red label?
I. White liniment
II. Calamine lotion
III. Cod liver oil emulsion
a. I, II and III
b. I and II
c. II and III
d. III only
201. Which of the following is not correct about HLB system?
a. It is used to classify surfactants
b. Hydrophilic surfactants form O/W emulsion
c. HLB values of about 8-18 are O/W emulsifiers
d. Tweens are lipophilic surfactants
202. Which of the following have liquid as continuous phase?
I. Emulsions
II. Aerosols
III. Suspensions
a. I, II and III
b. II and III
c. I and III
d. Only III
203. Microemulsions are
I. Thermodynamically unstable system
II. Optically transparent
III. O/W system stabilized by surfactant
a. I, II and III
b. II and III
c. I and II
d. Only I
204. An agent responsible for developing the pressure within an aerosol container and expelling the product when the
valve is opened
a. Concentrate
b. Propellant
c. Air displacement
d. Glidant
205. Space sprays include
I. Room deodorizers
II. Perfumes and colognes
III. Paint sprays
a. I, II and III
b. II and III
c. I and III
d. I only
e. III only
206. Method of filling aerosols
I. Cold filling
II. Liquid filling
III. Pressure filling
a. I and III
b. II and III
c. I, II and III
d. III only
e. I and II
207. Which of the following gases is NOT used as aerosol propellant?
a. CFC
b. CO₂
c. Helium
d. NO
208. Inhalational aerosols are commonly employed
a. As anti-infective
b. As contraceptive
c. In anorectal conditions
d. In asthma therapy
209. All of the following products are inhalational aerosols EXCEPT
a. Azmacort
b. Proctofoam
c. Ventolin aerosol
d. Intal inhaler
210. Metered-dose inhalers are classified as
a. Inhalations
b. Insufflations
c. Aerosols
d. Sprays
211. Correct statements regarding aerosols include all of the following EXCEPT
a. Room disinfectants belong to aerosols termed as surface sprays
b. An aerosol is commonly referred to as “pressurized package”
c. Dip tube is a part of the valve assembly in the aerosol system
d. Cold filling of aerosols require -34.5°C to -40°C
212. Aqueous vehicle for parenteral products include
I. Water for injection
II. Bacteriostatic water for injection
III. Sodium chloride injection
a. I, II and III
b. II and III
c. I and III
d. I and II
213. Large volume parenterals for maintenance therapy is employed for patients
I. Entering or recovering from surgery
II. Who are unconscious and unable to take fluids, electrolytes and nutrition orally
III. Who have suffered a heavy loss of fluids and electrolytes such as diarrhea
a. I, II and III
b. I and II
c. II and III
d. I only
214. Propofol USP is a
a. Solution for injection
b. Dry solid for injection
c. Injectable emulsion
d. Injectable suspension
215. Method of sterilization conducted in an autoclave is
a. Steam sterilization
b. Dry heat sterilization
c. Sterilization by filtration
d. Gas sterilization
216. The following sterile fluids are classified as large volume parenterals EXCEPT
a. Ringer’s injection
b. Total parenteral nutrition
c. Humulin R
d. Dextrose 5% injection
217. Parenteral drug products should possess the following characteristics EXCEPT
I. Sterilized using either autoclaving, dry heat or bacterial filtration
II. Isotonic
III. Colored
a. I, II and III
b. II and III
c. I and II
d. Only III
218. Intrathecal administration is the injection of drug into the
a. Joint fluid area
b. Spinal fluid
c. Heart
d. Under the skin
219. Irrigation solutions are
I. Sterile solutions
II. Intended to bathe or wash wounds, surgical incisions or body tissues
III. Injected into the vein
a. I, II and III
b. II and III
c. I and III
d. I and II
e. II only
220. Ringer’s injection USP contains
I. Sodium chloride
II. Potassium chloride
III. Calcium chloride
a. I, II and III
b. II and III
c. I and II
d. Only III
221. IV administration is needed when
I. An immediate action is required
II. An oral administration is ineffective
III. A prolonged action is required
a. I, II and III
b. I and II
c. II and III
d. I and III
222. Method of sterilization employed for heat-labile enzyme preparations, catheters, needles and plastic disposable
syringes
a. Sterilization by ionizing radiation
b. Gas sterilization
c. Dry heat sterilization
d. Steam sterilization
223. Commonly used fixed oils in injections include all of the following EXCEPT
a. Corn oil
b. Peanut oil
c. Sesame oil
d. Mineral oil
224. This is a long acting insulin
a. Insulin zinc ultralente
b. Isophane (NPH) insulin
c. Insulin lispro
d. Regular insulin
225. All of the following is true about LVP’s EXCEPT
a. Sterile
b. Do not require preservatives
c. Package in multiple dose containers
d. Container size has a maximum fill of 1 liter
226. All of the following statements are true regarding biologics EXCEPT
a. Biologic products must pass control requirements such as potency, sterility, pyrogens and constituent
material
b. Freezing is required in the storage of biologics
c. Biologics are generally administered by injection
d. Most biologics have an expiration date of a year or longer after the date of manufacture
227. This biologic product is also available in oral form as an enteric coated capsule
a. Measles vaccine
b. Rabies vaccine
c. Hepa B vaccine
d. Typhoid vaccine
228. Which of the following solutions should be sterile?
a. Douche
b. Enema
c. Ophthalmic solutions
d. Tinctures
229. Considerations in preparing ophthalmic preparations include the following EXCEPT
a. Sterility
b. Isotonicity
c. Colorant
d. Preservation
e. Buffering
230. Methylcellulose is used in ophthalmic solutions as
a. Buffer
b. Thickener
c. Isotonic agent
d. Preservative
231. Purposes of buffering of ophthalmic preparations include
I. For greater comfort to the eye
II. To enhance drug bioavailability
III. Aid in maintaining the drug in contact with the eye tissues
a. I, II and III
b. I and II
c. I and III
d. III only
232. All of the following otic preparations are indicated for bacterial infections of the ear EXCEPT
a. Auralgan otic solution
b. Cerumenex eardrops
c. Chloromycetin otic solution
d. Corticosporin otic solution
233. Drugs or combination of drugs that by virtue of their high vapor pressure can be carried by an air current to the
nasal passages where they exert their effect
a. Inhalant
b. Inhalation
c. Spray
d. Aerosol
234. An eyewash is also known as
a. Collyrium
b. Collutorium
c. Collunarium
d. Lavatio ori
235. Which of the following is an otic solution?
a. Bronkosol
b. Amyl nitrite
c. Eye-Mo
d. Cerumenex
236. Inhalation solutions are administered as fine mist of drug or vapors using the following EXCEPT
a. Inhaler
b. Vaporizer
c. Humidifier
d. Nebulizer
237. Which of the following is a nasal solution?
a. Cerumenex
b. Ocean mist
c. Benzedrex
d. Lugol’s solution
238. Nasal preparations are employed
I. As nasal decongestant for prevention and treatment of allergic rhinitis
II. To remove moisture and relieve dry, congested and inflamed nasal membranes
III. In the form of nose drops or sprays
a. I, II and III
b. II and III
c. I and III
d. I and II
239. Which of the following is NOT a radiopharmaceutical?
a. Co 57 capsules
b. I-131 solution injection
c. Rho (D) Immune globulin injection
d. Tc99m Albumin aggregated
240. Dispensing of radiopharmaceuticals
I. Typically in unit dose
II. Directly dispensed to the patient
III. With a special label such as “Caution – Radioactive Material”
a. I, II and III
b. II and III
c. I and III
d. I and II
e. III only
241. A nonradioactive pharmaceutical used in nuclear medicine as an alternative to a treadmill stress test prior to
cardiac imaging
a. Acetazolamide
b. Captopril
c. Dipyridamole
d. Cimetidine
242. A drug antidote for radiation exposure is
a. Cs
b. Acetazolamide
c. Prussian blue
d. Captopril
243. A radiopharmaceutical used diagnostically to evaluate thyroid fraction and morphology
a. Samarium – 153
b. Sodium iodide – 123
c. Holmium – 166
d. Cobalt – 57
244. Which of the following is produced by Monoclonal Antibodies technology?
I. Adalimumab (Humira)
II. Hepatitis B vaccine recombinant (Engerix B)
III. Rutuximab (Rituxan)
a. I, II and III
b. II and III
c. I and III
d. II only
245. The delivery of fluoride to the teeth may be accomplished through
a. Sonophoresis
b. Phonophoresis
c. Iontophoresis
d. Ultrasound
246. A novel drug delivery system Cyanocobalamin (Nascobal Gel) used in the treatment of Vitamin B12 deficiency is
available as
a. A controlled release sublingual application
b. A nasal gel
c. Microspheres for injection
d. Automatic injectors
247. The following advanced dosage forms are intended for oral administration EXCEPT
a. Striant mucoadhesive system
b. Gliadel wafer implant
c. Osmotic pump
d. Chewable dispersible tablet
248. A technique used to produce bio-technologic products that focused on the study of fraction of specific proteins
and intracellular expression
a. Gene therapy
b. Recombinant DNA technology
c. Monoclonal antibodies
d. Nucleotide blockade/ antisense
249. The following are products of biotechnology EXCEPT
a. Yttrium-90 microspheres (Therasphere)
b. Fomiversen sodium (Vitravene)
c. Epoeitin alfa (Epogen)
d. Systemic antihemophilic factors (Kogenate)
250. Which of the following is NOT a biological product?
a. Serum
b. Toxoid
c. Pellets
d. Anti-toxin
251. Also known as hydrocarbon ointment bases
a. Oleaginous bases
b. Water-removable bases
c. Absorption bases
d. Water-soluble bases
e. NOTA
252. These are solid or semi-solid adhesive spread upon a backing material or paper, fabric or plastic
a. Pastes
b. Creams
c. Glycerogelatins
d. Plasters
e. Cerates
253. The route used for insulin administration
a. Hypodermic
b. Intramuscular
c. Intradermal
d. Intravenous
e. Oral
254. The Z-track method is a technique for injection into which route?
a. Hypodermic
b. Intramuscular
c. Intradermal
d. Intravenous
e. Subcutaneous
255. The most widely used measure of the margin of a drug’s safety
a. Minimum effective concentration
b. TD 50
c. Therapeutic index
d. ED 50
e. LD50
256. The most optimal site for intramuscular injection for adults
a. Gluteal region
b. Deltoid muscle
c. Midlateral muscles of the thigh
d. Biceps brachii
e. Abdominal muscles
257. Propofol is an anesthetic agent which is packaged as a/an
a. Injectable emulsion
b. Injectable suspension
c. Drug for injection
d. Drug for injectable suspension
e. Enteral solution
258. Vehicle for injections that should contain in its label “Not for use in newborns”
a. Water for injection
b. Bacteriostatic sodium chloride injection
c. Sterile water for injection
d. Ringer’s injection
e. Saline for injection
259. The most commonly used antimicrobial agent for vehicles/solvents for injection
a. Benzyl alcohol
b. Ethyl alcohol
c. Propyl paraben
d. Methyl paraben
e. BHT
260. The usual volume for injection that can be comfortably injected subcutaneously
a. 2ml
b. 0.1ml
c. 5ml
d. 1.3ml
e. A and C are correct
261. Ointment base made form yellow wax and petrolatum
a. Simple ointment
b. Hydrophilic ointment
c. Petroleum jelly
d. Yellow petrolatum
e. Cold cream
262. A gel mass consisting of floccules of small distinct particles
a. Single-phase gel
b. Paste
c. Magma
d. Vanishing cream
e. NOTA
263. Ointment base made from cholesterol, stearyl alcohol, white wax and petrolatum
a. White ointment
b. Lanolin
c. Hydrophilic petrolatum
d. White petrolatum
e. White wax
264. The substance which the material to be sterilized is exposed to during gas sterilization
a. Propyl alcohol
b. Fluorinated hydrocarbons
c. Propylene glycol
d. Ethylene oxide
e. Acetic acid
265. A process which uses autoclaving to sterilize parenterals
a. Autoclaving
b. Membrane filtration
c. Dry heat sterilization
e. NOTA
266. Tablets originally used by physicians in compounding parenteral solutions
a. Dispensing tablets
b. Hypodermic tablets
c. Tablet triturates
d. Buccal tablets
e. Effervescent granules
267. Method used or blending powders wherein the different ingredients are enclosed in a rotating container to effect
mixing
a. Tumbling
b. Trituration
c. Geometric dilution
d. Sifting
e. Levigation
268. This substance is used as an opaquant for gelatin capsule shells
a. Silicon dioxide
b. Titanium dioxide
c. Calcium stearate
d. Magnesium stearate
e. Silicon oxide
269. The following are true about capsules EXCEPT
a. Calcium stearate can be used as a lubricant for the tablet and capsule powder formulation
b. Capsule sealing is done for all capsules
c. The largest capsule size is 000
d. Sorbitol is added to gelatin to make soft gelatin capsules
e. NOTA
270. These are semisolid dosage forms employed for the purpose of leaving a medication for long-term residence on
the skin
a. Pastes
b. Creams
c. Glycerogelatins
d. Plasters
e. Ointments
271. The usual volume of injection administered using the intradermal route
a. 2ml
b. 0.1ml
c. 5ml
d. 1.3ml
e. A and B are correct
272. Process used in the small-scale preparation of ointments to reduce the particle size and grittiness of added
powders
a. Trituration
b. Levigation
d. Spatulation
e. Fusion
273. The base most frequently used for chewable tablets
a. Sorbitol
b. Sucrose
c. Mannitol
d. Lactose
e. Glucose
274. Disc-shaped solid dosage forms containing a medicinal agent in a hard candy or sugar base
a. Pastilles
b. Effervescent tablets
c. Pills
d. Troches
e. Implant
275. Method used when blending a small amount of potent substance with a large amount of powdered diluents
a. Levigation
b. Trituration
c. Spatulation
d. Geometric dilution
e. Tumbling
276. These are alcoholic or hydroalcoholic solutions of volatile substances
a. Elixirs
b. Liniments
c. Spirits
d. Aromatic waters
e. Syrups
277. Pyroxylin is obtained by the action of a mixture of these acids on cotton
a. Nitric and sulfuric acids
b. Nitric and hydrochloric acids
c. Sulfuric and hydrochloric acids
d. Acetic and sulfuric acids
e. NOTA
278. Common ingredient (classification) imparting pharmacologic effect to antiseptic solution, NF and Mouthwash NF
a. Alkaloids
b. Volatile oils
c. Waxes
d. Gums
e. Resins
279. Precipitate formed when calcium hydroxide solution is exposed to the atmosphere
a. Calcium sulfate
b. Calcium phosphate
c. Calcium carbonate
d. Calcium chloride
e. Calcium borate
280. Stabilizing agent/reducing agent used in potassium iodide solution
a. Sodium sulfate
b. Sodium borate
c. Sodium thiosulfate
d. Sodium iodide
e. Sodium chloride
281. The order of mixing solutions containing combinations of alcohol and water as solvents
a. Alcohol to water
b. Water to alcohol
c. A and B can be done
d. NOTA
e. Salt is added
282. Syrup prepared by excessive heating undergoes the following changes EXCEPT
a. Caramelization
b. Sweeter taste
c. Fermentation
d. Clarification
e. Inversion
283. Flavored hydroalcoholic solutions to which glycerin is often added to enhance the solvent and preservative
properties
a. Elixirs
b. Spirits
c. Tinctures
d. Glycerites
e. Concentrates
284. The type of solute in tinctures
a. Volatile
b. Non volatile
c. A and B are correct
d. NOTA
e. Alcohol
285. Thick aqueous suspensions of freshly precipitate inorganic substances in a colloidal or very fine state of
subdivision generally intended for internal use
a. Magmas
b. Tinctures
c. Suspensions
d. Emulsions
e. Lotions
286. The external phase of an emulsion is the
a. Dispersed phase
b. Continuous phase
c. Discontinuous phase
d. Globules
e. Surfactant
287. Chemical decomposition prevented by the use of amber colored containers
a. Oxidation
b. Reduction
c. Polymerization
d. Complexation
e. Leaching
288. Which is NOT a property of invert sugar?
a. Subject to fermentation
b. Caramelizes
c. Sweeter than sucrose
d. Colorless than dextrose
e. Easily decomposed
289. Type of emulsion that requires the addition of preservative
a. W/O
b. O/W
c. Transparent emulsions
d. Seed emulsions
e. Microemulsions
290. Clear colloidal dispersions of one liquid dispersed in another and also known as transparent emulsions
a. Seed emulsions
b. Microemulsions
c. Gum-resin emulsion
d. Emulsions of volatile oils
e. In-situ emulsions
291. Routes of administration for emulsions EXCEPT
a. Parenteral
b. Oral
c. Topical
d. Intranasal
e. NOTA
292. Another terminology for ointment EXCEPT
a. Unguentum
b. Salve
c. Pessaries
d. Chrisma
e. Water
293. Order of melting ingredients in preparing ointment by fusion
a. From highest to lowest mpt
b. From lowest to highest mpt
c. All together
d. Separately with no particular order
e. AOTA
294. Apparatus used when a method calls for mechanical incorporation (extemporaneous preparation)
a. Erlenmeyer flask
b. Mortar and pestle
c. Beaker
d. Crucible with cover
e. Ointment slab
295. Ointment like preparations which are usually stiffer, less greasy and more absorptive than ointments
a. Creams
b. Emulsions
c. Pastes
d. Cataplasms
e. Cerates
296. An ideal suppository should melt
a. Above body temperature
b. Within body temperature
c. At room temperature
d. At extreme temperature
e. A little above body temperature
297. The suppository base for vaginal administration
a. Polyethylene glycol
b. CMC
c. Gelatin
d. Waxes
e. Theobroma oil
298. Common preservatives of emulsions
a. Polysorbates
b. Sorbitans
c. Parabens
d. Acids
e. Alcohols
299. Which dosage form must meet requirements for sterility as set by official compendium?
a. Rectal suppositories
b. Ophthalmic ointments
c. Oral suspensions
d. Topical emulsions
e. Rectal emulsions
300. Instructions involving the proper route of administration of a drug is most significant for
a. Suspensions
b. Ointments
c. Suppositories
d. Tablets and capsules
e. Ophthalmic drops
PHARMACEUTICAL DOSAGE FORMS
C 1. Solution which has the same osmotic pressure and pH as human fluid is:
A) Saturated B) Hypertonic C) Isotonic D) Hypotonic
A 2. Acacia reproduces color with some substance due to the presence of:
A) Peroxidase B) Acid C) Impurities D) Any of the above
D 3. Spirit of peppermint is prepared by:

A) Simple solution B) Chemical reaction C) Distillation D) Solution with maceration
D 4. Brandy is made from:

A) Molasses B) Fermented malt juice C) Fermented juice of grapes D) None of the above
E 5. Preservative added to syrup:

A) Glycerin C) Sodium Benzoate E) All of the above
B) Benzoic acid D) Methyl Paraben
C 6. Levigation is often applied in:

A) Syrups B) Solutions C) Ointments D) Tinctures
D 7. General formula for infusions uses a strength of:

A) 10% B) 15% C) 20% D) 5%
B 8. One of the following is not a biological product:

A) Serum B) Antihistamine C) Toxoid D) Anti-toxin
B 9. Concentration of “Diluted Alcohol” by volume is:

A) 10% B) 50% C) 70% D) 20% E) 85%
B 10. Aromatic water may be prepared by triturating the oil with:

A) Acacia B) Talc C) Kaolin D) None of the above
C 11. Phenol produces a clear solution with:

A) Water B) Ammonia C) Glycerin D) Liquid petrolatum
C 12. One of the following is not a process of extraction:

A) Maceration B) Digestion C) Comminution D) Decoction E) Percolation
E 13. Separation of immiscible liquids may be carried out by:

A) Glass syringe B) Pipette C) Separatory funnel E) All of the above D) Florentine receiver
B 14. Liquid preparations that contain one or more chemical substances usually non-volatile dissolved in water is:
A) Emulsions B) Solutions C) Lotions D) Syrups
D 15. Triturations usually have a strength of:

A) 5% B) 1% C) 15% D) 10% E) None of the above
B 16. A small scale comminution is:

A) Maceration B) Levigation C) Digestion D) None of the above
D 17. Process of converting a liquid into vapor and condensing back to liquid is:
A) Sublimation B) Condensation C) Evaporation D) Distillation
A 18. Chemical change caused by heat:

A) Incineration B) Evaporation C) Sublimation D) All of the above
C 19. One of the following has strength of 10% opium:

A) Laudanum B) Paregoric C) Dover’s powder D) All of the above
B 20. Glycerin suppositories are solidified by the use of:

A) Stearic acid B) Sodium stearate C) Glycerol triacetate D) White wax
E 21. Tablet is the preferred form as dosage form because of:

A) Stability B) Economy C) Precision of dosage D) Convenience E) All of the above
D 22. Liquid preparations representing water-soluble principles of animal and plant drugs are:
A) Spirits B) Tincture C) Fluidextracts D) None of the above
A 23. The preservatives for juices:

A) Benzoic acid B) Sodium benzoate C) Alcohol D) Glycerin
C 24. Purity means:

A) Purified coloring substance C) U. S. P. or N. F. statement of required purity
B) Pure food and drugs act D) Substance requires purification
D 25. The HLB system is used to classify:

A) Flavors B) Colors C) Perfumes D) Surfactants
B 26. Most drugs are:

A) Strong electrolytes B) Weak electrolytes C) Non-electrolytes D) Highly ionic
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B 27. The usual purpose of chilling medication prior to administration is to increase:

A) Absorption B) Palatibility C) Stability D) Ionization
C 28. The U. S. P. Pyrogen test is performed on:

A) Dogs B) Guinea pigs C) Rabbits D) Cats
A 29. According to the U. S. P. standard, a refrigerator may be used to store pharmaceutical which specify
storage in a:
A) Cold place B) Controlled room temperature C) Dark place D) None of the above
B 30. The process of grinding substances to a very fine powder is termed:

A) Levigation B) Trituration C) Sublimation D) Percolation E) Maceration
A 31. An aqueous solution which serves as a cleansing or an antiseptic agent directed

against a part or into a cavity of the body is a/an:
A) Douche B) Enema C) Gargle D) Spray
B 32. The official hydrogen peroxide solution U. S. P. is also known as:

A) Diluted peroxide B) 10 volume peroxide C) 15 volume peroxide D) 30 volume peroxide
A 33. A synonym for cold cream, U. S. P. is :

A) Petrolatum rose water ointment C) Wool fat ointment
B) Vanishing cream D) Rose water ointment
B 34. Container impervious to air:

A) Light-resistant Tight container C) Single dose container
B) Hermetic container D) All of the above
B 35. The term “impalpable” refers to s substance that is:

A) Colorless B) Not perceptible to touch C) Greasy D) Tasteless
C 36. Cyanocobalamin is:

A) A steroid B) Hallucinogen C) A vitamin D) An enzyme
C 37. The non-aqueous vehicle used in injection:

A) Alcohol B) Glycerol C) Vegetable oils D) Liquid petrolatum
B 38. Which one of the following solutions should be sterile when dispensed:
A) Tinctures B) Opthalmic solutions C) Spirits D) Syrups E) None of the above
D 39. Bulk powders are:

A) Triturations B) Dentrifices C) Douche powder D) All of the above
D 40. Oleoresins are:

A) Volatile oils B) Waxes and resins C) Fixed oils and resins D) None of the above
A 41. A chromagen is:

A) A colored substance B) Certified dye C) A dye fixative D) A precursor of color
A 42. Alcohol is a specific potentiating agent when used with it:

A) Anti-histamine B) Penicillin C) Aspirin D) Sulfonamide
B 43. Rancidity of fats may be due to:

A) Impurities B) Oxidation at double bond C) Reduction to alcohol D) Hydrogenation at double bond
C 44. This is a tool for monitoring drug utilization:

A) A drug receipt B) A drug invoice C) A drug profile D) Prescription
A 45. These are roles of the pharmacists except:

A) Diagnose diseases and prescribe prescription drugs C) Recommend OTC drugs
B) Recognize self-limiting diseases D) Advise patients on expected drug side effect
C 46. These are developing trends in a pharmacist’s function except:

A) Influence the physician in choice of drugs C) Diagnosis of diseases
B) Use of generics D) Advise the physician on dosage regimens
A 47. OTC drugs are:

A) Nonprescription drugs B) Prescription drugs C) Regulated drugs D) Potent drugs
D 48. This represents the quality of the product and the professionalism of the compounding pharmacists:
A) Price of the medicine B) Name of the drug store C) Name of the prescriber D) Label
D 49. Recovery of an ambulatory patient depends upon this factor in this medication:
A) Brand product B) Generic product C) Expenses D) Compliance
D 50. Spans and Tweens are:

A) Phospholipids C) Highly polymerized mannuronic acid anhydrides
B) Glycoside D) Polyoxyalkalene derivatives
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C 51. Which of the following is not a method of splitting emulsions:

A) Centrifuging B) Adding electrolytes C) Filtering D) Heat
B 52. The term PSIG in reference to aerosols means:

A) Per square inch of glass C) Atmospheric pressure
B) Pounds per square inch gauge D) Propellant safety in glass
A 53. A disadvantage of sodium saccharin as a sweetening agent is :

A) Bitter after taste C) Poor strength compared to glucose
B) Solubility in water D) Poor strength compared to gulein
B 54. According to the USP, the instruction protect from light in a monograph indicated storage in a :
A) Dark place B) Light-resistant container C) Amber glass bottle D) Hermetic container
A 55. The pharmacist may suggest Riopan Plus in place of Riopan when the patient desires:
A) Relief from gas B) Greater antacid capacity C) A chewable tablet D) Lower sodium levels
A 56. Solubility of a substance may be expressed in several ways. When a quantitative statement of solubility is
given in the USP, it is a generality expressed as:
A) mL of solvent required to dissolve 1 gram of solute
B) G of solute soluble in 1 mL of solvent
C) G of solute soluble in 100 mL of solvent
D) mL of solvent required to dissolve 100G of solute
B 57. The expiration date on a pharmaceutical container states “Expires on July 1997”. This statement means that
by that expiration date, the product may have lost:
A) 50% of its activity
B) Sufficient activity to be outside USP monograph requirement
C) 5% of its activity
D) All of its activity
D 58. Which of the following agents is/are available in a sublingual dosage form?
A) Isorbide dinitrate (Isordil) C) Hydrogenated argot alkaloids (Hydergine)
B) Glycerin D) All of the above
B 59. Upon exposure to air, Aminophylline solutions may develop:

A) A gas B) Crystals of Theophylline C) A precipitate D) A straw color
A 60. A chelate must always contain a:

A) Multivalent metal B) Triple bond C) Amine group D) Ethyllenediamine group
D 61. Official forms of water include:

A) Water for injection C) Bacteriostatic water for injection
B) Sterile water for injection D) All of the above
C 62. Insulin preparations are usually administered by:

A) Intradermal injection B) Intramuscular injection C) Subcutaneous injection D) Intravenous
B 63. “Winged” needles are most closely associated with which type of injections?
A) Intramuscular C) Subcutaneous
B) Intravenous D) Length of needle
A 64. The term piggyback is most commonly associated with:

A) Intermittent therapy C) Intravenous bolus
B) Total parenteral nutrition D) Flow intravenous infusions
B 65. The designation “minibottles” refers to:

A) 10-30 mL glass vials
B) Partially filled parenteral bottles with 50 to 150 mL volumes
C) Any parenteral bottle with a capacity of less than 1 mL
D) Vials with a capacity of less than 10 mL
A 66. The term venoclysis is most associated with:

Intravenous infusions C) Intravenous injections
Intrathecal injections D) Peritoneal dialysis
B 67. Which of the following commonly available large-volume dextrose solutions for intravenous use is isotonic?
A) 2.5% B) 5.0% C) 10% D) 50%
A 68. The busher injection is:

A) An automatic device for self-injecting C) Wyeth’s cartridge injection unit
B) A pre-filled syringe unit D) A disposable syringe and needle system
D 69. Valium (diazepam) is available in which of the following dosage forms?

A) Elixir B) Tablet C) Injection solution D) B and C only
A/C 70. This antacid containing mixture of aluminum and magnesium hydroxide is marketed under the name of:
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A) Maalox B) Amphojel C) Mylanta D) Titralac
B 71. The shaft portion of the needle is called the :

A) Bevel B) Cannula C) Lumen D) Hub
B 72. Alcoholic and hydroalcoholic solutions prepared from vegetable materials or from chemical substances,
prepared usually by maceration and percolation.
A) Extracts B) Tinctures C) Fluidextracts D) Elixirs
B 73. Concentrated (1g/mL) alcoholic or hydroalcoholic solutions representing the therapeutically active principles
of vegetable drugs prepared by percolation process:
A) Extracts B) Fluidextracts C) Tinctures D) Elixirs
A 74. Clear, pleasantly flavored, sweetened hydroalcoholic liquids intended for oral use as flavors and vehicles for
substances:
A) Elixirs B) Tinctures C) Fluidextract D) Extracts
B 75. Aqueous solutions used for treating the pharynx and nasopharynx by forcing air from the lungs through the
solution which is held in the throat:
A) Mouthwashes B) Gargles C) All of the above D) None of the above
B 76. A homogenous mixture in which the molecules of the solute are dispersed among hose of the solvent:
A) Suspensions B) Emulsions C) Solutions D) All of the above
D 77. Purified water may be prepared by:

A) Distillation B) Ion-exchange resin C) Reverse osmosis D) All of the above
D 78. Syrups may be prepared by:

A) Solution with heat B) Agitation without heat C) Percolation D) All of the above
D 79. Spirits, popularly known as essences, are alcoholic or hydroalcoholic solutions of volatile substances
prepared by:
A) Simple solution B) Distillation C) Chemical reaction D) All of the above
C 80. A two-phase system prepared by combining 2 immiscible liquids, one of which is uniformly dispersed
throughout the other:
A) Suspension B) Solution C) Emulsion D) Magma
B 81. Preparations containing finely divided drug particles uniformly distributed throughout a vehicle in which the
drug exhibits a minimum degree of solubility:
A) Emulsion B) Suspension C) Solution D) None of the above
A 82. Lugol’s solution is:

A) Strong iodine solution C) Povidone-iodine solution
B) Potassium iodine oral solution D) None of the above
D 83. The following solvents are used in the preparation of oral solutions, syrups and elixirs except:
A) Alcohol, USP B) Purified water, USP C) Propylene glycol D) Ethylene glycol
B 84. An example of an anionic emulsifying agent is:

A) Benzalkonium chloride C) Polyethylene glycol
B) Sodium lauryl sulfate D) Magnesium trisilicate
C 85. The following substances produce which emulsions, except:

A) Gelatin B) Egg yolk C) Cholesterol D) Casein
D 86. Suppositories are prepared by:

A) Melting from a smelt B) Compression C) Hand rolling D) All of the above
B 87. Bougies is another term for:

A) Vaginal suppositories B) Urethral suppositories C) Rectal suppositories D) None of the above
C 88. Anhydrous lanolin is a /an:

A) Hydrocarbon ointment base C) Absorption ointment base
B) Water-removable ointment base D) Water-soluble ointment base
C 89. Cold cream is a /an:

A) Water in oil (w/o emulsion) C) All of the above
B) Absorption ointment base D) None of the above
B 90. The following are hydrocarbon ointment base except:

A) Petrolatum B) Hydrophilic petrolatum C) White petrolatum D) Mineral oil
A 91. Medicated or non-medicated semisolid preparations intended for external application:

A) Ointments B) Lotions C) Liniments D) All of the above
C 92. Which of the following sterilization methods is (are) used for heat-labile pharmaceutical preparations?
1) Moist-heat sterilization 3) Sterilization by filtration
2) Dry-heat sterilization 4) Gas sterilization
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A) 1, 3 and 4 B) 1 and 3 only C) 3 and 4 only D) 3 only
B 93. Castor oil is a / an:

A) Saline laxative B) Stimulant laxative C) Bulk-forming laxative D) Emollient laxative
A 94. The saline cathartics:

1) Act by increasing the osmotic load of the gastrointestinal tract
2) Act by local irritation on the intestinal tract
3) Are salts of poorly absorbable anions and cations
4) Water soluble and are taken with large amounts of water
A) 1, 3 and 4 B) 2, 3 and 4 C) 1 and 3 D) 1 and 4
B 95. Solid dosage forms in which one or more medicinal and/or inert substances are enclosed within a small shell
or container generally prepared from a suitable form of gelatin:
A) Tablets B) Capsules C) Troches D) Pastilles
C 96. Granules or powders consisting of sodium bicarbonate, a suitable organic or inorganic acid and other
ingredients are known as:
A) Dusting powder B) Dentrifices C) Effervescent salts D) Insufflations
D 97. Which of the following capsule size is the largest?

A) 1 B) 0 C) 00 D) 000
B 98. What substance is/are added to render soft gelatin capsules elastic or plastic like?
A) Mineral oil B) Sorbitol C) Carnuba wax D) All of the above
A 99. Widely used solid dosage forms of medicinal substances usually prepared with the aid of suitable
pharmaceutical adjuncts by compression or molding and contain medicinal substances with or without suitable
pharmaceutical adjuncts:
A) Tablets B) Bulk powders C) Capsules D) Divided powders
C 100. Which of following is / are true of buccal tablets?

1) Intended to be dissolved beneath the tongue
2) Provide absorption of drugs that are destroyed by the gastric juice
3) Dissolved very promptly to give rapid drug effects
A) 1 and 2 B) 2 and 3 C) 2 only D) 1, 2 and 3
B 101. The method for the preparation of compressed tablets wherein the granulation is formed by compacting
large masses of the mixture and subsequently crushing and sizing these pieces into smaller granules:
A) Wet granulation method C) Direct compression method
B) Dry granulation method D)All of the above
D 102. The ideal excipient for the preparation of chewable tablets containing moisture sensitive drugs:
A) Lactose B) Saccharin sodium C) Dextrose D) Mannitol
C 103. Which of the following is / are used in tablet formulation to reduce friction during tablet compression?
1) Calcium stearate 2) Magnesium stearate 3) stearate acid
A) 1 and 2 B) 1 and 3 C) 1, 2 and 3 D) None of the above
D 104. Lubricants contribute to the preparation of compressed tablets by:

1) Improving the flow of the granulation
2) Prevent adhesion of the tablet formulation to the punches and dies during compression
3) Reduces friction
4) Give a sheen to the finished products
A) 1 and 2 B) 2 and 3 C) 1, 2 and 3 D) 1, 2, 3 and 4
A 105. Advantages of controlled-release drug dosage forms are:

1) Extended daytime and nighttime activity of the drug 3) Increased dosage frequency
2) Reduced incidence of side effects 4) Decreased patient compliance
A) 1 and 2 B) 1 and 3 C) 2 and 3 D) 1, 2, 3 and 4
D 106. Method(s) utilized to achieve controlled drug release from solid dosage forms:
A) Coated heads as granules B) Complex formation C) Non-exchange resin D) All of the above
B 107. Percent weight-in-volume:

A) # of grams of a constituent in 100g of preparation
B) # of grams of a constituent in 100mL of preparation
C) # of grams of a constituent in 1000g of preparation
D) # of grams of a constituent in 1000mL of preparation
D 108. Simple syrup is:

A) Supersaturated solution of sucrose in purified water C) Highly unstable
B) Prone to microbial growth D) None of the above
B 109. The following are toxicity contributors except:

A) Dextrose B) Sodium acetate C) Sodium chloride D) Boric acid
D 110. Methods of detecting the type of emulsion:
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1) Drop dilution test 2) Dye or indicator test 3) Electric conductance test

A) 1 only B) 2 only C) 1and 2 D) 1, 2 and 3
A 111. Agents used in tablet and capsule formulation to improve flow properties of powder mixtures except:
A) Lactose B) Colloidal silica C) Cornstarch D) Talc
C 112. The following are used as colorants in pharmaceutical preparations except:

A) Erythrosin B) Caramel C) Yellow mercuric oxide D) Red ferric oxide
B 113. Type 1 glass is:

1) Treated soda-lime glass 2) Intended for parenteral products 3) Resistant to leaching alkali
A) 1 and 2 B) 2 and 3 C) 2 only D) 1, 2 and 3
C 114. The following are colloidal emulsions except:

A) Mild silver protein solution C) Calamine solution
B) Tragacanth solution D) Bentonite magma
D 115. Ringer’s injection, USP contains:

1) Sodium chloride 2) Sodium lactate 3) Calcium chloride 4) Potassium chloride
A) 1 and 2 only B) 3 and 4 only C) 1, 2 and 3 D) 1, 3 and 4
A 116. The process of depriving a drug of its soluble constituent by passage of a solvent through the powder
contained in a suitable vessel:
A) Percolation B) Filtration C) Decantation D) Sublimation
B 117. Wet masses of solid matter applied to the skin for the purpose of reducing inflammation:
A) Pills B) Poultice C) Ointment D) Lotion
A 118. Solution of arsenic and mercuric iodide is also known as:

A) Donovan’s solution B) Lugol’s solution C) Burow’s solution D) Dobell’s solution
A 119. They are mixtures or solutions of medicinal substances with glycerin:

A) Glycerites B) Emulsion C) Suspension D) Elixir
C 120. If a 3-year old child has fever and is vomiting, what dosage form for fever is appropriate for him?
A) Suspension B) Syrup C) Suppository D) Injection
A 121. They are solid or semisolid preparations of the soluble and active principles of drugs prepared by
percolation of the drug with appropriate menstruum and evaporation of the percolate:
A) Extracts B) Fluidextracts C) Percolate D) Ointment
C 122. They are solutions or mixtures of various substances in external application and are applied with rubbing
and friction to the affected area:
A) Lotion B) Glycerites C) Embrocations D) Mucilage
B 123. Solvent used in extracting active constituents from plants and animals is termed as:
A) Vehicle B) Menstruum C) Base D) Water
B 124. Class of preparations in which medicinal substance is combined with saccharine substances like jellies or
pulp of fruits are called:
A) Syrup B) Confections C) Glycerites D) Tinctures
A 125. What dosage form of Magnesium Sulfate solution is used as treatment for eclampsia?
A) Injection B) Tablet C) Capsules D) Solutions
C 126. A product designed for administration to the body in the diagnosis or treatment of disease is called:
A) Drugs B) Injection C) Dosage forms D) Resins
A 127. It is a condition of emulsion wherein the dispersed phase floats out and concentrates on top:
A) Creaming B) Oil in water emulsion C) Cracked or broken emulsion D) Water in oil emulsion
B 128. A kind of emulsifier which stabilizes the emulsion by forming a protective film around the globules of a
dispersed phase preventing their coalescence:
A) Quasi emulsifier B) True emulsifier C) Oil D) Water
A 129. Any substance combined with an active drug to make the latter agreeable to convenient dosage is called:
A) Excipient B) Diluent C) Lubricant D) Disintegrator
A 130. Substances added in a suspension to overcome agglomeration of the dispersed particles and to increase
the viscosity of the medium so that the particles settle down slowly is called:
A) Suspending agents B) Glycerites C) Inert substance D) Water
B 131. A method of preparing emulsion wherein the gum is mixed first with the oil, then the water is added last is:
A) English method B) Continental method C) Percolation D) None of the above
A 132. A colloidal system consisting of very finely subdivided liquid or solid particles dispersed and surrounded by
a gas called:
A) Aerosols B) Inhalers C) Vaporizer D) All of the above
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C 133. Sterile pharmaceutical preparations that are to be administered through one for more layers of the skin:
A) Enema B) Suppository C) Injections D) Troches
B 134. Which one if the following is for external use?

A) Lugol’s solution B) Boric acid C) Cod liver oil emulsion D) Milk of magnesia
A 135. Which one of the following preparations is a saturated solution?

A) Aromatic water B) Elixirs C) Emulsion D) Solutions
C 136. The following dosage forms possess shake well label except:
A) Magmas B) Lotion C) Syrups D) Suspension
D 137. Oil vehicle for injections must be from plant origin for the reason that:
A) They are liquid at room temperature C) They will not become rancid rapidly
B) They may be metabolized D) All of the above
A 138. Dosage forms which do not contain any medication is known as:
A) Placebo B) Film coated C) Sugar coated D) Powders
D 139. The following preparations are injectables except:

A) Syntocinon B) Vincristin C) Insulin D) Nitroglycerine
D 140. Which of the following statements is not true for aromatic waters?
A) It is a saturated aqueous solution C) It is often used as flavoring vehicle
B) It can be prepared by steam distillation D) It is a preparation of volatile oil in alcohol
C 141. Boric acid solution used for eye wash:

A) Boric acid solution 4% C) Boric acid solution 2%
B) Boric acid solution 5% D) Boric acid solution 10%
D 142. All of the following helps to impart satisfactory compression characteristics to the formulation of tablet
except:
A) Diluents B) Binders C) Lubricants D) Sweetening agents
D 143. Which one is not a disintegrator?

A) Starch B) Cellulose C) Gums D) Calcium stearate
C 144. One of the following preparations is an antidiarrheal:

A) Dulcolax tablet B) Cellulose C) Diatabs D) Diamox
B 145. Used for treatment of gout:

A) Ridamol B) Purinase C) Diatabs D) Inderal
D 146. It is not a part of a primary emulsion:

A) Dispersed phase B) Dispersion medium C) Emulsifying agent D) Alcohol
C 147. An example of a true emulsifier:

A) Chondrous B) Dextrin C) Acacia D) Agar
A 148. Aqueous preparation made by extracting vegetable or animal drugs by maceration or percolation with hot
and cold water:
A) Infusions B) Decoctions C) Tinctures D) None of the above
B 149. Solutions representing the water-soluble constituents of plant drugs prepared by boiling the drugs in water:
A) Infusions B) Decoctions C) Tinctures D) None of the above
C 150. The method for extemporaneous preparation for emulsion from volatile oils or oleaginous substances of low
viscosities:
A) Dry gum method B) Wet gum method C) Bottle method D) None of the above
A 151. The following are fatty or oleaginous suppository bases except:

A) Glycerinated gelatin B) Theobroma oil C) Glyceryl monostearate D) Glyceryl monopalmitate
C 152. Which of the following is (are) true on parenteral products?

1) Makes use of purified water, USP as solvent 3) For I. V. purposes only
2) Sterile, pyrogen-free preparation
A) 1 and 2 only B) 2 and 3 only C) 2 only D) 1, 2 and 3
A 153. The following are fungal preservative used in pharmaceutical preparations except:
A) Sodium bisulfate B) Sodium benzoate C) Sodium propionate D) Benzoic acid
D 154. Which statement is not true with suspending agents?

A) It keeps the insoluble ingredients in suspension long enough for a uniform dose.
B) It keeps the insoluble ingredients --- finely divided state.
C) It improves the palatability of the mixture.
D) It serves as a preservative.
B 155. Dose of Magnesia magma USP as laxative:
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A) 4cc B) 15cc C) 30cc D) 5cc
A 156. Official name fro Amphojel:

A) Aluminum hydroxide gel USP C) Aluminum Phosphate gel USP
B) Magnesia Magma USP D) Bentonite Magma USP
A 157. Products considered as sterile:

A) Eye Mo C) Drixine nasal drops
B) Dequadin throat lozenges D) Aspilet chewable tablets
C 158. HCL or NaOH are added in parenteral solution as:

A) Isotonic adjustor B) Antimicrobial preservative C) pH adjunct D) Diluent
A 159. Trade name for attapulgite:

A) Polymagma B) Diatabs C) Asmasolon D) Inderal
D 160. The following criteria are required for a good suppository base except:
A) Should dissolve rapidly in the body cavity C) Inert
B) Non-irritating D) Should be white
D 161. Which of the following statements is not true with vanishing cream?
A) They are immediately absorbed and therefore will disappear on the surface.
B) It is also used as ointment.
C) Incompatible with acids and acidic substances.
D) It is a water ion oil emulsion.
D 162. Which of the following is not true with plasters?

A) It is free from fats. C)Supper in the immobilization area
B) Chiefly used for their adhesiveness.. D) It must be white.
C 163. It is not a natural source of drug

A) Mineral source B) Plant source C) Synthetic source D) Animal source
A 164. Drug constituents which come from animal source:

A) Insulin B) Tannins C) Alkaloids D) Volatile oils
A 165. Which is not true with volatile oils?

A) Can be saponified B) Aromatic odor C) Generally liquids D) Insoluble in water
A 166. Dosage form of insulin:

A) Injection B) Tablet C) Capsules D) Pills
D 167. An “ultra” short-acting barbiturate (Sodium Thiopenthal) is used primarily as a/an:

A) Sedative B) Hypnotic C) Anticonvulsant D) Anesthetic
D 168. The following route of administration will provide the highest bioavailability of drug:
A) Oral B) Rectal C) Intramuscular D) Intravenous
C 169. The following are diuretics except:

A) Chlorothiazide B) Aminophyllin C) Tolbutamide D) Diamox
B 170. Titanium dioxide is used as a solar ray protectant --- in the preparation of:
A) Burn lotion B) White capsules C) Topical anesthetic D) Antiseptics
B 171. Cimetidine (Tagamet) is used in the treatment of:

A) Congestive heart failure B) Ulcers C) Hypertension D) Edema
C 172. The greatest threat from morphine overdose is:

A) Spinal cord paralysis B) Renal failure C) Respiratory depression D) Cardiovascular collapse
B 173. 100% proof alcohol is:

A) Absolute alcohol B) 50% Ethyl alcohol C) 100% Ethyl alcohol D) 95% Ethyl alcohol
C 174. Vitamin B6 is:

A) Thiamine B) Riboflavin C) Pyridoxine D) Nicotinic acid
C 175. Magnesium stearate is used in tablet manufacturing as:

A) Disintegrant B) Binder C) Lubricant D) Source of Mg
C 176. Flourocarbons are preferred to other hydrocarbons as propellants because of this decided advantage:
A) They require lower pressures. C) They are not inflammable
B) They are less expensive. D) All of the above.
D 177. One of the following is an oil-soluble vitamin:

A) Ascorbic acid B) Thiamine C) Riboflavin D) Vitamin D
B 178. The most popular and acceptable commercial dosage forms are:
A) Hard gelatin capsules C) Soft elastic capsules
B) Tablet D) Divided powders
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A 179. “Selsun Blue” is used mainly as a/an:

A) Anti-dandruff shampoo B) Bath additive C) Antiseptic lotion D) Topical anesthetic
B 180. The chemical substances used as radiopaque in x-ray examination of the GIT:
A) NaHCO3 B) BaSO4 C) Flourescein dye D) Radioactive iodine
B 181. Polyethylene Glycol polymers used as ointment vehicles are called:

A) Sodium alginate B) Carbowax C) Silicones D) Veegum
D 182. Vitamin K is associated with:

A) Hemoglobin concentration B) Bone formation C) Cardiac function D) Blood coagulation
C 183. A plant source of antineoplastic drug is:

A) Nux vomica B) Digitals C) Vinca rosa D) Belladonna
D 184. Bioavailability of drugs may be adversely affected by:

A) Solubility B) Wettability C) Particle size of drug D) All of the above
B 185. The following products are intended for topical administration except:
A) Benzelkonium chloride solution C) Aluminum chloride solution
B) Lugol’s solution D) Golden gargle
B 186. Solid extractives consisting chiefly of principles of vegetable substances that are soluble in alcohol but
insoluble in water:
A) Abstracts B) Resins C) Oleoresins D) Extracts
D 187. White capsules are those treated with:

A) Silicon dioxide B) Calcium oxide C) Salad D) Titanium dioxide
D 188. Ideal containers for dispensing dusting powders:

A) Wide-mouth bottles B) Pasteboard boxes C) Amber-colored bottles D) Sifter-top container
C 189. The diluent used in triturations is:

A) Starch B) Talc C) Lactose D) Cellulose
D 190. Combinations or mixtures of drugs which liquefy due to a lowering of their melting point:
A) Diquescent B) Efflorescent C) Hygroscopic D) Eutectic mixture
B 191. “Bullet-shaped” capsules are known as:

A) Pearls B) Pulvules C) Cluteid D) Pastilles
A 192. An example of a “non-medicated, ready-to-apply” plaster:

A) Adhesive tape B) Salonpas C) Belladonna plaster D) Corn plaster
B 193. Special highly absorptive cataplasms are called:

A) Poultices B) Epispastics C) Siloxanes D) Veegums
A 194. Rectal suppositories are:

A) Cone-shaped B) Globular C) Ovoid D) Bowel-shaped
C 195. External applications resembling ointments and generally employed for protection or covering especially
for burns:
A) Plasters B) Pastes C) Dressings D) Plasters
D 196. Semi-solid, very stiff, very absorptive, non-greasy and highly concentrated applications:
A) Chrisma B) Epispastics C) Salves D) Pastes
C 197. Ointments containing wax, spermacettic or any hard fusible material are prepared by:
A) Incorporation by levigation C) Fusion
B) Compression D) Hand-rolling
B 198. Method of preparation employed for spirits when it is desired to introduce the coloring matter of the drugs
into the preparation:
A) Simple solution B) Chemical reaction C) Solution with maceration D) Distillation
MATCH THE FOLLOWING:

C 199. Clyster A. Vaginal or urethral douches
A 200. Irrigations B. Non-prescription medication
B 201. O.T.C. medications C. Enema
D 202. “Empyrheumatic” D. “smoke-like”
C 203. Castellani’s paint A. Limonada Purgante

A 204. Magnesium citrate soln B. Cherry juice
D 205. Merbromin solution C. Carbol-Fuchsin solution
B 206. Succus carasi D. Mercurochrome
C 207. Lysol A. Povidone-iodine solution

A 208. Betadine solution B. Dimenhydrinate syrup
D 209. Corn solvent C. Saponated oresol solution
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B 210. Dramamine syrup D. Salicylic acid collodion
C 211. Chor-trimeton elixir A. Irish moss mucilage

D 212. Dexedrein syrup B. Zinc oxide paste
A 213. Carageenan C. Chlorpheniramine elixir
B 214. Lassar’s zinc paste D. Dextro-amphetamine syrup
D 215. Vioform inserts A. Kaolin cataplasm

A 216. Antiphlogistine B. Acetylsalicylic acid suppositories
B 217. Supirin C. Whitfield ointment
C 218. Benzoic-salicylic acid ointment D. Iodochlorhydroxyquin suppositories
C 219. Slugging method A. Rod-shaped or cylindrical troches

D 220. Lubricants B. Wafers
A 221. Bacillus C. Dry granulation or precompression
B 222. Cachets D “Flow-regulators”
C 223. Pastilles A. Granulators

D 224. Bolus B. Layered pills
B 225. Concentric pills C. Soft, felatin-containing lozenges
A 226. Binders D. Pills for veterinary use
D 227. P.A.S. tablets A. Antinauseant

C 228. Nitroglycerine tablets B. Anti-arrhythmic
A 229. Dramamine syrup C. Sublingual coronary vasodilator
B 230. Quinidine tablets D Anti-tubercular
C 231. Leukeran A. Thyroid inhibitor

D 232. Aralen B. Antihypertensive
A 233. Tapazole C. Antihypertensive
B 234. Serpasil D. Antimalarial
C 235. Parabens are used in syrups as:

A) Buffer B) Thickener C) Preservative D) Sweetener
A 236. Water can be purified by:

A) Distillation B) Solution C) Chemical reaction D) None of the above
B 237. A form of resin except:

A) Natural B) Distilled C) Prepared D) Synthetic
C 238. Science that affect bioavailability considerations is/are except:

A) Physical B) Chemical C) Commercial D) Biological
B 239. Non-toxic powders for local application without systemic effect:

A) Dentrifices B) Dusting C) Insufflation D) Douche powders
D 240. Type of lotion according to use is :

A) Cosmetic B) Medicinal C) Sunscreen D) All of the above
B 241. Type of coating for tablets consisting of a thin layer of a water insoluble polymeric substance is:
A) Sugar coating B) Film coating C) Chocolate coating D) Enteric coating
B 242. A type of solid preparation prepared by compression, small, cylindrical in shape, and administered by
implantation is:
A) Lozenges B) Pellets C) Chewable D) None of the above
D 243. Characteristics of pills except:

A) Adhesive B) Firm C) Plasticity property D) Chewable
A 244. A rectal injection employed to visualize the gastrointestinal tract for diagnosis purposes is:
A) Enemas B) Douche C) Washes D) Suppository
C 245. Solutions of various drugs in aqueous vehicle applied to the mucous membrane of the nose and throat by
means of a nebulizer is:
A) Emulsions B) Suspensions C) Sprays D) Insufflations
A 246. A form of extract depending upon the extent of removing the solvent except:
A) Liquid extract B) Semiliquid C) Pilular D) Powdered
C 247 Viscous preparations intended for warm, external application to a body surface is:
A) Glycerites B) Ointments C) Poultices D) Glycerogelatins
A 248. A solution containing the maximum amount of solute in a certain quantity of solvent is termed:
A) Saturated B) Supersaturated C) Pure D) Colloidal solution
C 249. Thixotropic emulsions or suspensions intended for external application to the body:
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A) Ointment B) Cream C) Lotion D) Magma
C 250. Tablets that release carbon dioxide when dissolved in water:

A) Sublingual B) Buccal C) Effercescent D) Pellet
D 251. Tablets for subcutaneous implantation into body tissues:

A) Buccal B) Enteric coated C) Sublingual D) Pellets
C 252. Hygroscopic and deliquescent substances may be incorporated into powders by:
A) Addition of diluent B) Double wrapping C) A and B D) Addition of volatile solvent
D 253. Suppositories are administered when:

A) A local effect is desired. C)A drug cannot be tolerated orally
B) A systemic effect is desired. D) All of the above.
B 254. This improves the rate of flow and prevents adhesion of tablet granulations to dies and punches of tablet
machine:
A) Starch B) Magnesium stearate C) Mannitol D) Kaolin
C 255. This is used as a binder, diluent and disintegrator in tablets:

A) Talc B) Magnesium stearate C) Starch D) Kaolin
A 256. The ideal container for ointment:

A) Collapsible tin tubes B) Glass jars C) Porcelain jars D) Plastic jars
B 257. These equipments are used in the preparation of ointment except:

A) Steam bath B) Mold C) Mortar and pestle D) Mechanical mixer`
D 258. This is classified as a topical suspension:

A) Calamine lotion B) Selenium sulfide C) Retin-A D) All of the above
A 259. The following are natural emulsifying agents except:

A) Tween 80 B) Acacia C) Agar D) Gelatin
C 260. The following statements are true for the HLB system of surfactants except:
A) Hydrophilic surfactants have high HLB (8-18). C) Hydrophilic surfactants form w/o emulsions
B) Lipophilic surfactants have low HLB (3-6). D) Lipophilic surfactants form w/o emulsions.
A 261. The following preparations are classified as antacids except:

A) Kaopectate B) Creamalin C) Magnesia magma D) Phosphagel
D 262. Instability of emulsions is caused by:

A) Flocculation B) Creaming C) Inversion D) All of the above
D 263. This is the common ingredients of antidiarrheal suspensions:

A) Kaolin B) Pectin C) Calamine D) A and B
C 264. These are methods of determining emulsion type except:

A) Drop dilution B) Dye Solubility C) Solubility test D) Conductivity test
D 265. This preparation contains magnesium hydroxide as the active ingredient:

A) Gelusil B) Kremil-S C) Milk of magnesia D) All of the above
D 266. The stability of a drug dosage form is influenced by:

A) Temperature B) Light C) Humidity D) All of the above
A 267. Clear, colorless, odorless, liquid sterilized and suitably packaged contains no bacteriostatic agent:
A) Sterile water for injection C) Water for injection
B) Bacteriostatic water for injection D) Distilled water
A 268. A 36.8% w/w solution of HCl contains:

A) 36.8 gm. HCl in 100gm solution. C) 36.8 gm. HCl in 100 ml of solution
B) 36.8 gm. HCl in 100 gm solvent
C 269. Which statement is not true about syrup USP?

A) Contains 85% w/v sucrose. C) Has a low solvent capacity for water-soluble drug
B) Has a specific gravity of 1.3. D) It is self-preserved.
B 270. The following syrups: phenergan, tacaryl, cohistan are classified as:
A) Antitussive B) Antihistamine C) Tranquilizer D) Antihelmintic
B 271. Which of the following active ingredients is not a component of cough and cold preparations?
A) Dextromethorphen HBr B) Dicyclomine HCl C) Guaifenesin D) Acetaminophen
A 272. The following syrups contain dextromethorphan HBr except:

A) Ferro-mar B) Mucotrol C) Coderex D) Cosyr
B 273. The following preparation: privine, visine and eye are classified as:
A) Mouthwash B) Ocular decongestant C) Antibacterial D) Antitussive
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A 274. The generic name of the preparations in ? is:

A) Tetrahydrozoline hydrochloride C) Dextromethorphan HBr
B) Tomolol Maleate D) Phenylephrine HCl
D 275. Complete fusion of droplets in an emulsion followed by ultimate separation of 2 immiscible phases is a
condition called:
A) Inversion B) Creaming C) Hydrolysis D) Breaking
C 276. Means of identifying water in oil emulsion:

A) Identifying emulsifier C) Oil miscibility
B) Measurement of viscosity D) Water miscibility
A 277. These are characteristics or water in oil emulsion except:

A) Good conductor of electricity C) Immiscible with water
B) Miscible with oil D) Poor conductor of electricity
C 278. These are equipment for homogenization except:

A) Colloid mill B) Homogenizer C) Sieve D) Mortar and pestle
A 279. Water impurities like calcium and magnesium salts can be removed by:
A) Ion-exchange B) Adsorption C) Evaporation D) Sublimation
A 280. Fusing together of droplets into larger globules:

A) Coalescence B) Aggregation C) Creaming D) Sedimentation
B 281. Ointments that demonstrate some systemic effect are:

A) Epidermic B) Diadermic C) Endodermic D) All of the above
B 282. Substance added to tablets to impart cohesiveness:

A) Diluent B) Binder C) Lubricant D) Flavoring agent
D 283. Flavoring agents are added to:

A) Compressed tablets B) Chewable tablets C) Lozenge D) B and C
B 284. Trituration in a mortar or on an ointment slab to prepare ointments:

A) Fusion B) Mechanical incorporation C) Comminution D) A and B
A 285. Ointments containing hard fusible bodies are prepared by:

A) Fusion B) Mechanical incorporation C) Levigation D) Trituration
B 286. Colligative properties are useful in determining:

A) pH B) 0.9% C) 0.8% D) 9%
C 287. The following ingredients can be used in the formulation of analgesics except:
A) Acetaminophen B) Mefenamic acid C) Theophylline D) Aspirin
A 288. These solvents are used to affect the solubility of certain drugs and to reduce hydrolysis except:
A) Water B) Prophylene glycol C) Ethyl alcohol D) Polyenthylene glycol
A 289. The following anti-infective agents are used in the formulation of mouthwashes except:
A) Sodium chloride B) Sodium borate C) Hexetidine D) Detylpyridinum chloride
D 290. This is used as a clarifying agent in liquid preparations:

A) Magnesium stearate B) Talc C) Infurorial earth D) B and C
D 291. Suspensions can be used for this type of injectable product:

A) Intravenous B) Intramuscular C) Intradermal D) B and C
D 292. The pH of an ophthalmic solution has a considerable effect on:

A) Therapeutic action of the drug C) Comfort of the patient
B) Stability D) All of the above
C 293. Isotonicity is critical for this injectable product:
A) Intravenous B) Intradermal C) Subcutaneous D) Mineral oil
A 294. The most hyroscopic of the following liquids is:

A) Glycerin B) Acetone C) Alcohol D) Mineral oil
B 295. The release of an ingredient from packaging components into the actual product is described by the term:
A) Adsorption B) Leaching C) Permeation D) Diffusion
C 296. Add the necessary bulk to a formulation to prepare tablets of the desired size:
A) Binders B) Lubricants C) Diluents D) Disintegrator
A 297. Component in parenteral preparations present in the largest quantity:

A) Vehicle B) Solute C) Anti-oxidant D) Buffers
D 298. Properties of ideal ointment base except:

A) Washability B) Non-dehydrating C) Ease of compounding D) Greasy
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C 299. Less irritating solution can be obtained by producing an:

A) Hypertonic solution B) Hypotonic solution C) Isotonic solution D) All of the above
A 300. Kills all living organism including spores and viruses:

A) Steam under pressure B) Bacterial filtration C) Chemical sterilization D) None of the above
D 301. Used to stabilize a solution against the chemical degradation that would occur if there is a marked changed
in pH:
A) Anti-oxidants B) Anti-microbials C) Preservatives D) Buffers
C 302. Physiological salt solution:

A) 9% NaCl solution B) 0.09% NaCl solution C) 0.9% NaCl solution D) 74% NaCl solution
C 303. The most frequently used base in the preparation of vaginal suppositories where the prolonged localized
action of the medicinal agent is usually desired:
A) Polyethylene glycols B) Cacao butter C) Glycerinated gelatin D) Beeswax
D 304. Any temperature not exceeding 8 C:

A) Warm B) Cool C) Room temperature D) Cold
B 305. Emulsions having an oleaginous internal phase and an aqueous external phase are referred as:
A) W/O B) O/W C) W/O/W D) O/W/O
C 306. The process of grinding a drug in a mortar to reduce its particle size is termed:
A) Levigation B) Spatulation C) Trituration D) Bumbling
A 307. Gelatin is a:
A) Protein B) Carbohydrate C) Lipid D) Fat
B 308. A semi-solid emulsions of either the o/w or w/o type:

A) Lotion B) Creams C) Paste D) None of the above
B 309. Enhance the flow of the tableting material into the tablet dies and punches:
A) Disintegrator B) Lubricant C) Adhesive D) Fillers
B 310. Characteristically, chewable tablets are, except:

A) Pleasant tasting B) Leave bitter aftertaste C) Cool taste D) None of the above
C 311. A mixture of semi-solid hydrocarbons obtained from petroleum:

A) Mineral oil B) Paraffin C) Petrolatum D) White ointment
C 312. The following are non-medicated syrups except:

A) Tolu balsam syrup B) Orange syrup C) Ipecac syrup D) Cherry syrup
B 313. Ferrous sulfate syrup, NF is a :

A) Non-medicated syrup B) Medicated syrup C) Simple syrup D) None of the above
B 314. Desirable qualities of pharmaceutical suspension except:

A) Should pour readily and evenly from its container.
B) Particles should settle rapidly.
C) Particles should be readily redispensed upon gentle shaking.
D) Should be such that the particle size of the suspension remains fairly constant throughout long
periods of undisturbed standing.
A 315. Dry gum method of preparing emulsions is also known as:

A) 4:2:1 method B) English method C) Forbes bottle method D) Wet gum method
D 316. An emulsion is considered to be physically unstable if:

A) Dispersed phase upon standing tends to form aggregates of globules.
B) “Creaming” of the emulsion.
C) “Breaking” of the emulsion.
D) All of the above.
A 317. If the powders of vegetable and animal drugs pass through a no. 60 sieve and not more than 40% through
a no. 100 sieve, the drug is officially:
A) Fine B) Coarse C) Very coarse D) Moderately coarse
C 318. Powders commonly dispensed in a bulk container except:

A) Dentrifices B) Douche powders C) Potent drug D) Denture powders
B 319. The following are true about granules except:

A) More stable physically and chemically than are the corresponding powders from which they were
prepared.
B) More likely to cake or harden upon standing than are powders.
C) Their surface area is less than that of powders.
D) More easily “wetted” by a solvent that a certain powder.
D 320. A process in which the properly comminuted drug is permitted to soak in the menstruum until the cellular
structure is softened and penetrated by the menstruum and the soluble constituents are dissolved:
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A) Percolation B) Digestion C) Decoction D) Maceration
C 321. Used for the sterilization of heat-sensitive solutions:

A) Dry-heat sterilization C) Sterilization by filtration
B) Steam sterilization D) Autoclave
D 322. Drugs could possibly penetrate intact skin after topical application through except:
A) Walls of hair follicles B) Sweat glands C) Sebaceous glands D) Veins
A 323. Mineral oil is the synonym of :

A) Liquid petrolatum B) Paraffin C) Petrolatum jelly D) White ointment
C 324. These are necessary characteristics of ophthalmic except:

A) Clarity B) Sterility C) High viscosity D) Isotonicity
C 325. These products need to be pyrogen-free:

A) Syrup B) Tablets C) Parenterals D) Elixirs
D 326. USP specifies this volume as the upper limit for single-dose parenterals:
A) 30ml B) 20ml C) 500ml D) 1000ml
A 327. USP specifies this volume as the upper limit for multiple-dose parenterals:
A) 30ml B) 20ml C) 50ml D) 100mnl
B 328. Douches are liquid preparations intended for:

A) Topical use B) Body cavities C) Systemic use D) Compresses
B 329. Problem often encountered with suspensions:

A) Rough B) Caking C) Creaming D) Dispersability
D 330. This is an oil-in-water emulsion:

A) Cold cream B) Butter C) Dairy cream D) Vanishing cream
A 331. These are reasons for enteric coating except:

A) For rapid onset of action. C) Active constituent is unstable in acid medium.
B) Prevent gastric irritation. D) Active constituent is optimally absorbed in alkaline medium.
D 332. Tablet dosage form not requiring disintegration:

A) Film-coated B) Enteric coated C) Sustained release D) Chewable
C 333. The most common disintegration in tablet products:

A) Velgum B) Talc C) Corn starch D) Magnesium stearate
B 334. The use of too much binder in tableting can affect:

A) Bioavailability B) Moisture content C) Dissolution rate D) Disintegration
A 335. Calamine powder is a mixture of zinc oxide and :

A) Ferric oxide B) Aluminum oxide C) Caramel D) Amaranth
D 336. Which of the following is not a function of the lubricant in a tablet formulation:
A) Improving flow properties of granules
B) Reducing powder adhesion into the dies and punches
C) Reducing punch and die wear
D) Improving tablet wetting in the stomach
B 337. The capping of a tablet may be the result of any of the following except:
A) Excessive pressure of compression C) Excessive fine powder
B) Excessive lubricant D) Insufficient binder
C 338. Recommended ratio of oil to water to acacia in the preparation of an extemporaneous emulsion:
A) 2:4:1 B) 1:2:4 C) 4:2:1 D) 2:4:1
C 339. Glycerogelatins contain:

A) Glucose B) Agar C) Glycerin D) All of the above
D 340. FD and C dyes may be used for:

A) Food B) Cosmetic C) Drugs D) Any of the above
B 341. GMP is enforced by the :

A) USAN B) BFAD C) NBI D) None of the above
A 342. Washes are used to treat the:

A) Buccal cavity B) Vagina C) Rectum D) Nasal cavity
C 343. A douche is used to remove foreign particles form the eyes is:
A) Nasal B) Pharyngeal C) Eye D) All of the above
D 344. Coloring agents added to pharmaceuticals are used for:
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A) Product identification C) Sensory adjunct to palatability

B) Aesthetic value D) All of the above
D 345. To increase rate of solution of a solute is to increase:

A) Agitation B) Temperature C) Surface area of solute D) All of the above
A 346. Artificial sweeteners are added to syrup preparations to:

A) Prevent hyperglycemia C) Act as preservative
B) Aid acidic syrup D) Serve as aesthetic agent
A 347. A very soluble solute is an expression of one gram dissolved in:

A) Less than one part of solvent./ C) From 1 to 10 parts of solvent
B) From 10 to 30 parts of solvent D) 30 to 100 parts of solvent.
D 348. Sodium lauryl sulfate is:

A) Alcohol B) Ketone C) Lotion D) Wetting agent
C 349. Collodions are made flexible by the addition of:

A) Olive oil B) Gelatin C) Castor oil D) Camphor
B 350. The type of extract used for ointment or pastes is:

A) Semiliquid B) Pilular C) Powdered D Any of the above
C 351. Water used as a vehicle for pharmaceutical preparations is:

A) Sterile water for injection C) Aromatic water
B) Bacteriostatic water for injection D) Any of the above
A 352. A type of liniment applied by massage:

A) Oily B) Alcoholic C) Dental D) A and B
B 353. Glycerites contain high percentage of glycerine which is about:

A) 60% B) 50% C) 65% D) 100%
A 354. Naming of a proprietary drug is a responsibility of :

A) Manufacturer B) USAN council C) BFAD D) All of the above
C 355. The term “drug labeling” includes the following except:

A) Labels B) Company literature C) Containers D) Inserts
C 356. An amount of drug administered to a person after contraction of an illness is:

A) Prophylactic dose B) Usual dose C) Therapeutic dose D) Dosage regimen
B 357. The official room temperature is:

0 0 0 0
A) 30 C B) 25 C C) 30 C – 40 C D) Temperature of the working area
D 358. Reaction kinetics study can predict:

A) Shelf-life of the product B) Expiry date C) Therapeutic use D) A and B
D 359. Community Considered a practice of pharmacy except:

A) pharmacy C)Hospital pharmacy
B) Pharmaceutical manufacturing D) Wholesaler of RTW clothes
B 360. To remedy the problem of volatile liquid substance is to:

A) Coating the substance C)Make into a tablet
B) Place in a soft gelatin capsule D) Any of the above
C 361. Cation in hard water is:

A) Potassium B) Sodium C) Calcium D) Manganese
A 362. Over the counter drugs are:

A) Used for simple conditions C) Too dangerous to use in self-medication
B) Need a prescription D) With Rx symbol on the label
C 363. Container where its contents are protected from loss of the drug by effervescence, deliquescence and
evaporation is :
A) Hermetic container B) Well-closed container C) Tight container D) All of the above
B 364. To improve taste of drugs is to add:

A) Coloring matter B) Flavoring agent C) Alcohol D) Sodium chloride
D 365. Stability of drugs may be:

A) Physical B) Chemical C) Toxicological D) All of the above
C 366. Pharmacokinetics involve the following processes except:

A) Absorption B) Metabolism C) Circulation D) Elimination of drugs
A 367. Aqueous solutions use a major ingredient as:

A) Water C) Hydroalcohol
B) Alcohol D) Benzene
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B 368. Non-toxic powders for local application without systemic effect is:
A) Dentrifices B) Dusting C) Insufflations D) Douche powders
D 369. A non-medicated ointment except:

A) Hydrocarbon base B) Absorption base C) Water-soluble base D) Zinc oxide ointment
A 370. Iodine tincture differs from iodine solution in that the tincture contains:
A) Alcohol as vehicle B) Water as vehicle C) Acetone as vehicle D) Chloroform as vehicle
B 371. A powder preparation used with a toothbrush to clean the teeth is:
A) Insufflation B) Dentrifices C) Trituration D) Dusting powder
D 372. A method of preparing effervescent salt is by:

A) Fusion B) Wet method C) Molding D) A and B
D 373. A way to prepare ointment except:

A) Trituration B) Spatulation C) Fusion D) Levigation
A 374. Fluid extract is also called:

A) 100% tincture B) 10% tincture C) 36% tincture D) 50% tincture
B 375. To mask bitter tasting drugs in formulations, the flavoring vehicles used is:
A) Orange flavor B) Cocoa flavor C) Cherry flavor D) Any of the above
C 376. Excessive heat has a temperature of:

0 0 0 0 0
A) 30 C – 40 C B) 25 C – 35 C C) Above 40 C D) None of the above
D 377. Mucilages are used primarily to aid in suspending insoluble substances in liquids due to their:
A) Colloidal character B) Base of preparation C) Viscosity D) A and C
B 378. Liniments are applied by rubbing so they are also called:

A) Ointments B) Embrocations C) Rubefacient D) Creams
C 379. Preparation used to relieve temporarily the toothache is:

A) Liniment B) Jelly C) Toothache drops D) Chlorobutenol
D 380. Theory of emulsification is:

A) Surface Tension Theory B) Oriented-Wedge Theory C) Plastic ? Theory D) All of the above
A 381. HLB value needed for oil in water type of emulsion is:
A) 8 – 18 B) 3 – 6 C) 1 – 5 D) 5 – 6
C 382. Suspensions are prepared by, except:

A) Dispersion B) Precipitation C) Solution D) Double decomposition
A 383. Gels belong to:

A) Suspensions B) Emulsions C) Solution D) Ointments
C 384. In colloidal dispersions, if the dispersed phase interacts appreciably with the dispersion medium, it is:
A) Lyophobic B) Amphilic C) ? D) Any of the above
A 385. Aqueous liquid preparations which contain suspended insoluble solid substances intended for internal
use is:
A) Mixtures B) Magmas C) Milks D) Lotions
A 386. Finely divided powders introduced into body cavities such as the ears, nose, throat and vagina are:
A) Insufflations B) Triturations C) Dusting D) Douche powders
A 387. Capsules prepared from shells of gelatin to which glycerin or a polyhydric alcohol has been added is:
A) Soft Gelatin Capsules B) Hard Gelatin C) Cachets D) Troches
B 388. Table triturates for use by the physicians in his extemporaneous preparation of parenteral solutions are:
A) Pastilles B) Hypodermic Tablets C) Sublingual D) Pellets
D 389. Solid dosage forms designed to release the drug slowly for more sustained action are:
A) Timed-release tablets B) Pills C) Extended-action tablets D) A and B
A 390. Capsule size for human use, except:

A) 000 B) 2 C) 3 D) 1
C 391. A method of extraction applicable to drugs whose desired constituents are both water soluble and heat
stable is:
A) Maceration B) Infusion C) Decoction D) Percolation
B 392. When tinctures are prepared from single vegetable drugs, the amount of crude drug is:
A) 20 g B) 10 g C) 50 g D) 100 g
C 393. Piperazine citrate syrup belongs to a class of:
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A) Flavoring syrup B) Non-medicated syrup C) Medicated syrup D) Syrup used as vehicle
B 394. In labels of OTC drugs, one important data placed in the principal display panel is:
A) Storage condition B) Pharmacologic category C) Rx symbol D) Control number
B 395. A practice of pharmacy except:

A) Pharmaceutical research C) Community dispensing
B) Diagnosing an illness D) Engaged in teaching students in allied professions
B 396. Sterile water for irrigation requires the solvent as:

A) Purified water B) Water for injection C) Bacteriostatic water D) Water, USP
C 397. The process of obtaining aromatic water by redistillation one or more times from the fresh delicate drugs is:
A) Practical distillation B) By solution C) Cohobation D) Exhaustive solution
A 398. A rectal injection employed to visualize the gastrointestinal tract for diagnostic purposes is:
A) Enemas B) Douches C) Washes D) Suppositories
A 399. One disadvantage of sucrose as a sweetener in formulation of syrups upon storage in a bottle is:
A) Cap-locking B) Viscosity C) Molds growth D) Expensive
B 400. In percolation, the rate of flow described as “percolate slowly” is:

A) 1-3 ml/minute B) Not exceeding 1 ml/minute C) 3-5 ml/minute D) 5-10 ml/minute
A 401. The process of preparing fluidextracts by percolation where the first 85% of the percolate is reserved then
continued until exhaustion is:
A) Process A B) Process B C) Process C D) Process D
B 402. Dental preparations employed primarily as temporary covering for exposed pulps are:
A) Cataplasms B) Cements C) Pellets D) Creams
C 403. External applications resembling ointments in consistency but remaining semisolid at body temperature,
0 0
liquefy at 50 C and remain pliable in thin film below 28 C are called:
A) Contraceptives B) Ointments C) Dressings D) Pastes
B 404. Plastic masses composed of gelatin, glycerin, water and a medicament applied by first melting are:
A) Pastes B) Glycerogelatins C) Dressings D) Ointments
D 405. Method of mixing powders as dosage forms is by:

A) Sifting B) Tumbling C) Spatulation D) Any of the above
B 406. The “block and divide” method of packaging powders after mixing is employed for:
A) Potent drugs B) Non-potent C) Raw materials D) Extractives
B 407. Pairs of liquids when mixed results as a homogenous system such as alcohol and water are:
A) Immiscible B) Miscible C) Insolution D) Repel each other
C 408. A form of extraordinary maceration which consists of the application of gentle heat:
A) Infusion B) Percolation C) Digestion D) Decoction
D 409. Tinctures of potent drugs usually have a strength of:

A) 5% by vol. B) 5% by wt C) 10% by vol. D) 10% by wt.
A 410. One of the following is not employed as a suppository base:

A) Paraffin B) Glycerinated gelatin C) Hydrogenated vegetable oil D) Cacao butter
D 411. The process of mixing powders together by shaking or rotating them in a closed container is:
A) Spatulation B) Trituration C) Sifting D) Tumbling
B 412. Solutions representing water-soluble plant principles prepared by boiling the drug in water:
A) Infusion B) Decoction C) Extracts D) Fluidextracts
B 413. Hydroalcoholic preparations which are sweetened and flavored:

A) Spirits B) Elixirs C) Syrups D) Tinctures
D 414. Magmas are:

A) Aqueous solutions B) Alcoholic solutions C) Emulsions D) Suspensions
A 415. A eutectic mixture in powders occurs when:

A) There is lowering in melting point. C) Hygroscopic mixture
B) Lowering in boiling point D) Efflorescence
C 416. Potassium iodine is used in Lugol’s solution as:

A) Preservative B) Reducing agent C) Aid in the solubility of iodine D) All
C 417. White lotion is prepared by:

A) Hydration B) Trituration C) Precipitation D) None
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D 418 The capacity of a teaspoon is :

A) 10 ml B) 15 ml C) 1 ml D) 5 ml
B 419. Sulfurated potash is used in the preparation of:

A) Calamine lotion B) White lotion C) Yellow lotion D) Black lotion
A 420. Penicillin-calcium is the salt of choice for topical use of penicillin because:
A) It is more irritating and less hygroscopic C) More stable
B) More soluble D) All
B 421. Sodium borate in Cold Cream acts:

A) Preservative B) Forms scar C) Vehicle D) Solubilizing agent
B 422. Liquid preparation that contains one or more chemical substances usually non-volatile, dissolved in water:
A) Emulsions B) Solutions C) Lotions D) Elixirs
D 423. Water is used in place of alcohol in Iodine tincture because:

A) Iodine is more soluble in water than in alcohol
B) Alcoholic solutions have been too strong for general purposes
C) Free iodine is not liberated ion aqueous solutions
D) None of the above
B 424. Glycerine suppositories are solidified by the use of:

A) Stearic acid B) Sodium stearate C) Glycerol triacetate D) White wax
D 425. Another name for polyethylene glycol polymers is:

A) Silica gel B) Sodium alginate C) Friar’s paste D) Carbowax
D 426. USP liniment containing camphor:

A) Camphor and soap liniment B) Chloroform liniment C) Camphor liniment D) All of the above
E 427. Liquid preparations representing the water-soluble principles of plant drugs are:
A) Spirits B) Fluidextracts C) Tinctures D) All E) None
A 428. Colloidions are liquid preparations containing pyroxylin in a mixture of:

A) Ethyl ether & ethanol C) Ethanol and glycerin
B) Ethanol and propanol D) Mathanol and Propanol
C 429. Imparts pink color to calamine:

A) Silicon dioxide B) Titanium dioxide C) Ferric oxide D) Carmine
D 430. Cacao butter used as suppository base is also known as:

A) Linseed oil B) Cottonseed oil C) Lanolin D) Theobroma oil
C 431. Surfactants tends to enhance absorption due to:

A) Effects on biological membrane C) Reduction of interfacial tension
B) Effects on dissolution rate D)Increase in interfacial tension
A 432. Glycerin has a specific gravity of 1.15; one liter of it weighs:

A) 1250g B) 473g C) 550g D) 4800g
B 433. The form of water most commonly used for production of parenterals is:
A) Deionized B) Water for injection C) Sterile water for injection D) Purified water
A 434. Iodine tincture differs from iodine solution in that the tincture contains:
A) Alcohol as vehicle B) Water as solvent C) Acetone as vehicle D) Alcohol-acetone as solvent
D 435. Percolation may be used to classify:

A) Solutions B) Ointments C) Suspensions D) Syrups
D 436. A class of bulk powders:

A) Triturations B) Douche powders C) Divided powders D) A and B
D 437. Water can be purified by:

A) Distillation B) Solution C) Reverse osmosis D) A and C
B 438. A type of suppository that relieves constipation is:

A) Vaginal B) Rectal C) Urethral D) Aural
A 439. Levigation is a process of reducing particle size in preparation of:

A) Ointments B) Emulsions C) Solutions D) A and B
B 440. A powder preparation used with a toothbrush to clean the teeth is:
A) Insufflation B) Dentrifices C) Dusting D) Douche
D 441. A way to prepare an ointment by incorporation is by:

A) Spatulation B) Fusion C) Trituration D) A and C
B 442. The classification of drugs as legally obtained are the following except:
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A) Over the counter B) Cosmetics C) Legend D) Prescription
A 443. These are non-medicated ointments except:

A) Non-water removable base B) Absorption base C) Greaseless bases D) Hydrocarbon bases
A 444. The type of liniment applied by massage is:

A) Oily B) Alcoholic C) Aqueous D) A and B
B 445. Ingredients of salicylic acid collodion except:

A) Camphor B) Menthol C) Castor oil D) Ether
B 446. An example of distilled spirit is:

A) Peppermint spirit B) Whisky C) Rum D) Camphor spirit
D 447. The dry-gum method of preparing emulsions is also called:

A) English method B) Continental method C) 4:2:1 method D) B and C
A 448. Pleasantly flavored, sweetened, hydroalcoholic preparation is:

A) Elixir B) Spirit C) Syrup D) Glycerites
A 449. Spirits are similar to elixirs as to:

A) Solvent mixture B) Solute C) Sweetness D) A and B
B 450. Kaolin mixture is used as:

A) Anti-infective B) Adsorbent C) Cure for diarrhea D) Suspending agent
A 451. Oleovitamins generally consist of:

A) Vitamins A & D B) Vitamin B C) Vitamin A & B D) Vitamin A
C 452. The method of preparing emulsions containing volatile oils is by:

A) Dry gum B) Wet gum C) Bottle D) Continental
B 453. An example of an animal-source emulsifier is:

A) Acacia B) Gelatin C) Bentonite D) Agar
C 454. A method of preparing solutions, except:

A) Extraction B) Simple solution process C) Dispersion D) Chemical reaction
B 455. An aqueous solution used to evacuate the bowel is:

A) Suppository B) Enemas C) Infusion solution D) Decoction
B 456. Waters having the odor and taste similar to the drug from which they are prepared are called:
A) Purified water B) Deionized water C) Water for inhalation D) Aromatic waters
D 457. One way to improve the appearance of a dosage form is to add:

A) Colorant B) Flavorant C) Preservative D) A and C
D 458. The term “labeling” includes:

A) Labels B) Company literature C) Containers D) A and B
B 459. A container that is impervious to air and gas under the usual conditions of handling is considered to be
A) Well-closed B) Hermetically closed C) Tightly closed D) B and C
B 460. Drug interaction with water forming breakdown products is:

A) Oxidation B) Hydrolysis C) Neutralization D) A and B
C 461. The temperature of a cold place is:

A) 8 – 15 C B) 15 – 30 C C) Not exceeding 8 C D) 25 C
C 462. Certified dyes and colorants used for drugs and cosmetics but not for food are:
A) FD and C dyes B) D and C dyes C) D and C dyes external D) B and C
A 463. Reaction kinetics study can help predict the:

A) Shelf-life B) Potency C) Toxicity D) Effectivity of a formulation
C 464. Water used as a vehicle in pharmaceutical preparations is:

A) Sterile water for injection B) Water, USP C) Aromatic water D) Deionized water
A 465. Gargles are used to treat the :

A) Pharynx B) Lungs C) Oral cavity D) A and B
B 466. The term “sparingly soluble” refers to parts of solvent that can dissolve one part of solute is:
A) 10 – 100 B) 30 – 100 C) Less than 1 D) 1 – 10
D 467. Gels under suspension system consist of:

A) Small inorganic particles C) Large organic particles
B) Small organic particles D) A and C
B 468. Toothache drops are used to:
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A) Cure toothache C) Cure gingivitis

B) Remedy pain due to toothache D) B and C
B 469. Type of resins that is used to deionized water is:

A) Natural resins B) Synthetic resins C) Prepared resins D) Resins
A 470. The committee that approves naming of nonproprietary drugs is:

A) US Adopted Names Council C) USP/NF Committee
B) Manufacturer of the specific drug D) A or B
B 471. Solubility of a drug increases in:

A) Exothermal reaction B) Endothermal condition C) Cold condition D) A or B
C 472. Characteristic of water for inhalation except:

A) Sterile B) No added substance C) Purified by boiling D) Purified by distillation
D 473. The major impurity of hard waters is:

A) Calcium ion B) Sodium ion C) Magnesium ion D) A and C
B 474. Main component of all types of collodion:

A) Acetone B) Pyroxylin C) Camphor D) Castor oil
D 475. The dry method of preparing granulations for tablets is adopted for:
A) Heat sensitive drugs C) Tablets with potent drugs
B) Moisture sensitive drugs D) A and B
B 476. Characteristic of salicylic acid collodion:

A) Used as corn solvent C) Used to dissolve skin blemishes
B) Used as keratolytic D) A and B
B 477. In packaging of powders, the “block and divide” process is applied to:
A) Potent drugs B) Non-potent drugs C) Inactive components D) A and C
B 478. Mixture of two liquids forming a homogenous system is termed:

A) Insoluble B) Miscible C) Immiscible D) A and B
C 479. Method of preparing suppositories:

A) Molding from a melt C) A and B
B) Hand rolling and shaping D) Trituration
B 480. Type of tablet coating where the first coat is s? is:

A) Enteric B) Sugar coating C) Film coating D) Micro coating
D 481. Components of effervescent granules, except:

A) Sodium bicarbonate B) Tartaric acid C) Citric acid D) Sodium Carbonate
B 482. Benzoic acid as a preservative should be used in a concentration of:

A) 1.0% B) 0.1 – 0.2% C) 0.01 – 0.02% D) 0.5%
B 483. An official water containing one or more bacteriostatic agents is:

A) Sterile water for injection C) Purified water
B) Bacteriostatic water for injection D) Aromatic water
D 484. A viscosity builder in syrup preparations is:

A) Sorbitol B) Glycerin C) Mucilage D) A and B
A 485. The length of time that a drug substance maintains its original qualities is:
A) Shelf-life B) Expiration date C) Stability D) A and C
D 486. Alcoholic liniments are used for:

A) Penetrating effect B) Rubefacient C) Massage D) A and B
B 487. A sugar that does not contribute to dental caries is:

A) Sorbitol B) Mannitol C) Dextrose D) Sucrose
A 488. The chief constituent of honey is:

A) Invert sugar B) Sucrose C) Pentose D) Evulose
B 489. The continental method of preparing emulsions has its first step the combination of:
A) Gum and water B) Gum and oil C) Oil and water D) Gum and active ingredient
D 490. Pyroxylin is also called:

A) Nitrocellulose B) Collodion C) Gun cotton D) A and C
A 491. Glycerites are stable to microorganisms due to:

A) High glycerin content B) Powdered ingredients C) Sugar content D) Alcohol content
B 492. HLB value suitable for W/O type of emulsion is:

A) 8 – 18 B) 3 – 6 C) 6 – 8 D) 4 – 6
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C 493. An ointment base called greaseless is:

A) Hydrocarbon base B) Absorption base C) Water-soluble base D) Water removable base
D 494. Caramelization of sucrose is due to its:

A) Fructose content B) Glucose content C) Evulose content D) A and C
D 495. A preparation made to administer medications in measured or prescribed amount is :

A) Dosage form B) Pharmaceutical C) Extract D) A and B
C 496. The type of stability where resistance to microbial growth is maintained until its expiry date is:
A) Chemical B) Toxicological C) Microbiological D) Physical
A 497. Controlled room temperature means that the temperature is maintained thermostatically between:
0 0 0 0 0 0
A) 15 – 30 C B) 25 C C) 8 -15 C D) 30 C
D 498. Jellies are used by physicians as lubricants for:

A) Rectal thermometer B) Gloves for surgical use C) Stoppers D) A and B
B 499. Type of liniment according to solvent is:

A) Aqueous B) Oily C) Ethereal D) Acetone
A 500. Purpose of pharyngeal douche is:

A) Cleans throat in supportive condition C)Treatment for lung disease
B) Antiseptic for aural cavity D) A and C
C 501. An artificial sweetener used for preparing syrups is:

A) Sucrose B) Liquid glucose C) Saccharin D) Lactose
C 502. The finely divided particles of a suspension, except:

A) Suspensoids B) Dispersed particles C) Lipid D) A and B
B 503. A container which protects its contents from extraneous solids under normal conditions of handling and
shipment is:
A) Hermetic container B) Well-closed container C) Tight container D) Well-sealed container
A 504. A new drug has to be approved by the______ before distribution to the public.
A) BFAD B) BIR C) DOH D) Narcotics Division
C 505. The third component of an emulsion is:

A) Suspending agent B) Active ingredient C) Emulsifier D) B and C
B 506. Exothermic substances tend to:

A) Increase B) Decrease C) No effect D) Explosive effect on solubility
B 507. Collodions evaporates fast due to the presence of a volatile solvent as:
A) Chloroform B) Ether C) Carbon tetrachloride D) Hexane
D 508. A way to prepare gel is :

A) Hydration of chemical substances C) Chemical reaction of inorganic substances
B) Mixing organic substances D) A and C
A 509. An aqueous preparation used as suspending agent due to its colloidal property is:
A) Mucilages B) Mixtures C) Paste D) Jellies
D 510. Characteristic of oil prepared by Forbes Bottle Method for emulsions is:
A) Volatile B) Fixed oil C) Low viscosity oil D) A and C
C 511. Substances that give bulk or body to aqueous and viscoid solutions, except:
A) Sugars B) Polyols C) Lactose D) Polysaccharides
A 512. A percolation process which sets aside the first 85% of the percolate then collects the weak percolate until
exhaustion is:
A) Process A B) Process B C) Process C D) Process D
C 513. Suppositories when inserted into body cavities change, except:

A) Melt B) Soften C) Harden D) Dissolves
A 514. A small round dosage form for oral administration is:

A) Pills B) Pellet C) Tablet D) Sachet
B 515. Water soluble base for suppository is:

A) Petrolatum B) Polyethyene glycols C) Theobroma oil D) Cocoa butter
A 516. A semisolid preparation that is stiffer and less greasy than ointments is:
A) Pastes B) Dressing C) Cerates D) Creams
C 517. A process of preparing effervescent salt is by:

A) Slugging B) Mix with kaolin C) Fusion D) Trituratrion
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B 518. A method of preparing ointments except:

A) Fusion B) Infusion C) Spatulation D) Trituration
B 519. Juices have the advantage over artificial flavor in that it is:
A) Sweeter B) Still with its natural flavor C) More stable D) Cheaper
B 520. Tablets that are used by a few physicians in his extemporaneous preparation of parenteral solutions are:
A) Tablet triturates B) Hypodermic tablets C) Implantation tablets D) Cachets
B 521. To insure the stability of a dosage form for its intended shelf-life, what is placed or stated in the label?
A) Proper dosage B) Proper storage C) Proper net contents D) Proper name of the product
A 522. The similarity of gargles with mouthwashes is:

A) Antiseptic use B) Site of action C) Constituents D) Formula
B 523. An amount of drug administered to protect the person form contracting the disease is:
A) Therapeutic dose B) Prophylactic dose C) Pharmacologic dose D) A and C
A 524. The term “irrigations” also refer to:

A) Vaginal douche B) Rectal douche C) Eye douche D) Pessaries
A 525. Any substance of a drug product intended to furnish pharmacologic effect is:
A) Excipient B) Active ingredients C) Drug substance D) B and C
B 526. Insoluble powders for opthalamic use must be:

A) Less than 200 microns in size C) Pyrogen-free
B) Impalpable to the touch D) Gives preservative action
C 527. The most used diluent for tablets is:

A) Sucrose B) Talc C) Lactose D) Calcium stearate
C 528. Emulsifiers are added to formulations of emulsions for the following purposes except:
A) Increase viscosity C) Promotes separation of layers
B) Prevents coalescence D) Stabilize the emulsion
B 529. Aspilets for children are:

A) Sublingual B) Chewable C) Buccal D) Soluble tablets
D 530. This is a common lubricant for tablets:

A) Starch B) Acacia C) Mannitol D) Magnesium stearate
C 531. Simultaneous processes that occur when a tablet or other form is introduced into the gastrointestinal tract
except:
A) Disintegration B) Deaggregation C) Precipitation D) Dissolution
C 532. Class of colloidal system except:

A) Lyophilic B) Lyophobic C) Fine dispersions D) Amphiphilic
A 533. Pulverization accomplished with another substance is:

A) By intervention B) Chemical reaction C) By spray drying D) By trituration
C 534. OTC labels of products or dosage forms indicate in front the:

A) Expiry date B) Storage C) Pharmacologic category D) Formula
C 535. The characteristic ingredient in poultices:

A) Kaolin B) Water C) Oil D) Calcium carbonate
B 536. A term derived from the Latin words which means “through to strain” is:
A) Maceration B) Percolation C) Infusion D) Decoction
B 537. A plant exudate containing benzoic and dinnamic acids is:

A) Resins B) Balsams C) Oleoresins D) Resins
A 538. The extract with a plastic consistency is known as:

A) Pilular B) Powdered C) Semiliquid D) A and B
C 539. A type of coating that disintegrates in the intestines and not in the stomach is:
A) Sugar B) Chocolate C) Enteri D) Film
B 540. Disk-shaped solid dosage form with hard candy base is:
A) Troches B) Lozenges C) Pellet D) Pills
B 541. A material derived from the honeycomb of the bees is:

A) Honey B) Beeswax C) Sugars D) A and C
D 542. Decoction is a method of extraction from drugs which is:

A) Water soluble B) Alcohol soluble C) Heat stable D) A and C
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D 543. Component of white ointment is:

A) 95% petrolatum B) 5% wax C) 2% lanolin D) A and B
A 544. Type of oleoresin obtained by incising the trunk of a tree is:

A) Natural oleoresin B) Prepared oleoresin C) Synthetic oleoresin D) B and C
B 545. Process “P” of extraction refers to:

A) Maceration B) Percolation C) Infusion D) Decoction
A 546. An ointment base used to prepare epidermic ointment is:

A) Hydrocarbon base B) Greaseless base C) Absorption base D) Cream base
B 547. Products prepared from fresh ripe fruits used as vehicle in liquid dosage forms:
A) Exudates B) Juices C) Jellies D) Synthetic flavors
C 548. Preparation used for its deodorant and refreshing effect:

A) Buccal tablets B) Elixirs C) Mouthwash D) Lozenges
B 549. Another term for vaginal suppositories is:

A) Bougies B) Pessaries C) Enema D) Vaginitis
C 550. A product of extraction using the proportion of one gram of the crude drug to one gram of the
extractive is:
A) Tincture B) Spirit C) Fluidextract D) Extract
A 551. An agent used in the diagnosis, prevention, treatment and cure of disease in man or animal is:
A) Drug B) Excipient C) Additive D) Inactive agent
A 552. Extraction process where boiling water is added to the mixture of crude drug with water, the proportion is
about 90% and then cooled is:
A) Infusion process B) Percolation C) Decoction process D) Maceration process
A 553. Water can be purified by the following processes, except:

A) Solution B) Reverse osmosis C) Distillation D) Demineralization
B 554. Glycerites contain high percentage of glycerin which is about:

A) 60% B) 50% C) 85% D) 65%
B 555. An alcoholic or hydroalcoholic solution of a volatile substance is:

A) Elixir B) Spirits C) Fluidextract D) Collodions
B 556. A product of extraction of crude drugs which is 2 to 6 times as potent is:

A) Fluidextract B) Extract C) Semiliquid extract D) Tincture
D 557. Mucilages may be obtained by:

A) Dispersing gum in water C) Extraction of glycosides from plants
B) Extracting the mucilaginous principles from plants D)A and B
D 558. Sucrose as a sugar for syrups is subject to degradative actions:

A) Oxidation B) Hydrolysis C) Fermentation D) B and C
B 559. Broad groups of emulsifying agents, except:

A) Natural B) Organic material C) Finely divided solids D) Synthetic
D 560. A way to choose the specific emulsifiers for emulsions is:

A) Based on the hydrophilic-lipophilic balance value (HLB)
B) Based on the number of unsaturated portions of the molecule of the emulsifier
C) Based on the number of ethylene oxide units in the molecule of the emulsifier
D) A and C
A 561. A dental preparation containing phenol dissolved in paraffin then molded into sticks is:
A) Dental wax B) Dentrifice C) Cement D) A and C
D 562. Type of lotion according to use is:

A) Cosmetic B) Medicated C) Skin lotion D) A and B
B 563. Type of distilled spirit derived from cereal grains is:

A) Wine B) Whisky C) Brandy D) A and B
D 564. Non-nutritive syrups are those which contain:

A) Artificial sweetener B) Viscosity builder C) Simple syrup D) A and B
D 565. The preparation of oleovitamins may be by:

A) Combining vitamin concentrate with fish liver oil
B) Combining fish liver oil with a bland vegetable oil
C) Combining vitamin concentrate with olive oil
D) A and B
B 566. Ingredients in toothache drops except:
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A) Oil of cloves B) Ether C) Benzocaine D) Alcohol
C 567. The mixing of powders may be the following except:

A) Sifting B) Tumbling C) Sieving D) Trituration
A 568. To prepare opaque capsules for distinction, the insoluble substance added to gelatin is:”
A) Titanium dioxide B) Calcium carbonate C) Aluminum hydroxide D) A and B
B 569. Characteristic of tablet triturates are, except:

A) Soluble in water C) Small usually cylindrical
B) Insoluble in water D) Prepared by molding or compression
D 570. Methods of preparing tablet granulations for heat sensitive and moisture sensitive drugs may be by:
A) Slugging B) Wet method C) Dry method D) A and C
B 571. Characteristics of chemicals suitable for direct compression process except:

A) Free-flowing C) With cohesive properties
B) Eutectic when combined with other excipients D) Easily compressible
C 572. Sterilization method for injectables that are sensitive to heat is by:
A) Moist heat B) Dry heat C) Membrane filtration D) A and C
C 573. Packaging of suspensions require:

A) Wide mouth containers C) A and B
B) Containers having adequate airspace above the liquid D) Narrow mouth bottles
D 574. Non-medicated elixirs are used:

A) As vehicle for a therapeutic agent C) As a diluent for existing medicated elixir
B) As a therapeutic agent D) A and C
C 575. Reasons for preparing oral suspensions except:

A) Some drugs are more stable in suspension than in solution
B) Ease of swallowing liquid preparations
C) Disagreeable taste of some drugs in suspension
D) Flexibility of administration of doses
A 576. The powder paper used for packaging divided powders which are hygroscopic or deliquescent may be:
A) Waxed paper B) Clean coupon bond C) Parchment paper D) Glassine paper
C 577. When no specific storage are provided in the label, it is understood that the product should be protected as
follows except:
A) From moisture B) From freezing C) From cool place D) From excessive heat
D 578. Practice of pharmacy may be chosen from the following except:

A) Pharmaceutical research C) Pharmacist in the government service
B) Teaching in a college of pharmacy D) Manager of a pharmaceutical company
A 579. Qualities required for sterile water for injection except:

A) With added substance B) Sterile C) Pyrogen-free D) Meet standards for dissolved solids.
C 580. Use of sterile water in formulations:

A) Water for inhalation B) Water for irrigation C) A and B D) For topical solution
D 581. The therapeutic factor considered in designing a dosage form is:

A) Environment B) Age of the patient C) Nature of the illness D) B and C
C 582. The Rx symbol is required to be indicated in labels of the following except:

A) Legend drugs B) Dangerous drugs C) OTC drugs D) Prescription drugs
B 583. The study about the relationship between physical, chemical and biological sciences as they apply to drug
action is:
A) Biology B) Biopharmaceutics C) Pharmacokinetics D) A and C
B 584. A term derived from the Latin word “macerare” means:

A) Digestion B) Maceration C) Percolation D) Infusion
D 585. Plasters when applied to the body produce:

A) Occlusive action B) Macerating action C) Rubefacient D) A and B
B 586. A type of extract that can be used for semisolid preparation is:
A) Powdered B) Pilular C) Semiliquid D) A and C
A 587. Percolation process using boiling water as the menstruum is :

A) Process B B) Process A C) Process D D) Process C
C 588. A suppository base that is water-soluble is:

A) Cocoa butter B) Theobroma oil C) Polyethylene glycols D) Glycerinated gelatin
B 589. An example of plant exudates except:
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A) Resins B) Tannins C) Resins D) Balsams
B 590. Percolation process using pressure and suitable for commercial purposes is:
A) Process A B) Process C C) Process D D) Process B
C 591. An ointment base used for diadermic ointment preparation is:

A) Hydrocarbon base B) Absorption base C) Greaseless ointment base D) Cream base
A 592. Powders which at one time was official as 1:1 dilution is called:
A) Triturations B) Insufflations C) Bulk powders D) Divided powders
C 593. Characteristics of poultices when applied to the skin, except:

A) Apply while warm C) Relieves gastric pain
B) Spread over muslin cloth before application D) Relieves muscle pain and inflammation
B 594. Example of hydrocarbon obtained from petroleum and used as ointment bases are:
A) Petrolatum B) Propylene glycols C) Paraffin D) Mineral oil
C 595. Tinctures may be prepared from the following sources except:

A) Animal source B) Plant source C) Soil D) Chemical source
B 596. Refined wool fat used as base for semisolid is also called:
A) Lanolin B) Anhydrous lanolin C) Beeswax D) Petrolatum
D 597. Characteristics of topical aerosols:

A) Applied without using the fingertips C) Requires an applicator in the spread of the aerosol
B) Expensive packaging D) A and B
B 598. Film-coating consist of the following ingredients except:

A) Cellulose acetate phthalate B) Shellac C) Beeswax D) Vanillin
C 599. Colorants are added to pharmaceutical preparations for following purposes except:
A) For aesthetic value C) For higher price of the product
B) To distinguish one product from another D) For elegance
D 600. Syrups may be prepared by:

A) Solution of ingredients with heat C) By maceration
B) Percolation D) A and B
A 601. When a solvent at a given temperature has dissolved all of the solute it can, it is:
A) Saturated B) Supersaturated C) Solution D) Suspension
B 602. Magnesium citrate solution resulting from mixing citric acid with magnesium carbonate is prepared by:
A) Simple solution B) Chemical reaction C) Dispersion D) Extraction
B 603. A type of tablet for delayed release of medication is:

A) Chewable B) Sustained release C) Compressed D) Effervescent
D 604. Solid dosage forms administered other than oral route:

A) Pellets B) Vaginal tablets C) Troches D) A and B
A 605. Type of sterilization using steam under pressure is:

A) Moist heat B) Dry heat C) Microfiltration D) Inspissation
A 606. Examples of sterile products:

A) Dialysis solutions B) Pellets C) Cough syrups D) A and B
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Philippine Association of Colleges of Pharmacy
PHARMACEUTICAL DOSAGE FORMS QUESTION
1. It is the process of comminution in which a paste is formed by combining the powder

material and a small amount of liquid in which the powder is insoluble.
I. levigation III. Spatulation
II. Pulverization by intervention
A. I only D. II and III
B. III only E. I, II and III
C. I and II
2. Powders containing deliquescent and hygroscopic materials should be wrapped in
what kind of paper?
I.Vegetable parchment III.Waxed paper
II.Glassine paper
B. III only E. I,II and III
C. I and II
3. This method is used when a small amount of potent substances is to be mixed
with a large amount of diluents.
A. Block and divide method C. geometric dilution E. trituration
B. Spatulation D. sifting
4. In preparing effervescent granulated salts, which of the following statement/s hold/s
true?
I. Effervescent granules can be prepared using two methods, the dry and
wet methods.
II. The effervcence from the released CO2 serves to mask the bitter or salty
taste of drugs.
III. Using tartaric acid as the sole acid would result in a sticky mixture which is
difficult to granulate.
A. I only C. I and II E. I, II and III
B. III only D. II and III
5. Which of the following powders can be classified as bulk powders?

I. Douche III. Insufflation
II. Dusting powder

C. I and II E. I, II and III
B. III only
6. The following statement/s hold/s true for capsules:

I. They are solid dosage forms in which material agents &/ or inert
substance are enclosed within a small shell of gelatin.
II. Gelatin capsules may be hard or soft depending on their composition.
III. Soft gelatin capsules are used by community pharmacist in the
extemporaneous compounding of prescriptions.
7. Normally how many % of water is contained in a hard gelatin capsule?
A. 8-10 C. 20-25 E.5-10
B. 12-16 D. 2-5
8. The largest size of hard, empty capsule that can be swallowed is :
A. 00 C. 00 E. 0
B. 000 D. 5
9. The following statement/s is/are true:
I. Gelatin is obtained by the partial hydrolysis of collagen obtained from the
skin, white connective tissue and bones of animals.
II. Although gelatin is insoluble in cold water, it does soften through the
absorption of up to ten times the weight of the water.
III. Gelatin is soluble in hot water and in warm gastric fluid; a gelatin capsule
rapidly dissolves and exposes its contents.
B. III only E. I, II and III
C. I and II
10. Prolonged exposure to high humidity can affect in vitro dissolution of capsules
containing:
I. tetracycline
II. Chloramphenicol
III. Nitrofurantoin
11. This chemical agent is used to render the capsule opaque:
A. titanium dioxide C. Magnesium oxide E. lactose
B. Sorbitol D. Silica
12. The following statement/s is/are true for soft gelatin capsules (SGC):
I. SGC is made of gelatin to which glycerin or a polyhydric alcohol has been
added.
II. Methyl parabens can be used as preservatives to retard microbial growth.
III.SCGs can be prepared using the “punch” method and also require opaquants
to reduce transparency and render characteristics feature to the capsule shell.
13. Types of liquids that may be encapsulated into soft gelatin capsules include the
following:
I. Vegetable and aromatic oils
II. Propylene glycol
III. Polyethylene glycols
14. Substances added to capsules must possess the following characteristic/s:
I. Are harmless in the quantities used
II. Do not exceed the minimum amounts required to provide their intended effect
III. Do not impair the product’s bioavailability, therapeutic efficacy or safety
15. These are compressed tablets coated with substances that resist dissolution in
gastric fluid but integrate in the intestine.
I. Film-coated tablets III. Enteric-coated tablets
II. Sugar-coated tablets
16. This type of coating imparts the same general characteristics as sugar coating with
the added advantage of greatly reduced time period required for the coating operation.
I. Enteric coating III. Film coating
II. Single-layer coating
17. These tablets were originally used by physicians in the extemporaneous preparation
of parenteral solutions.
I. Chewable tablets III. Hypodermic tablets
II. Dispensing tablets
18. Enteric-coated tablets have the following characteristic/s:
I. Have delayed-release features
II. The containing system used should only be aqueous-based and not organic-
solvent based to resist the breakdown in gastric fluids
III. Are intended to pass through the stomach intact to disintegrate and release their
drug-content for absorption along the intestines
A. I only C. I and III E. I, II and III
B. II & III D. III only
19. Example of materials used in enteric coating includes:
I. Shellac III. Polyvinyl acetate phthalate
II. Cellulose acetate phthalate
A. I only C. II only E. I, II and III
B. I and II D. II and III
20. The following statement/s is/are true for compressed tablets:

I. These are tablets formed by compression and may contain other special coating
if desired.
II. Tablet diameters and shapes are determined by the die and punches used in the
compression of the tablet.
III. They are made from powdered, crystalline or granular materials, alone or in
combination with binders, disintegrants, controlled-release polymers, lubricants,
diluents and colorants.
A. I only C. II only E. I, II and III
B. I and II D. II and III
21. This is a method of preparing tablets in which the powder mixture is compacted in
large pieces and subsequently broken down or sized into granules.
A. Wet granulation C. Direct compression
B. Dry granulation
22. For some granular chemicals like potassium chloride, this method of preparation is
of an advantage to use.
A. Wet granulation
B. Dry granulation
C. Direct compression
23. The problems most commonly encountered during direct compression include:
I. Capping III. Lamination
II. Splitting
A. I only D. III only
B. II and III E. I, II and III
C. I and III
24. For chemicals which do not possess cohesive and free-following properties, the
following excipients could be used to impart necessary qualities for the production of
tablets b direct compression.
I. Spray-dried lactose III. Fume silicon dioxide
II. Magnesium stearate
A. I only D. II only
B. I and II E. I, II and III
C. II and III
25. The following statement/s is/are true for wet granulation method:
I. Liquid binder is added to the powder mixture to facilitate the adhesion of the
powder particles
II. Over-wetting of the powder can result in granules that are too soft for proper
tableting and under-wetting can result in tablets that are too hard
III. Granules may be dried in thermostatically controlled ovens which constantly
record the time, temperature and humidity.
A. I only C. I & III E. I, II, III
B. I & II D. II & III
26. Lubricants contribute to the preparation of compressed tablets by:
I. Improving the flow of granulation in the hopper to die cavity
II. Preventing the adhesion of the tablet formulation to the punches and dies during
compression
III. Reducing friction between the tablet and die wall during the tablet’s ejection from
the tablet machine
A. I only B. I & II C. I & III
D. II & III E. I, II, III
27. A fluid-bed granulator performs which of the following steps?
I. Preblends the formulation powder, including active ingredients, fillers,

disintegrants, in a bed by fluidized air.
II. Granulates the mixture by spraying onto the fluidized powder bed, suitable liquid
binder, as an aqueous solution of acacia, hydroxypropyl cellulose or povidone
III. Drying the granulated product to the desired moisture content

28. Dry granulation:
Used for tablet
I. Ingredients that is sensitive to moisture or unable to withstand elevated
temperature during drying
II. One of the constituents, either the active ingredient or the diluents, must
have cohesive properties
III. Includes more number of steps than wet granulation

29. Aspirin, which is hydrolyzed on exposure to moisture, is prepared into tablet using
the dry granulation method. Other drugs which should be prepared using this process
include:
I. Ascorbic acid II. Methenamine III. Thiamine HCl
30. This process is a form of pelletization, which refers to the formation of spherical
particles from wet granulations.
A. Spheronization C. Compaction E. Double
B. Slugging D. Precompression compression
31. This method consists of bringing together a highly dispersed liquid and a sufficient
volume of hot air to produce evaporation and drying of the liquid droplets.
A. Spray drying C. Spray chilling E. Dry heating
B. Spray congealing D. Moist heating
32. Spray-dried powder particles possess the following characteristic/s:
I. They are homogenous, approximately spherical in shape and nearly uniform in
size.
II. Have low bulk density with rapid rate of solution
III. Preparation is less economical than other processes
A. I only B. III only C. I & II
33. This the only carbohydrate used in the preparation of compressed tablet which
possesses high heat stability.
A. lactose C. sucrose E. fructose
B. mannitol D. starch
34. The following statement/s is/are true used in the preparation of sugar-free chewable
tablets?
I. Mannitol is used as the excipient in most chewable tablets.
II. These tablets are formulated to disintegrate smoothly in the mouth with or
without active chewing.
III. These tablets are particularly useful for children and adults who have difficulty
swallowing other solid dosage forms
35. Which excipient/s is/are used in the preparation of sugar-free chewable tablets?
I. Lactose
II. Dextrose
III. Xylitol
A. I only C. I & II E. I, II, III
B. III only D. II & III
36. Tablet coating has the following advantage/s:
I. Protect the medicinal agent destructive exposure to air and/or humidity
II. Mask the unpleasant taste of the drug
III. Provide special characteristics of drug release
A. I only C. II & III E. I, II, III
B. I & II D. I & III
37. Film coated tablets possess the following characteristic/s:
I. Less resistant to destruction by abrasion than are sugar coated tablets
II. Coating may be colored to make tablets attractive and distinctive
III. Film-coating solutions may be non-aqueous or aqueous
A. I only C. II only E. III only
38. This substance provides water solubility or permeability to the film to ensure
penetration by body fluids and therapeutic availability of the drug.
A. alloying substance C. film former E. glossant
B. Plasticizer D. surfactant
39. Problems encountered on the use of aqueous based film coating solution include:
I. Slow evaporation of the solvent-based solutions
II. Expensive as compared to volatile solvents
III. Increased likelihood of water interference with the tablet formulation
A.I only C. I & III E. I, II, III
40. AQUACOAT is a commercially available water-based colloidal coating dispersion
which contains 30% ethyl cellulose pseudolatex. Pseudolatex dispersion has:
I. A high solid content for greater coating activity
II. Low viscosity which allows less water to be used in the coating dispersion
III. Low viscosity which permits greater coat penetration into the crevices of
monogrammed or scored tablets

41. This is a problem often encountered in film coating process characterized by
roughness of the tablet surface due to failure of spray droplets to coalesce.
A. peeling C. orange-peel effect E. bridging
B. picking D. mottling
42. This problem corresponds to the filling-in of the score line or indented logo on the
tablet by the film.
43. This problem is characterized by the appearance of small amounts of film fragments
flaking from the tablet surface.
44. The following statement/s is/are true for pills:
I. Are small, round, solid dosage form containing a medicinal agents and intended
to be administered orally
II. Have been replaced today by compressed tablets and capsules
III. Are placed in the mouth, where they dissolve slowly, liberating the active
ingredient
45. These are forms of oral medication which are discoid-shaped solids containing the
medicinal agent in a suitably flavored base.
I. Troches
II. Pastilles
III. Lozenges
46. The following drug is/are available in pellet forms:
I. Testosterone III. Desoxycorticoster
II. Estradiol one
47. This type of dosage form allows a reduction in dosing frequency to that presented
by a conventional dosage form.
A. Extended-release C. Repeat action E. Targeted release
B. Delayed-release D. Modified-release
48. This type dosage form is designed to release the drug form at a time other than
promptly after administration.
49. The following statement/s hold/s true for extended-release dosage forms:
I. There is reduction in drug blood level fluctuations.
II. There is frequency reduction in dosing
III. There is reduction in terms of adverse side effects.
A. I only C. II only E. I, II, III
50. In general, the drugs best suited for incorporation into an extended-release product
have the following characteristic/s:
I. Exhibit either very slow or very fast rates of absorption and excretion
II. Are uniformly absorbed from the gastrointestinal tract
III. Used in the treatment of acute rather than chronic conditions
A. I only C. II only E. III only
51. This is process by which solids, liquids or even gases may be encapsulated into
miscroscopic size particles through the formation of thin coating of “wall” material
around the substance being encapsulated.
I. Microencapsulation
II. Microscoencapsulation
III. Micromeritics

52. The following statement/s is/are true when embedding drug in inert plastic matrix:
I. The drug is granulated with an inert plastic material such as polyethylene and the
granulation is compressed into tablets
II. The drug is rapidly released from the inert plastic matrix by diffusion.
III. The compression of the tablet creates the matrix or plastic form that retains its
shape during the leaching of the drug and through its passage through the
alimentary tract.
53. The effectiveness of the hydrophilic matrix systems is based on the successive
processes of:
I. Hydration of the cellulose polymer
II. Gel formation on the polymer’s surface
III. Tablet erosion and subsequent and continuous release of the drug
54. Which of the following statement/s on drug release form the dosage form is correct:
I. The release of the drug in a drug-resin complex is dependent upon the pH of the
GIT only.
II. The release of the drug in a drug-resin complex is dependent upon the pH and
the electrolyte concentration in the GIT.
III. Release is less in the acidity of the stomach than in the less acidic environment
of the small intestines.
A. Only the first statement is true
B. Only the second statement is true
C. The first two statements are true
D. The last two statement are true
E. All the true
55. These tablets are prepared so that an initial dose of drug is released immediately
followed later by a second dose.
56. The following statement/s is/are true for ophthalmic inserts:
I. Eliminates the problem of rapid loss of administered drug due to the blinking of
the eye and flushing of lacrimal fluids
II. The rate of drug diffusions is controlled by the polymer composition, membrane
thickness, and solubility of the drug.
III. Ocusert and lacrisert are example of ophthalmic inserts
57. These are solid dosage forms which are designed to be inserted under the skin by
special injectors or by surgical incision.
A. Implants C. Plasters E. Troches
B. Cachets D. Pills
58. The following should be observed in the use of oral modified-release dosage forms:
I. These products should not be crushed or chewed.
II. Nonerodible plastic matrix shells and osmotic tablets remain intact throughout GI
transmit and empty shell or “ghost” from osmotic tablets may be seen in stool
III. Patients being fed by enteral nutrition through a nasogastric feeding tube should
not receive this type of drug.
59. The release of a drug from an oral dosage form may be intentionally delayed until it
reaches the intestines for several reasons. The purpose may be:
A. to protect the drug destroyed by gastric fluids
B. to reduce gastric distress caused by drugs particularly irritating to the stomach
C. to facilitate GI transit for drugs which are better absorbed from the intestines
D. A & B only
E. AOTA
60. It is the most common “wall” forming material used in microencapsulation.
A. lactose C. dextrose E. starch
B. gelatin D. sorbitol
61. The following statement/s is/are true for ointments:
I. These are semi-solid preparations intended for external application to the skin or
mucous membranes.
II. They may be medicated or nonmedicated
III. Nonmedicated ointments are used as protectants, emollients or lubricants.
B. I & II D. III only
62. The following statement/s is/are true for hydrocarbon bases:
I. Also termed as oleaginous bases
II. Have an emollient effect and are effective as occlusive dressing
III. Permit the incorporation of powdered substances with the use of a levigating
agent
63. Yellow ointment is an example of
A. Hydrocarbon base D. Water-removable
B. Oleaginous base base
C. Absorption base E. A& B
64. The following ointment base/s is/are classified as hydrocarbon base/s:
I. Petrolatum
II. White ointment
III. Polyethylene Glycol Ointment
65. Petrolatum, USP is:
A. A purified mixture of semi-solid hydrocarbons from petroleum that has been
wholly or nearly decolorized
B. Also known as Yellow ointment
C. Is also known as white Vaseline
D. Water-soluble
E. Water-washable
66. Yellow ointment USP is:
I. Also called as “Simple Ointment”
II. Has Yellow wax and petrolatum as the main ingredients
III. Bleached and purified wax obtained from the honeycomb of the bee, Apis
mellifera
67. The following statement/s is/are true for absorption bases:
These bases permit the incorporation of aqueous solution resulting in the formation of
water-in-oil emulsions
These bases are not easily removed from the skin with water
These bases may be used as emollient although they do not provide the degree of
occlusions afforded by hydrocarbon bases.
68. Hydrophilic petrolatum is:
A. Hydrocarbon base
B. Oleaginous base
C. Absorption base
D. Water-removable base
E. Water-soluble
69. Lanolin USP:
I. Is classified as hydrocarbon ointment base
II. Contains not more than 2% of water
III. Is a purified, wax-like substance that has been cleaned, deodorized and
decolorized
70. These are ointment bases which resemble creams in appearance.
A. Hydrocarbon base
B. Water-soluble base
C. Absorption base
E. Oleaginous base
71. The following statement/s is/are true for Hydrophilic Ointment USP:
I. When preparing, stearyl alcohol and white petrolatum are melted together at 90
degrees
II. Stearyl alcohol and white petrolatum comprise the oleaginous phase of the
emulsion
III. Sodium lauryl sulfate acts as the emulsifying agent
A. I only D. II & III
B. III only E. I, II, III
C. I & II
72. These ointment bases are referred to as “greaseless” bases.
A. Hydrocarbon base
C. Absorption base
E. Oleaginous base
73. Polyethylene glycol Ointment, NF is:
A. Hydrocarbon base
C. Absorption base
E. Oleaginous base
74. The following statement/s is/are true for ointment base:
I. Water-soluble bases have the ability to absorb serous discharges
II. Hydrocarbon bases can remain on the skin for prolonged periods of time without
drying out
III. Water-removable bases can also be called as water-soluble bases.
B. I & II D. II only
75. The following statement/s is/are true for the preparation of ointment using the
incorporation method
I. By this method, the components are mixed until a uniform preparation is attained
II. This method does not involved the process of levigating
III. Mortar and pestle or spatula may be used to rub the ingredients together on an
ointment slab
76. The following statement/s is/are true about levigation:
I. Levigation allows both reduction of particle size and the dispersion of the
substance in the vehicle.
II. Glycerin is the levigating agent used for bases where water is the external phase
III. The amount of levigating agent used should be about equal in volume to the solid
maerial.
77. The following statement/s is/are true for the preparation of ointments by fusion:
I. All or some of the components of an ointment are combined by being melted
together and cooled with constant stirring until congealed.
II. Heat-labile substances are added last when the temperature of the mixture is low
enough.
III. Medicated ointments containing beeswax, paraffin, stearyl alcohol are prepared
using this method.
78. These are semi-solid preparation containing one or more medicinal agents
dissolved or dispersed in either an oil-in-water emulsions or in another type of water-
washable base.
A. Creams C. paste E. lotion
B. gel D. ointments
79. The following statement/s is/are true:
I. Vanishing creams are water-in-oil emulsions containing small amounts of water.
II. Creams find primary application in topical skin products and in products used rectally
and vaginally
III.Ointments are preferred more by patients due to ease of spreadability
80. These are semi-solid systems consisting of dispersion of small or large molecules in
an aqueous liquid vehicle rendered jelly-like through the addition of a gelling agent.
A. Creams C. Gelatin E. Pastes
B. Gel D. Ointments
81. The following statement/s is/are true regarding gels:
I. Gels may thicken on standing, forming a thixotrope and must be shaken before
use.
II. Milk of magnesia is an example of a single-phase gel
III. Gels and jellies are two different terms
82. The following statement/s is/are true for pastes:
I. They generally contain a smaller proportion of solid material than ointments.
II. They are less greasy and less stiffer than their counterpart ointments due to
reduced amount of based used.
III. They remain in place after application and are effectively employed to absorb
serous secretions.
A. I only C. I&III E. I, II, III
B. I&II D. III only
83. Zinc oxide paste:
I. Can be applied to hairy parts of the body
II. Prepared by levigating and mixing 25% each of zinc oxide and starch with white
petrolatum
III. Also known as Lassar’s Plain Zinc Paste
A. I only C. I&III E. I, II
B. III only D. II&III
84. These are solid or semi-solid adhesive masses spread upon a backing material of
Paper, fabric, moleskin or plastic
A. Creams
B. Plasters
C. Paste
D. Ointments
E. Lotion
85. How many % of glycerin is contained in a glycerogelatin preparation?
A. 15% C. 40% E. 10%
B. 35% D. 5%
86. The following statement/s is/are true for glycerogelatins:
I. They are applied to the skin for long term residence
II. They are intended to be swallowed just like gelatin capsules
III. They are applied to the affected area with affine brush
87. Zinc Gelatin:
I. Jelly
II. Used to treat varicose ulcers
III. Glycerogelatin
88. The following statement/s is/are true for topical agents:
I. Pastes offer even greater occlusion and more effective than ointment at
absorbing serous discharge
II. Ointment spread more easily than creams.
III. These agents also include ophthalmic solutions, suspensions, and inserts.
A. I only B. III only C. I&III
D. II&III E. I, II, III
89. The ointment base selected for an ophthalmic ointment must possess the following
characteristic/s:
I. Non-irritating to the eye
II. Permits the diffusion of the medicinal substance throughout the secretions
bathing the eye
III. Have a softening point close to the body temperature
90. The use of ophthalmic ointments and gels offers the following advantage/s:
Provides extended residence time on the surface of the eye
Blurring of vision can be encountered
Increase the bioavailability for absorption into ocular tissues
91. The factor/s which play/s a part in percutaneous absorption is/are:
I. Molecular weight III. solubility
II. Partitioning coefficient
A.I only C. I&II E. I, II, III
B. II only D. II&III
92. The following statement/s is/are true about percutaneous absorption:
I. The amount of drug percutaneously absorbed per unit of surface area per time
interval increase as the concentration of the drug substance in the transdermal
drug delivery system is increased.
II. The hydration of the skin hinders percutaneous absorption
III. The longer the period of time the medicated application is permitted to remain in
contact with the skin, the greater will be the total drug absorption.
93. The following statement/s is/are true about percutaneous absorption:
I. Drugs penetrate through the skin better in their unionized form.
II. Non-polar drugs tend to cross the cell barrier through the lipid-rich regions
(transcellular route) whereas the polar drugs favor transport between cells
(intracellular)
III. More drugs are absorbed when the drug substance is applied and concentrated
on a smaller surface area.
94. The selection of a permeation enhancer in developing a TDDS should be based on:
I. Efficacy in enhancing skin permeation
II. Biocompatibility with other components
III. Physicochemical compatibility with other components
95. The design objectives of TDDS include:
I. To deliver the drug at an optimal rate of the skin for percutaneous absorption at
the therapeutic levels
II. To adhere well to the patient’s skin and have a patch-size, appearance and site-
placement that encourage patient acceptance
III. To occlude the skin to ensure the one-way flux of the drug into the stratum
corneum
96. Transdermal Drug Delivery System:
I. Avoids gastrointestinal drug absorption difficulties
II. Avoids the occurrence of contact dermatitis
III. Drug therapy cannot be terminated rapidly.
97. The following can be formulated as TDDS
I. Scopolamine
II. Nicotine
III. Clonidine
98. Which of the following statement should be considered in the use of TDDS?
I. Rotating locations within the recommended site should be avoided in the
application of replacement patches.
II. Wet or moist skin can hinder drug permeation beyond that which is intended
III. Use of skin lotions should be avoided at the application site because they affect
skin hydration and can also alter the partition coefficient between the drug in the
TDDS and the skin.
99. This layer functions to store and release the drug at the skin-site.
A. occlusive backing membrane
B. release-liner
C. matrix system
D. hydrophilic layer
E. Adhesive layer
100. TDDS offers the following advantage/s:
I. Avoid first-pass effect
II. Provide extended therapy with a single application
III. Non-invasive
101. The following statement/s hold/s true for suppositories:
I. They are solid dosage forms of various weights and shapes, usually medicated,
for insertion into the rectum, vagina, or urethra.
II. After insertion, they soften, melt, disperse or dissolve in the cavity fluids.
III. They are intended to exert local effects only.
102. Pessaries:
I. Usually globular or oviform and weighs 2g each when cocoa butter is the base
II. Employed principally to combat infections occurring in the female genitourinary
area
III. The most commonly used base consist of combination of the various molecular
weight PEG

103. Rectal suppositories:
I. Pediatric suppositories are more narrow and pencil-shaped than the typical
bullet-shaped adult suppository
II. Suppositories intended for female are about half the length and weight of the
male counterpart.
III. Have both local and systemic effects
A. I only C. I&II E. I, II, III
B. III only D. I&III
104. The following statement is/are true:
I. The dose of the drug administered rectally may be greater than or less than the
dose of the same drug given orally.
II. A rectum that is void offers greater absorption than a rectum distended with fecal
matter.
III. Lymphatic circulation is not involved in the absorption of rectally administered
drugs.

105. Rectal absorption is affected by both physiologic and physicochemical factors.
Physiologic factors would include:
I. pH
II. colonic contents
III. lack of buffering capacity
106. In choosing a suppository base, one needs to assess if:
I. The base remains solid at room temperature but softens, melts or dissolves
readily at body temperature
II. The active ingredient would be released more readily from the base
III. The base is compatible with the other components in all aspects

107. Glyceryl monopalmitate is an example of this type of suppository base.
A. Fatty base C. Water-soluble base E. Absorption base
B. Water-miscible base D. Miscellaneous base
108. This type of suppository base includes mixtures of fatty and water-soluble bases.
A. Fatty base
B. Water-miscible base D. Miscellaneous base
C. Water-soluble base E. Absorption base
109. Cocoa butter:
I. Because of triglyceride content, it exhibits marked polymorphism
II. Phenol and chloral hydrate can increase its melting point when incorporated with
it.
III. The β form has a greater stability and melting point.

110. This suppository base is the most frequently used for vaginal suppositories.
A. glycerinated glycerin
B. PEG
C. cocoa butter
D. polyoxyl 40
E. Wecobee base
111. the most frequently employed method in the preparation of suppositories both on
small scale and on industrial scale is:
A. molding C. hand rolling E. melting
B. compression D. hand shaping
112. Suppositories of which ointment bases are suitable for preparation by molding?
I. Cocoa butter
II. Glycerinated gelatin
III. PEG
113. In the preparation for compression into molds, the suppository base and other
formulative ingredients are combined by thorough mixing. Which of the following
statement/s hold/s true for this method?
I. Friction causes the base to soften into a paste like consistency.
II. Compression is suited for making suppositories containing medicinal substances
that are heat stable
III. Mortar and pestle can be used for small scale preparations.
114. The pharmacist should inform the patient about the proper use of suppositories.
This should include:
I. Suppositories should be allowed to warm to room temperature before insertion if
they are to be stored in a refrigerator.
II. Glycerinated gelatin or PEG suppositories should not be allowed to come in
contact with moisture in any case.
III. Bullet-shaped rectal suppositories should be inserted point-end first.

115. The packaging and storage of the suppositories is very important to prevent the
environment and moisture induced deterioration or loss of activity. The guidelines for
packing and storage should include:
I. Suppositories from cocoa butter base are usually individually wrapped or
otherwise separated in compartmentalized boxes.
II. Suppositories from cocoa butter base must be stored below 30◦C preferably in a
refrigerator.
III. Suppositories from PEG bases may be stored at usual room temperature without
the requirement for refrigeration.
116. Solutions are liquid preparations that contain one or more chemical substances
dissolved in a suitable solvent or mixture of mutually miscible solvents. Which of the
following solvents may be used in the preparation of solutions?
I. Alcohol USP III. Glycerin, USP
II. Propylene Glycol, USP
117. Next to water, alcohol is the most useful solvent in pharmacy. The following
statement/s is/are true for alcohol:
I. It is preferred often because of its miscibility with water and its ability to dissolve
many water-insoluble ingredients.
II. When alcohol is already used, propylene glycol should not be added anymore
because the two solvents are immiscible
III. Alcohol USP contains not less than 99.5% C2H5OH by volume.
118. Glycerin is a clear syrupy liquid with a sweet taste and may be used as a solvent
for the preparation of solutions. Other feature/s of this solvent is/are:
I. Miscible with water but not with alcohol
II. Has preservative qualities and is used as stabilizer
III. Solutes are slowly soluble in it unless rendered less viscous by heating
119. Ordinary drinking water obtained from tap is not generally acceptable for the
manufacture of most aqueous pharmaceutical preparations or for the extemporaneous
compounding of prescription mainly because of:
I. The chemical incompatibilities that may result from the combination of dissolved
solids present and the medicinal agent being added
II. Precipitation, discoloration and occasional effervescence
III. The difference between the use of purified and ordinary tap water is of no
consequence.
120. Purified water, USP:
I. Obtained by distillation, ion-exchange treatment, reverse osmosis or other
suitable process
II. Intended for use in the preparation of aqueous dosage forms other than
parenterals
III. 1000 times more free of dissolved solids than is water
121. The main methods used in the preparation of purified water are distillation and ion-
exchange. In distillation:
I. The first 5% of the aqueous distillate must be discarded
II. The last portion of the water about 100% of original volume, remaining in the
distillation apparatus must be discarded
III. Water purified in this manner is referred to as demineralized water
B. II only D. II & III
122. The ion-exchanged process involves the passage of water through a column of
cation and anion exchangers. As compared to the distillation process, this method:
I. Has simpler equipment and thus, permits case of operation
II. Eliminates the use of heat
III. Has costly and troublesome maintenance of equipment
A. I only D. II & III
B. I & II E. I, II, III
C. I & III
123. Water impurities like calcium and magnesium can be removed by:
A. ion-exchange
B. absorption
C. filtration
D. distillation
E. reverse osmosis
124. This method of preparing purified water removes virtually all virus, bacteria,
pyrogens, organic molecules and 90-99% of all ions.
I. Distillation
II. Ion-exchange
III. Reverse osmosis
A. I only C. III only E. I, II, III
125. Some chemicals are only slowly soluble and require an extended time for
dissolving. In this case, the pharmacist should employ:
I. Application of heat
II. Reduction of the particle of the solute
III. Rigorous agitation during the preparation
126. The following statement/s is/are true for the application of heat in the dissolution of
some chemicals in a particular solvent:
I. Many medicinal agents are destroyed at elevated temperature and the
advantage of rapid solution may be completely offset by deterioration.
II. Elevated temperatures cannot be maintained for pharmaceuticals and the net
effect of heat is simply an increase in solubility
III. Application of heat for calcium salts is highly recommendable.
127. Certain antibiotics which have insufficient stability in aqueous solutions are
available in dry powder mixtures ready for reconstitution. Example of these mixtures
would include:
I. Cloxacillin Na for oral solution
II. Oxacillin Na for oral solution
III. Penicillin V Potassium for oral solution
128. Magnesium Citrate Oral Solution is a colorless to slightly yellow, clear, effervescent
liquid having a sweet, acidulous taste and lemon flavor. Which of the following
statement is/are correct regarding its preparation?
I. In carbonating the solution the bicarbonate may be added in tablet form rather
than as a powder.
II. Magnesium carbonate is reacted with excess citric acid.
III. It is required to contain an amount of magnesium citrate equivalent to
between 1.55 and 1.9 g MgO in each 100 mL
129. These are concentrated, aqueous preparations of a sugar or a sugar-substitute
with or without added flavoring agents and medicinal substances.
I. Syrups
II. Honeys
III. Juice
130. Most syrup contains the following component/s.
I. Flavorants
II. Colorants
III. Antimicrobial preservatives
131. Syrups are useful as diluting agents for water-soluble drugs and act as both
solvent and flavoring agents. Which medicated syrup can be used to disguise the taste
of urea?
I. Acacia syrup
II. Glycyrrhiza Syrup
III. Aromatic Eriodyctyon Syrup
B. II only D. I & III
132. Most syrup contains a high proportion of sucrose, usually 60-80%. Which of the
following statement/s hold/d true?
I. Sucrose is used because of its desirable sweetness and viscosity of such
solutions
II. The aqueous sugar medium of dilute sucrose solution is an efficient nutrient
medium for the growth of microorganisms.
III. Concentrated sugar solutions may no longer require addition of preservatives.
133. Syrup, NF:
I. Simple syrup
II. Prepared by dissolving 85g of sucrose in enough purified water to make 100 ml
III. Has a specific gravity of 1.313
134. The amount of preservative required to protect syrup against microbial growth
varies with the proportion of water available for growth. What is the usual effective
concentration of benzoic acid as a preservative?
A. 1% C. 0.1-0.2% E. 10%
B. 1-2% D. 0.01-0.02%
135. Example of preservatives used in the preparation of syrups would include:
I. Sodium benzoate
II. Glycerin
III. benzoic acid

136. Syrups are most frequently prepared depending on the physical and chemical
characteristic of the ingredients. This method would include:
I. Solution with the aid of heat
II. Solution by agitation without the aid of heat
III. Addition of sucrose to a Medicated Liquid or flavored liquid

137. Syrups prepared using solution with the aid of heat method applies when it is
desired to prepare the syrup as quickly as possible. However, there are limitations
on using this method and these limitations include:
I. Can be used only when the components are not damaged or volatilized by
heat
II. Inversion of sucrose might occur
III. Caramelization might occur
138. Which of the following statement/s is/are true?
I. Syrups prepared by solution by agitation without the aid of heat method is
more stable than syrups prepared with the aid of heat.
II. Syrups can be sterilized by autoclaving.
III. The viscous nature of syrups permits easy dissolution of the solids to be
added.
139. Which method is used in the preparation of ipecac syrup?
I. Solution with the aid of heat
II. Solution by agitation without the aid of heat
III. Percolation
140. Elixirs:
I. Are clear, sweetened, hydroalcoholic solutions intended for oral use
II. Can be medicted or nonmedicated like syrups
III. Those containing 2-5% alcohol are usually self preserving
141. The relative sweetness of aspartame when compared to sucrose is
A. 1:1 C. 180:1 E. 550:1
B. 30:1 D. 300:1
142. Compared with syrups, elixirs are:
I. Less sweet but more viscous
II. Less effective in masking the taste of medicinal substance
III. Sweeter but less viscous
143. Elixirs can be prepared by which method/s?
I. Solution by agitation
II. Admixture of Two or more liquid ingredients
III. Percolation
144. Tinctures are alcoholic or hydroalcoholic solutions prepared from vegetable
materials or from chemical substances.
The following statement/s is/are true about tinctures:
I. The alcoholic content protects against microbial growth and keeps the alcohol-
soluble extractives in solution.
II. They must be tightly stoppered and not exposed to excessive temperatures.
III. They contain high alcoholic content.
145. Tinctures of potent drugs for which no proportion of active principles has been
fixed, shall have the strength of:
A. 10% by weight
B. 20% by weight
C. 40% by weight
D. 50% by weight
146. These are aqueous or oleaginous solutions in the form of coarse droplets or as
finely divided solids to be applied topically, most usually to the nasal-pharyngeal tract or
skin.
A. Sprays C. lotions E. AOTA
B. inhalants D. tinctures
147. These are clear, saturated, aqueous solutions of volatile oil or other aromatic or
volatile substances.
A. medicated water
B. spirits
C. aromatic waters
D. A & C
E. AOTA
148. Aromatic waters may be prepared by distillation or solution of the aromatic
substance with or without the use of a dispersing agent. Example of these preparation
include:
I. Stronger rose water
II. Peppermint water
III. Peppermint spirit
149. Peppermint Spirit USP is prepared by:
A. Solution with maceration
B. Chemical reaction
C. Distillation
D. Fermentation
E. Simple solution
150. This preparation is an aqueous solution directed against a part or into a cavity of
the body.
A. douche C. enema E. insufflations
B. irrigation D. gargle
151. The following statement/s hold/s true for douches:
They function as cleansing or antiseptic agent
They are most frequently dispensed in the form of a powder with directions for
dissolving in a specified quantity of water
They are usually directed to the appropriate body part by using bulb syringes.
152. Enemas are employed to evacuate the bowel, influence the general system by
absorption or to affect a local disease.
Which of the following statement/s hold/s true for enemas?
I. They may possess anthelmintic, nutritive, sedative, or stimulating
properties
II. They may contain radiopaque substances for roentgenographic
examination of the lower bowel.
III. Evacuation enemas are to be retained in the intestine and should not be
used in larger quantities than 150 ml for an adult.
153. In using evacuation enemas, the pharmacist should advise the patient to:
I. Squeeze all of the contents out of the disposable plastic bottle
II. Gently insert the rectal tip with steady pressure
III. Take note that the product will most probably work within 5 to 10 minutes.
A. I only
B. II only
C. I & II
D. II & III
E. I, II, III
154. Because irrigation solutions come in contact with exposed tissues, they must meet
stringent requirements of the USP such as:
I. Sterility
II. Total solids
III. Bacterial endotoxins
155. Mucilages:
I. Are thick, viscid, adhesive liquids produced by dispersing gum in water
II. Are resistant to decomposition
III. Used primarily to aid in suspending insoluble substances in liquid
156. Acacia mucilage NF XII differs from Tragacanth Mucilage BPC in that:
I. Acacia mucilage contains alcohol and chloroform water while Tragacanth Mucilage
does not
II. Acacia mucilage contains benzoic acid as a preservative while Tragacanth Mucilage
does not
III. Acacia mucilage show maximum viscosity at pH 5.
A. I only B. II only C. I & II
157. Jellies are a class of gels in which the structural coherent matrix contains a high
portion of liquid usually water. They are used as lubricants for:
I. Surgical gloves
II. Catheters
III. Rectal thermometers
158. Pyroxylin is obtained by the action of which acid/s on cotton?
I. Nitric acid
II. Hydrochloric acid
III. Sulfuric acid
159. Pyroxylin consists chiefly of cellulose tetranitrate and has the appearance of raw
cotton when dry but is harsh to the touch. Other features of pyroxylin include:
I. Exceedingly flammable
II. Soluble in acetone but not in glacial acetic acid
III. One part is slowly but completely soluble in 25 parts of a mixture of 1 volume of
ether and 3 volume of alcohol.
160. Flexible collodion is prepared by adding castor oil and camphor to collodion. How
many percent of castor oil required in this preparation?
A. 3% C. 2% E. 1%
B. 5% D. 0.5%
161. Salicylic acid collodion contains how many percentage of salicylic acid in flexible
collodion?
A. 3% C. 10% E. 1%
B. 5% D. 15%
162. Salicylic acid collodion finds its use as:
I. Keratolytic agent III. Corn remover
II. Wart remover
163. Liniments are alcoholic or oleaginous solutions or emulsions of various medicinal
substances intended for external application to the skin with rubbing. They may be used
as:
I. Counterirritant II. Astringent III. rubefacient
164. The following statement/s is/are true for liniments:
I. They are not applied to broken skin because excessive irritation might result.
II. Oleaginous liniments are more irritating to the skin than alcoholic liniments
III. Oleaginous liniments are employed primarily when massage is desired.
B. II only D. I & II
165. Glycerin or glycerites contain ______of glycerin.
A. 50% C. 10% E. 0.5%
B. 25% D. 1%
166. These are concentrated preparations of vegetable or animal drugs obtained by the
removal of the active constituents of the respective drugs with the suitable menstrual
and evaporation of all or nearly all of the solvent.
A. fluid extract C. extractive E. macerate
B. distillate D. extraction
167. This is a method of extraction in which the properly comminuted drug is permitted
to soak in the menstruum until the cellular structure is softened and penetrated by the
menstruum and the soluble constituents is dissolved.
A. percolation C. decoction E. evaporation
B. infusion D. maceration
168. This method of extraction is a process in which the soluble constituent of a
comminuted drug is extracted by the slow passage of a suitable solvent through a
column of the drug.
A. percolation C. decoction E. evaporation
B. infusion D. maceration
169.These preparation are made so that each mL contains the therapeutic constituents
of 1g of the standard drug that it represents.
A. fluid extract C. extractive E. distillate
B. macerate D. infusate
170. This is a form of extract which is of a plastic consistency, prepared with nearly all
of the menstruum removed.
I. Pilular II. Solid III. Semiliquid
171. The particles of the dispersed phase vary widely in size, from large particles visible
to the naked eye down to the particles of colloidal dimensions, falling between 1.0nm
and 0.5 um in size. Dispersions containing particles of 10-50um in size are referred as:
A. coarse dispersions C. fine dispersions E. soluble dispersions
B. colloidal dispersions D. ultra-fine dispersions
172. Fine dispersion includes:
I. Emulsions II. Gels III. Magmas
173. Coarse dispersion includes:
I. Emulsions II. Gels III. Magmas
174. Suspensions are prepared because some drugs are chemically unstable when in
solution but stable when suspended. Other reason/s for preparing suspensions
include/s:
I. flexibility in the administration of certain doses
II. Ease of swallowing especially for children as compared to solids
III. The undesirable taste of the drugs can be masked.
175. Therapeutic efficacy, chemical stability of components and permanency of
preparation should all be considered in the preparation of suspensions. Other desirable
qualities of suspensions should include:
I. Settle slowly and be easily redispersed upon gentle shaking of container
II. The particle size if the suspensoid remains fairly constant throughout long periods of
undisturbed standing
III. The contents should pour easily and readily from its container.
176. Viscosity agent decreases the rate of settling of deffloculated particles or provides
the stability in flocculated suspensions. Other desirable qualities of suspension should
include/s:
I. Acacia gum III. Sodium carboxymethyl cellulose
II. PVP

177. This is a process of particle size reduction in which the shearing action of high
velocity compressed air stream on the particles in a confined space produces the
desired ultrafine or micronized particles.
I. micropulverization III. Fluid energy grinding
II. jet-milling
178. The following statement/s is/are true of flocs or floccules:
I. It is measures which avoid the formation of a cake in suspensions.
II. It has a less rigid or loose aggregation of particles held by weak particle-to-particle
bonding forces.
III. It settles more rapidly than fine particles
A. I only B. II only C. II & III
D. I & II E. I, II, III
179. Which of the following can function as flocculating agents?
I. Bentonite Magma III. Benzalkonium chloride
II. KCl
180. Wetting agents are used to make the powder more penetrable by the dispersion
medium. These agents include;
I. Glycerin II. PVP III. Alcohol
A. I only C. I & III
E. I, II, III
181. The following should be observed during packaging and storage of suspensions:
I. All suspensions should
II. They should be stored in tight containers protected from freezing, excessive heat and
light
III. Extemporaneously prepared suspensions should be placed in light resistant
containers.
182. In emulsion terminology, the dispersed phase is referred to as:
I. internal phase III. Continuous phase
II. External phase
183. If the oleaginous phase is the internal phase, then the emulsion is referred to as:
A. o/w emulsion C. w/o emulsion
B. o/w/o emulsion D. w/o/w emulsion
184. The absorption of which drugs can be enhanced when prepared n the form of oil-
in-water emulsion?
I. Griseofulvin II. Sulfonamides III. Vitamin A
185. Emulsions offer a number of advantages over other liquid dosage forms.These
include:
I. The therapeutic properties and the spreading ability of the constituents are increased
II. Taste or odor of oil can be masked partially or wholly
III. The absorption and the penetration of medicaments are controlled more easily
186. In preparation an emulsion, a third phase called the emulsifying agent is
necessary. Which of the following are classified as natural emulsifying agent/s?
I. Acacia
II. bentonite
III. lecithin
A. I only
B. II only
C. I & III
D. I & II
E. I, II, III
187. Synthetic emulsifying agents are most effective at lowering the interfacial tension
between the oil and water phases.
Examples of these agents include:
I. Veegum
II. Benzalkonium chloride
III. cholesterol
188. This theory of emulsification assumes monomolecular layers of emulsifying agent
curved around a droplet of the internal phase of the emulsion.
A. surface tension theory
B. plastic-film theory
C. oriented wedge theory
D. interfacial film theory
E. molecular layer theory
189. This theory places the emulsifying agent at the interface between the oil and water,
surrounding the droplets of the internal phase as thin layer of film adsorbed on the
surface of drops.
I. interfacial film theory III. molecular layer theory
II. interfacial film theory
190. This emulsifying agent has a disadvantage of producing emulsions that are too
fluid and which becomes more fluid upon standing.
A. gelatin C. egg yolk E. bentonite
B. casein D. lecithin
191. The following agent/s can be used as thickening agent/s:
I. agar
II. stearyl alcohol
III.cetylalcohol

192. In small scale extemporaneous preparation of emulsion, these methods may apply:
I. Dry gum method III. Forbes method
II. Wet gum method
193. In this method, the emulsifying agent is mixed with the oil before the addition of
water.
I. Dry gum method III. Forbes method
II. Wet gum method
194. Which of the following statement/s hold/s true for emulsion:
I. In its preparation, if alcohol is needed, add it directly to the primary emulsion to avoid
its volatilization.
II. Bottle method is suited for viscous oils
III. A mortar with a rough rather than smooth inner surface must be used in triturating
the emulsifier with oil in dry method preparation.
B. III only D. I & II
195. These are thermodynamically stable, optically transparent, isotropic mixtures of a
biphasic oil-water system stabilized with surfactant.
A. microemulsion C. W/O/W emulsion E. W/O emulsion
B. auxillary emulsion D. O/W emulsion
196. An emulsion is considered to be physically unstable if:
I. The internal or dispersed phase upon standing tends to form aggregates of globules
II. Large globules rise to the top or fall to the bottom of the emulsion to form a
concentrated layer of internal phase
III. All or part of the liquid of internal phase
197. Which of the following statement/s is/are true:
I. Creaming is a reversible process
II. Breaking is a reversible process
III. Sedimentation is an irreversible process
198. Mineral oil emulsion is a/an:
A. o/w emulsion C. w/o emulsion E. microemulsion
B. o/w/o D. w/o/w emulsion
199. This is used for preparing fluidextracts with boiling water as the menstruum,
alcohol being added as a preservative to a concentrated percolate.
A. Process A B. Process B C. Process D
D. Process E E. Process C
200. This is an alternative for process A in which percolation is conducted on a column
of drug much greater in length than in diameter.
A. Process A C. Process D E. Process C
B. Process B D. Process E
201. This is a percolation method that can be modified for fluidextracts that must be
assayed.
A. Process A C. Process D E. Process C
B. Process B D. Process E
202. It is the taking up of a certain amount of liquid without a measurable increase in
size.
A. Syneresis C. imbibition E.Xerogelation
B. Swelling D.Thixotrophy
203. Xerogels are formed when the liquid is removed from a gel and only the framework
remains. Examples of these are:
I. gelatin sheets III. Acacia tears
II. tragacanth ribbons
204. A classification of gels which would include ingredients that are dispersible as
colloidal or soluble in water is called hydrogels. Example of hydrogels includes:
I. Carbowax bases II. Bentonite III. Silica
205. Magnesium aluminum silicate, also known as Veegum, in concentrations of
_______, form firm, thixotropic gels.
A. 10% C. 2% E. 0.5%
B. 5% D. 1%
206. In the preparation of gels, the following statement/s hold/s true:
I. Inorganic salts would cause gelation to occur at higher concentrations.
II. Alcohol may cause precipitation or gelation
III. Higher concentration and higher molecular weights of polymers would produce
stronger gels.
207. Bentonite magma is a preparation of ____ bentonite, a native, colloidal hydrated
aluminum silicate, in purified water.
A. 10% C. 5% E. 0.5%
B. 2% D. 1%
208. Aluminum hydroxide gel is an aqueous suspension of a gelatinous precipitate
composed of insoluble aluminum hydroxide and the hydrated aluminum oxide,
equivalent to about ____of aluminum oxide.
A. 1% C. 5% E. 3%
B. 2% D. 4%
209. Milk of Magnesia, USP is a preparation containing between 7 and 8.5 % of
magnesium hydroxide. The following statement/s hold/s true regarding its preparation:
I. 0.1% citric acid may be added
II. Flavoring oils should exceed 0.05% concentration but not more than 2% to enhance
the palatability of the preparation.
III. The preparation should be stored in tight containers preferably at temperature above
and freezing and below 35◦C
210. Gels are defined as semi-solid systems consisting of dispersions made up of either
small inorganic particles or large organic molecules enclosing and interpenetrated by a
liquid. Other feature/s of these preparations include/s:
I. Some gels are clear as water in appearance while others are turbid.
II. Gels are considered as colloidal dispersions
III. Carbowaxes are gels
211. These are pressurized dosage forms containing one or more active ingredients
which upon actuation emit a fine dispersion of liquid and/or solid materials in gaseous
medium.
A. aerosols C. inhalations E. nebulizers
B. inhalers D. insufflators
212. Aerosols intended to carry the active ingredient to a surface are termed:
I. space spray II. Surface spray III. Surface coatings

213. Aerosols offer the advantages of:
I. portion of medication may be easily drawn from the package without contamination or
exposure to the remaining material
II. Topical medication may be applied in a uniform, thin layer to the skin without touching
the affected area
III. Protection of medicinal agents adversely affected by atmospheric oxygen and
moisture
214. Fluorinated hydrocarbon gases:
I. may be liquefied b cooling below their boiling point
II. May be liquefied by compressing the gas at room temperature
III. are liquid at room temp.
215. The usual aerosol valve assembly is composed of the following parts:
I. actuator II. Housing III. Gasket
216. Compressed gases may be used to prepare aerosols. The use of nitrogen:
I. will result in the emission of the product in essentially the same form as it was placed
in the container
II. Contributes adversely to the odor and taste of product
III. Offers protection on products subject to oxidation
217. These materials may be used in the manufacture of aerosol containers:
I. glass II. Metals III. Plastics
218. In compressed gas filled aerosols:
I. there is no reservoir of propellant
II. Lower gas pressures are required as compared to liquefied gas filled aerosols
III. Gases like carbon dioxide and nitrous oxide may be used
219. The use of topical aerosols:
I. can be used easily in applying medication to small area
II. The procedure of applying the preparation to desired surface area is less messy than
with most other types of topical preparations.
III. Provides a means of applying the drug in a convenient way
220. In the filling of aerosol containers with propellant, which of the following is/are
observed to be true?
I. In the cold method, both the product concentrate and the propellant must be cooled to
temperature of 30◦F to -40◦F
II. There is less danger of moisture contamination of the product in cold filling over the
pressure filling
III. Less propellant is lost in the process of pressure filling.
221. Sterile water for injection:
I. must be pyrogen-free
II. May not contain an antimicrobial agent
III. May contain a slightly greater amount of total solids than Water for Injection
222. Sterilization by filtration depends upon the removal of microorganisms by
adsorption on the filter medium or by sieving mechanism. Major advantages of this
method include:
I. speed in the filtration of small quantities of solution
II. Ability to sterilize effectively thermo labile materials
III. Inexpensive
223. Ethylene oxide:
I. may be used to sterilized heat-sensitive and moisture-sensitive materials
II. May be substituted by propylene oxide gas
III. exerts its action by denaturation and precipitation
224. This process means the complete destruction of all living organism and their
spores or their complete removal from the prepration.
A. Sterilization C. disinfection E. decontamination
B. asepsis D. antisepsis
225. USP specifies restrictions on the fixed vegetable oils which may be employed in
parenteral products. These include:
I. they must remain clear when cooled to 10◦C
II. They must not contain mineral oil or paraffin
III. They must contain no polyunsaturated fatty acids
226. Ringer’s Injection USP contains:
A. Sodium chloride only
B. Sodium chloride and potassium chloride
C. Sodium chloride and calcium chloride
D. Sodium chloride, potassium chloride and calcium chloride
E. Sodium chloride and sodium lactate
227. Bacteriostatic water for injection:
I. One or more antimicrobial agents
II. Packaged in pre-filled syringes or in vials containing not more than 100 ml
III. Only to be used in parenterals that are administered in small volumes
228. Single dose container:
I. Hermetic container
II. Example is ampul
III. Permits withdrawal of successive portions of the contents
229. In most heat sterilization, spores of which microorganism are most commonly
employed?
A. Bacillus stearothermophilus
B. Bacillus subtilis
C. Bacillus pumilus
D. Clostridium botulinum
E. Clostridium perfringens
230. Dry heat sterilization is usually carried out in sterilizing ovens specifically designed
for this purpose. Which of the following characterize/s this method?
I. Higher temperature and prolonged exposure are required
II. Works by denaturation and coagulation of some of the organism’s essential protein
III. May be used for fixed oils, mineral oil and petroleum products
A. I only
B. II only
C. I & III
D. II & III
E. I, II, III
231. It is an electrochemical method that enhances the transport of some solute
molecules by creating a potential gradient through the skin tissue with an applied
electrical current or voltage.
A. iontophoresis C. ultrasonophoresis E. electrophoresis
B. sonophoresis D. phonophoresis
232. Iontophoresis induces an increased migration of ionic drugs into the skin by
electrostatic repulsion at the active electrode: negative ions are delivered by the
cathode and positive ions by anode. The advantages of this process include:
I. Eliminates gastrointestinal incompatibility, erratic absorption and first pass metabolism
II. Reduces side effects and interpatient variability
III. Avoids the risks of infection, inflammation
233. Rapidly –dissolving drugs:
I. designed as orally administered drugs for patients that have difficulty swallowing
standard tablets/ capsules
II. disintegrate and dissolves within 30-60 seconds in the mouth
III. Friability is an inherent problem
234. The following statement/s is/are true for radiopharmaceuticals:
I. It is a radioactive pharmaceutical agent or drug that is used for diagnostic or
therapeutic procedures.
II. They are used as tracers of physiological processes.
III. Incidence of adverse effect is very low
235. This container protects the contents from extraneous solids and from loss of the
article under ordinary conditions of handling, shipment, storage and distribution.
A. well-closed container D. light-resistant container
B. tight container E. amber-colored bottle
C. hermetic container
236. A freezer is:
A. cold place C. excessively cold place
B. cool place D. refrigerator temperature
237. These injections are administered into the corium of the skin, usually in volumes of
about a tenth of a milliter.
A. intravenous C. intramuscular
B. intradermal D. epicutaneous
E. subcutaneous
238. Some drugs are administered rectally for their local effects and others for their
systemic effects. Which of the following are true regarding the rectal administration of
drugs?
I. Rectal administration may be preferred for those drugs destroyed or inactivated by the
environment of stomach and intestine
II. Approximately 505 of a dose of drug absorbed from rectal
III. Absorption of drugs from the rectum is frequently irregular and difficult to predict.
239. Subcutaneous administration of drugs involves their injection through the layers of
the skin into the loose subcutaneous tissue. Which of the following statement/s is/are
true about this kind of administration?
I. vasodilator may be used to enhance subcutaneous absorption of drugs
II. All substances, weather lipid soluble or not, cross the capillary membrane at rates
that are much more rapid than the rates of their transfer across other body membranes.
III. After injection, the drug comes into the immediate vicinity of blood capillaries and
permeates them by diffusion or filtration.
240.These substance are used to prevent the dying out of preparations due to the
agent’s ability to retain moisture.
A. levigating agent C. plasticizer E. occluding agents
B. humectant D. antioxidant
241. Glidants are agents used in tablet and capsule formulations to improve the flow
properties of the powder mixture. Examples of these are:
I. Talc III. magnesium stearate
II. colloidal silica
242. This is an agent used to dissolve another pharmaceutic substance or a drug in the
preparation of solution.
A. solvent C. chelating agent E. solubilizer
B. vehicle D. co-solvent
243. Butylated hydroxyanisole and butylated hydroxytoluene are examples of:
A. antioxidants C. clarifying agents E. co-solvents
B. humectants D. buffering agents
244. Cinnamon, orange and raspberry flavors may be used to make ____drugs more
palatable.
A. salty C. sour E. rancid
B. bitter D. pungent
245. Benzalkonium chloride, cresols, and phenylmercuric nitrates are examples of:
A. stiffening agent C. coloring agents E. ranti-oxidants
B. preservatives D. buffering agents
246. The term “soluble” refers to parts of solvent hat can dissolve one part of solute is:
A. 10-100 C. 10-30 E. 1-10
B. 30-100 D. less than 1
247. The similarity of gargles with mouthwashes is:
I. antiseptic use III.Formula
II. Site of action
248. It is a process of strongly heating organic substances with access to air.

A. Carbonization C. Ignition E. Drying
B. Calcinations D. Incineration
249. When tinctures are prepared from single vegetable drugs, the amounts of crude
drugs used to prepare 100 ml of the tincture generally for potent drug is:
A. 10g C. 50g E. 100g
B. 20g D. 75g
250. The following substances may be used as colorants:
I. caramel II. red ferric oxide III. yellow mercuric oxide
251. The release of an ingredient from the packaging component into the contents is
best described by the term:
A. sorption C. permeation E. dissolution
B. leaching D. diffusion
252. The disadvantages of using sodium saccharin as a sweetening agent is/are:
I. less sweet than sucrose
II. has a cariogenic potential and is contraindicated to phenylketonurics
III. has bitter after taste
253. The following method/s is/are considered as comminution technique/s:
I. Spatulation III. Pulverization by intervention
II. Trituration
254. Brandy and whisky are prepared by means of:
I. Distillation III. Chemical reaction
II. Solution with maceration
255. These are very fine powders intended for the different body cavities like ears,
nose, etc.
I. dusting powder II. douche powder III. insufflations
256. Vanishing creams are the most common creams available in the market due to
large amount of water contained and an acid called:
A. salicylic acid C. stearic acid E. undecylenic acid
B. benzoic acid D. acetic acid
257. Juices have the advantage over artificial flavor in that these are:
I. sweeter II. More stable III. Natural
258. Oleovitamins generally consist of:
I. Vitamin A II. Vitamin D III. Vitamin B
259. Spiritus frumentis is also called
A. brandy C. Whisky E. AOTA
B. rum D. A & C
260. This type of water is specific for multidose parenteral products.
A. water for injection
B. Sterile Water for injection
C. Bacteriostatic Water for Injection
D. Sterile Water for Inhalation
E. Purified Water
261. This is a process of redistilling one or more fresh delicate drugs with small
quantities of volatile products.
A. steam distillation C. maceration E. reverse osmosis
B. cohobation D. reflux distillation
262. Which of the following substances is/are needed when compounding Magnesium
Citrate solution?
I. sodium bicarbonate
II. magnesium citrate
III. magnesium carbonate
A. I only B. II only C. I & III

D. I & II E. I, II, III
263. Main constituent/s present in toothache drops:
I. menthol II. eugenol III. benzoate
264. Most widely used container for aerosols:
A. glass C. tin-plated steel E. glassine paper
B. plastic D. aluminum
265. Lanolin differs from wool fat in that lanolin:
A. contains less water
B. has been further purified
C. contains more water
D. is obtained from natural sources
E. contains a greater quantity of cholesterol
266. This substance is used to replace part of cocoa butter to obtain the proper melting
point.
A. vegetable oil
B. petrolatum
C. glycerin
D. gelatin
E. white wax
267. Rose water ointment differs from Petrolatum rose water ointment because the
former contains:
A. mineral oil C. sodium borate E.cetyl ester wax
B. white wax D. almond oil
268. Petrolatum USP is not soluble in
A. chloroform C. ether E. petroleum ether
B. ethyl alcohol D. benzene
269. A very fine powdered chemical is defined as one that will
A. completely pass through a # 80 sieve
B. completely pass through a # 120 sieve
C. completely pass through a # 20 sieve
D. completely pass through a # 60 sieve and not more than 40% through a #100 sieve
E. completely pass through a # 80 sieve and not more than 60% through a #60 sieve
270. Camphor is usually milled by which of the following techniques?
A. trituration
B. levigation
C. geometric dilution
D. attrition
E. pulverization by intervention
271. Unit dose packaging for tablets or capsules is exemplified by
I. strip packaging III. wide mouth bottles
II. blister pack
272. Ingredients in toothache drops:
I. oil of cloves II. alcohol III. benzocaine
273. Controlled room temperature means that the temperature is maintained
thermostatically between:
A. 15-30 ◦C C. 8-15 ◦C E. -4-8 ◦C
B. 25 ◦C D. 30 ◦C
274. Gels belong to:
A. dispersion C. solution E. creams
B. emulsion D. ointments
275. HLB value needed for an oil-in-water type of emulsion:
A. 8-18 C. 1-5 E. 1-12
B. 3-6 D. 6-12
276. Which of the following preparations is a saturated solution?
A. aromatic water C. emulsion E. extract
B. elixir D. solution
277. Magnesium stearate is used in tablet manufacturing as:
A. lubricant C. binder E. diluent
B. source of Magnesium D. disintegrant
278. Instability of emulsion is caused by:
I. creaming II. sedimentation III. electrolytes
279. A eutectic mixture in powders occurs when:

I. there is lowering in melting point III. Efflorescence
II. Hygroscopic mixture
280. Bulk powders are:
A. insufflations C. dentrifices E. AOTA
B. douche powders D. A & B
281. In the infusion method of making cocoa butter suppositories, which substance is
most likely to be used to lubricate the mold?
A. mineral oil C. cetyl alcohol E. magnesium silicate
B. propylene glycol D. stearic acid
282. A very fine powdered chemical is defined as one that:
A. completely pass through a # 80 sieve
B. completely pass through a # 120 sieve
C. completely pass through a # 20 sieve
D. completely pass through a # 60 sieve and not more than 40% through a #100 sieve
E. completely pass through a # 80 sieve and not more than 60% through a #60 sieve
283. Which solution is used as an astringent?
A. Strong Iodine Solution USP
B. Aluminum Acetate Topical Solution USP
C. Acetic Acid NF
D. Aromatic Ammonia Spirit USP
E. Benzalkonium Chloride Solution USP
284. The particles in an ideal suspension should satisfy which of the following criteria?
I. Their size should be uniform
II. They should be stationary or move randomly
III. They should remain discrete
285. Mechanisms that are thought to provide stable emulsification include the:
I. formation of interfacial film
II. Lowering of interfacial tension
III. Presence of charge on the ion
286. Ceramic mortar may be preferable to a glass mortar when:
I. volatile oil is added to a powder mixture
II. colored substances are mixed into the powder
III. Comminution is desired in addition to mixing
287. The particle size of the dispersed solid in a suspension is usually greater than
A. 0.5 mm C. 0.3 mm E. 0.1 mm
B. 0.4 mm D. 0.2 mm
288. Forms of water that is suitable for use in parenteral preparations:

I. Purified water, USP
II. for injection, USP
III. Sterile Water for Injection, USP
289. The sedimentation of particles in a suspension can be minimized by:
I. adding sodium benzoate
II. Increasing the viscosity of the suspension
III. Reducing the particle size of the active ingredient
290. Substances used to insulate powder components that liquefy when mixed include:
I. talc
II. Kaolin
III. Light magnesium oxide
291. The following statement/s is/are true for Cold Cream:

I. It is oil-in-water emulsion
II. The use of almond oil rather than mineral oil makes a more stable cream.
III. Cold cream prepared with almond oil makes a better emollient base.
292. Which type of soaps form an o/w emulsion?
I. alkali soap
II. Metallic soap
III. Polyvalent soap
293. The USP permits ___% of sulfur dioxide to prevent decomposition of gelatin during
manufacture of hard gelatin capsules.
A. 5%
B. 0.5%
C. 1%
D. 0.15%
E. 10%
294. Colors and dyes disguise off-color drugs, provide product identification and product
identification and produce a more aesthetically appealing product. Which type of dye is
typically used as dry powder?
A. Lakes
B. F & D
C. D & C
D. F D & C
E. AOTA
295. Adsorbents are inert substances which hold quantities of fluid in an apparently dry
state. Examples of adsorbents include:
I. MgO
II. Mg carbonate
III. Bentonite
296. Witepsol bases contain natural saturated fatty acid chains between C12 and C18.
Which of the following fatty acids is its major component?
A. Lauric acid
B. Myristic acid
C. Stearic acid
D. Palmitic acid
E. Oleic acid
297. Witepsol bases offer the following characteristic:
I. They exhibit polymorphism like cocoa bases
II. They solidify rapidly in the mold
III. The interval between softening and melting temperature is very small
298. Wecobee bases have an action similar to that of Witepsol bases. Wecobee bases
are derived from:
A. mineral oil
B. coconut oil
C. almond oil
D. olive oil
E. cocoa butter
299. Acacia is classified as a natural emulsifying agent. It is usually as a___%
dispersion in water.
A. 35
B. 10
C. 25
D. 50
E 30
300. Unlike acacia, tragacanth does not contain the enzyme oxidase which catalyzes
the decomposition of organic chemicals. Tragacanth is usually used as a ____%
dispersion in water.
A. 10%
B. 6%
C. 20%
D. 30%
E. 15%
Pharmaceutical Dosage Forms and Drug Delivery System B. Diluents E. Surfactants
C. Lubricants
1. The purpose of Phase 3 clinical trial is;
I. Safety 10. Characteristics of Stevia powder include;
II. Effectiveness I. A natural, non-toxic sweetener
III. Dosage II. Contraindicated to phenylketonurics
A. I, II and III III. About 30 times sweeter than sucrose
B. I and III A. Only 1 D. II and III
C. II and III B. I and II E. III only
D. I and II C. I and III
E. I only
11. A hermetic container which permits withdrawal of successive
2. Which of the following is a correct statement regarding portions of the contents without changing the strength of the
TDDS? remaining portion
A. Ortho Evra is a testosterone transdermal A. Multiple dose vial
system. B. Single dose ampule
B. Skin lotion may be used at the application site C. Blister package
of transdermal patches to avoid irritation. D. Large plastic bottle for capsule
C. Physical exercise and extreme ambient E. Tamper-evident package
temperatures (e.g. sauna) may increase the
absorption of drug from Nitroglycerin patch. 12. Photodegradation can be prevented by packaging drugs in a
D. Absorption of drug from TDDS is greater if the light resistant container. Which of the following containers is
patch is applied to a site with a thick horny NOT light resistant?
layer. A. Colorless bottle covered with aluminum foil
E. TDDS should be removed when showering, B. Bottle covered with carbon paper
bathing or swimming. C. Transparent plastic container
D. Amber colored bottle
3. Which of the following phrases describe the elixir dosage E. Opaque plastic container
form?
I. Sweetened and flavored 13. This plastic material is rigid and has good clarity thus, is used
II. The product contains alcohol as preservative in blister packaging of capsules and tablets is;
III. Medicated or nonmedicated A. PET
A. I only D. I and II B. PVC
B. II and III E. I, II and III C. PETG
C. I and III D. APET
E. APETG
4. Which of the following preparations is for external use only?
A. Lugol’s solution 14. Simple syrup can be prepared by;
B. Iodine tincture I. Percolation
C. Magnesium citrate solution II. Solution with heat
D. Belladonna tincture III. Agitation without heat
E. Diphenhydramine elixir A. I, II and III are correct
B. I and II are correct
5. A preparation applied to the skin with a fine camel’s hair C. II and III are correct
brush or glass applicator is known as: D. Only II is correct
A. Glycerite D. Cataplasm E. I and III are correct
B. Liniment E. Glycerogelatin
C. Collodion 15. Features of ophthalmic ointments and gels include;
I. Must be packaged in collapsible ointment
6. For orally administered drug, the dosage form used as tubes having elongated narrow tip
clinical trial material for Phase 1 is; II. Non-sterile preparation
A. Capsule with excipients III. Ointment bases should have a softening point
B. Capsule containing active ingredient alone close to body temperature, both for comfort
C. Tablet without excipient and for drug release
D. Tablet with excipient A. Only I is correct
E. Solution form B. I and III are correct
C. II and III are correct
7. If a drug product requires an antioxidant, which of the D. I and II are correct
following would be used? E. I, II and III are correct
A. Fumed silica 16. Ointment base classified as hydrocarbon base include;

B. Titanium dioxide I. Petrolatum
C. Benzalkonium chloride II. White ointment
D. Butylhydroxyanisole III. PEG ointment
E. Phenylmercuric nitrate A. Only I is correct
B. I and III are correct
8. The following are physicochemical properties to be C. II and III are correct
considered in dosage form design except; D. I and II are correct
A. Physical state E. I, II and III are correct
B. Nature of the illness
C. Polymorphism 17. How many percent of glycerin is contained in glycerogelatin?
D. Solubility A. 15% D. 5%
E. Dissociation constant B. 35% E. 10%
C. 40%
9. Which of the following excipients are added to tablet
formulations to provide enough bulk for compression? 18. Papers, Moleskin, linen are types of what component of
A. Glidants D. Disintegrants plasters?
A. Adhesives D. Corticosporin Otic Solution
B. Backing material E. Maxitrol Drops
C. Absorbents
D. Medicaments 28. Aromatic Spirit of Ammonia is a reflex stimulant
E. Container administered;
A. Orally
19. Creams ointments may be medicated or nonmedicated. B. Topically into the abdomen
Which of the following preparations contain a depigmenting C. By rubbing into the affected area
medicament? D. By inhalation
A. Crotamiton cream E. By subcutaneous injection
B. Tolnaftate cream
C. Hydroquinone cream 29. A pharmaceutical solvent water intended for the preparation
D. Mupirocin ointment of aqueous dosage forms except those intended for
E. Tretinoin cream parenteral administration is officially known as;
A. Water, USP
20. Type of ointment that must meet sterility test and B. Purified Water, USP
requirements for metal particles. C. Water for Injection, USP
A. Dermatologic ointment D. Sterile Water for Injection, USP
B. Ophthalmic ointment E. Bacteriostatic Water for Injection, USP
C. Rectal ointment
D. Nasal ointment 30. A topical solution employed as astringent was or wet
E. Vaginal ointment dressing is;
A. Aluminum Subacetate Topical Solution
21. An enema used for the diagnostic visualization of the GIT is; B. Povidone-Iodine Solution
A. Starch enema C. Coal Tar Topical Solution
B. Barium sulfate enema D. Hydrogen Peroxide Solution
C. Aminophylline enema E. Chlorhexidine Topical Solution
D. Nutritive enema
E. Hydrocortisone enema 31. Pharmaceutical solutions are of different characteristics,
uses and methods of preparation. Which of the following
22. Nasal preparations are employed; statements correctly describe a specific solution?
I. As nasal decongestant for prevention and A. Magnesium citrate solution is prepared by simple
treatment of allergic rhinitis solution method
II. To restore moisture and relieve dry, congested B. Liniments are ethereal solutions
and inflamed nasal membranes C. Embrocations are used externally and are applied
III. In the form of nose drops or sprays with rubbing
A. I, II and III D. Bactidol® is a collyrium
B. I and II E. Douches are rectal injections
C. II and III
D. I and III 32. An aqueous solution used for irrigative cleansing of the
E. I only vagina is termed as;
A. Enema D. Douche
23. Flexible collodion,USP, is rendered waterproof by the B. Lavatio ori E. Collunarium
addition of; C. Embrocation
A. Menthol D. Camphor
B. Castor oil E. Alcohol 33. Characteristics of large volume parenterals include all of the
C. Ether following EXCEPT;
A. Sterile
24. Which of the following statements is correct? B. Isotonic
A. Diapid nasal spray is used for the prevention and C. Package in containers not exceeding 1 liter
treatment of perennial allergic rhinitis D. Meet standards for particulate matter
B. Lugol’s solution contains sodium iodide as co- E. Colored
solute
C. Simple syrup can be prepared by percolation 34. The method of sterilization employed for heat-labile enzyme
D. Calcium hydroxide Topical Solution is also known preparations, catheters, needles and plastic disposable
as Liquor Carbonis Detergens syringes is;
E. Magnesium citrate solution is used as antidiarrheal A. Sterilization by ionizing radiation
B. Gas sterilization
25. This tincture is a topical protectant. C. Autoclaving
A. Belladonna tincture D. Steam sterilization
B. Compound benzoin tincture E. Dry heat sterilization
C. Tolu balsam tincture
D. Sweet orange peel tincture 35. Parenteral preparations are of different types. Which of the
E. Iodine tincture following is a dry Solid for Injection?
A. Propofol, USP
26. Which method is used in the preparation of Ipecac Syrup? B. Imipenem and Cilastatin for Injectable Suspension,
A. Solution with the aid of heat USP
B. Solution by agitation without the aid of heat C. Methylprednisolone Acetate Suspension, USP
C. Solution by chemical reaction D. Insulin Injection, USP
D. Percolation E. Cefuroxime for Injection, USP
E. Any of these methods
36. Pastes are semi-solid preparations that generally contain a
27. All of the following otic preparations are indicated for larger proportion of solid materials so are;
bacterial infections of the ear EXCEPT; I. Less greasy and stiffer than ointments
A. Auralgan otic Solution II. More macerating and more penetrating than
B. Cerumenex Eardrops ointments
C. Chloromycetin Otic Solution
III. Are effectively employed to absorb serous 45. Characteristic of drug substance best suited for incorporation
secretions into an extended release product include;
A. I and II D. III only I. Uniformly absorbed form the GIT
B. II and III E. I, II and III II. Possess a good margin of safety
C. I and III III. Used in the treatment of acute rather than
chronic conditions
37. Considerations in the use of TDDS include; A. Only I is correct
I. Rotating locations within the recommended B. I and III are correct
site should be avoided in the application of C. I and II are correct
replacement patches D. I, II and III are correct
II. TDDS should be removed when showering, E. Only I is correct
bathing or swimming
III. Use of the skin lotions should be avoided at 46. Camphor is usually comminuted by which of the following
the application site because they affect skin techniques?
hydration and can also alter the partition A. Trituration
coefficient between the drug in the TDDS and B. Levigation
the skin C. Sieving
A. I, II and III D. II and III D. Pulverization by intervention
B. I and II E. III only E. Micronization
C. I and III
47. The vehicle of Effervescent granulated salts usually contain;
38. All of the following statements are true regarding biologics, I. Citric acid
EXCEPT; II. Tartaric acid
A. Biologic products must pass control requirements III. Sodium bicarbonate
such as potency, sterility, pyrogens and constituent A. I, II and III
materials. B. I and III
B. Freezing is required in the storage of biologics. C. II and III
C. Most biologics have an expiration date of a year or D. Only II is correct
longer after the date of manufacture. E. I and II
D. Biologics are generally administered by injection
E. Toxoids and Vaccines are biologics for active 48. Pharmaceutics is concerned with the following areas of
immunity pharmaceutical dosage form design EXCEPT;
A. Formulation
39. Which of the following biologics is available in oral form as B. Manufacture
enteric coated capsules? C. Stability
A. Typhoid vaccines D. Sales and marketing
B. Hepatitis B vaccine E. Effectiveness
C. Diphtheria and Tetanus Toxoids
D. Measles Virus Vaccine 49. Drug substance can be protected from the destructive
E. Hepatitis Vaccine influences of atmospheric oxygen or humidity through;
I. Coated tablets
40. Methylcellulose is used in ophthalmic solutions as; II. Enteric coated tablets
A. Buffer D. Thickener III. Sealed ampoules
B. Preservative E. Isotonic agent A. I, II and III D. I and III
C. Sterilizing agent B. I and II E. III only
C. II and III
41. Which of the following preparations is NOT sterile?
A. Eye drop 50. Preformulation considerations include all of the following
B. Implant EXCEPT;
C. Suppository A. Polymorphism
D. Solution for Injection B. Stability in the presence of expected excipients
E. Dialysis Solution C. Membrane permeability
D. Particle size
42. A novel drug delivery system Cyanocobalamine (Nascobal E. Dissolution
Gel) used in the treatment of vitamin B12 deficiency is
available as; 51. Liquid drugs such as Vit A, D and E are formulated as;
A. A controlled release sublingual application A. Sublingual tablet
B. Microspheres for injection B. Soft gelatin capsule
C. A nasal gel C. Nasal inhaler
D. Automatic injector D. Compressed tablets
E. Chewable dispersible tablet E. Hard gelatin capsule
43. Products of biotechnology include all of the following 52. The original appearance, palatability, uniformity, dissolution
EXCEPT; and suspendability are retained. The type of stability
A. Estring described is;
B. Interferon A. Physical
C. Human Growth Factor B. Chemical
D. Rituximab C. Toxicologic
E. Epoeitin alfa D. Microbiologic
E. Therapeutic
44. Advair diskus is a novel preparation for;
A. Oral inhalation 53. Approaches in the stabilization of drug products against
B. Parenteral administration hydrolytic decomposition include all of the following
C. Subgingival application EXCEPT;
D. Vaginal insert A. Replacement of atmospheric oxygen present in
E. Topical delivery container with an inert gas such as nitrogen
B. Supply drug in a dry form for reconstitution
C. Refrigeration D. Punch method
D. Use of buffering agents E. Both B and C
E. Suspending the drug in non-aqueous vehicle rather
than dissolving them in an aqueous medium 62. A tablet excipient that causes adhesion of powder particles in
tablet granulation
54. Based on USP guidelines for extemporaneously prepared A. Lubricant D. Diluent
drug products, the stability of water containing formulation B. Disintegrant E. Antiadherents
prepared from ingredients in solid form is; C. Binder
A. Not later than 25% of the time remaining until the
products expiration date or 6 months whichever is 63. An excipient used in sugar free-chewable tablet
earlier. A. Mannitol D. Lactose
B. A beyond use date of 6 months B. Sorbitol E. Crystalline maltose
C. A beyond use date not later 14 days on storage at C. Xylitol
cold temperature
D. A beyond use date of the intended duration of 64. In preparing vaginal inserts, the following excipients are used
therapy or 30 days whichever is earlier EXCEPT;
E. None of these A. Lubricant
B. Disintegrating agent
55. TRUE statements regarding flavoring of pharmaceuticals C. Filter
include all of the following EXCEPT; D. Coating agent
A. Fruit or citrus flavors combat acid or sour taste of E. Dispersing agent
drugs
B. Children prefer less sweet with tart rather than a 65. Wecobee bases used in suppositories are triglycerides
fruit flavor pharmaceutical derived from;
C. Organic esters, alcohols and aldehydes are A. Mineral oil
pleasant to taste B. Coconut oil
D. Chewable tablets and lozenges are usually flavored C. Almond oil
and sweetened D. Olive oil
E. In selecting a flavorant, the age of the intended E. Theobroma oil
patient must be considered
66. In preparing suppositories by molding from a melt, lubricating
56. The following products require the addition of preservatives the mold is required if the suppository is;
EXCEPT; A. PEG-based
A. Syrups B. Cocoa butter-based
B. Emulsions C. Glycerinated gelatin based
C. Semisolid preparations D. Both B and C
D. Ophthalmic products E. All of these
E. Large volume parenterals
67. Suppositories using this base should be moistened first with
57. Strip packs, blister packs, tape seals and bubble packs are water to avoid irritation to the tissue upon insertion;
examples of; A. Cocoa-butter
A. Light-resistant packaging B. Glycerinated gelatin
B. Compliance packaging C. Wecobee base
C. Child-resistant packaging D. Glyceryl monopalmitate
D. Tamper-resistant packaging E. Witepsol base
E. Adult-senior use packaging
68. TRUE statement about PEG-based suppositories include;
58. Characteristics of APET and PETG plastic materials include; I. Stored at room temperature
I. Transparent II. Leaks from the orifice
II. Unsuitable for gamma radiation III. It dissolves in the body fluid to release the
III. Has excellent luster active drug
A. I, II and III D. I and III A. I, II and III
B. I and II E. III only B. I and III
C. II and III C. II and III
D. I and II
59. Problems encountered with plastic containers include all of E. I only
the following EXCEPT;
A. Permeability 69. Tablets may differ in terms of release mechanism. Which of
B. Alkalinity these tablets has delayed-release feature?
C. Leaching A. Sugar-coated tablets
D. Deformation upon storage B. Film-coated tablets
E. Sorption C. Chewable tablets
D. Enteric coated tablets
60. The following drug products require colorants EXCEPT; E. Instant dissolving/disintegrating tablet
A. Capsules
B. Compressed tablets 70. Reasons for suspension include;
C. Sugar-coated tablets I. Sustaining effect
D. Suppositories II. Taste
E. Suspension III. Stability
A. I, II and III
61. Two plasticized gelatin ribbons are continuously and B. II and III
simultaneously fed with liquid or paste fill between the rollers C. I and II
of the rotary die mechanism. What method of preparing SGC D. III only
is described? E. I and III
A. Plate process
B. Rotary die process 71. Characteristics of particles of suspension in ideal situation
C. Reciprocating die process include;
I. Perfectly spherical in dilute suspension A. I and III
II. No collision of particles B. II and III
III. Settling of particles obey Stokes’ Law C. I and II
A. I, II and III D. III only
B. II and III E. I, II and III
C. I and II
D. III only 80. Aluminum hydroxide gel is;
E. I and III I. Prepared by chemical reaction method
II. An antacid
72. A technique of reducing particle size producing 10-50um III. Applied externally
particle diameter is; A. I and II
A. Dry milling B. II and III
B. Micropulverization C. I and II
C. Micronization D. III only
D. Spray drying E. I, II and III
E. Fluid energy grinding
81. The first step in the continental method of preparing emulsion
73. Bentonite, a suspending agent is classified as; is the combination of;
A. Clay A. Gum and water
B. Plant colloid B. Gum and oil
C. Synthetic C. Oil and water
D. Cellulose D. Gum and active ingredient
E. Protein substance E. Gum, water and oil are mixed all together
74. Caking of particles in suspension can be prevented by 82. Surfactants of HLB value 3 to 6 are employed as;
inducing flocculation. Which of the following can be A. O/W emulsifier
employed as flocculating agent? B. W/O emulsifier
I. Diluted bentonite magma C. Antifoaming agents
II. Surface active agent D. Wetting agents
III. Electrolytes E. Solubilizing agents
A. I, II and III
B. II and III 83. This theory of emulsification assumes monomolecular layers
C. I and II of emulsifying agent curved around a droplet of the internal
D. I and III phase.
E. III only A. Surface tension theory
B. Plastic-film theory
75. These substances increase the viscosity of the dispersion C. Oriented-wedge theory
medium. D. Interfacial film theory
A. Wetting agents E. Molecular layer theory
B. Flocculating agents
C. Suspending agents 84. Creaming of emulsion, though reversible, is not esthetically
D. Solubilizing agents acceptable. This problem can be remedied by increasing the
E. All of these viscosity of the external phase. Which of the following can
promote the desired condition?
76. TRUE statements regarding packaging, labeling and storage A. Agitation
of suspensions include; B. Reformulation
I. Packaged in an oversized container to facilitate C. Addition of suspending agents
thorough mixing D. Addition of preservatives
II. A “shake well” label must be affixed E. Addition of thickeners
III. Must be protected from freezing
A. I, II and III 85. The separation of internal phase from the emulsion is called;
B. II and III A. Aggregation D. Flocculation
C. I and III B. Creaming E. Sedimentation
D. I and II C. Breaking
E. III only
86. Microemulsions are;
77. The following are oral suspensions EXCEPT; I. Thermodynamically stable system
A. Maalox suspension II. Optically transparent
B. Combantrin suspension III. O/W system stabilized by surfactant
C. Mesalamine suspension A. I, II and III
D. Amoxicillin suspension B. II and III
E. Gaviscon Liquid suspension C. I and II
D. I and III
78. Which of the following properties is undesirable in E. only I
pharmaceutical suspension?
A. Thixotropy 87. Inhalation aerosols are commonly employed;
B. Caking A. As anti-infective
C. Cracking B. As contraceptives
D. Bleeding C. In anorectal conditions
E. Flocculation D. In asthma therapy
E. As local anesthetic
79. Single phase gels;
I. Are made up of small inorganic particles 88. In mixing powder, the diluent is added in portions to the
II. Exhibit thixotropy potent drug, with trituration after each addition. What
III. Are those in which no apparent boundaries principle is described?
exist between the dispersed phase and the A. Levigation technique
dispersion medium B. Geometric dilution
C. Pulverization with intervention 97. A chemical compound that has a fundamental desired
D. Comminution biologic or pharmacologic activity is referred to as;
E. Spatulation A. Prodrug
B. Lead compound
89. Powders containing deliquescent and hygroscopic materials C. Goal drug
should be wrapped in what kind of paper? D. All of these
I. Vegetable parchment E. None of these
II. Glassine paper
III. Waxed paper 98. These are solid dosage forms which are designed to be
A. I only inserted under the skin by special injectors or by surgical
B. III only incision.
C. I and II A. Pellets
D. II and III B. Inserts
E. I, II and III C. Plasters
D. Pills
90. In dry or fusion method of preparing effervescent granulated E. Troches
salt, the binding agent used is;
A. Alcohol-water mixture 99. Cocoa butter, NF is also known as;
B. Water of crystallization of citric acid A. Yellow wax D. Spermaceti
C. Alcohol, 95% B. Paraffin E. Lanolin
D. Lanolin C. Theobroma oil
E. Acacia mucilage
100. One of the following is NOT used in the preparation of oral
91. A tablet which is 50% larger and heavier than the original solutions, syrups and elixirs.
uncoated one is; A. Ethylene glycol
A. Sugar-coated tablet B. Alcohol, USP
B. Film-coated tablet C. Propylene glycol
C. Enteric-coated tablet D. Purified water, USP
D. Chocolate coated tablet E. Glycerin, USP
E. Gelatin coated tablet
101. Salicylic acid collodion contains how many percent of
92. Solid dosage administered by oral route include; salicylic acid in Flexible Collodion, USP?
I. Hypodermic tablets A. 5% D. 15%
II. Troches B. 3% E. 1%
III. Lollipops C. 10%
A. Only I is correct
B. II and III are correct 102. Compared with syrups, elixirs are;
C. I and II are correct I. Less sweet
D. I, II and III are correct II. Less effective in masking the taste of medicinal
E. I and III are correct substances
III. More viscous
93. Amount administered to a patient after exposure or A. I, II and III D. II only
contraction of the illness B. II and III E. I only
A. Prophylactic dose C. I and II
B. Therapeutic dose
C. Priming dose 103. TRUE statements concerning bulk powders;
D. Maintenance dose I. Oral powders are mixed with water or other
E. Minimum effective concentration beverages before swallowing
II. Douche powders are dissolve in warm water
94. Factors considered in determining a drug’s dose during for vaginal use
clinical trial include all of the following EXCEPT; III. Dusting powders include topical anti-infective,
A. Age antifungal and antiperspirant
B. Body weight A. I, II and III are correct
C. Appearance and taste B. I and III are correct
D. Pathologic state C. II and III are correct
E. Tolerance D. Only II is correct
E. I and II are correct
95. The copies of the NDA submitted by the applicant include;
I. Field copy 104. Blending of powders may be accomplished by;
II. Pre-approval copy I. Spatulation
III. Archival copy II. Sifting
A. I, II and III III. Levigation
B. II and III A. I, II and III D. I and II
C. I and II B. I and III E. III only
D. I and III C. II and III
E. III only
105. Different technologies are employed in preparing modified
96. Clinical trial materials include; release products. Glucotrol XL, Procardia XL and Covera HS
I. The proposed new drug are examples of;
II. Placebos A. Coated beads/granules
III. Comparator drug B. Microencapsulation
A. I only C. Matrix tablet
B. I and III D. Osmotic tablet
C. II and III E. Hydrocolloid system
D. I and III
E. I, II and III 106. F, D and C lakes are used to color;
I. Sugar coated tablets
II. Pharmaceutical suspension E. I, II and III
III. Syrups
A. III only D. I and III 115. A sugar-based lozenge on a stick (lollipop) used in
B. II and III E. I, II and III controlling breakthrough pain in cancer patients is;
C. I and II A. Fentanyl Actiq
B. Dormicum
107. Advantages of film-coating over sugar-coating include; C. Dequadin
I. More durable D. Difflam
II. Less bulky E. Alaxan-FR
III. Less time consuming to apply
A. I, II and III are correct 116. Spansule capsule is;
B. I and III are correct I. An example of extended release product
C. II and III are correct prepared by embedding drug in a slowly
D. Only I is correct eroding hydrophilic matrix system
E. Only III is correct II. A capsule containing beads of different coating
thickness
108. Characteristic of added substances to capsule formulation; III. A half-colored, half-transparent hard gelatin
I. Harmless in quantities used capsule containing colored beads or granules
II. Do not interfere with requisite compendial A. Only III is correct
assays and tests B. I and III are correct
III. Do not impair product’s bioavailability, C. II and III are correct
therapeutic efficacy or safety D. I and II are correct
A. I, II and III are correct E. I, II and III are correct
B. I and III are correct
C. II and III are correct 117. The transdermal patch used in travel-related nausea and
D. Only I is correct vomiting that is to be worn in a hairless area behind the ear
E. I and II are correct is;
A. Transdermal Nicotine
109. TRUE statements about the function of excipients used in B. Transdermal Clonidine
tablet formulation EXCEPT; C. Transdermal Testosterone
A. Binders promote granulation D. Transdermal Nitroglycerin
B. Glidants promote the flow of the tablet granulation E. Transdermal Scopolamine
C. Lubricants help the patient to swallow the tablet
D. Diluents make up the desired bulk of the tablet 118. A part of a monolithic transdermal system that functions to
formulation store and release the drug at the skin-site is the;
E. Disintegrants promote the breakup of tablets after A. Occlusive backing layer
administration B. Liquid drug reservoir
C. Semi permeable membrane
110. The vehicle used in Calamine Lotion is; D. Matrix system
A. Aluminum acetate solution E. Adhesive layer
B. Lead acetate solution
C. Calcium hydroxide solution 119. TRUE statement about vanishing cream include;
D. Magnesium hydroxide solution I. A W/O type of cream
E. Purified water, USP II. Also known as Petrolatum Rose Water
Ointment
111. Propofol, USP is a/an; III. Contains large amount of water that
A. Solution for injection evaporates after application leaving a thin film
B. Dry solid for injection of stearic acid
C. Injectable emulsion A. I, II and III D. I and III
D. Injectable suspension B. II and III E. III only
E. Not an injectable product C. I and II
112. All of the following are used as vehicle in various dosage 120. Fleet enema is an example of;
forms EXCEPT; A. Diagnostic enema
A. Syrup, USP B. Nutritive enema
B. Peanut oil C. Evacuation enema
C. Anise oil D. Non medicated enema
D. Bacteriostatic water for injection E. Hydrocortisone enema
E. White petrolatum
121. Which of the following phrases describe the elixir dosage
113. TRUE statement regarding tartrazine include; form?
I. An FD&C color additive I. A Colloidal dispersion
II. Can cause hypersensitivity reactions in some II. Alcohol and water are its primary solvents
individuals III. The product is self-preserving due to high
III. Imparts red color to the preparation alcohol content
A. I only D. II and III A. II only
B. II only E. I, II and III B. II and III
C. I and II C. I and III
D. I and II
114. Type II glass container is; E. I, II and III
I. Highly resistant borosilicate
II. Can be used as container for parenterals 122. A colorless to slightly yellow, clear, effervescent liquid having
III. Treated soda-lime glass a sweet, acidulous taste and a lemon flavor;
A. I and III A. Citric acid syrup
B. II and III B. Magnesium citrate Solution
C. I only C. Simple syrup
D. I and II D. Calcium hydroxide solution
E. Aluminum acetate solution C. II and III are correct
D. I and II are correct
123. Magnesium aluminum silicate is also known as; E. I, II and III are correct
A. Kaolin D. Bentonite
B. Acacia E. Tragacanth 133. Method used to achieve controlled release from solid dosage
C. Veegum form
I. Coated beads and granules
124. Several processes affect the stability and pharmaceutical II. Complex formation
elegance of dispersions. Reversible process include; III. Ion-exchange resin
I. Caking A. I, II and III are correct
II. Creaming B. I and III are correct
III. Breaking C. I and II are correct
A. I, II and III D. II and III D. II and III are correct
B. I and II E. II only E. Only I is correct
C. I and III
134. Components of glycerogelatin EXCEPT:
125. The delivery of fluoride to the teeth may be accomplish A. Gelatin
through; B. Petrolatum
A. Sonophoresis D. Ultrasound C. Medicinal agent
B. Phonophoresis E. All of these D. Glycerin
C. Iontophoresis E. Water
126. The drug antidote for radiation exposure is; 135. Drug dosage form/s that is/are protected from the destructive
A. Cs D. Prussian blue influence of atmospheric oxygen or humidity.
B. Acetazolamide E. Gallium A. Coated tablets D. Both A and B
C. Captopril B. Sealed ampules E. Both A and C
C. Enteric coated
127. A radiopharmaceutical used diagnostically to evaluate thyroid
fraction and morphology. 136. Drug dosage form that are protected from the destructive
A. Samarium-153 influence of gastric acid after oral administration.
B. Sodium Iodide-123 A. Enteric coated tablets
C. Holmium-166 B. Coated tablets
D. D. Cobalt-57 C. Sealed ampoules
E. Stronium-89 Chloride D. Flavored syrups
E. Suspension
128. This nonradioactive drug is used as an alternative to a
treadmill stress test prior to cardiac imaging. 137. The amount of heat absorbed when 1 g of a liquid vaporizes
A. Dipyridamole (Persantine) is known as the heat of vaporization of that liquid and is
B. Cimetidine (Tagamet) measured in _______.
C. Captopril (Capoten) A. Celsius
D. Furosemide (Lasix) B. Calories
E. Acetazolamide (Diamox) C. Grams
D. Liter
129. Inorganic hydrogels; E. Atmosphere
I. Single Phase System
II. Bentonite Magma 138. Use to promote and maintain dispersion of finely subdivided
III. Containing ingredients dispersible in water particles of liquid in a vehicle in which it is immiscible.
A. I and II A. Emulsifying agent
B. II and III B. Levigating agent
C. I, II and III C. Plasticizer
D. I and III D. Solvent
E. I only E. Humectant
130. Upward creaming takes place in unstable emulsions in which 139. Used as a filtering aid for its adsorbent qualities.
the internal phase has a _____ density than the external A. Emulsifying agent
phase. B. Humectants
A. Lesser C. Levigating agent
B. Greater D. Solvent
C. Equal E. Clarifying agent
D. Minimal
E. Exceedingly high 140. Used to prevent drying or preparations, particularly ointments
and creams.
131. Which of the following can exhibit a reversible sol-to-gel or A. Levigating agents D. Humectant
gel-to-sol transformation? B. Plasticizer E. Solvent
A. Gels C. Ointment base
B. Magmas
C. Lotions 141. Liquid used as an intervening agent to reduce the particle
D. Mixture size of a powder by grinding, usually in a mortar.
E. Both A and B A. Plasticizer
B. Emulsifying agent
132. Membrane-controlled transdermal system contains the C. Solvent
following layers; D. Levigating agent
I. An occlusive backing layer E. Chelating agent
II. Drug matrix system
III. Microporous rate-limiting membrane 142. Used to impart color to liquid and solid preparations.
A. Only III is correct A. Flavorant
B. I and III are correct B. Colorant
C. Clarifying agent 152. Characteristics of dosage forms that influence the
D. Solvent bioavailability of oral drugs.
E. Humectant A. Disintegration rate D. Storage condition
B. Dissolution rate E. All of the above
143. Used in tablet and capsule formulations to improve flow C. Product age
properties of the powder mixture.
A. Tablet lubricant 153. Physiologic factors that influence the bioavailability of oral
B. Tablet glidant drugs.
C. Tablet disintegrant A. Gastric emptying time
D. Tablet opaquant B. Intestinal transit time
E. Tablet polishing agent C. Gastrointestinal abnormality
D. Pathologic condition
144. Used in tablet formulations to reduce friction during tablet E. All of the above
compression.
A. Tablet lubricant 154. Site of sublingual route of administration
B. Tablet glidant A. Rectal D. Under the tongue
C. Tablet disintegrant B. Heart E. Spine
D. Tablet opaquant C. Bone
E. Tablet polishing agent
155. A coronary vasodilator used in the prophylaxis and treatment
145. Which of the following given is consider as example of a of angina pectoris, which dissolve under the tongue.
tonicity agent? A. Aspirin D. Phenytoin
A. Sodium chloride B. Aspilet E. Warfarin
B. Mineral oil C. Nitroglycerin
C. Sodium glycolate
D. Liquid glucose 156. Which statement is not true for rectal route of administration?
E. Hydroxyl cellulose A. Used for local effect
B. Used for systemic effect
146. It describes the passage of (drug) molecule through a C. Preferred for drugs that are destroyed or inactivated by
membrane that does not actively participate in the process. the environments of the stomach and intestines.
A. Drug absorption D. 100% of drug absorbed bypass the liver
B. Transport mechanism E. Inconvenient
C. Passive diffusion
D. Osmosis 157. Which statement is not true in parental route of drug
E. Dissociation administration?
A. Rapid absorption
147. The rate and extent to which an active drug ingredient or B. Little is lost
therapeutic moiety is absorbed from a drug product and C. For uncooperative unconscious patients
becomes available at the site of action. D. Once injected, withdrawal of drug is easy
A. Drug’s solubility E. Sterile
B. Adsorption
C. Peak concentration 158. Semisolid that has greater aesthetic appeal for their non
D. Bioavailability greasy character, ability to vanish into the skin upon rubbing and
E. Serum concentration time ability to absorb serous discharges from the skin lesions.
A. Pastes D. Powder
148. Drug products that contain the identical therapeutic moiety or B. Lotions E. Ointment
its precursor but not necessarily in the same amount or C. Creams
dosage form as the same salt or ester.
A. Pharmaceutical alternatives 159. Semisolid that contain more solid materials, stiffer and less
B. Pharmaceutical equivalents penetrating, preferred when protective action is desired.
C. Bioequivalence drug product A. Ointment D. Suspension
D. Therapeutic equivalent B. Pastes E. Lotion
E. Bioavailability C. Creams
149. Drug products that contain identical amounts of the identical 160. Dosage form of choice if increased spreadability over large
active drug ingredients, that is, the same salt or ester of the areas of skin is desired.
same therapeutic moiety, in identical dosage forms but not A. Cream D. Pastes
necessarily containing the same inactive ingredients. B. Ointment E. Powder
A. Pharmaceutical alternatives C. Lotion
B. Pharmaceutical equivalents
C. Bioequivalent drug product 161. Characteristics of ophthalmic preparations, EXCEPT
D. Therapeutic equivalents A. Sterile
E. Bioequivalence B. Free of grit
C. Usually absorbed in great extent
150. Drug substance physiochemical properties that influence D. Solution, ointment and suspension form may be
bioavailability of oral drugs. employed
A. Particle size D. Liquid solubility E. None of the above
B. Salt form E. All of the above
C. Hydration 162. Site of excretion of volatile drugs
A. Kidney D. Saliva
151. Pharmaceutical ingredients that influence bioavailability of B. Sweat glands E. Lacrymal fluids
oral drugs. C. Lungs
A. Fillers D. Lubricants
B. Binders E. All of the above 163. Example of drug that enter breast milk and may be passed
C. Coatings on to nursing infants EXCEPT
A. Theophylline D. Diltiazem
B. Reserpine E. None of the above
C. Barbiturates B. Extended release E. Targeted release
C. Delayed release
164. Method for the determination of particle size
A. Sieving D. Light scattering 176. Dosage form designed to release the drug at a time other
B. Microscopy E. All of the above than promptly after administration
C. Sedimentation rate A. Modified release D. Repeat action
B. Extended release E. Targeted release
165. Solid dosage forms in which medicinal agents and/or inert C. Delayed release
substances are enclosed in a small shell of gelatin.
A. Capsules D. Suppositories 177. Drug release directed toward isolating or concentrating a
B. Tablets E. Coated tablet drug in a body region, tissue, or site of absorption or for drug
C. Pills action.
A. Modified release D. Targeted release
166. It is obtained by the partial hydrolysis of collagen obtained B. Extended release E. Repeat action
from the skin, white connective tissue, and bones of animals. C. Delayed release
A. Agar D. Albumin
B. Gelatin E. Dye 178. Absorption bases obtained from the wool of sheep, is a
C. Talc purified waxlike substance that has been cleaned, deodorize, and
decolorized.
167. Capsule sizes available for human use A. Petrolatum D. Yellow ointment
A. 00 D. 3 B. Lanolin E. None of the above
B. 1 E. All of the above C. White ointment
C. 2
179. Package for ointments and other semisolid preparations.
168. Temperatures that thermally bond the capsules’ cap and A. Large mouth jars
body. B. Metal tubes
A. 15°C-20°C D. 30°C-35°C C. Plastic tubes
B. 20°C-25°C E. 40°C-45°C D. Well closed container
C. 25°C-30°C E. All of the above
169. Preservative used for soft gelatin capsules 180. Plastic masses containing gelatin (15%), glycerin (40%),
A. Glycerin D. 80% ethyl alcohol water (35%) and medical substance (10%).
B. Sorbitol E. 95% ethyl alcohol A. Gels D. Glycerogelatins
C. Methylparaben B. Pastes E. Gelatins
C. Plasters
170. Compressed tablets coated with a thin layer of a polymer
capable of forming a skin like film. 181. The ideal molecular weight of a drug for transdermal drug
A. Sugar coated D. Enteric coated delivery is
B. Film coated E. Buccal tablet A. 1000 and below D. 400 and below
C. Gelatin coated B. 800 and below E. None of the above
C. 600 and below
171. Tablet which has a smooth rapid disintegration when chewed
or allowed to dissolved in the mouth has a creamy base, usually 182. Advantages of transdermal drug delivery systems EXCEPT
of specially flavored and colored mannitol. A. It can avoid gastrointestinal drug absorption difficulties
A. Sugar coated tablet B. It avoid first pass effect
B. Enteric coated tablet C. They are noninvasive
C. Buccal tablet D. Only potent drugs are suitable candidates for
D. Chewable tablet transdermal delivery
E. Sublingual tablet E. They are easily and rapidly identified in emergencies
172. Prepared by compressing granular effervescent salts that 183. The first transdermal system for hypertension
release gas when in contact with water. A. Nicotine D. Estradiol
A. Molded tablet D. Effervescent tablet B. Clonidine E. Nifedipine
B. Tablet triturates E. Dispensing tablet C. Nitroglycerin
C. Hypodermic tablet
184. General guidelines for TDDS’s EXCEPT
173. Used to determine the tablet’s durability A. It should be apply to clean, dry skin
A. Hardness tester B. Udr og skin lotion should be avoided at the application
B. Friability site
C. Disintegration testing apparatus C. It can be physically altered by cutting
D. Microprocessor D. It may be left on when showering, bathing, or swimming
E. Tablet dissolution E. It should be applied with thoroughly clean hands
174. Described dosage forms having drug release features based 185. Suppositories that are shaped like a bullet, or torpedo or the
on time, course and/or location that are designed to accomplish little finger
therapeutic or convenience objectives not offered conventional or A. Rectal
immediate release form. B. Vaginal
A. Extended release C. Urethral
B. Modified release D. Nasal
C. Delayed release E. Aural
D. Repeat action
E. Targeted release 186. Suppositories that are usually globular, oviform, or cone-
shaped and weigh about 5g when cocoa butter is the base.
175. Dosage forms that allows a reduction in dosing frequency A. Rectal D. Nasal
from that necessitated by a conventional dosage form, such as B. Vaginal E. Aural
solution or an immediate release dosage form. C. Urethral
A. Modified release D. Repeat action
187. Solid dosage forms intended for insertion into the body
orifices where they melt, soften or dissolve and exert local or 198. Clear, sweetened hydroalcoholic solutions intended for oral
systemic effects. use and are usually flavored to enhance their palatability.
A. Suppositories D. Emulsion A. Syrups
B. Tablets E. Lozenges B. Elixir
C. Pills C. Solutions
D. Juice
188. The most frequently employed suppository bases. E. Magma
A. Water miscible bases
B. Polyethylene glycols 199. Self preserving elixir and do not require the addition of an
C. Fatty bases antimicrobial agent.
D. Glycerin A. 2%-4% alcohol
E. Polyoxyl 40 stearate B. 4%-6% alcohol
C. 6%-8% alcohol
189. Type of suppositories that is thinner and tapered, often about D. 8%-10% alcohol
5mm in diameter. E. 10%-12% alcohol
A. Rectal
B. Urethral 200. Alcoholic or hydroalcoholic solutions prepared from
C. Vaginal vegetable materials or from chemical substances.
D. Nasal A. Elixir D. Solution
E. Aural B. Syrup E. Juice
C. Tinctures
190. Example of rectal suppositories
A. Clindamycin phosphate 201. Water-soluble organic mercurial antibacterial agent used
B. Clotrimazole topically for its bacteriostatic and mild fungistatic properties.
C. Miconazole nitrate A. Hydrogen peroxide topical solution
D. Nonoxynol-9 B. Povidone iodine topical solution
E. Bisacodyl C. Chlorhexidine gluconate
D. Thimerosal topical solution
191. Example of vaginal suppositories E. None of the above
A. Bisacodyl D. Hydromorphone
B. Chlorpromazine E. Clotrimazole 202. Component/s of douche powders EXCEPT
C. Hydrocortisone A. Boric acid
B. Zinc sulfate
192. A viscous liquid, miscible with water and alcohol, frequently C. Detergents
substituted for glycerin in modern pharmaceutical formulations. D. Sodium citrate
A. Isopropyl alcohol D. Glycerol E. None of the above
B. Purified water E. Tap water
C. Propylene glycol
203. Component/s of douche powder
193. Purified water, USP, is obtained by the following EXCEPT A. Boric acid D. Sodium chloride
A. Distillation B. Alum E. All of the above
B. Ion exchange treatment C. Menthol
C. Reverse osmosis
D. All of the above 204. Medicinal substances employed topically in the mouth
E. None of the above EXCEPT
A. Benzocaine eugenol
194. Processes referred to in the industry as cross-flow B. Sodium fluoride
membrane filtration. C. Carbamide peroxide
A. Ion exchange method D. Parachlorophenol
B. Reverse osmosis E. None of the above
C. Cation exchange
D. Anion exchange 205. Medical substances employed topically in the mouth.
E. Distillation method A. Benzocaine
B. Camphorated parachlorophenol
195. Methods of expressing the strengths of pharmaceutical C. Carbamide peroxide
preparations EXCEPT D. Lidocaine
A. %w/v E. All of the above
B. %w/w
C. %w/w 206. The withdrawal of desired constituents from crude drugs
D. Ratio strength through the use of selected solvents in which the desired
E. Ratio strength constituents are soluble.
A. Distillation D. Mixing
196. A normal physiologic body response to rid itself of a noxious B. Extraction E. Trituration
or toxic substance, such as rotavirus or Escherichia coli. C. Osmosis
A. Diarrhea
B. Vomiting 207. Concentrated preparations of vegetable or animal drugs
C. Acidosis obtained by removal of the active constituents of the respective
D. Hypovolemic shock drug with suitable menstrua
E. Fever A. Percolates D. Fluidextracts
B. Macerates E. Solvents
197. Concentrated aqueous preparations of a sugar or sugar C. Extracts
substitute with or without flavoring agents and medicinal
substances. 208. Process in which a comminuted drug is extracted of its
A. Syrups D. Magma soluble constituents by the slow passage of a suitable solvent
B. Elixir E. Juice through the column of a drug.
C. Solutions A. Extraction D. Percolation
B. Digestion E. Infusion E. Wet gum method
C. Maceration
219. Semisolid systems consisting of dispersion made up of either
209. It is a process in which the properly comminuted drug is small inorganic particles or large organic molecules enclosing and
permitted to soak in the menstruum until the cellular structure is interpenetrated by a liquid.
softened and penetrated by the menstruum and the soluble A. Suspension D. Collodion
constituents are dissolved. B. Gels E. Ointment
A. Infusion D. Percolation C. Emulsion
B. Maceration E. Extraction
C. Decoction 220. The taking up a certain amount of liquid without a
measurable increase in volume.
210. Preparations containing finely divided drug particles A. Imbibition D. Thixotropy
distributed uniformly throughout a vehicle in which the drug B. Swelling E. Xerogel
exhibits a minimum degree of solubility. C. Syneresis
A. Magma D. Suspension
B. Tinctures E. Gel 221. Taking up a liquid by a gel with an increase in volume
C. Emulsions A. Imbibition D. Thixotropy
B. Swelling E. Xerogel
211. Reason/s for preparing suspensions EXCEPT C. Syneresis
A. Drugs are chemically unstable in solution
B. Ease of swallowing 222. It occurs when the interaction between particles of the
C. Used to prepare a palatable liquid dosage form dispersed phase becomes so great that on standing, the
D. Flexible in administration of a range of doses dispersing medium is squeezed out in droplets and the gel
E. None of the above shrinks.
A. Imbibition D. Thixotropy
212. The study of flow which addresses the viscosity B. Swelling E. Xerogel
characteristics of powders, fluids and semisolids. C. Syneresis
A. Stokes
B. Colligative properties 223. A reversible gel sol with no change in volume or
C. Embryology temperature.
D. Rheology A. Imbibition D. Thixotropy
E. Embryology B. Swelling E. Xerogel
C. Syneresis
213. Guidelines in packaging and storage of suspensions
EXCEPT 224. It is formed when the liquid is removed from a gel and only
A. Use wide mouth container the framework remains
B. Adequate airspace above the liquid A. Imbibition
C. Tight container B. Swelling
D. Clear bottle C. Syneresis
E. Protected from freezing D. Thixotropy
E. Xerogel
214. A dispersion in which the dispersed phase is composed of
small globules of a liquid distributed throughout a vehicle in which 225. Example/s of gelling agent
it is immiscible. A. Acacia D. Ethylcellulose
A. Suspension D. Emulsion B. Alginic acid E. All of the above
B. Magma E. Tincture C. Bentonite
C. Gel
226. Pressurized dosage forms that upon actuation emit a fine
215. In emulsion terminology, the dispersed phase is the dispersion of liquid and/or solid materials containing one or more
A. External phase active ingredients in a gaseous medium.
B. Internal phase A. Magma D. Aerosol
C. Continuous phase B. Gel E. Inhalant
D. All of the above C. Inhalation
E. None of the above
227. Components of an aerosol formulation
216. Phases of emulsion EXCEPT A. Product concentrate
A. Dispersed phase B. Propellant
B. Dispersion medium C. Active ingredient
C. Emulsifying agent D. All of the above
D. External phase E. None of the above
228. Liquefied gas propellants used in aerosol products which are
217. Continental method of emulsion preparation is also referred being phased out
as A. Dichlorodifluoromethane
A. Dry gum method B. Difluoroethane
B. 4:2:1 method C. Chlorofluorocarbon
C. English method D. Chlorofluorocarbon
D. All of the above E. Dichlorotetrafluoroethane
E. A & B only
229. Part of the usual aerosol valve assembly that supports the
218. Method which is useful for the extemporaneous preparation actuator and delivers the formulation in the proper from to the
of emulsions from volatile oils or oleaginous substances of low chamber of the actuator.
viscosities. A. Stem D. Mounting cup
A. Forbes bottle method B. Gasket E. Housing
B. English method C. Spring
C. Dry gum method
D. Auxiliary method
230. Part of the usual aerosol valve assembly that holds the 240. Tablets that are prepared by compressing granular
gasket in place and is the mechanism by which the actuator effervescent salts or other materials having the capacity to
retracts when pressure is released, returning the valve to the release gas (CO2) when in contact with water.
closed position. A. Effervescent tablet
A. Stem D. Mounting cup B. Press coated tablet
B. Gasket E. Housing C. Layered tablets
C. Spring D. Enteric coated tablets
E. Multiple compressed tablets
231. Part of the usual aerosol valve assembly that is attached to
the aerosol can or container and holds the valve in place. 241. Tablets prepared by compressing tablets to a special tablet
A. Actuator D. Mounting cup machine and compressing another layer around the performed
B. Stem E. Spring tablet.
C. Gasket A. Press coated tablet
B. Layered tablets
232. Part of the usual aerosol valve assembly which extends from C. Melt-in-your mouth tablets
the housing down into the product and brings the formulation from D. Multiple compressed tablets
the container to the valve. E. Enteric coated tablets
A. Stem D. Spring
B. Dip tube E. Actuator 242. Defined as solid dosage forms in which one or more
C. Gasket medication and/or inert substances are enclosed within a small
shell or container of suitable forms of gelatin.
233. Part of the usual aerosol valve assembly which are made of A. Capsule
plastic EXCEPT B. Tablet
A. Actuator C. Powder
B. Housing D. Caplet
C. Stem E. Both A and B
D. Mounting cup
E. Dip tube 243. Disc-shaped, solid dosage form containing a medicinal agent
and flavoring agent, intended to be slowly dissolved in the oral
234. Temperature necessary to liquefy the propellant gas in cavity or mouth for local effect.
aerosol A. Lozenges D. Caplet
A. 0°C and below B. Troches E. Both A and B
B. -10°C to -15°C C. Pills
C. -34.5°C to -40°C
D. -15°C to -20°C 244. Sterile solutions that are compounded and package for
E. -20°C to -25°C instillation into the eyes.
A. Ophthalmic solutions
235. Sterile, pyrogen limited preparations intended to be B. Ear preparations
administered parentally C. Eye drops
A. Aerosols D. Nasal preparations
B. Injections E. Ophthalmic ointments
C. Ophthalmic solution
D. All of the above 245. Preservative mixture which is effective against some strains
E. None of the above of Pseudomonas aeruginosa, an organism that can invade an
abraded cornea and cause ulceration and blindness.
236. Small amount of powder may be blended by the movement A. Polymixin B, Benzethonium chloride
of a pharmaceutical spatula thru the powders on a sheet of paper B. Benzalkonium chloride, Thimerosal
or pill tile C. Benzalkonium chloride, Polyxmyxin B
A. Spatulation D. Tumbling D. Phenyl mercuric nitrate, Chlorobutanol
B. Trituration E. all of the above E. Polymixin B and sodium benzoate
C. Sifting
246. Ophthalmic preparation which is used to increase the
237. Very fine powders intended for the different body cavity such corneal contact time of a drug substance and thus provide a more
as ears, nose, throats, teeth and vagina. sustained action.
A. Douche powder A. Ophthalmic suspension
B. Dusting powder B. Ophthalmic ointment
C. Insufflations C. Ophthalmic drops
D. Teas D. Ophthalmic solution
E. Inhalations E. Otic suspension
238. Study of particles 247. Chloromycetin 1% ophthalmic ointment

A. Micromeritics A. Silver nitrate ophthalmic solution
B. Micromerics B. Pilocarpine HCl Ophthalmic solution
C. Micrometics C. Chloramphenicol Ophthalmic ointment
D. Micromintics D. Naphazoline Ophthalmic solution
E. None of the above E. Polymixin B Ophthalmic solution
239. A thin semi-opaque paper having limited moisture resistant 248. Preparations usually placed in the ear canal by drops or in
qualities. small amounts to remove excessive cerumen, treat ear infection,
A. Simple white bond paper pain and inflammation.
B. Vegetable parchment A. Aural preparation
C. Glassine B. Ear preparation
D. Waxed C. Nasal preparation
E. Colored bond paper D. Ophthalmic preparation
E. Both A and B
249. Most common preservative used in ophthalmic preparations.

A. Benzalkonium chloride 259. This is a method of preparing tablets in which the powder
B. Thimerosal mixture is compacted in large pieces and subsequently broken
C. Chlorobutanol down or sized into granules.
D. Both A and C A. Wet granulation
E. All of the above B. Dry granulation
C. Direct compression
250. Tinactin solution D. Slugging
A. Tolnaftate E. Compactness
B. Povidone Iodine
C. Carbol-fuschin 260. For some granular chemicals like potassium chloride, this
D. Calcium hydroxide method of preparation of tablet is an advantage to use.
E. Thimerosal A. Wet granulation
B. Dry granulation
251. Liquid preparations composed of pyroxylin dissolve in a C. Direct compression
solvent mixture equally composed of alcohol and ether with or D. Geometric dilution
without added medicinal substances. E. Slugging
A. Glycerogelatin D. Plaster
B. Sponge E. Paste 261. This substance provides water solubility or permeability to
C. Collodion the film to ensure penetration by body fluids and therapeutic
availability of the drug.
252. Plastic masses intended for topical application containing A. Alloying substance
gelatin, glycerin, water and added medicinal materials. B. Plasticizer
A. Glycerogelatin C. Film former
B. Gelatin D. Glossant
C. TDDS E. None of the above
D. Plasters
E. None of the above 262. Problem often encountered in film coating process
characterized by roughness of the tablet surface due to failure of
253. Common topical dusting powder to prevent irritation and spray droplets to coalesce.
chafing. A. Peeling
A. Tolnaftate powder B. Picking
B. Chloride powder C. Orange peel effect
C. Plain talcum powder D. Bridging
D. Nystatin powder E. None of the above
E. All of the above
263. Corresponds to the filling-in of the score line or intended logo
254. Fabrics and/or film even coated on one side with a pressure on the tablet by the film.
sensitive adhesive mixture. A. Peeling
A. Petrolatum gauze B. Picking
B. Absorbent gauze C. Bridging
C. Adhesive tapes D. Mottling
D. Adhesive bandage E. None of the above
E. Gauze
264. Most common wall forming material used in
255. Contains 1% of liquefied phenol in calamine lotion microencapsulation.
A. Phenolated calamine lotion A. Lactose D. Dextrose
B. White lotion B. Gelatin E. None of the above
C. Sulfur lotion C. Sorbitol
D. Calamine lotion
E. All of the above 265. The following ointment base/s is/are classified as
hydrocarbon base/s:
256. It is a process of comminution in which a paste is formed by A. Petrolatum USP
combining the powder material and a small amount of liquid in B. White ointment
which the powder is insoluble. C. Polyethylene glycol ointment
A. Levigation D. Both A and B
B. Trituration E. Both A and C
C. Spatulation
D. Sifting 266. Polyethylene glycol is an example of
E. All of the above A. Hydrocarbon base
B. Water removable base
257. Powders containing deliquescent and hygroscopic materials C. Absorption base
should be wrapped in what kind of paper? D. Water soluble base
A. Vegetable parchment E. All of these
B. Glassine paper
C. Bond paper 267. Petrolatum USP is:
D. Waxed paper A. A purified mixture of semi-solid hydrocarbons from
E. Colored paper petroleum that has been wholly or nearly decolorized
B. Also known as Yellow ointment
258. This type of coating imparts the same general characteristics C. Also known as White ointment
as sugar coating with the added advantage of a greatly reduced D. Water soluble
time period required for the coating preparation. E. None of the above
A. Enteric coating
B. Film coating 268. Hydrophilic petrolatum USP is classified as:
C. Multiple layer coating A. Hydrocarbon base
D. Single layer coating B. Oleaginous base
E. None of the above C. Absorption base
D. Water removable base
E. All of the above 279. Flexible collodion is prepared by adding castor oil and
camphor to collodion. How many % of castor oil is required in this
269. Semi-solid preparations containing one or more medicinal preparation?
agents dissolved or dispersed in either an oil-in-water emulsion or A. 3% D. 0.5%
in another type of water washable base. B. 5% E. 0.005%
A. Creams D. Ointments C. 2%
B. Gel E. All of the above
C. Paste 280. Salicylic acid contains how many percentage of salicylic acid
in Flexible collodion?
270. How many percent of glycerin is contained in a A. 3% D. 15%
glycerogelatin preparation? B. 5% E. 20%
A. 15% D. 5% C. 10%
B. 35% E. 10%
C. 40% 281. Glycerin or glycerites contain ____ of glycerin
A. 50% D. 1%
271. This type of suppository base includes mixtures of fatty and B. 25% E. 0.5%
water soluble bases. Example is Polyoxyl 40 stearate. C. 10%
A. Fatty base
B. Water miscible base 282. These are concentrated preparations of vegetable or animal
C. Water soluble base drugs obtained by the removal of the active constituents of the
D. Miscellaneous base respective drugs with suitable menstrual and evaporation of all or
E. None of the above nearly all the solvent.
A. Fluidextract
272. Glyceryl monopalmitate is an example of this type of B. Distillate
suppository base C. Extractive
A. Fatty base D. Extraction
B. Water miscible base E. None of these
C. Water soluble base
D. Absorption base 283. This method of extraction is a process in which the soluble
E. Greaseless constituents of a comminuted drug are extracted by the slow
passage of a suitable solvent through a column of the drug.
273. The most frequently employed method in the preparation of A. Percolation
suppositories both on small scale and on industrial scale is: B. Infusion
A. Molding C. Decoction
B. compression D. Maceration
C. Hand rolling E. Steam distillation
D. Hand shaping
E. None of the above 284. These preparations are made so that each mL contains the
therapeutic constituents of 1 g of the standard drug that it
274. Water impurities like calcium and magnesium can be presents.
removed by: A. Fluid extract
A. Ion exchange B. Macerate
B. Absorption C. Extractive
C. Filtration D. Infusate
D. Distillation E. Extract
E. All of the above
285. Coarse dispersion includes:
275. The amount of preservative required to protect against A. Emulsion
microbial growth varies with the proportion of water available for B. Gel
growth. What is the usual effective concentration of benzoic acid C. Magma
as preservative? D. All of the above
A. 1% D. 0.01-0.02% E. None of the above
B. 1-2% E. 0.001-0.002%
C. 0.1-0.2% 286. In emulsion terminology, the dispersed phase is referred to
as:
276. Relative sweetness of aspartame when compared to sucrose A. Internal phase
is B. External phase
A. 1:1 D. 300:1 C. Continuous phase
B. 30:1 E. 500:1 D. Dispersion medium
C.180:1 E. Both B and C
277. Tinctures of potent drugs for which no proportion of active 287. If the oleaginous phase is the internal phase, then the
principles has been fixed, shall have the strength of: emulsion is referred to as:
A. 10% by weight A. o/w emulsion
B. 20% by weight B. o/w/o emulsion
C. 40% by weight C. w/o emulsion
D. 50% by weight D. w/o/w emulsion
E. 60% by weight E. None of the above
278. Peppermint spirit USP is prepared by: 288. This emulsifying agent has a disadvantage of producing
A. Solution with maceration emulsions that are too fluid and which becomes more fluid upon
B. Chemical reaction standing.
C. Distillation A. Gelatin
D. Fermentation B. Casein
E. None of the above C. Egg yolk
D. Bentonite
289. In a small scale extemporaneous preparation of emulsion, 299. It has been employed to study cerebral physiology and a
these/this method/s may be applied: rapidly growing non invasive modality for the diagnosis and
A. Dry gum method management of cancer.
B. Wet gum method A. Positron emission tomography
C. Forbes method B. Hydroxyl ethylene diphosphonate
D. All of the above C. Radiopharmacy
E. None of the above D. Radiation
290. These are thermodynamically stable, optically transparent,
isotropic mixtures of a biphasic oil-water system stabilized with 300. Radiopharmaceutical drugs that are used for the treatment of
surfactants. non Hodgkin lymphoma
A. Microemulsion A. Bexxar
B. Auxiliary emulsion B. Ceretec
C. w/o/w emulsion C. Choletec
D. o/w emulsion D. Prosta scint
E. w/o emulsion E. Myoview
291. Mineral Oil emulsion is a/an:

A. o/w emulsion
B. o/w/o emulsion
C. w/o emulsion
D. w/o/w emulsion
292. This is used for preparing fluidextracts with boiling water as

the menstruum, alcohol being added as a preservative to the
concentrated percolate.
A. Process A
B. Process B
C. Process D
D. Process E
E. Process M
293. This is a percolation method that can be modified for

fluidextracts that must be assayed.
A. Process A
B. Process B
C. Process C
D. Process E
E. Process M
294. Magnesium aluminum silicate, also known as veegum, in

concentrations of _____, forms firm, thixotropic gels.
A. 10% D. 1%
B. 5% E. 0.5%
C. 2%
295. Bentonite magma is a preparation of ___ bentonite a native

colloidal hydrates aluminum silicate in purified water.
A. 10% D. 1%
B. 2% E. 0.5%
C. 5%
296. In moist heat sterilization, spores of which microorganisms

are most commonly employed?
A. Bacillus stearothermophilus
B. Bacillus subtilis
C. Bacillus pumilus
D. Clostridium botulinum
297. A rectal preparation for therapeutic, diagnostic, or nutritive

purposes.
A. Enema
B. Elixir
C. Collodion
D. Suppositories
E. Foam
298. A solid or semisolid mass supplied on a backing material and

intended to provide prolonged contact with the skin.
A. Patch
B. Plaster
C. Film
D. Foam
E. Gum
PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS
1) All of the following statements are true, EXCEPT

A. Mydriatics, dilate the pupils
B. Drugs could be used to diagnose liver malfunctions
C. Drugs cou;ld render the blood more or less coagulable
D. Cathartics, increaser urine output
E. Emetics induce vomiting
2) New drugs may be derived from which of the following

A. Plant or animal sources
B. Through chemical synthesis
C. Biotechnology
D. As by products of microbial growth
E. All of these
3) A term used to describe a compound that requires metabolic biotransformation after administration to
produce the desired pharmacologic effect
A. Enzyme
B. Prolonged release
C. Prodrug
D. New drug
E. New molecular entity
4) A clear, saturated, aqueous solution of volatile oils or other aromatic or volatile substances
A. Aromatic waters
B. Gargles
C. Douches
D. Irrigation solutions
E. Enemas
5) An aqueaous solution directed against a part or into a cavity of the body, and functions as a cleansing or
antiseptic agent
A. Aromatic waters
B. Gargles
C. Douches
D. IIrrigation solutions
E. Enemas
6) An aqueous solution frequently containing antiseptic, antibiotics, and/or anesthetics used for treating the
pharynx or nasopharynx by forcing air from the lungs through the gargle held in the throat
A. Aromatic waters
B. Gargles
C. Douches
D. Irrigation solutions
E. Enemas
7) These are concentrated, viscous, aqueous solutions of sugar substitute with or without flavors and
medical substances
A. Syrups
B. Honeys
C. Mucilages
D. Jellies
E. Elixirs
8) A thick, viscous, adhesive liquid that is produced by dispensing gum in water or by extracting the
mucilaginous principles from vegetable substances in water
A. Syrups
B. Honeys
C. Mucilages
D. Jellies
E. Elixirs
9) This component makes collodion flexible

A. Pyroxylin
B. Camphor
C. Castor oil
D. A and B
E. B and C
10) Which of the following statements is TRUE regarding elixirs?

I. Ethanol and water are the main ingredients
II. Clear, pleasantly flavoured, sweetened hydroalcoholic liquids for oral use
III. These are more fluid than syrups
A. I only
B. III only
C. I and II
D. II and III
E. I, II, and III
11) These are propellant driven drug suspensions or solutions in liquefied gas propellant with or without a co-
solvent and is intended to deliver the drug into the respiratory tract
A. Inhalation solutions
B. Metered dose inhalers
C. Nebules
D. Nebulizers
E. Inhalants
12) These are alcoholic or oil based solutions or emulsions containing therapeutic agents intended for
external application
A. Irrigation solutions
B. Liniments
C. Jellies
D. Spirits
E. Elixirs
13) These preparations were once called “embrocations”

B. Liniments
C. Jellies
D. Spirits
E. Elixirs
14) These are also known as “essences”

B. Liniments
C. Jellies
D. Spirits
E. Elixirs
15) Storage recommendation for spirits

A. Store in clear glass bottles that have tight lids
B. Store in tight, light resistant containers
C. Store in a cool, dry place
D. A and B
E. B and C
16) An advantage of emulsions over other liquid forms

I. Poorly water soluble drugs may be incorporated
II. The unpleasant odor or taste of oils can be marked
III. Absorption may be enhanced by the increased size of the internal phase
A. I only
B. III only
C. I and II
D. II and III
E. I, II, and III
17) These are semisolid systems consisting of either suspensions made up of small inorganic particles or
large organic molecules interpenetrated by a liquid
A. Spirits
B. Suspension
C. Gels
D. Emulsions
E. Lotions
18) The process of placing solid ingredients into a stoppered container with 750 mL of the prescribed solvent
and allowed to stand for a period of at least 3 days in a warm place, with frequent agitation, until all
soluble matter is dissolved
A. Solution
B. Maceration
C. Percolation
D. Digestion
E. Decoction
19) A form of maceration where gentle heal is applied during the process of extraction
A. Solution
B. Maceration
C. Percolation
D. Digestion
E. Decoction
20) The process of extracting water soluble and heat stable constituents from crude drugs by boiling in water
for 15 minutes, cooling, straining and passing sufficient cold water through the drug to get the required
volume
A. Solution
B. Maceration
C. Percolation
D. Digestion
E. Decoction
21) These are alcoholic or hydro-alcoholic solutions prepared from vegetable materials of from chemical
substances
A. Tinctures
B. Fluid extracts
C. Extracts
D. Percolate
E. Lotions
22) These are liquid preparations of vegetable drugs containing alcohol as solvent or as a preservative or
both, that each mL contains 1 g of the standard drug it represents
A. Tinctures
B. Fluidextracts
C. Extracts
D. Elixirs
E. Lotions
23) Also known as cataplasms, these represent one of the most ancient of pharmaceutical preparations
A. Pastes
B. Powders
C. Creams
D. Ointments
E. None of these
24) These are semisolid dosage forms that contain one or more drug substances intended to be applied
topically, EXCEPT
A. Pastes
B. Powders
C. Creams
D. Ointments
E. None of these
25) These are also known as pessaries

A. Urethral suppositories
B. Vaginal douche
C. Vaginal suppositories
D. Suppository base
E. None of these
26) Which of the following is TRUE regarding suppository bases?

I. Nontoxic and nonirritating to the mucous membranes
II. Melts or dissolved in rectal fluids
III. Stable on storage
A. I only
B. II only
C. I and II
D. II and III
E. I, II and III
27) These tablets contain sodium bicarbonate and an organic acid (i.e. tartaric or citric acid) in addition to the
drug substance
A. Effervescent tablets
B. Sugar-coated tablets
C. Film-coated tablets
D. Controlled release tablets
E. Enteric coated tablets
28) Compressed tablets that are coated with a substance resistant to gastric fluid and contain substances
that are destroyed or inactivated in the stomach
B. Sugar-coated tablets
C. Film-coated tablets
D. Controlled release tablets
E. Enteric coated tablets
29) These are flat, oval tablets designed to be dissolved under the tongue
A. Buccal tablets
B. Hypodemic tablets
C. Tablet inturates
D. Sublingual tablets
E. Molded tablets
30) Which of the following are reasons for enteric coating of tablets?
I. To protect the drug in the dosage form from the effects of gastric acid
II. To minimize the irritating effects of certain drugs on the gastric mucosa (eg. NSAIDS)
III. To deliver the drug to the intestine for local effects
A. I only
B. III only
C. I and II
D. II and III
E. I, II and III
31) Which of the following statements is TRUE regarding controlled release dosage forms?
I. The patient would have to take the medication more frequently
II. The patient takes the drug less frequently, therefore improving drug adherence
III. These reduce fluctuation in drug concentration in the blood
A. I only
B. III only
C. I and II
D. II and III
E. I, II and III
32) The passage of drug molecules through a membrane that does not actively participate in the process,
where the movement of molecules is from the side with high concentration to the side with low
concentration
A. Passive diffusion
B. Facilitates transport
C. Active transport
D. Drug dissolution
E. Drug distribution
33) Which of the following statements is TRUE?

I. Some drugs are better absorbed in the amorphous form as compared to the crystalline form
II. Some drugs have better stability in the crystalline form as compared to the amorphous form
III. A drug’s stability and absorption profiles are not affected by their physical form, so it does not
matter whether the amorphous or crystalline form is used
A. I only
B. III only
C. I and II
D. II and III
E. I, II and III
34) This is the property where a single chemical substance may exist in more than one crystalline form
A. Polymorphism
B. Crystallization
C. Gel formation
D. Suspension
E. Amorphous form
35) These are fillers used to prepare tablets of the proper size and consistency
A. Tablets
B. Diluents
C. Disintegrants
D. Film coating
E. Glidants

I. The dissolution rate of a salt form of a drug is generally quite different from that of the parent
compound
II. The state of hydration of a drug molecule can affect its solubility and pattern of absorption
III. The various polymorphic forms of the same chemical have the same physical properties, i.e same
solubility and dissolution profiles
A. I only
B. III only
C. I and II
D. II and III
E. I, II and III
37) The term describes the rate and extent of absorption of an active drug ingredient or therapeutic moiety
from a drug product and becomes available at the site of action
A. Bioavailability
B. Bioequivalence
C. Pharmacokinetics
D. Pharmacodynamics
E. Pharmaceutics
38) These are pharmaceutical equivalents that provide essentially the same therapeutic effect when
administered to the same individuals in the same dosage regimens.
A. Bioequivalence
B. Pharmaceutical equivalents
C. Therapeutic equivalents
D. Pharmaceutical alternatives
E. Therapeutic alternatives
39) Which of the following statements is TRUE regarding subcutaneous injections?

I. These are administered in relatively small volumes of 2Ml OR LESS
II. For patients receiving multiple injections, it is advisable to rotate injection sites
III. Administering epinephrine prior to a subcutaneous injection will reduce the rate of absorption of
the drug
A. I only
B. III only
C. I and II
D. II and III
E. I, II and III
40) Salicylates decrease the binding capacity of thyroxine to proteins resulting to which of the following?
A. Increased effect of salicylates
B. Salicylates become less protein bound
C. No change in either drug’s therapeutic effect
D. Decreased effect of thyroxine
E. Increased effect of thyroxine
41) Which of the following statements is TRUE regarding powders?

I. The use of powdered substances in the preparation of other dosage forms is extensive
II. Powders are more stable than liquid dosage forms and are rapidly soluble
III. Powders have a large surface area that is exposed to atmospheric conditions requiring them to
be dispensed in tight containers
A. I only
B. III only
C. I and II
D. II and III
E. I, II and III
42) Which of the following is a characteristic of topical powders?

A. Uniform, small particle size that is non-irritating to the skin
B. Free flowing and impalpable
C. Adheres to the skin
D. All of these
E. None of these
43) A base or whole used in topical powders

A. Calcium stearate
B. Aromatic material
C. Magnesium stearate
D. Talc
E. Antimicrobial agent
44) These are finely diluted powders intended to be applied into a body cavity
A. Oral powder
B. Topical powder
C. Insufflations
D. Nasal powders
E. Snuffs
45) Powders of vegetable and animal origin drugs officially defined as “all particles pass through a No 80
sieve. There is no limit to greater fineness.”
A. Very coarse
B. Very fine
C. Coarse
D. Fine
E. Moderately Coarse
46) The following are methods for determining particle size, EXCEPT
A. Sieivng
B. Microscopy
C. Sedimentation Rate
D. Light energy diffraction
E. Dissolution
47) A term used to define grinding a drug substance in mortar to reduce particle size
A. Trituration
B. Communition
C. Geometric dilution
D. A and B
E. B and C
48) Levigation is used to reduce particle size and grittiness of the added powders in the small-scale
preparation of which of the following dosage forms
A. Capsule
B. Tablets
C. Ointments
D. Elixirs
E. Spirits
49) Equipment used to facilitate levigation

A. Mortar and pestle
B. Ointment tile and spatula
C. Sieve
D. A and B
E. B and C
50) Which of the following statements is TRUE regarding blending powders?

I. It is best to reduce particle size of powders individually prior to weighing and blending
II. Spatulation is an ideal method for blending powders containing potent substances
III. Spatulation is not to be used when mixing powders that tend to form eutectic mixture
A. I only
B. III only
C. I and II
D. II and III
E. I, II and III
51) Which of the following is TRUE for both deliquescent and hygroscopic powders?
A. Both absorb moisture from the air
B. Both release moisture into the air
C. Both may liquefy when they absorb or release moisture
D. A and C
E. B and C
52) A disadvantage for using oral powders

A. Undesirable smell of the drug
B. Undesirable taste of the drug
C. Undesirable texture of the drug
D. Difficult to swallow
E. Difficult to dispense
53) Which of the following inhalation powders is administered using a Diskhaler?

A. Relenza Rotadisk
B. Flovent Rotadisk
C. Advair Diskus
D. A and B
E. B and C
54) Which of the following statements is TRUE regarding bulk powders?

I. Dispensing medicated powders in bulk quantities is limited to nonpotent substances
II. Patients should be informed about the proper handing, storage, measurement and preparation of
bulk powder prescription and non-prescription preparations
III. Since bulk powders do not contain potent substances, there is no need to keep them away from
children and animals
A. I
B. III
C. I and II
D. II and III
E. I, II and III
55) This is a transparent, waterproof paper used for packaging divided powders that contain hygroscopic or
deliquescent materials
A. Glassine paper
B. Bond paper
C. Wax paper
D. Vegetable parchment
E. Plastic wrap
56) This dosage form is composed of dry aggregates of powder particles that may contain one or more active
ingredients, with or without other ingredients
A. Granules
B. Flakes
C. Beads
D. Capsules
E. Powders
57) Which of the following statements regarding granules is/are TRUE?
I. Granules have better flowing characteristics compared to powders
II. Granules are less likely to cake or harden upon standing as compared to powders
III. Granules are easily wetted by liquids as compared to certain light and fluffy powders
A. I
B. III
C. I and II
D. II and III
E. I, II and III
58) A dosage form that is preferred by adults especially by those who are on several medications
A. Bulk powders
B. Tablets
C. Syrups
D. Suspensions
E. All of these
59) A patient comes to the pharmacy asking for a refill for his blood pressure medication, the name of which
he could not recall. Upon checking his profile, there are two blood pressure medicines on file, what
information would you ask the patient to help identify the needed medication?
A. Dosage form (tablet or capsule)
B. Color
C. Shape
D. Score marks or other markings
E. All of these
60) Which of the following dosage forms must be left intact?

A. Enteric coated tablets
B. Sublingual tablets
C. Buccal tablets
D. Extended release dosage forms
E. All of these
61) Which of the following statements is TRUE regarding capsule shells?

I. Depending on their composition, gelatin capsule shells may be hard or soft
II. The shell may be composed of two pieces, a body and a cap
III. The capsule shell may be a single piece that is often referred to as a soft gelatin capsule
A. I
B. III
C. I and II
D. II and III
E. I, II and III
62) The dessicant material most commonly used when packaging capsules containing hygroscopic agents
A. Silica gel
B. Clay
C. Charcoal
D. All of these
E. None of these
63) The largest capsule size intended for human use

A. 000
B. 00
C. 1
D. 4
E. 5
64) Commonly used diluents for hard shell capsules

A. Starch
B. Lactose
C. Talc
D. A and B
E. B and C
65) This is added to capsule formulations to assist the breakup and distribution of the capsule’s contents
in the stomach
A. Glidants
B. Lubricants
C. Disintegrants
D. Diluents
E. None of these
66) Fumed silicon dioxide, magnesium stearate, calcium stearate, stearic acid or talc are examples of
A. Glidants
B. Diluents
C. Disintegrants
D. Colorants
E. None of these
67) A hard gelatin capsule may be filled with all of the following EXCEPT
A. Powder or granules
B. Pellet mixture
C. A capsule
D. A tablet
E. Water-immiscible non-volatile liquid
68) These are tablets that are prepared by molding resulting to very soft and soluble tablets that are designed
for rapid dissolution
A. Compressed tablets
B. Gel tablets
C. Tablet triturates
D. Effervescent tablets
E. Molded tablets
69) These are small, usually cylindrical, molded, or compressed tablets containing small amounts of usually
potent drugs
A. Compressed tablets
B. Gel tablets
D. Effervescent tablets
E. Molded tablets
70) A disadvantage of formulating rapidly disintegrating or dissolving tablets
A. Drug loading
B. Taste masking
C. Friability
D. Stability of the product
E. All of these
71) Rapidly disintegrating or dissolving tablets are designed to dissolve in the mouth within
A. 15 seconds
B. 15 minutes
C. 25 seconds
D. 25 miutes
E. 20 seconds
72) These are also known as lozenges

A. Lollipops
B. Troches
C. Pellets
D. Pills
E. Bolus tablets
73) Which of the following statements is TRUE regarding modifies release dosage forms?
I. An enteric coated tablet is an example of a modified release tablet
II. Modified release products provide a delayed release of the drug
III. Modified release products provide an extended release of the drug
A. I
B. III
C. I and II
D. II and III
E. I, II and III
74) Extended release technology for solid dosage forms is based on which of the following:
I. Modifying drug dissolution by controlling access of biologic fluids through the use of coatings
II. Controlling drug diffusion rates from dosage forms
III. Chemical reaction or interaction between the drug or pharmaceutical barrier and the site-specific
biologic fluid
A. I
B. III
C. I and II
D. II and III
E. I, II and III
75) Spansule (SmithKlineBeecham) is an example of this type of dosage form.
A. Multitablet system
B. Coated beads, granules, microspheres
C. Hydrophilic matrix system
D. Microencapsulated drug
E. None of these
76) An example of a product using a hydrophilic matrix base of HPMC for extended drug release
A. Oramorph SR Tablets (AllPharma)
B. Spansule capsule (SmithKlineBeecham)
C. Micro-K Extencaps (Wyeth)
D. Glucotrol XL-ER tablets (Pfizer)
E. Procardia XL-ER tablets (Pfizer)
77) This is composed of a core tablet surrounded by a semipermeable membrane coating having a 0.4 mm
diameter hole produced by a laser beam.
A. Oral osmotic drug delivery system
B. Ion-exchange resin
C. Gradumet (Abbott)
D. Spansule
E. Complex formation
78) A characteristic of a drug best suited for incorporation into an extended release product
I. Exhibits very slow or very fast absorption and excretion rates
II. Are uniformly absorbed from the GIT
III. Possess a good margin of safety
A. I
B. III
C. I and II
D. II and III
E. I, II and III
79) A counseling point when dispensing modified release tablets and capsules
A. Do not crush or chew
B. It is normal to see empty shells from osmotic tablets in the stools
C. A modified release tablet may be crushed and mixed with food for NGT feeding
D. A and B
E. B and C

I. Topical dermatological products are designed to deliver drugs into the skin too treat
dermatological conditions
II. Transdermal products are designed to deliver drugs through the skin into the circulation for
systemic effects
A. I
B. III
C. I and II
D. II and III
E. I, II and III
81) An example of an oleaginous ointment base
A. Petrolatum USP
B. Hydrophilic Petrolatum USP
C. Auqaphor
D. Lanolin USP
E. Modified Lanolin USP
82) A water-soluble ointment base

A. Polyethylene glycol
B. White Petrolatum
C. Lanolin
D. Hydrophilic ointment
E. Petrolatum
83) Method used for ointment preparation

A. Incorporation
B. Fusion
C. Compression
D. A and B
E. B and C
84) The process of mixing the solid material in a vehicle where it is not soluble to make a smooth dispersion
A. Trituration
B. Geometric dilution
C. Levigation
D. Fusion
E. Pulverization by intervention
85) The process of dissolving the gummy material in a solvent and then spread out on a pill tile to allow the
solvent to evaporate leaving a thin film of the material on which the other ointment ingredients are spread
A. Trituration
C. Levigation
D. Fusion
86) The process of combining all or some of the components of an ointment by melting together and then
coated with constant stirring until congested
A. Incorporation
C. Spatulation
D. Fusion
87) Recommended packaging for topical dermatologic products

A. Large mouth jars
B. Plastic or metal tubes
C. Syringes
D. All of these
E. None of these
I. Creams are easier to spread and remove than ointments
II. Pastes are semisolid preparations that are stiffer than ointments
III. Because of the stiffness of pastes they are effective in absorbing serous secretions
A. I
B. III
C. I and II
D. II and III
E. I, II and III
89) Carbomer 904, carboxymethylcellulose, tragacanth are examples of

A. Levigating agent
B. Gelling agent
C. Preservatives
D. Surfactants
E. Antimicrobial agent
90) A gel mass consisting of floccules of small distinct particles is termed a two-phase system, often referred
to as
A. Jelly beans
B. Magma
C. Plaster
D. Emulsion
E. Solvent
91) Milk of Magnesia is an example of a/an

A. Gel
B. Ointment
C. Emulsion
D. Gelatin
E. Plaster
92) Which of the following statements is TRUE regarding topical dermatological products?
I. Oleaginous bases provide greater occlusion and emollient effects than hydrophilic bases
II. Water-soluble bases are non-greasy and easy to remove
III. Ointments are better at absorbing serious discharge as compared to pastes
A. I
B. III
C. I and II
D. II and III
E. I, II and III
93) Counselling points when dispensing a dermatologic product

I. Thoroughly clean the affected area with soap and water and pat dry with a soft cloth
II. Apply a thin layer of medication on the affected area
III. Cover the affected area with a bandage after application of medication
A. I
B. III
C. I and II
D. II and III
E. I, ii and III
94) When dispensing over the counter dermatologic products, the pharmacist most ensure which of the
following
A. The patient understands the proper method of administration
B. The patient knows how often to apply the medication and how long should it be used
C. Special warnings (in relation to pregnancy or nursing)
D. All of these
E. None of these
95) An important reminder to the patient when dispensing an ophthalmic ointment

A. The tip of the ointment tube must not touch any surface including the eyes, eyelid, or fingertip
B. Blurring of vision after application is cause for alarm
C. It is okay to share ointment with your spouse
D. All of these
E. None of these
96) All of the following are advantages of utilizing the rectal route for drug administration, EXCEPT
A. Breakdown of drugs susceptible to gastric acid is avoided
B. Larger doses of drugs could be administered compared to oral administration
C. Unpleasant smelling or tasting drugs with limited oral administration could be administered
D. Achievement of a rapid drug effect systemically as an alternate to injection
E. None of these
97) Since first pass is partially avoided when administering drugs rectally, what would be the fate of drugs
that are subject to extensive first pass metabolism when given orally when they are administered as
suppositories
A. There would be lower blood levels of he drug
B. There would be higher blood levels of the drug
C. There would be no difference in the blood levels
D. There would be less effect of the light
E. None of these
98) A distressed mother comes to the pharmacy for a consultation because her 5-month old son has fever
and does not want to take his paracetamol drops. She said the pediatrician advised her to go to the
pharmacy and get the suppository form of the drug. She has never used a suppository before, how would
you consult this patient?
A. Assure her that the suppository would be a better option for her child right now since he could not
take in oral medicines
B. Advise her to wash her hands before and after administering the suppository
C. The drug should be unwrapped and inserted into the rectum and hold it in place for a few seconds
D. All of these
E. None of these
99) All of the following are ideal characteristics of a suppository base, EXCEPT
A. Solid at room temperature
B. Soften, melt or dissolve readily at body temperature
C. Non-irritating to the mucous membrane
D. Chemically and physiologically inert
E. A pleasing appearance is not necessary
100) An example of a fatty or oleaginous suppository base
A. Glycerinated gelatin
B. Cocoa butter
C. Wecobee bases
D. A and B
E. B and C
101) Recommended packaging for glycerin suppositories and glycerinated gelatin suppositories
A. Wrapped in metallic foil
B. White, opaque, plastic bottles
C. Tightly closed glass containers
D. Separated in compartment boxes
E. All of these
102) A solvent used for liquid preparations

A. Ethyl alcohol
B. Purified water
C. Glycerin
D. Propylene glycol
E. All of thes
103) Which of the following statements is TRUE regarding solutions?

I. Most solutions are prepared by simple mixing of solutes with the solvent
II. Particle size reduction is one of the techniques that may be used to hasten dissolution of solutes
in the solvent
III. Most pharmaceutical solutions are supersaturated with solute
A. I
B. III
C. I and II
D. II and III
E. I, II and III
104) Which of the following statements about antibiotic powders or granules for reconstitution is
TRUE?
I. Certain antibiotics are formulated as powders or granules for reconstitution because of insufficient
stability in aqueous solutions
II. The dry powder or granules contain the active drug, flavorant, colorant, buffers, etc which are
mixed with a prescribed amount of purified water just before dispensing
III. Once these are reconstituted, the expiry date is still the same as what the manufacturer has
indicated on the label
A. I
B. III
C. I and II
D. II and III
E. I, II and III
105) When dispensing solutions, which of the following may be requested from the pharmacist
A. A commercially prepared oral solution
B. Dilute the concentration of a solution for pediatric use
C. Extemporaneously compound a syrup from capsules if syrup form is needed but is not available
D. Reconstitute a dry powdet mixture of an antibiotic
E. All of these
106) A patient reminder when dispensing oral rehydrations solutions

A. Add the recommended amount of water for powders for reconstitution
B. These should not be given or mixed with other electrolyte-containing liquids
C. These could be given with other liquids such as Gatorade
D. A and B
E. B and C
107) Magnesium citrate also known as citrate of magnesia is used as a

A. Saline cathartic
B. Emetic
C. Antiemetic
D. Osmotic cathartic
E. Enema
108) Which of the following statements regarding syrups is TRUE/

I. Syrups could either be medicated or nonmedicated
II. Syrups provide a pleasant means of administering a liquid form of a disagreeable-tasting drug
III. Any water-soluble drug that is stable in aqueous solutions may be added to a flavored syrup
A. I
B. III
C. I and II
D. II and Iii
E. I, II and III
109) All of the following are examples of nonmedicated syrups EXCEPT

A. Cherry syrup
B. Orange syrup
C. Ora-Sweet
D. Syrup
E. None of these
110) Which of the following statements regarding nonmedicated syrups is TRUE?

I. Sugar-free syrup is available for use for preparations intended for diabetic patients
II. Certain flavored syrups may have an acidic medium while others may be neutral or slightly basic
III. Syrups contain sugar (sucrose) or sugar substitutes to provide sweetness and viscosity
A. I.
B. III
C. I and II
D. II and III
E. I, II and III
111) Which of the following statements regarding transdermal drug delivery systems is TRUE?
I. The larger the TDDS, the more drug is absorbes
II. TDDS provide extended therapy with a single application
III. There is poor compliance in patients on TDDS because the patch needs to be applied more
frequently than when taking oral dosage forms
A. I
B. III
C. I and II
D. II and III
E. I, II and III
112) The following statements regarding TDDS are true, EXCEPT

A. TDDS may be applied to any part of the body, depending on the patient’s preference
B. Skin lotion should be avoided at the application site
C. TDDS should not be physically altered by cutting
D. TDDS should be worn for the full period stated in the product’s instructions
E. The patient or caregiver should be instructed to wash hands thoroughly before and after applying a
TDDS
113) A disadvantage of using elixirs

A. Ease of dosage administration compared to solid dosage forms
B. Containes colorants to enhance appearance
C. Alcoholic content is a concern among children and adults who choose to avoid alcohol
D. All of these
E. None of these
114) Which of the following statements is TRUE regarding liquid dosage forms?
I. Preferably, these medicines should be measured using calibrated devices for administration
II. The pharmacist should be careful when selecting a liquid product to dispense and take into
consideration the patient’s current condition and medications taken
III. For convenience, these medicines could be measured using a teaspoon or tablespoon depending
on the recommended dosage
A. I
B. III
C. I and II
D. II and III
E. I, II and III
115) An example of a medicated tincture taken orally

A. Paregoric USP
B. Benzoin tincture
C. Iodine tincture
D. Elixir and solution
E. Chloral hydrate syrup
116) The following are examples of solutions applied to the skin EXCEPT
A. Chlorhexidine gluconate (Hibiclens)
B. Clotrimazole (Lotrimin Solution)
C. Ketoconazole (Nizoral A-D)
D. Diphenhydramine (Benadryl Liquid Solution)
E. Tofralate (Tinactin solution)
117) An example of a topical oral solution

A. Benzocaine solution
B. Cetylpyridinium chloride solution
C. Nystatin oral suspension
D. All of these
E. None of these
118) Which of the following statements regarding liniments is TRUE?

I. Liniments with an alcoholic or hydroalcoholic vehicle is used primarily when massage is desired
II. Oleaginous liniments are useful when rubefacient, counterirritant, or penetrating action is desired
III. Liniments are not applied to skin areas that are broken or bruised because this could result to
excessive irritation
A. I
B. III
C. I and II
D. II and III
E. I, II and III
119) The following preparations should have the auxillary label, “SHAKE WELL”
A. Milk of Magnesia
B. Liniments
C. Nystatin suspension
D. All of these
E. None of these
120) Desired feature/s in a suspension

A. Particles should settle slowly, and should be readily dispersible upon gentle shaking of the container
B. The suspension should pour readily and evenly from its container
C. The particle size are variable even though long periods of undisturbed standing
D. A and B
E. B and C
121) The following preparations are packaged in wide-mouth containers EXCEPT

A. Ciprofloxacin and suspension
B. Milk of Magnesia
C. Ointments
D. All of these
E. None of these
122) Acacia, tragacanth and pectin are examples of
A. Capsule fillers
B. Emulsifying agents
C. Colorants
D. Levigating agents
E. Buffers
123) The following are considered as colloidal dispersions, EXCEPT

A. Gels
B. Magmas
C. Oral solutions
D. A and B
E. B and C
124) An example of a topical emulsions

A. Lotions
B. Shamposs
C. Ointments
D. A and B
E. B and C
125) Which of the following statements regarding colloidal dispersions is TRUE?

I. A colloidal dispersion has larger particle size of the disperse phase as compares to true solutions
II. True solutions scatter light and appear clear
III. Colloidal dispersions do not scatter light and appear opaque
A. I
B. III
C. I and II
D. II and III
E. I, II and III
126) Characteristics of gels, EXCEPT

A. Swelling
B. Imbibition
C. Thixotropy
D. Syneresis
E. None of these
127) The taking up of certain amount of liquid by a gel without a measurable increase in volume is
termed
A. Imbibition
B. Swelling
C. Thixotropy
D. Syneresis
E. All of these
128) The taking up of a liquid by a gel with an increase in volume is termed
A. Imbibition
B. Swelling
C. Thixotropy
D. Syneresis
E. All of these
129) This term is used to describe gel and formation with no change in volume or temperature
A. Imbibition
B. Swelling
C. Thixotrophy
D. Syneresis
E. All of these
130) A topical gel that is used as a bleach for hyperpigmented skin

A. Benzoyl peroxide topical gel
B. Clindamycin and benzoyl peroxide topical gel
C. Hydroquinone gel
D. Salicylic acid gel
E. Augmented betamethasone dirpoprionate topical gel
131) The reason for allowing the mixture of bentonite and purified water to stand for 24 hours before it
may be stirred
A. The standing period ensures complete hydration and swelling of the bentonite
B. The standing period allows the mixture to cool down
C. The standing period would eliminate the need for preservatives
D. All of these
E. None of these
132) This has been used as a topical vehicle and protectant

A. Bentonite Magma
B. Milk of Mgnesia
C. Aluminum hydroxide gel
D. Starch glycerite
E. None of these
133) Advantage/s of aerosol dosage forms

A. It is difficult to withdraw a portion of the medication and doing so risks contamination of the whole
product
B. The aerosol container protects medicinal agents adversely affected by atmospheric oxygen and
moisture
C. Applying aerosol medications is a messy process requiring cleanup after each application
D. It is difficult to control dosage especially In inhalant aerosols
E. All of these
134) Component/s of an aerosol formulation
A. Product concentrate
B. Propellant
C. Emulsifying agent
D. A and B
E. B and C
135) Which of the following statements is TRUE regarding metered dose inhalers?
I. Metering valves are employed when the formulation is a potent medication
II. Each metered dose is delivered though the mouthpiece upon actuation of the aerosol u’it's valve
III. Metered dose inhalers indicated how many actuations are left in the inhaler
A. I
B. III
C. I and II
D. II and III
E. I, II and III
136) Advantage/s of pressure filling for pharmaceuticals aerosols

A. There is more propellant lost in the process
B. There is less danger of moisture contamination of the product
C. There is less propellant lost in the process
D. A and B
E. B and C
137) Counselling points when dispensing aerosols

A. Remind patients not to puncture the containers
B. Avoid storing or using them near heat or an open flame
C. Shake the product well prior to use
D. Detailed instructions on how to use the product
E. All of these
138) The following are inhaled aerosols EXCEPT

A. Proctofam
B. Atrovent
C. Ventolin
D. Serevent
E. Azmacort
139) Which of the following statements regarding the use of pharmaceutical aerosols is TRUE?
I. These products are only effective when properly used
II. The pharmacist must demonstrate how to assemble, store, clean and use the inhalers
III. For patients having difficulty using an inhaler, the pharmacist should recommend the use of a
spacer with the inhaler
A. I
B. III
C. I and II
D. II and III
E. I, II and III
140) Counselling points when dispensing topical aerosols
A. The affected should be gently cleaned and pat dry prior to application of the medication
B. When applying the drug, the nozzle should be place directly on the skin
C. Once the medication is applied, the area should be covered with a bandage
D. A and B
E. B and C
141) These are a class of gels in which the structural coherent matrix contains a high proportion of
iquid, usually water
A. Hydrogen
B. Jellies
C. Organogels
D. Gelling agents
E. None of these
142) Conditions where the parenteral route is employed over the other routes of administration
A. When rapid drug action is required
B. When patient is uncooperative, unconscious, or unable to accept or tolerate oral medications
C. When the drug is ineffective when administered by any other route
D. All of these
E. None of these
143) A parenteral route where the drug is injected into the spinal fluid
A. Intraarticular
B. Intramuscular
C. Intrathecal
D. Intraspinal
E. Intrasynovial
144) A parenteral route where the drug is injected into the joint fluid area
A. Intraarticular
B. Intramuscular
C. Intrathecal
D. Intraspinal
E. Intrasynovial
145) Intravenous route of drug administration

A. Drug absorption is not a factor because the drug is injected directly into the bloodstream
B. Once a drug is administered intravenously, it could not be retrieved
C. IV doses are just about the same as oral doses, they are interchangeable
D. A and B
E. B and C
146) Propolol, USP is an example of this type ofinjectable material

A. Injectable suspension
B. For injection
C. For injectable suspension
D. Injection
147) Which of the following statements is TRUE regarding parenteral preparations?
I. Solvents of vehicles must meet special standards of purity and safety
II. The use of coloring agents is strictly prohibited
III. Parenteral products are always sterilized, must meet sterility standards, and must not exceed
allowable endotoxin limits
A. I
B. III
C. I and II
D. II and III
E. I, II and III
148) Sterile water for injection that contains one or more suitable antimicrobial agents
A. Sterile Water for Injection, USP
B. Water for Injection, USP
C. Bacteriostatic Water for Injection, USP
D. Sodium Chloride Injection, USP
E. Bacteriostatic Sodium Chloride, USP
149) The components of Ringer’s Injection, USP

I. Sodium chloride
II. Potassium chloride
III. Calcium chloride
A. I
B. III
C. I and II
D. II and III
E. I, II and III
150) In addition to the salts found in Ringer’s injection, this is a component of Lactated Ringer Injection
A. Lactic Acid
B. Sodium Lactate
C. Potassium Lactate
D. Calcium Lactate
E. Magnesium Lactate
151) Characteristics of nonaqueous vehicles used in injections

A. Nonirritating and nonsensitizing
B. Nontoxic in the amounts administered
C. No pharmacological activity
D. Should not affect the activity of the medicinal agent
E. All of these
152) A method of sterilization that is conducted in an autoclave

A. Steam sterilization
B. Dry heat sterilization
C. Filtration
D. Gas sterilization
E. Ionizing radiation
153) The mechanism of microbial destruction in dry heat
A. By denaturation and coagulations of some of the organism’s essential proteins
B. Destruction or disorientation of the vital structures of the cell, or alteration of the chemicals within or
supporting the microorganism to form deleterious new chemicals capable of destroying the cell
C. Physical removal of the organism by adsorption on the filter medium or sieving mechanism
D. Interferes with the metabolism of the bacterial cell
E. By dehydration of the microbial cell followed by slow oxidation
154) Which of the following statements regarding large volume parenterals is TRUE?
I. Used to replenish fluids or electrolytes or to provide nutrition
II. Usually administered in volumes 100 mL to 1 L or more per day by slow IV infusion
III. These preparations contain bacteriostatic agents
A. I
B. III
C. I and II
D. II and III
E. I, II and III
155) Because of the capacity of the eye to retain liquid and semisolid preparations is limited which of
the following is TRUE?
A. Topical applications are administered in small amounts
B. Liquid preparations are applied dropwise
C. Ointments are applied as a thin ribbon to the margin of the eyelid
D. All of these
E. None of these
156) Which of the following statements is TRUE regarding ophthalmic preparations?

I. The retention time on the eye surface is short
II. The amount of drug absorbed is only a small fraction of the amount administered
III. Some may necessitate more than once daily dosing
A. I
B. III
C. I and II
D. II and III
E. I, II and III
157) All of the following are pharmacologic categories of ophthalmic drugs EXCEPT
A. Anesthetics
B. Antibiotics
C. Diuretics
D. Astringent
E. Mydriatics
158) An example of a mydriatic

A. Timolol maleate
B. Tetracaine
C. Bacitracin
D. Atropine
E. Ketorolac
159) Method for sterilizing ophthalmic preparations containing heat-sensitive ingredients
A. Autoclaving
B. Steam sterilization
C. Filtration
D. Dry heat
E. UV light exposure
160) Which of the following statements is TRUE regarding the use of preservatives in ophthalmic
preparations?
I. Antimicrobial preservatives must be effective at the concentration employed in the formulation
II. Preservative-free preparations, packaged in single use containers, are also available
III. A commonly employed antimicrobial preservative is benzalkonium chloride 0.0064% is effective
against P. aeruginosa
A. I
B. III
C. I and II
D. II and III
E. I, II and III
161) Characteristics of ophthalmic preparations

I. Drug particles in ophthalmic suspensions must be micronized to minimize irritation and scratching
the cornea
II. Ophthalmic solutions must be sparkling clear ad free of all particulate matter for comfort and
safety
III. The formulation of an ophthalmic suspension may be considered when the medicinal agent is
insoluble or unstable in an aqueous vehicle
A. I
B. III
C. I and II
D. II and III
E. I, II and III

I. Most nasal preparations contain adrenergic agents and are employed for their decongestant
activity
II. Most of these preparations are in solution form and are administered as nose drops or sprays
III. Nasal decongestant are for long term use to manage rhinitis of the common cold
A. I
B. III
C. I and II
D. II and III
E. I, II and III
163) The following are characteristics of amyl nitrite, EXCEPT
A. Clear, yellowish liquid
B. Volatile
C. Acts as a vasodilator
D. Acts as a vasoconstrictor
E. Administered via inhalation
164) Also known as otic preparations

A. Eye preparations
B. Ear preparations
C. Aural preparations
D. A and B
E. B and C
165) Ear preparations are used for the following, EXCEPT

A. Removal of excessive cerumen
B. Management of pain
C. Treatment of infection
D. Management of rhinitis
E. Treatment of inflammation
166) Radio[pharmaceuticals are used for

A. Diagnosis
B. Treatment
C. Prophylaxis
D. Aand B
E. B and C
167) Which of the following statements regarding radiopharmaceuticals is TRUE?

I. Radiopharmaceuticals consist of a drug component and a radioactive component
II. Most radionuclides contain a component that emits gamma rays
III. Radiopharmaceuticals are used for diagnostic or therapeutic procedure
A. I
B. III
C. I and II
D. II and III
E. I, II and III
168) Which of the following is TRUE?

A. Unstable nuclides are radioactive
B. Stable nuclides are radioactive
C. Stable nuclides release energy
D. A and B
E. B and C
169) The amount of radiation absorbed by body tissue in which a radioactive substance resides
A. Radionuclide
B. Radiation dose
C. Radioactivity
D. Reaction dose
E. Radioactive half-life
170) TRUE regarding the activity of a radiopharmaceutical

A. All radioactivity increase with time
B. The larger the decay constant the faster the decay
C. The faster the decay, the shorter the half-life
D. A and B
E. B and C
171) All of the following are uses of radiopharmaceuticals EXCEPT

A. Diagnose disease
B. Evaluate progression of disease after specific intervention
C. Evaluate drug induced toxicity
D. Treat diseased tissue
E. Determine gestational age
172) Radiopharmaceutical that is used for thyroid imagine or assessment of thyroid function
A. 131 I
B. 99m Tc
C. 133 Xe
D. 89 Sr
E. 90 Y
173) Radiopharmaceuticals that is used for bone pain palliation associated with primary bone tumors
and metastatic bone lesions
A. 131 I
B. 90m Tc
C. 133 Xe
D. 89 Sr
E. 90 Y
174) This is used to treat patients from the harmful levels of Ca or thallium radiation exposure and
contamination
A. Gentian violet
B. Prussisn blue
C. Malachite green
D. Methylene blue
E. Tartrazine
175) The tracers used in PET imagine are natural biochemical labelled with radionuclides of the
following EXCEPT
A. Carbon
B. Nitrogen
C. Oxygen
D. Fluorine
E. Potassium
176) This is the application of genomic technology to genetic variation in response to pharmaceutical
compunds
A. Pharmacogenetics
B. Pharmacogenomics
C. Biotechnology
D. Pharmacoeconomics
E. Bioinformatics
177) These are techniques used to produce biotechnology products, EXCEPT

A. rDNA technology
B. MAb technology
C. Polymerase chain reaction
D. Gene therapy
E. Gamma ray emission
178) The following are considered novel drug delivery systems, EXCEPT
A. Autoinjection systems
B. Gliadel water
C. Ophthalmic ointment
D. Estring
E. Ophthalmic inserts
179) Adavantage/s of liposomes as drug delivery systems

I. Liposome-encapsulated drugs are delivered intact to various tissues and cells and can be
released when the liposome is destroyed
II. Liposomes can be used for both hydrophilic and lipophilic drugs without chemical modification
III. Other tissues and cells of the body are protected from the drug until it is released from the
liposome
A. I
B. III
C. I and II
D. II and III
E. I, II and III
180) This is a thin, flexible sheet of material, usually composed of a polymer material for oral
administration in a rapidly dissolving form
A. Water
B. Film
C. Microadhesive system
D. Lozenge
E. Pills
181) A DNA enzyme indicated for the treatment of cystic fibrosis
A. Domase alfa
B. Recombivax HB
C. Imatinib mesylate
D. Recombinant tenecteplase
E. Omalizumab
182) A thrombolytic agent marketed with a needleless administration set and recommended to be used
within the first hours of a heart attack
A. Domase alfa
B. Recombivax HB
E. Omalizumab
183) The first humanized therapeutic antibody for the treatment of asthma and the first approved
therapy designed to target IgE in the management of asthma
A. Domase alfa
B. Recombivax HB
E. Omalizumab
184) Monoclonal antibodies

I. These are purified antibodies produced by a single source or clone of cells
II. Specificity for the target antigen Is the primary characteristic for the MAb
III. When covalently linked with radioisotopes, contrast agents, or anticancer drugs, MAbs and be
used to diagnose and treat malignant tumors
A. I
B. III
C. I and II
D. II and III
E. I, II and III
185) Which of the following is TRUE regarding Granulocyte colony-stimulating factor (Filgrastim), a
drug produced via rDNA technology?
A. This is administered via deep IM injection
B. Care should be taken that the vial is not shaken prior to withdrawal of the drug
C. This should be stored in the freezer
D. If the patient will be travelling, dry ice should be used to keep Filgrastim frozen
E. Normal saline solution is the ideal diluent for Filgrastim
186) All of the following are classes of biotechnological drugs, EXCEPT
A. Interferons
B. MAbs
C. Tissue growth factors
D. Ocular inserts
E. Hematologic factors
187) Schiling test uses radiolabeled Vitamin B12. What radionuclide is used to label Vitamin B12?
A. 99m Tc
B. 18 F
C. 57 Co
D. 13 N
E. 68 Ga
188) This has been employed to study cerebral physiology and is has found increased use in cancer
diagnosis and management
A. Nuclear magnetic resonance (NMR)
B. Position emission tomography (PET)
C. Single-photon emission computed tomography (SPECT)
D. Medical ultrasonography
E. Computerized tomography (CT) scan
189) Factors considered before a drug substance is formulated into a dosage form
I. Physical and chemical characteristics of the drug
II. Therapeutic situations for which the drug will be used (i.e. emergency situations, nausea and
vomiting, etc)
III. Age of the intended patient
A. I
B. III
C. I and II
D. II and III
E. I, II and III
190) The most frequently encountered destructive processes for drug substances
A. Metabolism
B. Hydrolysis
C. Oxidation
D. A and B
E. B and C
191) The following routes of administration for nitroglycerin demonstrate extremely rapid onset of
action, EXCEPT
A. Oral
B. Intravenous
C. Buccal
D. Sublingual
E. All of these
192) A method where the potent drug is placed with an equal volume of the diluent in a mortar and is
mixed thoroughly by trituration. A second volume of diluent equal to the mixture is added and the
trituration is repeated. This process is continued until all of the diluent has been added.
A. Levigation
B. Eutexia
C. Geometric dilution
D. Alligation
E. Aliquot
193) An example of solids that form a eutectic mixture when mixed

A. Aspirin and lactose
B. Camphor and menthol
C. Salicylic acid and talc
D. All of these
E. None of these
194) A recommendation when dispensing hygroscopic or deliquescent powders

A. Dispense powders in light resistant bottles
B. Dispense in tight container and include a desiccant packet or capsule
C. Use an anhydrous salt form of the drug
D. Dispense powders in clear botlles
E. All of these
195) Desirable features of particles in suspension includes”

I. Particles settle rapidly
II. Readily redispersed upon gentle shaking
III. Remains fairly constant
A. I
B. III
C. I and II
D. II and III
E. I, II and III
196) Which of the following suspensions is used as a contrast medium to visualize the GIT for
diagnostic purposes
A. Cholestyramine
B. Barium sulfate
C. Mesalamine
D. Paroxetine
E. Sucralfate
197) Which of the following statements regarding the types of emulsion is TRUE?
A. O/W emulsions have an oleaginous internal phase and aqueous external phase
B. W/O emulsions have an aqueous internal phase and an oleaginous external phase
C. W/O emulsions have an oleaginous internal phase and an aqueous external phase
D. A and B
E. B and C
198) Ratio between oil, water and gum components of an emulsion when the continental or dry gum
method is used
A. 4:2:1
B. 3:2:1
C. 1:2:3
D. 1:2:4
E. 6:4:2
199) A reminder when forming the primary emulsion

A. Ensure that the mortar and pestle to be used are dry
B. Wedgewood or porcelain mortar (with a rough inner surface) may be used
C. A and B
D. B and C
200) An indication that an emulsion is unstable

A. The internal phase forms globules or aggregates upon standing
B. All or part of the liquid of the internal phase separates forming a distinct layer on top or bottom of the
emulsion
C. Presence of fungal growth
D. Large globules or aggregates float to the top or settle at the bottom
E. All of these
201) Which of the following should have an auxillary label indicating “Shake well before use”?
A. Amoxicillin for Oral Suspension
B. Serevent Inhalation Aerosol
C. Proctofoam
D. Gaviscon Liquid Antacid
E. All of these
202) The amount of bentonite present in Bentonite Magma

A. 10%
B. 1%
C. 2%
D. 5%
E. 0.5%
203) Which of the following preparations should not be frozen?

A. Aluminum hydroxide gel
B. Simethicone Emulsion
C. Maalox Suspension
D. Influenza virus vaccine
E. All of these
204) A pharmacist dispenses a newly reconstituted antibiotic product and counsels the patient
regarding the following
I. To shake the bottle well before withdrawing a dose
II. To store the product in the refrigerator when indicated
III. To discard any remaining portion of the product once therapy is completed
A. I
B. III
C. I and II
D. II and III
E. I, II and III
205) Aerosol products may be designed to expel their contents as

A. A fine mist
B. A steady stream
C. A coarse, wet or dry spray
D. A stable or fast-breaking foam
E. All of these
206) Aerosol type that is used to provide an airborne mist

A. Airborne spray
B. Surface spray
C. Metered dose inhaler
D. Space spray
E. None of these
207) The following are examples of a space spray, EXCEPT

A. Room deodorizer
B. Cologne
C. Room disinfectant
D. Insecticide sprays
E. None of these
208) Aerosols intended to carry the active ingredient to a surface

A. Airborne sprays
B. Surface sprays
C. Surface coatings
D. A and B
E. B and C
209) Hermetic container

I. Protects contents from light
II. Protects contents from atmospheric oxygen
III. Protects contents from moisture
A. I
B. III
C. I and II
D. II and III
E. I, II and III
210) A disadvantage of using stainless steel as a container for aerosol preparations
A. Has imcompatibility issues
B. High cost
C. A chance of leakage
D. Affects the efficacy of the product
E. Corrosion
211) Sweetening agent used in the manufacture of sugar-free chewable tablets

A. Sucrose
B. Xylitol
C. Stevia
D. Sorbitol
E. Glucose
212) An example of a plasticizer used in film coating of tablets

A. Castor Oil
B. FD&C lakes
C. Vanillin
D. Cellulose acetate phthalate
E. Beeswax
213) A problem encountered in tablet flim coating where there is uneven color distribution on the tablet
surface
A. Picking
B. Orange peel effect
C. Peeling
D. Mottling
E. Bridging
214) A problem encountered in tablet film coating where there is a roughness of the tablet surface due
to failure of spray droplets to coalesce
A. Picking
B. Orange peel effect
C. Peeling
D. Mottling
E. Bridging
215) Fentanyl Actiq is an example of what type of solid dosage form

A. Tablet triturate
B. Lollipop
C. Bolus tablet
D. Pill
E. Pellet
216) A patient maintained on Metoprolol tartrate 50 mg BID brings in a new prescription for Metoprolol
succinate extended release 100mg QD. What would be an important counseling point for the patient?
A. Advice patient that this couls be taken with or without food
B. Ensure that the patient is aware of the change in dosage form and dosing frequency
C. Advice patient that this could cause dizziness
D. Advice patient to take the medication at the same time everyday
E. Let the doctor know of any side effects encountered
217) This is a local anti-infective agent applied to the skin in general household first-aid
A. Compound Benzoin Tincture
B. Thimerosal tincture
C. Cetylpyridinium chloride solution
D. Iodine Tincture
E. Eugenol
218) This is used to protect and toughen the skin in the treatment of bedsome and ulcers
A. Coumpound benzoin tincture
B. Thimerosal tincture
C. Hydrogen peroxide solution
D. Iodine tincture
E. Eugenol
219) Coal tar topical solution is also known as

I. Liquor carbonis detergens
II. Liquor picis carbonis
III. Limewater
A. I
B. III
C. I and II
D. II and III
E. I, II and III
220) Method for preparing spirits

I. Simple solution
II. Solution by maceration
III. Distillation
A. I
B. III
C. I and II
D. II and III
E. I, II and III
221) The following are products that has an auxillary label of “For External Use Only”, EXCEPT
A. Flexible Collodion
B. Liniments
C. Phenobarbital Elixir
D. Betadine Solution
E. Green Soap Tincture
222) Components of a membrane-controlled transdermal systems

A. Drug reservoir usually in liquid or gel form
B. A rate controlling membrane
C. Backing, adhesive, and protecting layer
D. All of these
E. None of these
223) Recommended packaging for TDDS

A. Individual sealed packets
B. Envelope-type boxes
C. Sealed packets containing two TDDS each
D. Plastic boxes
E. None of these
224) All of the following are desirable characteristics of the adhesive layer of a TDDS, except
A. Nonirritating
B. Needs a lot of pressure to adhere to the skin
C. Remains in place for the intended period of use
D. Easy to peel-off after use
E. Compatible with all other components of the system
225) A patient reminder when dispensing TDDS

A. It should be left on when bathing, showering or swimming
B. It should not be altered by cutting
C. It should not be on a site that could be rubbed off by clothing
D. Lotion should be avoided on the site of application of the TDDS
E. All of these
226) A patient asks you how to safely dispose of his Fentanyl patches. What would you tell him?
I. Fold the patch in half, sticky sides together
II. Flush in the toilet
III. Throw in the trashcan
A. I
B. III
C. I and II
D. I and III
E. I, II and III
227) These are usually globular, oviform, or cone shaped and weigh about 5 g when cocoa butter is
the base
A. Rectal suppositories
B. Urethral suppositories
C. Bougles
D. Vaginal inserts
E. All of these
228) A characteristic of medication sticks

I. Cylindrical in shape, with weights ranging from 5 to 25 g
II. Packaged in an applicator tube for topical application
III. Applicator can be adjusted to continually expose new, fresh stick from inside the tube
A. I
B. III
C. I and II
D. II and III
E. I, II and III
229) The following are suppositories administered for systemic effect, EXCEPT
A. Ondansetron
B. Prochlorperazine
C. Indomethacin
D. Glycerin
E. Morphine
230) The following are examples of sweetening agents EXCEPT

A. Aspartame
B. Veegum
C. Mannitol
D. Sorbitol
E. Saccharin Sodium
231) Which of the following statements is TRUE about dispersed systems?

I. The dispersed phase in colloidal dispensions is intermediate between the particle size of true
solutions and coarse dispersions
II. True solutions are clear and do not scatter light
III. Colloidal dispersions, like true solutions, also do not scatter light
A. I
B. III
C. I and II
D. II and III
E. I, II and III
232) These substances, like acacia are self-dispersing upon addition to the dispensing medium
A. Natural colloids
B. Ampiphilic colloids
C. Lyophobic colloids
D. Artificial colloids
E. Lyophilic colloids
233) The following are examples of hydrogels, EXCEPT

A. Carbomer
B. Pectin
C. Sodium CMC
D. Tragacanth
E. Silica
234) Items that could be sterilized using an autoclave, EXCEPT

A. Solutions in sealed containers like ampules
B. Bulk solutions
C. Surgical instruments
D. Sealed empty vial
E. Glasswares
235) Advantage/s of bacterial filtration

I. Ability to sterilize thermolabile materials
II. Relatively inexpensive equipment required
III. Complete removal of living and dead microorganisms and other particular matter from the
solution
A. I
B. III
C. I and II
D. II and III
E. I, II and III
236) Biologic indicators

I. A characterized preparation of specific microorganisms resistant to a particular srerilization
process
II. May be used to monitor a sterilization cycle and or periodically to revalidate the process
III. There is only one form of the indicator, where the spores are added to identifies units of the
product being sterilized, and the process assessed based on these samples
A. I
B. III
C. I and II
D. II and III
E. I, II and III
237) In dry heat sterilization, the spores of which organism is utilized as a biologic indicator
A. Bacillus subtilis
B. Bacillus stearothermophilus
C. Streptococcus
D. Staphylococcus aureus
E. Bacillus pumitus
238) Endotoxins
I. Toxic, potent and unstable
II. Water soluble and will pass through 0.2 micron liters
III. Not destroyed by autoclaving
A. I
B. III
C. I and II
D. Ii and III
E. I, II and III
239) Suitable glass packaging for injections

I. Clear or colorless glass
II. Light
III. Amber glass
IV. Dark amber glass
A. I
B. III
C. I and II
D. II and III
E. I, II and III
240) Among the different types of glass suitable for parenteral preparations, which is the most resistant
to chemical deterioration
A. Type I
B. Type II
C. Type III
D. Type IV
E. Type V
241) Among the different types of glass suitable for parenteral preparations, which is the most resistant
to chemical penetration
A. Type I
B. Type II
C. Type III
D. Type IV
E. Type V
242) A long-acting basal insulin preparation for once daily SC administration at bedtime
A. Insulin glargine
B. Insulin detemir
C. Insulin Aspart
D. Regular insulin
E. Isophane insulin suspension
243) Counselling point for patient on insulin glargine and a rapid acting insulin
I. Avoid mixing both insulin to avoid pH changes that could result to clumping
II. Inject on separate sites
III. Mix in one injection to minimize number of injection administered
A. I
B. III
C. I and II
D. II and III
E. I, II and III
244) Insulin that could be administered intravenously

A. Insulin glargine
B. Regular insulin
C. Isophane insulin
D. Insulin aspart
E. Insulin lispro
245) An intermediate acting insulin

A. Regular Insulin
B. Insulin glargine
C. Insulin Aspart
D. Isophane (NPH) Insulin
E. Insulin lispro
246) Use/s of large volume parenterals

I. Maintenance therapy for patients entering or recovering from surgery
II. Maintenance therapy for patients who are unconscious and are unable to take fluids, electrolytes,
and nutrition orally
III. Replacement therapy for patients who have suffered heavy losses of fluids and electrolytes
A. I
B. III
C. I and II
D. II and III
E. I, II and III
247) Special considerations associated with parenteral therapy

A. Look-alike products
B. Adsorption of drugs to the container, IV sets
C. Absorption(sorption) of drugs on the container, IV sets, syringes, etc
D. Handling and disposed of chemotherapeutic agents for cancer
E. All of these
248) Irrigation solution that containes NaCl (8.6g/L), KCL (3g/L) and CaCl2 (0.33 g/L0 in purified water,
is sterile and pyrogen-free
A. Acetic Acid irrigation
B. Sodium Chloride Irrigation
C. Lactated Ringer Solution
D. Ringer Irrigation Solution
E. Sterile Water for Injection
249) Recommendations for handling and storing biologics

I. The cold chain should be maintained
II. A refrigerator dedicated solely to biologics is preferred to minimize door openings
III. Refrigerator and freezer temperature should be monitores daily
A. I
B. III
C. I and II
D. II and III
E. I, II and III
250) Examples of animate media used for growing viral vaccines

A. Cell cultures of chick embryo
B. Human diploid cell culture
C. Embryonic egg
D. Skin of living calves
E. All of these
251) Immune sore that cound be administered intravenously

A. Tetanus Immunoglobulin
B. Immunoglobulin IV
C. Cytomegalovirus immunoglobulin
D. A and B
E. B and C
252) The effect of hypotonic injections on blood cells

A. Crenation
B. Hemolysis
C. Dehydration
D. Swelling
E. Drying
253) Reasons for adjusting pH of and adding buffer to ophthalmic preparations

I. For greater comfort to the eye
II. To render the formulation more stable
III. To enhance the aqueous solubility of the drug
A. I
B. III
C. I and II
D. II and III
E. I, II and III
254) Thickening agent used in ophthalmic solutions
I. Methylcellulose
II. PVA
III. Hydroxypropylmethylcellulose
A. I
B. III
C. I and II
D. II and III
E. I, II and III
255) Factors that may affect ocular bioavailability

I. Drug protein binding
II. Drug metabolism
III. Lacrimal drainage
A. I
B. III
C. I and II
D. II and IIII
E. I, II and III
256) A decongestant ophthalmic solution

A. Naphcon-A
B. Opticrom Ophthalmic solution
C. Tobrex Ophtalmic Solution
D. Sodium Sulamyd ophthalmic solution
E. None of these
257) Less than 1 part of solvent is required to dissolve one part of solute
A. Very soluble
B. Freely soluble
C. Very slightly soluble
D. Soluble
E. Insoluble
258) More 10,000 parts of solvent is required to dissolve 1 part of solute

A. Very soluble
B. Freely soluble
C. Very slightly soluble
D. Soluble
E. Insoluble
259) This process is also referred to as cross-flow or tangential flow membrane filtration
A. Distillation
B. Ion exchange
C. Percolation
D. Reverse osmosis
E. UV exposure
260) A common method for expressing the concentration of pharmaceutical preparations
A. %w/v
B. Ratio strength
C. %v/v
D. %w/w
E. All of these
261) A concern for oral solutions

A. Color
B. Flavor
C. Friability
D. A and B
E. B and C
262) Sodium Citrate and Citric Acid Oral Solution

I. Contains 100 mg of Sodium Citrate and 67 mg of citric acid in each mL of aqueous solution
II. Administered orally in doses of 10 to 30 mL for up to four times daily
III. Used as a systemic alkalinizer
A. I
B. III
C. I and II
D. II and III
E. I, II and III
263) Syrup NF
I. Also known as simple syrup
II. It is prepared by dissolving 85g of sucrose in enough purifies water to make 100 mL of syrup
III. When properly prepared and maintained, it is resistant to microbial growth
A. I
B. III
C. I and II
D. II and III
E. I, II and III
264) An example of a syrup prepared by percolation

A. Ferrous Sulfate Syrup
B. Ipecac Syrup
C. Acetaminophen Syrup
D. Dextromethorpham and Guaifenesin syrup
E. Chlorpheniramine maleate syrup
265) Percentage of alcohol present in self-preserving elixirs

A. More than 5% to 10%
B. More than 10% to 12%
C. More than 1% to 5%
D. More than 25%
E. More than 15%
266) Digoxin Elixir, USP contain how much much digoxin per 5ml?
A. 0.25 mg
B. 0.125 mg
C. 0.75 mg
D. 0.5 mg
E. 1 mg
267) Tinctures
I. Stored in tightly stoppered containers
II. Must not be exposed to excessive temperatures
III. Many tinctures must be stored in light resistant containers
A. I
B. III
C. I and II
D. II and III
E. I, II and III
268) Also known as camphorated tincture of opium

A. Paregoric
B. Opium Tincture
C. Laudanum
D. A and B
E. B and C
269) A reason why lotions may be preferred over other semisolid preparations
A. Provides good occlusion
B. Easily washes off
C. Absorbs serous discharges from lesions
D. Nongreasy and increased spreadability over large areas of skin
E. Stiffer and less penetrating
270) This is an elliptical unit designed for continuous release of pilocarpine following placement in the
cul-de-sac of the eye
A. TDDS
B. Ocusert
C. Oramorph SR
D. Spansule
E. Troches
271) An example of a proprietary product using a hydrophilic matrix base of HPMC for extended drug
release
A. Ocusert
B. Gradumet
C. OROS system
D. Oramorph SR
E. Rynatan
272) These tablets release an initial dose immediately and a second dose follows other
A. Repeat action tablets
B. Compressed tablets
D. Microsphores
E. Microencapsulated drug
273) Aquaphor ® is an example of what type of ointment base

A. Absorption base
B. Water-removable base
C. Water-soluble base
D. Oleaginous base
E. None of these
274) Preservatives used in Hydrophilic Ointment USP

A. Methylparaben
B. Propylparaben
C. Stearyl alcohol
D. A and B
E. B and C
275) This test for ointments involve the determination of the net weight or volume of contents of filled
containers to ensure proper contents compared with the labeled amount
A. Minimum fill test
B. Content uniformity
C. Viscosity
D. Microbial content
E. USP labeling requirements
276) Type of plastic that offers transparency and a high degree of product chemical compatibility
A. HDPE
B. PP
C. LDPE
D. PET
E. Plastic laminates
277) This type of plastic is soft and resilient, and provides a good moisture barrier
A. HDPE
B. PP
C. LDPE
D. PET
E. Plastic laminates
278) Common tube size for ointments, creams, and gels

A. 1-, 2-, 3-g tubes
B. 2-, 10-, 20- g tubes
C. 4-,8-, 15-g tubes
D. 5-, 15-, 30-g tbes
E. 1-lb tubes
279) Factors affecting drug penetration to the skin
I. Physicochemical properties of the drug
II. Characteristtics of the pharmaceutical vehicle
III. Condition of the skin itself
A. I
B. III
C. I and II
D. II and III
E. I, II and III
280) USP tests specific for ophthalmic ointments

I. Sterility tests
II. Test for metal particles
III. Minimum fill test
A. I
B. III
C. I and II
D. II and III
E. I, II and III
281) The ideal molecular weight of a drug for transdermal drug delivery
A. 400 or less
B. 1000
C. 500 or more
D. 100 to 200
E. All of these
282) Transdermal patchfor motion-related nausea and vomiting

A. Scopolamine [atch
B. Nitroglycerin patch
C. Nicotine patch
D. Fentanyl patch
E. Testosterone patch
283) The vehicle used in Calamine lotion or liniment

A. Acetic acid solution
B. Olive oil
C. Glycerin
D. Calcium hydroxide solution
E. Mineral Oil
284) This glass type is described as highly resistant borosilicate glass

A. Type I
B. Type II
C. Type III
D. NP
E. None of these
285) This glass type is described as treated soda lime glass
A. Type I
B. Type II
C. Type III
D. NP
E. None of these
286) Problems encountered in the use of plastics in packaging

A. Permeability to atmospheric oxygen
B. Absorption of drugs from the contents to the container
C. Transmission of light through the container
D. Leaching of the constituents of the container to the internal contents
E. All of these
287) The term used to describe the movement of components of a container into the contents
A. Absorption
B. Leaching
C. Sorption
D. Adsorption
E. None of these
288) Which of the following drugs is exempt from child-resistant packaging

A. Nitroglycerin subingual tablets
B. Amoxicillin antibiotic
C. Gimepride tablets
D. Losartan tablets
E. Ibuprofen suspension
289) This type of container protects the contents from contamination be extraneous liquids, solids or
vapor; from loss of the article; and from efflorescence, deliquescence or evaporation under the ordinary
or customary conditions of handling, shipment, storage, and distribution and is capable of tight reclosure
A. Hermetic container
B. Tight container
C. Single-dose container
D. Well-closed container
E. Sterile hermetic container
290) Single-dose containers

I. Ampules
II. Prefilled syringes
III. Insulin pens
A. I
B. III
C. I and II
D. II and III
E. I, II and III
291) Single-unit packaging
I. Patient cup
II. Blister pack
III. Strip packaging
A. I
B. III
C. I and II
D. II and III
E. I, II and III
292) A disadvantage of the emulsifier is that it produces an emulsion that frequently too fluid and
becomes more fluid upon standing
A. Microcrystalline cellulose
B. Gelatin
C. Sodium lauryl sulfate
D. Tragacanth
E. Stearyl alcohol
293) HLB value of 3 to 6

I. Greatly lipophilic
II. Produce W/O emulsions
III. Greatly hydrophilic
A. I
B. III
C. I and II
D. II and III
E. I, II and III
294) HLB of 7 to 9
A. Antifoaming agents
B. Emulsifiers (W/O)
C. Solubilizers
D. Emulsifiers (O/W)
E. Wetting agents
295) These substances reduce interfacial tension between oil and water, minimizing surface energy
through the formation of globules
A. Wetting agent
B. Detergents
C. Solubilizing agents
D. Emulsifying agents
E. None of these
296) Microemulsions
I. Thermodynamically stable
II. Optically transparent
III. Sabilized by surfactants
A. I
B. II
C. I and II
D. II and III
E. I, II and III
297) A dosage form suitable for delivering drugs to the skin and consists of a drug that is impregnated
into a flexible, durable woven fabric or extruded synthetic material that is content with an adhesive agent
A. Pastes
B. Tapes
C. Plasters
D. Creams
E. TDDS
298) An example of a patch (not TDDS)

A. Lidoderm patch
B. Scopolamine patch
C. Nicotine patch
D. Nitroglycerin patch
E. Clonidine patch
299) True about patches and TDDS

I. One or more patches and TDDS could be applied at a time
II. Both patches and TDDS could be cut to the desired size to cover the affected area
III. Patient must wash hands before and after handling patches and TDDS
A. I
B. III
C. I and II
D. II and III
E. I, II and III
300) The suppository base is a homogenous blend of PEGs and polysorbate 80

A. Cocoa butter
B. Polybase
C. Witepsol H15
D. Fatty base
E. Wecobee W
Manufacturing Pharmacy
Multiple Choice
Identify the letter of the choice that best completes the statements or answer the question.
1. Which of the following is NOT used as a diluent or absorbent in the formulation of capsules?
a. Lactose
b. Magnesium carbonate
c. Kaolin
d. Light magnesium Oxide
e. Starch
2. The ___________________ come in contact with both the product and the propellant and therefore should be
resistant to both physical and chemical attack.
a. Valve
b. Dip tube
c. Actuator
d. Container
e. Propellant
3. The hydrocarbon base which is frequently used as a vehicle for ointment.
a. Cholesterol
b. Lanolin
c. Petroleum
d. Sorbitan monostearate monooleate
e. Mineral oil
4. Which of the following is NOT a characteristic of water soluble bases that are used in the formulation of ointment?
a. It is composed of many polar group
b. Water is required for their preparation
c. It is also called greaseless ointment base
d. It softens or melts when applied to the skin
e. It is composed of many ether linkages
5. Which of the following is frequently used as a peel strip for transdermal patches?
a. Polyesters
b. Acrylic
c. Silicone
d. Polyisobutylene
e. Starch
6. _________ are substances that make up the major portion of tablet.
a. Binder
b. Glidant
c. Lubricant
d. Diluent
e. Disintegrant
7. Which of the following is NOT used as a diluent in the formulation of a tablet?
a. Celutab
b. Corn starch
c. Lactose
d. Avicel
e. Ethyl cellulose
8. It is frequently used as a diluent in the formulation of chewable tablet.
a. Mannitol
b. Celutab
c. Avicel
d. Lactose
e. Sucrose
9. Method of preparing sodium chloride tablet.
a. Direct compression
b. Granulation by compression
c. Wet granulation
d. Spray drying
e. Slugging
10. _________ is the removal of the edges of tablets.
a. Capping
b. Cracking
c. Mottling
d. Chipping
e. Lamination
11. _________ are powders agglomerated to produce larger free-flowing particles.
a. Tablets
b. Granules
c. Capsules
d. Suppository
e. Ointment
12. When the ________is depressed the aerosol will deliver a spray precise volume.
a. Propellant
b. Valve
c. Actuator
d. Dip tube
e. Container
13. Transdermal delivery system used for the treatment of angina.
a. Estradiol
b. Glyceryl trinitrate
c. Nicotine
d. Hyoscine
e. None of the above
14. In adults, what is the common site for intramuscular injection?
a. Gluteals
b. Deltoid
c. Abdomen
d. Pectoralis
e. Thigh
15. A volume of about 0.1 mL is injected into the skin between the epidermis and the dermis
a. Intramuscular
b. Intravenous
c. Intradermal
d. Intra-arterial
e. Intra cardiac
16. Test animal used in Pyrogen Test.
a. Pigeon
b. Swiss mice
c. Guinea pig
d. Rabbit
e. Dog
17. Yellow ointment is a hydrocarbon base. What is the synonym for yellow ointment?
a. White petroleum jelly
b. Yellow petrolatum
c. Petroleum jelly
d. Simple ointment
e. Liquid petrolatum
18. What is the function of sorbic acid in the formulation of ointment?
a. Ointment base
b. Vehicle
c. Active ingredient
d. Preservative
e. Flavorant
19. What is the therapeutic use of Zinc Oxide Paste?
a. Protectant
b. Antifungal
c. Antiprupritec
d. Analgesic
e. Antiseptic
20. What gives calamine its characteristic pink color?
a. Zinc oxide
b. Ferric oxide
c. Lead oxide
d. Hydrogen sulfide
e. Lead sulfide
21. What is the smallest capsule size?
a. 000
b. 00
c. 0
d. 1
e. 5
22. Opacifying agent used in the production of opaque hard gelatin capsules
a. Titanium dioxide
b. Titanium oxide
c. Zinc oxide
d. Lactose
e. Starch
23. ___________ tablets are tablets with a coating that resists dissolution in the stomach but not in the intestines.
a. Enteric coated
b. Sugar coated
c. Film coated
d. Effervescent
e. Sublingual
24. Minimum permitted force for a satisfactory hard tablet.
a. 2 kg
b. 7 kg
c. 3 kg
d. 4kg
e. 1 kg
25. Commonly used lubricant in the formulation of tablets.
a. Lactose
b. Starch
c. Mannitol
d. Celutab
e. Magnesium stearate
26. A natural gum best used as a tablet binder when dry since it is difficult to disperse and forms a very heavy
mucilage in water.
a. Acacia
b. Tragacanth
c. Gelatin
d. Alginic acid
27. Materials which help the tablet break up and dissolve to release the medicament are called:
a. Anti-adherents
b. Solubilizing agents
c. Disintegrants
d. Diluents
28. This type of excipient must be added when lactose is used as a diluent in tablet manufacture.
a. Glidant
b. Lubricant
c. Anti-adherents
d. Buffers
29. The mesh size of regular lactose, USP
a. 20-40
b. 40-60
c. 60-80
d. 80-100
30. What is the effect on the tablet formulation if too much binder is added?
a. Tablet produced will be coarse and dry
b. Larger quantity of lubricants will be required to facilitate tablet ejection
c. Premature dissolution of active ingredient may occur particularly when wet binders are used
d. Mottling of tablet surfaces may occur for colored granules
31. What may happen to tablets if inadequate quantities of lubricants are used?
a. Tablet produced may be harder to disintegrate.
b. Tablets may be ejected too easily from the machine.
c. Formed tablets may have oily spots.
d. Formed tablets may have irregular striations on the edges.
32. The most efficient type of motion in sieving
a. Vibratory
b. Rotary
c. Side-tap
d. Bottom-tap
33. All of the following glass types may be subjected to the Powdered Glass Test except:
a. Highly resistant borosilicated glass
b. Treated soda-lime glass
c. Soda-lime glass
d. General purpose soda lime glass
34. The color of amber glass is produced largely by the presence of:
a. Iron oxide
b. Titanium dioxide
c. Magnesium oxide
d. Silicon dioxide
35. The following animals may be used in evaluating the toxicity plastic materials based on USP test procedures
EXCEPT:
a. Dogs
b. Rabbits
c. Mice
d. None of the above
36. Types of glass used for buffered aqueous solution with pH below 7.0
a. Type I glass
b. Type II glass
c. Type III glass
d. NP
37. The following are tests that evaluate the flammability and combustibility of pharmaceutical aerosols except:
a. Flash point
b. Vapor pressure
c. Flame extension
d. Closed drum test
38. Type of mill used for tough, fibrous materials
a. Hammer mill
b. Ball mill
c. Roller mill
d. Cutting mill
39. The common name for FD & C Red #2
a. Amaranth
b. Erythrosine
c. Ponceau SX
d. Carmine
40. Film coating defect that occurs as a consequence when products are processed under exceedingly humid
conditions
a. Spotting
b. Blistering
c. Bloom
d. Orange peel
41. Film coating defect that refers to the presence of mottled areas on the film coat due to migration of plasticizers,
dyes and other additives in the formulation.
a. Mottling
b. Blistering
c. Spotting
d. Bloom
42. These are excipients composed of inorganic materials which are used to provided added hiding or covering
power to tablet coating solutions:
a. Colorants
b. Opaquant-extenders
c. Plasticizers
d. Lakes
43. Coating process/es which serves to separate the tablet core from the water
a. Seal coat
b. Subcoat
c. Syrup coat
d. All of the above
44. A step in tablet sugar coating that involves the application of syrup concentrate to build up slid color rapidly.
a. Subcoating
b. Regular syruping
c. Heavy syruping
d. Grossing
45. Separation of the tablet into two or more distinct layers are called
a. Capping
b. Lamination
c. Blistering
d. Flaking
46. Tablet excipients that reduce interparticulate friction to ensure smooth and uniform flow of materials from larger
through smaller apertures in tablet presses are called:
a. Dusting agent
b. Lubricant
c. Anti-adherents
d. Glidants
47. Determination of moisture for effervescent tablets is conducted through:
a. Paar calorimeter
b. Karl Fisher method
c. Loss on drying
d. Azeotropic method
48. Tablet defect which may be revealed through the friability test or by shaking tablets vigorously in cupped hands.
a. Sticking
b. Lamination
c. Picking
d. Double impression
49. The number of tablet samples which must be assayed for Content Uniformity according to USP
a. 10
b. 15
c. 20
d. 30
50. Type of mill used for the reduction of solid particle size and for dispersion of suspensions containing poorly
wetted solids
a. Hammer
b. Rotor stator
c. Impact
d. Fluid-energy
51. Dispersion of high concentrations of insoluble powdered substances in a fatty or aqueous base
a. Creams
b. Lotions
c. Ointment
d. Pastes
52. Classification of temperature between 8C and 15C
a. Cold
b. Cool
c. Controlled room temperature
d. Warm
53. Pyrogens are produced by
a. Gram negative bacteria
b. Gram positive bacteria
c. Fungi
d. All of the above
54. The following tests official in USP/NF except:
a. Pyrogen test
b. Sterility test
c. Clarity test
d. Bacterial endotoxin test
55. Mouthwash is an example of
a. Oral solution
b. Topical solution
c. Otic solution
d. Nasal solution
56. To make a solution of a solid in a solvent, the concentration of the solid in the solvent
I. Must be below the solubility of the solid in that solvent
II. Must be above the solubility of the solid in that solvent
III. Must be at the solubility of the solid in that solvent
a. I only
b. II only
c. I and II
d. I and III
57. It is the major concern with regards to the physical stability of the solutions
a. Dissolution
b. Precipitation
c. Microbiological stability
d. Compatibility
58. Humectant is one of the basic ingredients of a mouthwash. Its usual concentration is
a. 5-25%
b. 5-20%
c. 10-20%
d. 10-25%
59. One of the economic considerations regarding processing in the selection of mixers includes
a. Miscibility
b. Processing time
c. Maintenance
d. Cost of equipment
60. It is defined as a process that tends to result in a randomization of dissimilar particles within a system
a. Blending
b. Mixing
c. Filtration
d. Homogenization
61. Carbomer, as suspending agent, has a usual concentration of
a. 0.5-1.0%
b. 0.5-2.0%
c. 0.1-0.5%
d. 0.5-1.5%
62. Carbomer, as a gelling agent, has a usual concentration of
a. 0.5-1.0%
b. 0.5-2.0%
c. 0.1-0.5%
d. 0.5-1.5%
63. Agents that can neutralize carbomer include
I. NaOH
II. KOH
III. Polar Organic Amines
IV. Strong Electrolytes
a. I only
b. I and II
c. I, II and III
d. III only
64. The following are functional categories if triethanolamine, except
a. Alkalizing agent
b. Emulsifying agent
c. Solubilizing agent
d. Suspending agent
65. Gel-based alcohol is an example of a/an
a. Aqueous solution
b. Non aqueous solution
c. Emulsion
d. Suspension
66. The following are FD&C certified red dyes that exhibit good stability in the presence of light, acid, and alkali
preparation, except
a. FD&C Yellow #5
b. FD&C Yellow #6
c. FD&C Red #40
d. FD&C Blue #4
67. The following are characteristics of gels, except
a. Water washable
b. Occlusive
c. Can absorb additional water
d. Lipid-free
68. The following are classified under suspension, except
a. Gels
b. Lotions
c. Magmas and milk
d. Liniments
69. A suspending agent that requires a high speed equipment and which is suitable for internal and external use
a. Carbomer
b. Bentonite
c. Sodium alginate
d. Tragacanth
70. It is employed to allow the displacement of air from hydrophobic materials and permit the continuous liquid
phase to surround the particles
a. Wetting agent
b. Suspending agent
c. Flavoring agent
d. Flocculating agent
71. Excess wetting agent may lead to the following
I. Foaming
II. Unpleasant taste
III. Caking
a. I and II
b. II and III
c. I and III
d. I, II, III
72. Xanthan gum, as flocculating agent, is classified under
a. Surfactant
b. Hydrophilic polymer
c. Clay
d. Electrolyte
73. The following are true for production areas for pharmaceuticals, except
a. Access is restricted to authorized personnel
b. Non-medicinal products should not be produced
c. Provisions should be made for proper air control
d. Performance of in-process controls is prohibited
74. The following can avoid cross contamination, except
a. Conducting campaign production
b. Recirculating of air
c. Wearing protective clothing
d. Using cleanliness status labels
75. Ointment base which allows absorption of serous discharges
a. Hydrocarbon base
b. Absorption base
c. Water-removable base
d. Water-soluble base
76. The following are penetration enhancers, except
a. Carbomer
b. Glycerin
c. Propylene glycol
d. Water
77. Water, as a solvent in wet granulation
a. Has the advantage of not being flammable
b. Has the advantage of adversely affecting drug stability due to extended exposure to heat
c. Requires less drying time than organic solvents
d. Both a and b
78. In wet granulation, the proper amount of binder should be added because
a. Insufficient wetting will result to hard granules
b. Over wetting will result to soft granules
c. Overly wet materials would prolong processing
d. Both A and B
79. Wet granulation
a. Always requires both a solvent and a binder or an adhesive
b. Always requires a solvent
c. Always requires a binder or adhesive
d. All of the above
80. Magnesium stearate should be present in not more than 1% w/w of the formulation because
a. An increase in disintegration time results beyond this limit
b. A decrease in disintegration time results beyond this limit
c. Granules become too flowable beyond this limit
81. Milling of dry ingredients is done to
a. Facilitate uniform blending in the mixing step
b. Remove or break lumps
c. Both a and b
82. Metallic strearates are usually passed through fine mesh screens before mixing with the granules to
a. Increase their covering power
b. Reduce the amount required
c. Both a and b
83. Dry granulation is used for active ingredients which are
a. Prone to solvent degradation
b. Unstable in heat and drying process
c. Either a or b
84. For a dry granulation process, given that the weight of all ingredients is 104 grams and the batch size is 400
tablets, what is the average tablet weight?
a. 385 mg
b. 260 mg
c. Insufficient data
85. Packaging and storage of sterile water for injection
a. Type III glass containers, single dose
b. Type II glass, single dose
c. Type III glass, multiple dose
86. Mechanism of action of saturated steam under pressure
a. Coagulation of cellular proteins
b. Oxidation
c. Alkylation
d. Lethal mutation
87. Mechanism of action of radioactive isotopes for sterilization
b. Oxidation
c. Alkylation
d. Lethal mutation
88. Mechanism of action of oven for sterilization
b. Oxidation
c. Alkylation
d. Lethal mutation
89. Mechanism of action of ethylene oxide gas for sterilization
b. Oxidation
c. Alkylation
d. Lethal mutation
90. Minimum requirement for efficiency of HEPA filter
a. 99.99% effective against 0.3 microns
b. 99.97% effective against 0.3 microns
c. 99.97% effective against 0.5 microns
d. 99.99% effective against 0.2 microns
91. Limits of bacterial endotoxin of sterile water for injection
a. Less than 0.25 USP Endotoxin Unit per mL
b. Less than 0.25 USP Endotoxin Unit per 100 mL
c. Less than 0.50 USP Endotoxin Unit per mL
d. Less than 0.20 USP Endotoxin Unit per mL
92. Surfactants are compounds with hydrophobic and hydrophilic portion to the following, except
a. Wetting
b. Foaming
c. Rinsability
d. Viscosity
93. Type of surfactant preferred for sensitive skin
a. Amphoteric
b. Nonionic
c. Cationic
d. Anionic
94. In case of coated tablets, it is a film defect caused by rapid drying or inadequate solution after each application
of coating solution
a. Blistering
b. Sweating
c. Orange peel
d. Wrinkling
95. Presence of an oily film or droplets of liquid on the surface of the coat which may indicate incompatibilities in the
film.
a. Blistering
b. Sweating
c. Orange peel
d. Wrinkling
96. The following are examples of true antioxidant except
a. BHA
b. Lecithin
c. BHT
d. Tocopherols
97. Which type of glass is recommended for dry powders and oleaginous preparations but not for preparations with
water.
a. Type II
b. NP
c. Type III
d. Type I
98. Cold sterilization refers to the removal of particulate matter down to the smallest size of
a. 2 microns
b. 0.2 microns
c. 0.3 microns
d. 0.5 microns
99. Dehydrogenation may be done by the following methods, EXCEPT:
a. Heating at 240C for 30 minutes
b. Boil with strong acid
c. Reverse osmosis
d. Distillation
100. Mannitol when used in parenterals acts as
a. Solubilizer
b. Isotonicity adjuster
c. Antioxidant
d. Preservative
101. Mechanism of action of dry heat sterilization is by
a. Coagulation of cellular protein
b. Oxidation
c. Sieving
d. Alkylation
102. A mechanism for determining and assigning necessary duties to people so they can work together effectively
is the
a. Chart
b. Quality rules
c. Organization
d. Management
103. The management guide which combine the chart and position description is considered as the
a. First basic tool
b. Second basic tool
c. Third basic tool
d. Fourth basic tool
104. The basic element of an organization where the types of work must be identified and grouped logically on
related elements is the
a. Delegation of authority
b. Determination of interrelationship among functions
c. Division of responsibility
105. The basic tool that clearly defines the authority, duty or responsibility of the areas in the chart is the
a. Position description
b. Organizational planning
c. Organizational manual
d. Chart description
106. The organizational chart can
a. Reveals little about working relationships
b. Assess strength and weaknesses in functions and personnel
c. Indicate delegated authority
d. Reveal company objectives and policies
107. It functions to investigate customer complaints or inquiries on product quality.
a. Central release section
b. Chemical control section
c. Inspection and checking section
d. Specification/Assay Dev. Section
108. It establishes the objectives and determines the basic policies and the general courses of the business.
a. Level I
b. Level II
c. Level III
d. NOTA
109. The specification and Assay Development Section is under the
a. Central release section
b. Technical director’s department
c. Chemical control section
d. Inspection/checking section
110. The section which samples retention or reserved samples withdrawn from the packaging line for FP’s and from
the warehouse for the RM’s.
a. Chemical control section
b. Inspection and checking section’
c. Technical/QC section
d. Central release section
111. Standard Operating Procedures are written for the following operations EXCEPT
a. Calibration of equipment
b. Receipt of materials and records
c. Consumer’s information records
d. Recall procedures
112. An establishment which is a registered owner of the drug product, procures the materials and packaging
components and provides the production monograph and quality control standards and procedures is the
a. Drug importer
b. Drug trader
c. Drug supplier
d. Drug manufacturer
113. The following are examples of common product complaints, EXCEPT:
a. Misbranding
b. Adulteration
c. Counterfeit
d. Elegance
114. Stage of research which involves manufacturing requirements, reviews basic information, product control and
patent application is the
a. Applied Research Stage
b. Clinical Research Stage
c. Pharmaceutical Research Stage
d. Preliminary Research Stage
115. The following are the usual criteria and standards for raw materials specifications, EXCEPT:
a. Refractive index
b. Crystal shape
c. Authenticity
d. Identification
116. The section responsible for the conduct of stability studies is the
a. Chemical control and testing section
b. Central release section
c. Assay and specification section
d. Inspection and checking section
117. An element of the organization where types of work area are identified and grouped logically according to
related elements is referred to as
a. Determining duties of people
b. Harmonious interrelationship among functions
c. Delegation of authority
d. Division of responsibility
118. It implies a procedure by which decisions are made regarding whether the production is processing as planned.
a. Master formula
b. Control
c. Sampling
d. Monitoring
119. The ability of a particular formulation in a specific container to remain within its physical, chemical, therapeutic
and toxicological specification is called
a. Overage
b. Shelf-life
c. Validation
d. Stability
120. The period of stability of a preparation is the time from the date of manufacture until its chemical or biological
activity
a. Has deteriorated
b. Is close to 100%
c. Is not less than 90% of the labeled potency
d. Has reached its maximum
121. An important parameter considered for the stability of drug products is
a. Loss of elegance
b. Increase in potency
c. Loss of moisture content
d. Loss of activity
122. Biological characterization of new drugs involve the following studies, EXCEPT:
a. Pharmacology
b. Physical pharmacy
c. Toxicology
d. Pharmacokinetics
123. Cross contamination can come from the following, EXCEPT:
a. Unclean clothing
b. Airborne particles
c. Improper dispensing
d. Inaccuracies in mix-ups
124. The color for quarantine sticker is
a. Green
b. Yellow
c. White
d. Red
125. An example of primary packaging material is a
a. Insert
b. Brochure
c. Label
d. Seal
126. The following are important document in the manufacture of drugs and cosmetics, EXCEPT:
a. Manufacturing monographs
b. Batch records
c. CGMP guidelines
d. Standard operating procedures
127. To prevent microbial contamination contributed by people, it is best to
a. Practice good personal hygiene
b. Tolerate injuries and illness
c. Clean equipment properly
d. Conduct quality control test
128. One good reason for inspecting the quality of the product during packaging and labeling operation is
a. To prevent mix-ups and errors
b. To monitor uniform labeling
c. To ensure approval of the product
d. To allow ease of reconciliation
129. Retention period for finished products should be
a. At least 2 years after the distribution of the first lot
b. One year after the expiration date of the product
c. At least 3 years after the manufacture is completed
d. At least 1 year after the expiration date of the last lot
130. Unclean clothing can contribute to
a. Cross contamination
b. Particulate contamination
c. Mix-ups
d. Microbial contamination
131. Republic Act No. 6675 is known as
a. Pharmacy Law
b. Food, Drugs, and Cosmetics Act
c. Narcotic Drug Regulation
d. Generics Act of 1988
132. In the formulation of liquids, the following consideration should be studied, EXCEPT:
a. Availability
b. Viscosity
c. Organoleptic characteristics
d. Stability
133. A tamper-evident packaging where a band is shrunked by heat or dried to conform to cap is the
a. Bottle seal
b. Strip pack
c. Shrink seal
d. Tape seal
134. The following qualities are tested for containers, EXCEPT:
a. Breakability
b. Drug compatibility
c. Toxicity
d. Light transmission
135. An example of non-aqueous solution is
a. Spray
b. Juice
c. Oleovitamin
d. Douche
136. Before a medicinal agent is formulated into one or more dosage forms, the following therapeutic matters are
considered, EXCEPT:
a. Gender
b. Manner of treatment(local or systemic)
c. Nature of illness
d. Age
137. An ideal preservative should be
a. Nonreactive with microbes
b. Available at all times
c. Incorporated in small amounts only
d. Effective against broad spectrum microbes
138. A preservative used in ophthalmic and nasal preparation is
a. Boric acid
b. Methyl paraben
c. Cetylpyridinium chloride
d. Phenol
139. The last step in the compounding procedure for liquid preparation prior to filling is
a. Nitrogen flushing
b. Volume adjustment
c. Filtration
d. Test for pH
140. The rapid formation of aggregates of emulsion droplets is called
a. Precipitation
b. Coalescence
c. Aggregation
d. Flocculation
141. The information that gives an indication of particle size and size range of the raw material along with the crystal
structure is the
a. Microscopic examination
b. Physical description
c. Particle size
d. Solubility
142. A major process by which foreign substances, including drugs, are eliminated from the body is called
a. Metabolism
b. Distribution
c. Absorption
d. Liberation
143. The main concerns for the formulation of suspensions are the following, EXCEPT:
a. To eliminate separation on standing
b. To create the required particle size
c. To decrease rate of settling
d. To permit easy resuspendability
144. The type of suspension system in which the particles settles as a dense sediment is called
a. Flocculated system
b. Colloidal system
c. Coagulated system
d. Deflocculated system
145. The following are suspending agents on suspension formulations, EXCEPT:
a. Tween 80
b. Carbopol
c. Methocel
d. Gelatin
146. The required amount of methyl and propyl paraben combinations as preservatives employed in pharmaceutical
products is
a. 0.1-0.2%
b. 0.1-0.5%
c. 15-20%
d. 0.002-0.01%
147. The study of the deformation and flow of liquid and semi-solid preparations referred to as
a. Emulsification
b. Suspendability
c. Compatibility study
d. Rheology
148. Particle size can be influenced by the following factors, EXCEPT:
a. Penetrability of particles intended to be inhaled for deposition deep in the respiratory tract
b. Grittiness of solid particles
c. Uniform distribution of a drug substance
d. Suspendability of particles intended to remain undissolved but uniformly dispersed in liquid vehicle
149. The method of mixing or blending small amounts of powders by movement of spatula through them on a sheet
of paper or ointment slab is called
a. Levigation
b. Comminution
c. Spatulation
d. Trituration
150. Solid preparations made up of sodium bicarbonate, citric acid, and tartaric acid are referred to as
a. Effervescent granules
b. Bulk powder
c. Divided powder
d. Aerosol granules
151. Hard gelatin capsules contain ______% of water
a. 12-16
b. 10-20
c. 0.1-1
d. 1-10
152. Which of the following ingredient is not present in hard gelatin capsule?
a. Diluent
b. Binder
c. Lubricant
d. Disintegrant
153. The following quality control tests apply to both hard gel and soft gel capsules, EXCEPT:
a. Disintegration test
b. Moisture permeation test
c. Content uniformity
d. Dissolution test
154. Tablets that are prepared by subjection to more than a single compression are called
a. Enteric-coated tablets
b. Film-coated tablets
c. Multiple compressed tablets
d. Molded tablets
155. Small, usually cylindrical, molded or compressed tablets containing small amounts of usually potent drugs are
known as
a. Dispensing tablets
b. Chewable tablets
c. Hypodermic tablets
d. Tablet triturates
156. An agent that “glue” powders together and cause them to form granules is the
a. Diluent
b. Binder
c. Glidant
d. Disintegrant
157. Metallic stearates are examples of
a. Disintegrants
b. Anti-adherents
c. Binders
d. Lubricants
158. The IPQC Test that determines the durability of a tablet and its ability to withstand abrasion in handling,
packaging and shipment; USP requires a maximum weight loss of not more than 1% is the
a. Tablet hardness
b. Tablet disintegration
c. Tablet thickness
d. Friability test
159. An ointment base which is anhydrous, water-insoluble and cannot absorb water is
a. Absorption base
b. Oleaginous base
c. Emulsion base
d. Water-soluble base
160. An example of a base that is washable in water and absorbs water is
a. Cold cream
b. PEG Ointment
c. Vanishing cream
d. Hydrous woolfat
161. A satisfactory suppository base should pass the following criteria, EXCEPT:
a. Should be nonsensitizing
b. Should dissolve rapidly in the cavity fluid
c. Should be firm
d. Should remain solid at room temperature
162. The following are the methods used for the preparation of suppositories, EXCEPT:
a. Congealing
b. Hand rolling
c. Fusion
d. Compression
163. Solid dosage forms intended to pass through the stomach intact to disintegrate and release their drug content
for absorption along the intestines are called
a. Molded triturates
b. Gelatin capsules
c. Chewable tablets
d. Enteric-coated tablets
164. Drug delivery systems that facilitate the passage of therapeutic quantities of drug substances through the skin
by means of percutaneous absorption and into the general circulation for systemic effects.
a. Transdermal drugs
b. Cream patches
c. Medicated plasters
d. Tablets
165. A special quality control test done for suspensions to measure the degree of air entrapped is called
a. Specific gravity
b. Coulter counter
c. Photomicroscopy
d. Physical stability
166. The following are characteristics of flocculates system of suspensions, EXCEPT:
a. The sediment is formed slowly
b. The flocculated suspensions exhibit plastic or pseudo plastic behavior
c. Particles in the suspension are in the form of loose agglomerates
d. The sediment is easily redispersed by small amount of agitation
167. A dilute concentration of suspension contains
a. 1-5% (w/v) solids
b. 2-10% (w/v) solids
c. 10-50% (w/v) solids
d. 50% (w/v) solids
168. The weight requirement for a rectal suspension contains
a. 2 g
b. 1g
c. 4g
d. 5g
169. Substances used to cause adhesion of powder particles in tablet granulations are called
a. Disintegrants
b. Binders
c. Diluents
d. Glidants
170. Excipient used to prevent the drying of preparations, particularly ointments and creams is called
a. Humectant
b. Vehicle
c. Plasticizer
d. Solvent
171. A non-greasy emulsion base with pH close to that of the skin is the
a. Unibase
b. Hydrophilic Petroleum
c. Lanolin
d. Dermovan
172. Products that are prone to decomposition by moisture generally are packed with a
a. Tight container
b. Vacuum seal
c. Absorbent cotton
d. Dessicant packet
173. The term that describes dosage forms having drug release features based on time, course, and/or location that
are designed to accomplish therapeutic or convenience objectives not offered by conventional forms is
a. Repeat Action
b. Extended Release
c. Modified Release
d. Delayed Release
174. A process by which solids, liquids, or even gases may be enclosed in microscopic particles by formation of thin
coatings of wall material around the substance is known as
a. Complex Formation
b. Microcompression
c. Film Coating
d. Microencapsulation
175. The best solvent used for the preparation of oral liquid dosage forms is
a. Purified Water, USP
b. Sterile Water for Injection, USP
c. Distilled Water, USP
d. Mineral Water
176. The sweetening agent employed to impart sweetness to chewable tablets is
a. Dextrose
b. Saccharin Sodium
c. Mannitol
d. Sucrose
177. An inert filter that creates the desired bulk, flow properties, and compression characteristics of tablets and
capsules is called
a. Lubricant
b. Surfactant
c. Diluent
d. Anti-adherents
178. Process employed both to comminute and mix powders is called
a. Trituration
b. Blending
c. Spatulation
d. Levigation
179. Tablets that are flat and oval which are intended to be dissolved beneath the tongue are called
a. Effervescent tablets
b. Molded tablets
c. Sublingual tablets
d. Buccal tablets
180. The test done for parenterals for the presence of bacterial endotoxins is the
a. Sterility test
b. Pyrogen test
c. Rabbit test
d. Limulus Amebocyte Tests
181. The following are methods of sterilization for parenteral products, EXCEPT:
a. Steam sterilization
b. Boiling
c. Filtration
182. Route of administration of parenterals or injections that provide effects that are less rapid bur generally longer
lasting is the
a. Intradermal route
b. Subcutaneous route
c. Intravenous route
d. Intramuscular route
183. Pressurized dosage forms that upon actuation emit a fine dispersion of liquid and/or solid materials containing
one or more active ingredients in a gaseous medium are known as
a. Inhalations
b. Aerosols
c. Sprays
d. Inhalants
184. A homogenous mixture of one or more solute dissolved or molecularly dispersed in a solvent is called
a. Emulsion
b. Syrup
c. Solution
d. Suspension
185. Which of the following is NOT considered in the preparation of pharmaceutical solutions?
a. Chemical modification
b. Absorption or penetration
c. Stability
d. Solubility
186. Which of the following is NOT a physical property of a solution?
a. Clarity
b. Odor
c. Vehicle
d. Viscosity
187. The best solvent to use for oral solutions is the
a. Diluted Alcohol, USP
b. Purified Water, USP
c. Propylene Glycol
d. Alcohol, USP
188. Which of the following is NOT an example of sterile solution/preparation?
a. Dialysis solution
b. Pellets of implants
c. Prefilled syringe
d. Diagnostic solution
189. A disadvantage of parenterals is
a. It needs to be administered by a professionally trained person
b. Difficulty in correcting error
c. Not recommended for patients who cannot take oral medications
d. It has immediate and controlled physiological effects
190. A functional requirement for Rubber Closures is
a. It should be easily subjected to sterilization.
b. It should not provide protection against bacterial contamination.
c. It should not make bacteria-proof seals.
d. It should provide complete barrier against vapor transport.
191. A suspension of a drug that can be formulated for topical application is
a. Calamine Lotion
b. Oxytetracycline Suspension
c. Chloramphenicol palmitate suspension
d. Prednisolone suspension
192. One of the following situations can avoid cross contaminations and mix-ups.
a. Components are tightly sealed.
b. Improper partitioning of working areas.
c. Components are improperly dispersed.
d. Wrong label
193. Aspilet tablets for children are
a. Sublingual
b. Buccal
c. Chewable
d. Soluble
194. Quarantined materials delivered in the warehouse are
a. Subject to test and assay
b. Releasable to production department
c. Rejectable
d. In-process products
195. Advantages of plastic containers over glass, EXCEPT:
a. Lightness in weight
b. Permeability
c. Lower cost
d. Resistant to impact
196. Used for mixing powder mixtures in large volume quantity
a. Drum roller
b. V-blender
c. Planetary mixer
d. Compactor mills
197. It is used for compacting the materials in the tablet machine.
a. Hopper
b. Feed frame
c. Dies
d. Punches
198. HEPA filters are used for the filtration of
a. Parenterals
b. Ophthalmics
c. Air
d. Solvents
199. Which of the following is NOT classified as a lubricant?
a. Lactose
b. Talc
c. Stearic acid
d. Calcium stearate
200. The container of choice for ointments.
a. Plastics
b. Glass
c. Wide mouth bottle
d. Collapsible tubes
201. Excessive use of binders in tablets affects
a. Bioavailability
b. Disintegration
c. Dissolution
d. AOTA
202. Methods used for the incorporation of small amounts of potent drugs with a large amount of diluent.
a. Spatulation
b. Sifting
d. Levigation
203. These are gas sterilants EXCEPT
a. Carbon Dioxide
b. Formaldehyde
c. Beta propiolactone
d. Sulfur dioxide
204. Method that will produce tablets of best quality.
a. Direct compression
b. Wet granulation
c. Dry granulation
d. AOTA
205. The attire or uniform used in parenteral production include
a. Cover-all
b. Facemasks
c. Boots and gloves
d. All of the above
206. Suspension adjunct used to prevent the product from drying at topical application.
a. Sweetening agent
b. Humectant
c. Preservative
d. Emollient
207. The following are natural emulsifying agent EXCEPT
a. Tween 80
b. Acacia
c. Agar
d. Gelatin
208. Solubility maybe enhanced through
a. Application of heat
b. Agitation
c. Reduction of particle size
d. All of the above
209. The period in which the product remain acceptable for use.
a. Stability
b. Shelf life
c. Accelerated stability studies
d. All of the above
210. A very simple, sensitive, and fast test for pyrogens using the amebocyte of te horseshoe crab.
a. Pyrogent test
b. LAL test
c. Rabbit test
d. Crab test
211. An agent that acts between surfaces in relative motion to prevent friction and wear.
a. Diluent
b. Binder
c. Disintegrant
d. Lubricant
212. Substance that glue powders together that cause them to form granules.
a. Diluent
b. Lubricant
c. Binder
d. Disintegrant
213. Aggregates of powders which adhere or bond to each other to form larger particles.
a. Powders
b. Granules
c. Microcapsules
d. Pellets
214. The relative intensity of a fragrance impression.
a. Dry out
b. Body
c. Strength
d. Thin
215. __________is a blend of fragrant complexes culminating in an intense heavy full-bodied fragrance.
a. Cologne-blend
b. Oriental
c. Bouquet
d. Floral
216. Which of the following is an example of animal secretion that is used in the formulation of fragrances?
a. Benzoin
b. Eugenol
c. Myrrh
d. Ambergris
217. Which of the following is used as flower oil in the formulation of fragrances?
a. Jasmine absolute
b. Clove oil
c. Myrrh
d. Cinnamon oil
218. Which of the following is used as an antidandruff agent in the formulation of shampoos?
a. Isopropyl alcohol
b. Butyl alcohol
c. Propylene alcohol
d. Selenium sulfide
219. Which of the following is used as a clarifying agent in the formulation of shampoos?
a. Terpineol
b. Citric acid
c. Selenium disulfide
d. Behenic acid
220. Which of the following is used as an opacifying agent in the formulation of shampoos?
a. Lauric acid
b. Behenic acid
c. Propylene glycol
d. Lanolin
221. ___________ increase the quality, volume, and stability of lather of shampoo.
a. Conditioning agent
b. Opacifying agent
c. Clarifying agent
d. Foam builder
222. Which of the following is NOT used as a humectant I the formulation of tooth paste?
a. Glycerine
b. Sorbitol
c. Dichlorphene
d. Propylene glycol
223. Which of the following is frequently used as a sweetening agent in the formulation of toothpaste?
a. Saccharin
b. Calcium carbonate
c. Glycerin
d. Wintergreen
224. Which of the following is frequently used as a staining dye in lipsticks?
a. Carnauba wax
b. Lanolin
c. Eosine
d. Castor oil
225. _______________ is used in the formulation of face powder because it provodes water proofing properties.
a. Silicate
b. Zinc stearate
c. Magnesium carbonate
d. Calcium carbonate
226. It is composed of magnesium trisilicate. It is the basic ingredients of all powder formulations.
a. Magnesium carbonate
b. Calcium carbonate
c. Talc
d. Kaolin
227. _______________ stiffens a cream.
a. Spermaceti
b. Ceresin
c. Lanolin
d. Beeswax
228. It is the purified honeycomb of the bee. It contributes to cream consistency.
a. Mineral oil
b. Beeswax
c. Cetyl alcohol
d. Cocoa butter
229. _______________ creams prevent skin melanogenesis.
a. Shaving
b. Hand
c. Suntan
d. Emollient
230. _______________ creams softens the skin.
a. Emollient
b. Cleansing
c. Shaving
d. Suntan
231. Which of the following statement is true?
a. The backing layer of transdermal patches should be impermeable.
b. None of the adhesive should stay on the peel strip.
c. The adhesive must hold the drug securely in place.
d. All of the above.
232. Largest capsule size.
a. 000
b. 0
c. 5
d. 1
233. Frequently employed method in the manufacture of ointments wherein the active ingredient is mixed with the
melted waxes and base.
a. Fusion method
b. Punch method
c. Dry granulation
d. Levigation
234. It is used as an antioxidant in the compounding of semisolid preparations.
a. Butylated hydroxyl toluene
b. Parabens
c. Sorbitan monostearate
d. Mineral oil
235. They are known as greaseless ointment bases.
b. Absorption bases
c. Water removable bases
d. Water soluble bases
236. It can be applied to moist skin lesions because it can absorb discharges.
b. Absorption bases
c. Water removable bases
d. Water soluble bases
237. It is a hydrocarbon base utilized as a vehicle in the compounding of semisolid preparations. And it spreads
easily on the skin.
a. Vanishing cream
b. Petroleum
c. Lanolin
d. Cholesterol
238. The ______________ come in contact with both the product and the propellant.
a. Propellant
b. Valve
c. Dip tubes
d. Actuator
239. The ______________ is responsible for developing the proper pressure within the container and it expels the
product.
a. Valve
b. Dip tubes
c. Propellant
d. Actuator
240. Which of the following is NOT a compressed gas?
a. Nitrogen
b. Butane
c. Nitrous oxide
d. Carbon dioxide
241. Which of the following statement is NOT true?
a. Oral aerosols are intended for administration as fine particles or as liquid mist via the respiratory system
or nasal passages.
b. The particle size of the active ingredient of aerosols must be considerably below 50 micrometers.
c. Hydrocarbons have greater range of solubility than the fluorinated carbons.
d. Compressed gases do not expand.
242. Which of the following is an example of a soft gel capsule?
a. Squibb
b. Amoxicillin
c. Flanax Forte
d. Ponstan SF
243. It is used as an opacifying agent in hard gelatin capsules.
a. Triethanolamine
b. Sorbitol
c. Saccharin
d. Titanium dioxide
244. Which of the following is NOT a torche?
a. Strepsils
b. Dequadin
c. Valda Pastilles
d. Dulcolax
245. ________________ are discoid shaped solid containing the medicinal agent in suitably flavored base.
a. Capsules
b. Powders
c. Aerosols
d. Troches
246. It is added in hard gel capsule to prevent decomposition during manufacture.
a. Sulfur dioxide
b. Titanium dioxide
c. Glycerin
d. Sorbitol
a. Geometric dilution is not necessary for incorporation of small amounts of potent drug.
b. Sieving is necessary to achieve mixing or reduction of agglomerates.
c. Powders must be protected against humidity, air oxidation, and loss of volatile ingredients.
d. Divided powders are dispersed in the form of individual doses and packed in papers properly folded.
248. The process of reducing substances to fine particles by rubbing them in a mortar with pestle.
a. Trituration
b. Pulverization by intervention
c. Levigation
d. Fusion
249. Which of the following is used as an antioxidant in the formulation of parenterals?
a. Sodium chloride
b. Sodium hydroxide
c. Sodium citrate
d. Sodium EDTA
250. What is the use of nitrogen in the formulation of parenterals?
a. Buffer
b. Tonicity contributor
c. Preservative
d. Antioxidant
251. Which of the following is used as a preservative in the formulation of parenterals?
a. Sodium citrate
b. Sodium EDTA
c. Sodium chloride
d. Methyl paraben
252. What is the use Purified Water, USP in the formulation of parenterals?
a. Tonicity contributor
b. Preservative
c. Antioxidant
d. Vehicle
253. Which of the following is NOT used in gas sterilization?
a. Ethylene oxide
b. Beta propiolactone
c. Nitrogen
d. Sulfur dioxide
254. Which of the following is NOT true about autoclave?
a. It makes use of moist heat.
b. It is considered a thermal process of sterilization.
c. It is considered as a chemical process of sterilization.
d. It is considered as a physical process of sterilization.
255. Nitrogen and carbon dioxide are examples of _________.
a. Synergist
b. Oxygen displacer
c. Reducing agent
d. Blocking agent
256. These are compounds that increase the effectiveness of antioxidants, particularly by blocking oxidative
reactions.
a. Blocking agents
b. Synergist
c. Chelating agent
d. Reducing agent
257. EDTA is classified as ________________.
a. Chelating agent
b. Synergist
c. Blocking agent
d. Oxygen displacer
258. Which of the following is NOT a blocking agent?
a. Sodium metabisulfide
b. Butyl hydroxytoluene
c. Ascorbic acid esters
d. NOTA
259. Ascorbic acid is classified as ______________.
a. Reducing agent
b. Blocking agent
c. Chelating agent
d. Oxygen displacer
260. Which of the following is NOT used as a preservative in parenteral preparations?
a. Benzyl alcohol
b. Methyl paraben
c. Propylene glycol
d. Chlorobutanol
261. Which of the following is NOT true about the Pyrogen Test?
a. It is designed to limit ta an acceptable level the risks of febrile reaction in the patient to the administration
by injection of a product.
b. Rabbit is used as test animal.
c. No individual rabbit should show a rise in temperature by 0.6 degrees Celsius.
d. The sum of the rise in temperature of 3 rabbits should not exceed 2.1 degrees Celsius.
262. What is the positive result for Bacterial Endotoxin Test?
a. Gel-clot formation
b. White precipitate
c. Green solution
d. Blue solution
263. What is the use of sorbitol in the formulation of Aluminum Hydroxide Gel, USP?
a. Sweetener
b. Flavorant
c. Viscosity builder
d. Vehicle
264. Which of the following is used as a preservative I the formulation of Aluminum Hydroxide Gel, USP?
a. Aluminum hydroxide
b. Sodium benzoate
c. Sodium saccharin
d. Distilled water
265. Which of the following is NOT true about the flocculated system of suspension?
a. It forms a clear particle free supernatant liquid and sediment.
b. Particles appear as floccules.
c. It frequently results in a poor suspension.
d. It exhibits a minimum of serious separation.
266. ______________ is used primarily to reduce the solid particle size and for the dispersion of suspension
containing particles.
a. Mechanical stirrers
b. Colloid mills
c. Homogenizer
d. Ultrasonifier
267. Which of the following is used to minimize the foam in the production of emulsion?
a. Spans
b. Cetyl alcohol
c. Tweens
d. Acacia
268. Which of the following has to be considered in the formulation of emulsions?
a. Consistency that will provide the desired stability and flow characteristics of emulsion must be attained.
b. The use of preservative, since emulsion consist of a number of ingredients which support the growth of
bacteria, molds, and yeast.
c. Use of antioxidants.
d. All of the above.
a. Oxidation readily occurs in vegetable oils.
b. Oxidation in emulsion produces rancidity.
c. Oxidation produces emulsion with pleasant odor.
d. BHA and BHT are most commonly used in cosmetics and pharmaceutical preparations.
270. _____________ help the tablet to dissolve once it is in an aqueous medium.
a. Diluent
b. Binder
c. Colorant
d. Disintegrant
271. What is the use of lactose in the formulation of Acetaminophen tablet?
a. Binder
b. Diluent
c. Disintegrant
d. Lubricant
272. What is the use of starch paste on the formulation of Acetaminophen tablet?
a. Colorant
b. Flavorant
c. Binder
d. Lubricant
273. Which of the following is used as a lubricant in the formulation of Acetaminophen tablet?
a. Lactose
b. Corn starch
c. Starch paste
d. Magnesium stearate
274. What is the therapeutic use of acetaminophen?
a. Diuretic
b. Analgesic
c. Expectorant
d. Dietary supplement
275. What is the therapeutic use of Soda Mint Tablet?
a. Antacid
b. Astringent
c. Antifungal
d. Keratolytic
276. _________________ is the term used, when the upper or lower segment of the tablet separates horizontally,
either partially or completely from the main body of a tablet and comes off a cap, during ejection from the tablet
press, or during subsequent handling.
a. Lamination
b. Capping
c. Picking
d. Binding
277. _________________ is due to rapid expansion of tablets when deep concave punches are used.
a. Lamination
b. Cracking
c. Capping
d. Binding
278. _________________ is the separation of a tablet into 2 or more distinct horizontal layers.
a. Picking
b. Lamination
c. Sticking
d. Chipping
279. _________________ are small, fine cracks observed on the upper and lower central surface of tablets, or very
rarely on the sidewall.
a. Chipping
b. Cracking
c. Mottling
d. Lamination
280. _________________ are solid dosage forms in which the drug is enclosed in either a hard or a soft, soluble
shell of a suitable form of gelatin.
a. Tablets
b. Capsules
c. Ointments
d. Solutions
281. What capsule size has the approximate capacity of 0.098 to 0.13g of materials?
a. 5
b. 4
c. 2
d. 3
282. What is the common method employed by a pharmacist in filling of capsules?
a. Punch method
b. Ouch method
c. Dry gum method
d. Hunch method
283. _________________ capsule is made from the mixture of gelatin, sugar and water with or without suitable
coloring agents.
a. Hard
b. Soft
c. Either A or B
284. What is the smallest capsule size?
a. 5
b. 1
c. 000
d. 0
285. What is the largest capsule size?
a. 5
b. 1
c. 000
d. 0
286. What is the appropriate capsule size for 0.65 to 1.82 materials?
a. 3
b. 1
c. 000
d. 0
287. Which of the following is NOT used in the formulation of Honey and Almond Cream?
a. White wax
b. Carnation oil
c. Stearic acid
d. Potassium carbonate
288. Which of the following id NOT used as a perfume in the formulation of Honey and Almond Cream?
a. Benzaldehyde
b. Rose oil
c. Coconut oil
d. Carnation oil
289. It is used as an opacifying agent and whitening pigment in the formulation of Face Powder.
a. Talc
b. Kaolin
c. Zinc oxide
d. Titanium dioxide
290. Which of the following is NOT used in the formulation of shampoo?
a. Lauric acid
b. Triethanolamine
c. Potassium carbonate
d. Glycerin
291. Which of the following is the active component of toothpaste?
a. Tawas
b. Glycerin
c. Hard soap
d. Precipitated calcium carbonate
292. Hair like string inside the bottle.
a. Overpress
b. Filament
c. Check
d. Split
293. Odd shapes and conditions that render the container completely unusable.
a. Freaks
b. Cracks
c. Stone
d. Splits
294. Partial fractures generally found in the hell area, but sometimes occurring at the shoulder.
a. Soft blister
b. Cracks
c. Stone
d. Mismatch
295. Small inclusion of any non-glass material.
a. Mismatch
b. Fin
c. Pinhole
d. Stone
296. A sunken center portion at the bottom of the bottle.
a. Soft blister
b. Freaks
c. Rocker bottom
d. Poor distribution
297. A wavy condition of horizontal lines in the body of the bottle.
a. Washboard
b. Hard blister
c. Seeds
d. Tear
298. Heavy glass on one side of the bottle.
a. Mark
b. Stuck
c. Long neck
d. Heel tap
299. Small bubbles in the glass.
a. Seeds
b. Stuck
c. Tear
d. Mark
300. __________________ for Injection USP is intended to be used within 24 hours following its collection.
a. Water
b. Purified Water
c. Sterile Water
d. Bacteriostatic Water
PHARMACEUTICAL MANUFACTURING
D 1. A means of administering drugs as formulated preparations is called:

a. pharmaceutical c. dosage forms
b. drug delivery system d. any of the above
D 2. A manufacturer who produces the products of a company without manufacturing facilities is a/ an:
a. ethical manufacturer c. biological manufacturer
b. proprietary manufacturer d. toll manufacturer
C 3. Primary package system as differentiated from secondary package systems:

a. are in direct contact with the product
b. have a direct effect on product shelf life
c. AOTA
d. None
A 4. The only true tamper resistant packaging:

a. aerosol containers c. breakable caps
b. sealed tubes d. shrink seals
B 5. Purified water that is free from pyrogen

a. purified water c. Any of the choices
b. water for injection d. NOTA
C 6. Viscosity enhancers are added to liquid preparations to:

a. improve pourability of products from container
b. improve palatability
c. both
d. none
B 7. The most inert grade of stainless steel used for high grade products
a. SS 304 c. SS 3004
b. SS 316 d. SS 3016
C 8. Filtration system which is recommended for handling large quantities is

a. gravimetric filtration c. pressure
b. vacuum d. cartridge filtration
A 9. Filling method which is advisable for highly viscous products

a. gravimetric filling c. any of the above
b. volumetric filling d. none
D 10. The advantages of emulsion over other dosage forms include:

a. increased therapeutic effects c. ability to mask unpleasant odors
b. increased spreading ability d. AOTA
D 11. Aggregates of powders which adhere or bond to each other to form larger particles
a. powders c. pellets
b. microcapsules d. granules
C 12. Storage conditions for capsules

a. 35-50% RH c. AOTA
b. 21-25ºC d. NOTA
B 13. Substance that “glue” powder together causing them to form granules
a. diluent c. lubricant
b. binder d. disintegrant
C 14. An agent that acts between surfaces in relative motion to prevent friction and wear
C 15. In film coating, when additives migrate to the surface, the problem is called:
a. blistering c. sweating
b. wrinkling d. bloom
B 16. An anteroom which separates the sterile from non sterile is a/an:
a. LAF c. HEPA
b. airlock d. AOTA
C 17. Area with no more than 100 particles of 0.5 micron size per cubic foot of environment:
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a. Class 0.5 c. Class 100

b. Class 500 d. Class 1000
B 18. A very simple, sensitive and fast test for pyrogens using the amoebocyte of the horse shoe crab.
a. Pyrogen Test c. Rabbit Test
b. LAL Test d. Crab Test
C 19. Ampules are sealed by:

a. Pull sealing c. any of the above
b. Tip sealing d. NOTA
B 20. The period in which the product remain acceptable for use:
a. Stability c. Accelerated Stability Studies
b. Shelf life d. any of the above
A 21. Flow property of liquid is related to:

a. Viscosity c. Optical Property
b. Volatility d. Miscibility
D 22. Solubility may be enhanced through the use of:

a. Application of heat c. Reduction of particle size
b. Agitation d. any of the above
D 23. Dispensing equipment in the name of suspension includes:

a. Blenders c. Colloid mill
b. Impellers d. all of the above
D 24. A suspension may be stabilized through the use of:

a. Suspending agents c. Viscosity enhancing agents
b. Hydrocolloids d. AOTA
D 25. Suspensions are evaluated by:

a. Sedimentation c. Measuring of Particle size
b. Ease of redispersability d. Any of the above
A 26. The ff are natural emulsifying agent, except:

a. Tween 80 c Agar
b. Acacia d. gelatin
A 27. Water soluble abases are prepared from

a. PEG c. Petrolatum
b. sorbitol d. mineral oil
A 28. Polyols may be used as:

a. humectant in creams c. prevent cap locking
b. viscosity contribution d. AOTA
B 29. Preservatives are added to semisolid preparations to be prevent the ff except

a. decomposition c. deterioration
b. container d. spoilage by bacteria and molds
A 30. Mixing equipment for acid materials

a. Sigma blade mixer c. Twin shell bed dryer
b. Ribbon blender d. AOTA
D 31. An ideal drug delivery system (DDS) is

a. capable of controlled delivery rates
b. not highly sensitive to physiological variables
c. based on physicochemical principles
d. Any of the above
D 32. Formulation methods of achieving sustained drug release including

a. use of coating c. microencapsulation
b. embedding the drug in a matrix d. AOTA
D 33. Gradual sedimentation in liquid products is due to:

a. chemical reaction c. bacterial growth
b. decomposition d. any of the above
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A 34. Filtration process wherein the liquid passes through one filter pad or disk
a. parallel c. both a and b
b. series d. none
A 35. A gravity operated filling set up is used for liquids which are
a. free flowing c. viscous
b. foaming d. either a or b
D 36. Solubility may be enhanced through

a. application of heat c. reduction of particle size
b. agitation d. AOTA
B 37. Suspension adjunct used to prevent the product from drying at topical application
a. sweetening agent c. preservative
b. humectant d. emollient
D 38. The aggregation of the dispersed globules into loose clusters within the emulsion
a. creaming c. phase inversion
b. cracking d. flocculation
D 39. The attire or uniform used in parenteral production include

a. cover all c. boots and gloves
b. face mask and head covers d. AOTA
A 40. CGMP means

a. Current Good Manufacturing Practice
b. Current General Manufacturing Program
c. Current General Manufacturing Practice
D 41. The quality of a medicinal and a related product is the sum of all factors which will contribute directly or
indirectly to the products
a. safety c. acceptability
b. effectiveness d. AOTA
B 42. Group which is responsible for auditing the control system for evaluating product quality
a. Quality Control c. Production
b. Quality assurance d. Medical
C 43. The disintegration medium of plain uncoated tablet is

a. simulated gastric fluid TS c. Distilled water
b. simulated intestinal fluid TS d. potable water
C 44. Quality control test that are performed on granules before compression into tablets are except:
a. sieve analysis c. angle of repose
b. bulk density d. AOTA
D 45. The most common method of tableting active ingredients which are chemically incompatible
a. microencapsulation c. add stabilizers
b. film coating d. use double layer tableting
D 46. Sealing of ampule is done by

a. Pull sealing c. Tip sealing
b. softening the neck of ampule d. a and c
C 47. Bullet shaped capsules are called

a. spansules c. pulbules
b. bougies d. NOTA
A 48. This is used to increase the resistance of gas

a. Sulfur dioxide c. Ethylene oxide
b. Titanium Oxide d. acid
A 49. The animal of choice for in vitro rectal absorption studies

a. dog c. rabbit
b. pig d. mouse
B 50. Method that will produce tablets of best quality

a. direct compression c. dry granulation
b. wet granulation d. any of the above
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C 51. Bubble test measure the efficiency of:

a. glass c. membrane filter
b. plastics d. air filter
A 52. A processing problem encountered only in the manufacture of tablets:

a. double impression c. molding
b. weight variation d. chipping
A 53. The coalescence of oil globules in a o/w emulsion is called:

a. cracking c. creaming
b. inversion d. sedimentation
C 54. The ff. are true for Spans, except:

a. they are resistant to addition of acids and electrolytes
b. they are hydrophobic
c. they have high HLB values
d. they from w/o emulsions
D 55. A variation of dry gum method of preparing emulsions using volatile oil is added to acacia in a bottle:
a. Oil method c. Emulsifier in oil method
b. English method d. Bottle method
A 56. Antioxidants which block an oxidative chain reaction in which they are not usually consumed:
a. BHT c. thiourea
b. EDTA d. tartaric acid
A 57. These are gas sterilants, except:

a. carbon dioxide c. beta propiolactone
b. formaldehyde d. sulfur dioxide
A 58. A sterilization method which destroys microorganism b y cellular protein coagulation:

a. autoclaving c. gas sterilization
b. dry heat sterilization d. none of the above
D 59. The usual contaminants of ophthalmic preparations are the ff., except:
a. Pseudomonas aeruginosa c. Aspergillus fumigatus
b. Bacillus subtilis d. Staphylococcus aureus
A 60. A commonly used capsule diluent:

a. lactose c. Calcium Phosphate
b. starch d. any of the above
C 61. An opacifying agent for capsules:

a. sulfur oxide c. titanium oxide
b. lactose d talc
B 62. A common levigating agent:

a. glycerin c. alcohol
b. mineral oil d. ether
C 63. Method used for the incorporation of small amounts of potent drugs with a large amount of diluent:
a. spatulation c. geometric dilution
b. sifting d. levigation
B 64. The ff. excipients impart satisfactory compression characteristics to the tablet formulation except:
a. glidant c. lubricant
b. disintegrant d. antiadhesive
A 65. Tablet weight is determined by:

a. volumetric fill of the disc c. amount and nature of bunder
b. pressure during compression d. all
C 66. One part of a slightly soluble material will dissolve in ________ part of solvent
a. 10-30 c. 100-1000
b. 30-100 d. 1000-10000
B 67. Brandy and whiskey are classified as:

a. elixirs c. aromatic waters
b. spirits d. juice
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B 68. The reduction of camphor with the aid of alcohol is called:

a. trituration c. levigation
b. pulverization by intervention d. any of the above
D 69. The prominently printed element on the label:

a. brand name c. pharmacologic category
b. Rx symbol d. generic name
C 70. A 600L paracetamol drops was manufactured. If it is packed in 60-mL bottle, the theoretical yield is:
a. 100 c. 10000
b. 1000 d. 5000
A 71. Invert sugar has the tendency to darken in color due to:
a. levulose c. glucose
b. sucrose d. lactose
A 72. A near saturated solution of sucrose in water:

a. simple syrup c. sucrose solution
b. syrup d. all
B 73. Acacia mucilage is x% dispersion in water:

a. 42 c. 5
b. 35 d. 25
C 74. Thixotropy is a characteristic demonstrated by:

a. jellies c. gels
b. magmas d. suppositories
C 75. Galenicals are also called:

a. extracts c. extractives
b. fluidextracts d. marc
A 76. The injection of large of volumes of a solution into substances tissue to provide a continuous, abundant
drug supply is called:
a. hypodermicyclics c. IM administration
b. IV administration d. intradermal administration
D 77. Excessive use of binders in tablet affectd:

a. bioavailability c. dissolution
b. disintegration d. all
C 78. Impart cohesive qualities to the tablet granulation:

a. diluent c. binder
b. lubricant d. disintegrant
A 79. Buccal tablets are intended to be dissolved:

a. swallow c. beneath the tongue
b. rapidly d. chewed
A 80. These are necessary components of a stable emulsion, except:

a. electrolyte c. dispersed phase
b. dispersion medium d. emulsifier
A 81. Problem often encountered in suspensions:

a. caking c. slow settling
b. smooth texture d. dispersatility
A 82. The different methods of determining the emulsion type are the ff., except:
a. Dry Gum c. Electrical conductivity
b. Drop dilution d. Dye
B 83. The container of choice for parenteral:

a. plastic c. metals
b. glass d tubes
C 84. The container of choice for ointments:

a. jars c. collapsible tubes
b. cans d. widemouth bottle
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A 85. Which of the ff. is not classified as a lubricant?

a. lactose c. Ca Stearate
b. Stearic acid d. talc
D 86. Spans & Tweens are:

a. binders c. preservatives
b. diluents d. surfactants
A 87. Filtration of a solution to a high degree of clarity:

a. polishing c. clarification
b. dialysis d. dissolution
D 88. Plastic containers are not recommended for pharmaceuticals because:

a. vapors permeate through the walls of the container
b. leeching of constituents from the plastic to the product
c. absorption of the drug molecules to the surface of the plastic
d. all of the above
e. none of the above
D 89. These are advantages of tablets, except:

a. economy c. blandness of taste
b. accuracy d. prolonged dissolution
C 90. HEPA filters are used for filtration of:

a. parenterals c. air
b. ophthalmics d. solvents
D 91. For compacting the materials in the tablet machine:

a. hopper c. dies
b. feedframe d punches
C 92. Tablet granulations can be dried faster using:

a. granulator c. fluid bed dryer
b. oven d. solar dryer
B 93. The partial or complete separation of the top or bottom of a tablet from the main body:
a. chipping c. lamination
b. capping d. picking
B 94. Used for mixing powder mixtures in large volume quantity:

a. drum roller c. planetary mixer
b. V-blender d. compactor mills
A 95. A roller mill is used to reduce the particle size of powders in:
a. ointment c. capsules
b. tablet d. emulsion
B 96. This is not part of the master formula record:

a. complete batch formula
b. price per dosage unit
c. weight of each
d. description of container & closure
B 97. This part of the sugar coating process is to round off tablet contours rapidly:
a. sealing d. finishing
b. subcoating e. polishing
c. syruping
Problems: Primaquine Phosphate tablets, 30mg/tab

Formula mg/tab batch of 600,000 tabs
a. Primaquine PO4 30 98. 18kg
b. Lactose 56.6 99. 33.96kg
c. Starch 16.6 100. 9.96kg
d. PVP 0.57 101. 0.342kg
e. Stearic acid 0.23 102. 0.138kg
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103. Tablet weight = 104 mg
For nos. 104-108 Match by writing the equivalent capital letter of each ingredient corresponding to the role of each
C 104. Disintegrant
B 105. Filler
A 106. Active Ingredient
D 107. Binder
E 108. Lubricant
For nos. 108-111: After tablet compression, the 3 drums collected were weighed
Data Gross Tare Net

Drum 1 20kg 0.05kg 108. 19.95kg
Drum 2 21kg 0.06kg 109. 20.94kg
Drum 3 20.3kg 0.04kg 110. 20.26kg
111. 61.15kg
112. Compute for the actual number of tablets. Answer: 587,980 tablets
113. Determine the %wastage. Answer: 2.0%
B 114. Which of the ff additives in parenterals reduces the f\pain of injection in areas with nerve endings?
a. buffers c. synergist
b. tonicity adjusters d. chelating agents
B 115. Weight variation test is carried out iin:

a. 10 tabs c. 30 tabs
b. 20 tabs d. 40 tabs
A 116. The component present in the largest quantity in parenterals

a. vehicle c. buffers
c. solutes d. antimicrobials
A 117. The water resistance of glass containers is tested by

a. amount of alkali released into water c. changes in pH
b. amount of acid released into water d. none
D 118. The buffers commonly used in parenterals

a. citrates d. any of the choice
b. acetates e. none
c. phosphates
D 119. Granulation by compression is also known as

a. dry granulation c. double compression method
b. precompression method d. all of the above
A 120. Primary packaging components except

a. labels d. caps
b. bottles e. stoppers
c. tubes
C 121. The degree of freedom is used in calculation of

a. average c. standard deviation
b. mean d. range
A 122. To control microorganisms in the air is to

a. install UV lamps in several areas c. install IR bulbs in several areas
b. provide ETO gas around the room d. any of the above
D 123. The work “quality” SQC refers to characteristic of a product from:

a. quantitative c. identification
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b. qualitative d. a & b
C 124. The measure of the variation of individual observations around the average is:
a. range c. standard deviation
b. average d. any of the choices
B 125. Advantages of plastic containers over glass, except:

a. lightness in weight c. lower transportation
b. permeability d. resistance to impact
D 126. Indicator employed in sterilization process is

a. chemical wax or pellet c. biological suspension
b. colored paper strips d. any
B 127. In labeling of a product, an unlabeled portion is provided for

a. elegance c. save cost of labels
b. viewing the contents d. all of the above
D 128. Property of IV solutions

a. with aqueous vehicle c. hypotonic
b. isotonic d. a & b
C 129. The material present in both enteric and film coating

a. wax c. cellulose acetate phthalate
b. parafilm wax d. a &c
B 130. A lyophobic substance is easily wet by

a. polar solvents c. water
b. nonpolar solvents d. hydroalcohols
D 131. Characteristics of iirigation solutions to wash wounds and body cavitites may be
a. sterile c. with additives
b. pyrogen free d. a & b
B 132. Plastic material used for ophthalmic solutions as package and applicator is
a. polypropylene c.polystyrene
b. polyethylene d. PVC
C 133. A colloid mill is used for the ff, except:

a. reduce particle size of solids c. granulation
b. homogenize viscous emulsion d. produce finely divided solids
D 134. Use of buffers in parenterals

a. pH stabilizer c. tonicity contributor
b. sterilizer d. a and c
D 135. Foam in emulsion is prevented

a. apply compressed air c. add polyethylene
b. add antifoaming agent d. a and b
A 136. the dispensing division of the warehouse requires

a. licensed pharmacist c. experienced scientist
b. licensed chemist d. a & b
D 137. Room temperature recognized by USP is

a. 25ºC c. 20ºC
b. 10-30ºC d. temp at the working area
B 138. Uneven distribution of colors on the surface of tablets is

a. peeling c. capping
b. mottling d. lamination
D 139. The Board of Trustees of a company functions as the

a. protector of the company’s asset
b. prepare policies
c. active planning
d. a&b
D 140. To remedy the irritating effects of UV radiation is to
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a. wear UV goggles for eyes c. put off the UV light during operation
b. covers skin with clothing d. AOTA
A 141. The inspection and checking section of QC is responsible for

a. sampling of raw materials c. chemical assaying
b. testing sterility of products d. doing pyrogen test
A 142. The part of the transdermal drug delivery system patch where the drug is stored
a. reservoir c. back strips
b. peel strips d. membrane
B 143. Practical method of determining method of hardness is

a. Eureka Tester c. Pfizer Tester
b. Rule of Thumb d. Rosche Tester
A 144. Method of tablet manufacture for easily compressible or adhesive ing is

a. direct compression c. wet method
b. slugging d. a&b
B 145. Limulus amoebocyte lysate is obtained from

a. rabbits c. white mice
b. king crab d. microorganisms
D 146. The building used for manufacturing of pharmaceutical shall be of adequate space for
a. orderly placement of materials
b. prevent mix up of drugs and packaging matls
c. avoid risk of cross contamination of raw materials and label
d. AOTA
C 147. Stoke’s Monsanto tester is used to measure

a. thickness c. hardness
b. friability d. disintegration of tablets
D 148. Pharmaceutical aerosols may be in the form of

a. solutions c. emulsions
b. powders d. AOTA
A 149. Hemodialysis is employed to remove toxins from the

a. blood c. kidney
b. peritoneal cavity
B 150. Implantation pellets are those which contain

b. active ing d. disintegrant in their formation
D 151. Property of tablet granulations to obtain good tablets:

a. compressibility c. noramal distribution of fines
b. fluidity d. AOTA
B 152. In the manufacture of semisolid emulsions, the mixing of the oil and aqueous phases is done at the
temperature of:
a. 30-40ºC c. 80ºC
b. 70-72ºC d. NOTA
A 153. Hard gelatin capsules are also referred to as:

a. dry-filled capsules c. soft elastic
b. pork skin capsule d. SEC type
C 154. To identify pharm. Products that are registered in BFAD, the label consists of:
a. expiry date c. DR number
b. Bar marks d. category
D 155. Packaging and labeling operations are controlled to:

a. prevent mix ups b/w drugs and labels
b. assure that only those products that meet the standards are distributed
c. identify the finished products with a control number
d. AOTA
A 156. Quarantined materials delivered in the warehouse are:

a. subject to test and assay c. rejectable
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b. releasable to production dept. d. in-process products
B 157. Advantage of liquid medicines:

a. special techniques required for poorly soluble drugs
b. rapidly absorbed in the body
c. easy to manufacture
d. requires pharmaceutical elegance
D 158. Instability of drug substances in liquid form may be caused by:

a. variation in pH c. light of radiation
b. reduced temperature d. a&c
A 159. Disadvantage of glass material used in packaging of liquids is:

a. releases insoluble flakes upon storage
b. resistance to decomposition
c. oxide contents may be reduced
d. b & c
C 160. To increase viscosity of the aqueous phase of an emulsion is to:

a. add more emulsifier c. add dissolved macromolecules
b. active ing d. antibiotics
A 161. In suspension formulation, the suspension adjuvants may be

a. buffers c. drug substance
b. actives d. antibiotics
C 162. Suspending agents added to suspension formulations, except:

a. gelatin c. parabens
b. veegum d. methocel
A 163. In semisolid preparations, petrolatum is a common hydrocarbon base due to its:

a. consistency c. easily washed with water
b. hydrophilic character d a&b
D 164. Large volume parenterals are employed for:

a. maintenance therapy c. prophylactic therapy
b. replacement therapy d. a & b
B 165. Insoluble powders for ophthalmic preparations must be:

a. less than 200 microns in particle size
b. impalpable to the touch
c. pyrogen free
d. give preservative action
D 166. Dialysis solutions as life-saving preparations has the ff characteristics, except:

a. requires a semipermeable membrane to separate one substance from another
b. contains dextrose for supplies of calories
c. used for individuals with kidney failure
d. used to separate RBC from WBC
A 167. CGMP standards and regulations are enforced by BFAD for the purpose of:
a. assuring quality
b. assuring the protection from moisture
c. developing new product
d. assuring sales
B 168. The president of a company has the function of:

a. protecting the assets of the company
b. active planning and control of business
c. management of the major department
d. a and c
D 169. The phenomenon applied to adsorption at solid surfaces is:

a. wetting property c. flocculation
b. detergency d. a & b
D 170. Plastic containers are of advantage to manufacturers for us ein:

a. packaging of IV infusion
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b. ophthalmic solutions
c. place of Al metal to hold rubber stoppers in vials and bottles
d. a & b
D 171. A colloid is employed to:

a. reduce solid particle size of suspensions
b. homogenize viscous emulsions
c. produce finely divided solids
d. any of the above
A 172. Polyols may be added to cream formulation as:

a. humectant c. active ingredient
b. viscosity contributor d. a & b
C 173. Aspilet tablets for children are:

a. sublingual c. chewable
b. buccal d. soluble
C 174. An aerosol is a dispersion of:

a. solid in alcohol c. solid in gas
b. solid in water d. liquid in liquid
D 175. What is measured in dissolution test of a tablet?

a. extent of drug absorbed
b. rate of absorption of the drug substance
c. rate of drug eliminated
d. a & b
B 177. A type of ointment base known as creams is:

a. water soluble base c. hydrocarbon base
b. water removable base d. a & b
D 178. Complaint about a product may be:

a. adulteration c. high price
b. decomposition d. a & b
B 179. Pfizer tester that determines force to break a tablet is used to measure:
a. thickness c. friability
b. hardness d. disintegration
B 180. Transdermal delivery system is a sophisticated patch that delivers the drug from the skin:
a. GIT c. liver
b. bloodstream d. dermis
C 181. Implantation tablets are those which are administered:

a. orally c. insertion into body tissues
b. through vagina d. rectally
C 182. Accdg. to Stoke’s law, the sedimentation rate of suspension is directly proportional to:
a. viscosity c. particle size
b. density d. specific gravity
B 183. Improperly sealed ampules should be tested for:

a. particulate matter c. bacteria
b. leak d. pyrogen
TRUE OR FALSE. Write/ Mark A if the statement is correct and B if not.
A 184. Single containers may be in ampules, vials, or in large 250mL- 1000mL.
B 185. Tamper-proof seals are popular nowadays to allow easy pilferage of the contents.
B 186. Biologic products are stored at room temperature.
A 187. Buccal tablets are those which contain drugs to be absorbed thru the oral mucosa.
B 188. The 2 acids contained in effervescent tablets are citric acid and acetic acid.
B 189. LAL Test for pyrogens is interpreted by rise in temperature of rabbits.
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A 190. In ampule sealing, a tip sealing is characterized by a bead at the tip of the ampule.
A 191. One great advantage of pharmaceutical aerosols is that medication is dispensed in a ready-to-use form at
the push of a button.
A 192. For semisolid aerosol, the formulation is similar to other semisolid preparation but depends on nitrogen
gas to the contents from package.
B 193. Homogenization of an emulsion is done to uniformly disperse the insoluble solid drug in the vehicle.
B 194. In the manufacture of emulsified semisolid, the mixing of the phases is done at a temperature of 43-45ºC
for intimate blending.
A 195. Hydrocarbon waxes are added to semisolid formulations to increase the viscosity of mineral oil and
prevents separation.
B 196. The natural emulsifiers like acacia form a colloidal layer to prevent coalescence of droplets.
B 197. Creaming in emulsions is the separation of emulsified droplets which are denser that settle at the
container.
B 198. The DDB is under the jurisdiction of the BFAD.
A 199. Spray drying technique can produce finely divided particles for suspension formulation.
B 200. Flint glass refers to the amber colored glasses used to protect from light.
A 201. The production control department of the plant division is in charge of inventory.
B 202. The approved for use materials are labeled with red color.
B 203. The medical department of a manufacturing establishment is in charge of:

a. plant & employee safety c. both a & b
b. house organ publication d. none
D 204. Facilities needed for pharmaceutical research:

a. library c. animal house
b. pilot plant d. all
A 205. The production department of a pharmaceutical manufacturing establishment is in charge of, except:
a. production personnel control
b. labeling & other packaging materials
c. inventory control
d. in-process analysis
C 206. One of the ff. is not a QC function:

a. inspection of container
b. labeling & other packaging material
c. inventory control
d. in process analysis
A 207. Documentation is the main responsibility of:

a. central release office
b. checking & investigation section
c. purchasing department
d. sales, promotion and merchandising department
C 208. It means any establishment engaged in operations involved in the production of drugs including
propagation, processing, compounding, finishing, filling, packing, repacking, and labeling in view of
storage distribution or sale of the product:
a. drug distributor c. drug manufacturer
b. drug trader d. none of the above
C 209. Statement of expiration date assure of:

a. absence of interaction c. full therapeutic efficacy
b. absence of toxicity d. recovers from ailment
B 210. The expiration date of paracetamol tablet states “January 1999”. This statement means that, by January
1999, the product will have lost its activity:
a. less than 90%
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b. sufficient activity to be outside the USP monograph requirement

c. meet BFAD requirement
d. comply with DOH requirement
A 211. The barcodes imprinted in labels of products serve to:

a. distinguish one product from another
b. impart elegance
c. meet BFAD requirement
d. comply with DOH requirement
A 212. These are quality assurance functions, except:

a. product forecasting
b. auditing, and control of all manufacturing documents before and after production
c. CGMP monitoring
d. environmental control
A 213. One of the ff. situations can avoid cross contamination and mix-ups:
a. components are tightly sealed
b. improper partitioning of working areas
c. components are improperly dispersed
d. wrong label
B 214. The manufacturing batch record should contain the ff. information, except:
a. in-process test, finished product QC test results
b. general manager’s signature
c. manufacturing procedures
d. dispensing batch number quantitative and qualitative formula
B 215. The QA inspectors usually inspect and audit warehouse CGMP’s :

a. stock rotation (FIFO)
b. all of these answers
c. separation of materials, quarantine, approved, rejected
d. protection of material from cross contamination
B 216. If a bottle of tablets has an expiration date of January 1999, the pharmacist may,
a. dispense the tablets only until January 1, 1999
b. dispense the tablets only until January 31, 1999
c. dispense the tablets only until January 15, 1999
d. continue to dispense the product if he has already opened the container
A 217. Reaction kinetics study can help predict the:

a. shelf life c. toxicity
b. effectivity of a formulation d. potency
D 218. In the CGMP, we usually consider the:

a. building c. equipment
b. personnel d. all
C 219. Any substance of a drug product intended to furnish pharmacologic effect is:
a. excipient c. actives
b. drug substance d. b & c
C 220. The concept where raw materials are purchased only at a time when it is needed and at a quantity
enough to carry out a single production
a. FIFO c. cost cutting
b. preformulation purchasing d. just-in-time
D 221. Soda Lime glass is also known as:

a. Type I c Type III
b. NP d. b &c
B 222. Container impervious to air:

a. tight container c. closed container
b. hermetic container d. single dose container
B 223. If you are QC inspector, what critical defect if found should stop the packaging operation and could be
processed if results of investigation are satisfactory:
a. inverted label c. smeared label
b. wrong label d. misaligned label
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A 224. Highly resistant borosilicate glass is also known as:

a. Type I c. Type III
b. Type II d. NP
A 225. It refers to the statement regarding the conditions, wherein the use of the product may cause harm to the
patient:
a. contraindication c. precaution
b. caution d. all of the above
C 226. Type of container that protects the content from extraneous solids, liquids, or vapors from loss of the
drug:
a. hermetic c. tight
b. well-closed d. light resistant
B 227. Single unit container include the ff., except:

a. sachets c. strip packages
b. collapsible tubes d. blister packs
C 228. It refers to the instruction and special care required in the use of the product to avoid undesired effects
and to ensure the safe and effective use of the drug:
a. caution c. precaution
b. contraindication d. all of the above
B 229. Component of closure that inserted in a cap to effect a hermetic seal between the closure and the
container
a. cap c. inner seal
b. liner d stopper
D 230. Common component of cap liners, stoppers and parts of dropper assembles:
a. metal c. plastic
c. glass d. rubber
D 231. One of the ff. is not an advantage of plastic over glass containers:
a. lightness in weight c. lower transportation cost
b. resistance to impact d. permeability
C 232. The all glass container for small volume parenterals:

a. vacoliter c. ampule
b. vials d. b & c
B 234. Tamper-resistant package except:

a. breakable caps c. bubble packs
b. liner d film wrappers
B 235. Material of plastic containers that can be remelted and reprocessed, except:
a. polystyrene c. polypropylene
b. melamine formaldehyde d acrylics
B 236. The product inserts fro many drug products contain statements. Which of the ff. sequences lists the 3 type
of caution in the order of least to most serious?
a. contraindication, precaution, warning
b. precaution, warning, contraindication
c. warning, contraindication, precaution
d. contraindication, warning, precaution
C 237. Advantages of glass containers, except:

a. inertness c. resistance to impact
b. rigidity d visibility
B 238. Package component used to prevent during shipping including cotton, rayon and polyester
a. inner weal c. liner
b. coil d. dessicant
C 239. Primary packaging materials, except:

a. bottles c. labels
b. capsules d. caps
C 240. Release or movement of the components of the container into the contents:
a. sorption c. leaching
b. breathing d. porosity
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D 241. Function of a package include:

a. for convenience c. for protection of content
b. for legal compliance d. all of the answers
A 242. Multiple dose containers include:

a. vials c. ampules
b. cartridges d pre-filled syringe
D 243. Functions of a package include:

a. to provide presentation c. for communication
b. to provide containment d. all of the above
B 244. Accdg. to USP standard, freezer or refrigerator can be used to store pharmaceuticals that specify storage
in a :
a. cool place c. dark place
b. cold place d controlled room temperature
C 245. Accdg. to the USP monograph instruction, protect from light indicates storage in:
a. dark place c. light resistant container
b. flint glass d. tight glass container
A 246. To assign in assuring the stability of a dosage form during transport and storage, the label shall indicate:
a. storage condition c. concentration of the drug
b. expiry date d. any of the above
C 247. The term soluble refers to part s of solvent that can dissolve 1 part of solute is:
a. 1-10 c. 10-30
b. 30-100 d. less than 1
B 248. The temperature of a cool place is:

a. not more than 8ºC c. 15-30ºC
b. 8-15ºC d. 25ºC
C 249. When 1 part of the solute dissolves in 1-10 parts of solvent, it is:
a. very soluble c. freely soluble
b. soluble d. sparingly soluble
C 250. The usual storage condition specified for biologicals is:

a. room temperature c. 2-8ºC
b. below 2ºC d. a cool place
A 251. Type of mill which makes use of compressed gas to cause turbulence inside the chamber.
a. fluid energy mill c. colloid mill
b. ball mill d. hammer mill
A 252. The ff. are preservatives used in dosage forms, except:

a. PG c. methylparaben
b. propylparaben d. Na benzoate
A 253. Filtration process wherein the liquid passes thru one filter pad or disc:
a. parallel c. a & b
b. series d none of the above
D 254. Factors that accelerate instability include:

a. temperature c. moisture
b. light d. all of the above
C 255. The composition of oral rehydration are:

a. amino acid, glucose, water
b. glucose, Na, K, HCO3, water
c. glucose, Na, K, Cl
d. citric acid, glucose, Ca, water
C 256. The generally accepted liquid product artificial sweetener:

a. cyclamate c. saccharin
b. glutamate d. glucose
C 257. Veegum is a/an:

a. organic gum c. clay
b. synthetic gum d. nonionic surfactant
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A 258. Type of resin that is used to deionize water:

a. synthetic c. prepared
b. resins d. natural
B 259. Buffers are used:

a. to bring about the solubility of insoluble substance
b. to maintain pH pf solution thus attaining maximum stability
c. as preservative
d. none of the answers
B 260. A finished product where sterility is not at its maximum observance:

a. ophthalmic c. theobroma oil
b. otic d. emulsified theobroma oil
B 261. 28% of an anti-pruritic preparation is composed of 3 active ingredients in ratio of 7:5:4. If marketing
requires 190kg batch size, determine the required amount of active ingredients:
a. 61.3kg c. 98.5kg
b. 53.2 kg d. 11.9kg
A 262. An eardrop preparation requires 0.017g of the active per 15 ml bottle presentation. If production calls for
1500 L batch size, determine the theoretical amount of the active needed.
a. 10.70 kg c. 23.70 kg
b. 16.05 kg d. 160.5 kg
C 263. Pressure operated filling set up is used for liquid which are
a. free flowing c. viscous
b. all of these d. foaming
D 264. A typical erythema score of 2 in the irritation test for ointment means
a. no visible reaction
b. intense erythema with edema
c. mild erythema
d. intense erythema
e. intense erythema with edema and vesicular erosion
B 265. Anhydrous lanolin has the ff property

a. water absorbing ability is less c. pleasant odor
b. more stable and free from rancidity d. non sticky consistency
A 266. Penetrometers are used to measure consistency and viscosity of

a. ointments c. micelles
b. suspensions d. thixotropic materials
C 267. Mixing equipment for solid materials except

a. sigma blade mixer c. Fitz Patrick Chilsonator
b. Ribbon blender d. Twin shell V blender
D 268. Solid dosage forms are more advantageous than liquid forms because of the ff reasons, except:
a. can be easily dispensed c. not prone to bacterial contamination
b. stability d. method of manufacture is easier
B/C 269. Granular forms are important because they

a. prevent segregation of powders c. are easier to wet
b. are more stable d. all of the above
C 270. A parvule is
a. bolus c. granule
b. wafer d. large pill
B 271. Materials added to provide cohesion in components for compression

a. lubricant c. fillers
B 272. Molded lozenges are referred to as:

a. Troches c. Extracts
b. Pastilles d. Film tab
B 273. Content uniformity tests is to be performed for all tablet products whose active ingredient is:
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a. 130 mg or less c. 324 mg

b. 50 mg or less d. 50 mg or more
D 274. Starch, povidone, Mg Stearate, and lactose added to Aspirin tablets are
a. actives c. vehicles
b. Inerts d. additives
A 275. For the disintegration test for enteric coated tablets, the immersion fluid is:
a. Simulated Gastric fluid TS c. water
b. oil d. PO4 buffer
A 276. The method for the preparation of compressed tablets wherein the granulation is formed by compacting
large masses of the mixture and subsequently crushing and sizing these pieces into smaller granules
a. dry granulation method c. direct compression method
b. wet granulation method d. all of the above
C 277. Aside from fluidity, powders for compression must possess

a. flowability c. compressibility
b. adhesiveness d. all of the above
B 278. Drugs that are available as sustained release dosage forms utilizing ion exchange resins include:
a. spansule c. gradumet
b. ionamine d. all of the above
A 279. Film coating problem due to internal stress

a. cracking c. mottling
b. lamination d. orange peel or roughness
C 280. The disintegration medium for plain uncoated tablet is:

a. Simulated Gastric Fluid TS c.DistilledWater
b. Simulated Intestinal Fluid TS d. a & c
B 281. The most commonly used of determining the particle size of powders and granules is:
a. coulter counter c. microscopy
b. sieve method d. none
D 282. The ff are binders, except

a. starch c. bentonite
b. acacia d. Cab-O-sil
B 283. Content uniformity is used to ensure which of the ff qualities in tablet products
a. disintegration c. purity
b. potency d. toxicity
B 284. For rapid disintegration of compressed tablet, this range of concentration of starch is recommended:
a. 5% c. 15-20%
b. 10-15% d. 20-25%
C 285. Rule of thumb is used for testing

a. ampules c. compressed tablets
b. hypodermic tablets d. vials
C 286. A tablet formulation calls for 2 active ingredients which are chemically incompatible. The best method to
be used is:
a. dry granulation c. double layered tablets
b. wet granulation d. spray drying
B 287. Poorly manufactured tablets may have small pinholes on the surface, this defect is called:
a. mottling c. capping
b. picking d. compacting
D 288. In the preparation of effervescent tablet, the most important ingredients necessary to give the
effervescent effects are:
a. NaHCO3 and Citric acid c. Na2CO3 and Tartaric acid
b. Citric acid and Tartaric acid d. a & c
A 289. Common binder used in tablets

a. gelatin solution c. liquid petrolatum
b. lycopodium powder d. lactose
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C 290. The theoretical weight of ten 10 tabs is 9.35 grams. Each tablet contains 425 mg of the active. Using this
data, determine the amount of additive needed to prepare 160,000 tablets.
a. 51.0 kg c. 81.6 kg
b. 102.5 kg d. 149.6 kg
D 291. Separation of a tablet into 2 or more distinct layers

a. mottling c. speculation
b. granulation d. lamination
C 292.Part of a tablet machine which controls the size and shape of the tablet is
a. punches c. die
b. hopper d. cam
C 293. Formulation methods of achieving sustained drug release include

a. use of coating c. all of these answers
b. microencapsulation d. embedding the drug in matrix
B 294. The method of tablet manufacture for easily compressible or adhesive ingredient is:
a. dry granulation c. slugging
b. direct compression d. wet method
B 295. One of the ff does not apply to uses of colloid mills

a. homogenize viscous emulsions c. produce finely divided solids
b. granulate d. reduce particle size of solids
A 296. One of the ff substances is not used as lubricant in tablet manufacture

a. starch c. Mg stearate
b. talc d. Ca Stearate
C 297. One of the ff is not an advantage of multi layered tablets

a. maybe coated tablet
b 2 incompatible drugs may be kept separated
c. accurate control of the delayed action part
d. each layer has a separate color for identity
D 298. The ability of the tablet to withstand abrasion in packaging, handling and shipping is evaluated by its:
a. content uniformity c. hardness
b. dissolution test d. friability
D 299. This is a common lubricant for tablets:

a. mannitol c. starch
b. acacia d. Mg stearate
D 300. Which of the ff is/ are used in tablet formulation to reduce friction during tablet compression?
(1) Calcium stearate

(2) Mg stearate
(3) Stearic acid
a. none of these answers c. 1 and 2

b. 1 and 3 d. 1, 2 and 3
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MANUFACTURING PHARMACY
1. A class of raw materials, which are to be subjected to tests and assays by the Quality Control
department, and are not yet to be use in the production of pharmaceuticals;
A. Approved for use materials C. Quarantined materials
B. Rejected materials
2. A standard document, which give instructions to the Production Department to produce a pharmaceutical
product for distribution/sale in the market;
A. Batch Production Record C. Master Formula
B. Finishing Order D. Manufacturing Order
3. A section of the warehouse which houses products which have been bottled, stripped or blister-packed,
but not yet labelled or packed into boxes/cartons. And are still awaiting the final disposition of the Quality
Control Department;
A. Finished Goods Section C. Returned Goods Section
B. In-Process Section D. Raw Materials Section
4. The Planning and Scheduling Division coordinates with this department on what products are required for
supply and market distribution, then plans and schedules the manufacture of the product;
A. Marketing C. Inventory Control
B. Purchasing D. Production Control
5. A method of filling liquids wherein the product is pumped, at constant pressure, through an orifice of
constant diameter and size. The fill amount is measured by the stroke of the piston;
A. Volumetric
B. C. Gravimetric
C. Constant level
6. An important parameter in the quality control of tablets, shown to be related to the tablet’s solubility
properties;
A. Tablet Thickness C. Filter cloth, non-woven
B. Tablet Disintegration D. All of the above
7. A special technique for poorly-soluble drugs, in which it is improved by the addition of a water-miscible
solvent, in which the drug will have increased water solubility;
A. Solubilization C. Complexation
B. Chemical modification D. Co-solvency
8. A class of preservative, which are often used for ophthalmic, nasal and parenteral products, but in oral
liquid preparations;
A. Mercurials C. Aldehydes
B. Quaternary ammonium compounds D. All of the above
9. A filter media composed of nylon, Teflon, PVC and silver. It is employed fo the micro-filtration of
parenteral solution;
A. Membrane Filter Media C. Filter cloth, non-woven
B. Filter cloth, woven D. All of the above
10. The following are the effects of Product Recalls to a drug-manufacturing firm;
A. Financial Loses C. Harmful and Bad Publicity
B. Mix-ups and Errors D. All of the above
11. Overages in the manufacture of pharmaceuticals are justified on the ff. conditions;
A. Clinical studies show that the average is therapeutically safe
B. The labile/unstable active cannot be possibly standardized
C. The overage allows for the equilibrium of the active within acceptable limits
D. All of the above
12. It refers to the addition of an active in an unstable pharmaceutical preparation, to compensate for the loss
during manufacture;
A. Chemical modification of the drug C. Manufacturing allowances
B. Manufacturing Overages D. All of the above
13. It refers to the rapid formation of emulsion droplets or aggregates due to the absence of a protective
barrier at the oil-water interface and the insufficient emulsifier surface overage;
A. Creaming C. Flocculation
B. Sedimentation D. Coalescence
14. For the pharmaceutical emulsions, the oil phase is restricted to this oil, unless otherwise, it is the specified
active of the product;
A. Olive oil C. Cottonseed oil
B. Corn oil D. Mineral oil
15. A class of finely divided solids that influence emulsification of polar solids by its tendency to be wetted by
water, and to be wetted by the oil phase of non-polar solids;
A. Eggyolk, cholesterol, gelatine C. TWEENS, SPANS, Carbowax
B. Bentonite, veegum, magnesium trisilicate D. All of the above
16. Examples of antioxidants incorporated into cosmetic type of emulsion;
A. Butylatedhydroxyanisole C. Butylatedhydroxytoluene
B. Tocopherol D. All of the above
17. An equipment thet mixes the components of emulsions by means of various impellers on shafts, which
are placed directly into the system to be emulsified;
A. Rotor stator C. Mechanical stirrers
B. Colloid mill D. ultrasonifiers
18. Raw materials of hydrocarbon nature, which are widely used in the manufacture of semi-solids, next to
water;
A. Petroleum jelly C. White wax
B. Mineral oil D. Paraffin
19. Raw materials which are widely used as humectants in semi-solids to prevent “crusting” in ointment and
creams contained in jars;
A. Glycerin C. Sorbitol, 70%
B. Propylene Glycol (low MW) D. All of the above
20. An absorption type of an ointment used for ophthalmic preparations;
A. Soft petroleum, sterile C. Lanolin, anhydrous
B. White wax D. Ozokerite
21. A method of manufacture of anhydrous ointments wherein the active/s are dissolved in the previously
melted mixtures of fats and waxes, at controlled temperatures;
A. Fusion method C. Levigation
B. Trituration/incorporation D. All of the above
22. A type of stability test, which involves temperatures in 10-degree increments. This test is performed to
identify the products of degradation of a product;
A. Real time stability test C. Stress test
B. Accelerated stability test D. All of the above
23. A method of preparation of suspensions, wherein finely divided powders are dispersed in an appropriate
liquid vehicle, with the aid of a surfactant, to ensure uniform wetting of hydrophobic surfaces;
A. Precipitation method C. Double decomposition
B. Dispersion method D. All of the above
24. The cause of capping, chipping and lamination of compressed tablets;
A. Wear and tear punches and die cavities
B. Difficulty in cleaning monograms which enclosed areas
C. Poor flow rate of granulations
D. Unequal lengths of the lower punches
25. In precipitation method of preparing suspensions, particle size control is important. For suspensions
intended for parenteral and inhalation us, the ideal particle size range is;
A. 1 micron and below C. 1 to 5 microns
B. 5 to 8 microns D. 8 to 10 microns
26. This equipment produces finely divided particles by spraying a mist of liquid through a heated chamber,
drying immediately and collecting the dried powders in a clean receptacle;
A. Micronization C. Freeze-drying
B. Homogenization D. Spray-drying
27. A parenteral route of administration in which an aqueous solution is preferred for optimum absorption. It
produces instantaneous pharmacological effect, since the drug is directly introduced into the bloodstream;
A. Intraspinal C. Intramuscular
B. Intravenous D. Subcutaneous
28. The potential sources of pyrogens in the manufacture of parenterals;
A. Contaminated water and solutes C. Contaminated equipments
B. Manufacturing methods D. All of the above
29. Air sampling techniques used for the environmental control test in the parenteral work area;
A. Collection of particulate matter, by drawing a sample through a clean sterile membrane filter
B. Collection of air sample into a measured volume of nutrient broth agar in an impinge
C. Drawing measured volume of air through a slit sampler
D. All of the above
30. An equipment, which allows for the draft-free flow of air cover over the parenteral work area, by providing
a total sweep of the confined area;
A. HEPA filter C. Membrane filter media
B. Laminar flow enclosure D. All of the above
31. When filling sterile powders into vials, the filling equipment employs a/an____in the sem of the funnel at
the bottom of the hopper. It regulates the volume of granular material into the vial to avoid clogging;
A. Indexing stars C. Filling wheel
B. Augers D. both B and C
32. Process/es that give/s rubber closure less friction, to enable easier mechanical insertion onto vials;
A. Halogenization C. Carbonization
B. Siliconization D. Both A and B
33. A more effective method of sterilization. Killing microorganisms through coagulation of its cell protein. It
also destroys vegetative forms of bacteria and spores at 121 C for 20 minutes at 20 psi;
A. Dry heat method C. Fractional method
B. Moist heat method D. Gas sterilization method
34. A non- thermal form of sterilization, which is used in the reduction of air-borne microbes, roduced by
mercury vapour lamps. This method has poor penetration capability;
A. Ultraviolet radiation C. Inspissation
B. Ionization method D. Tyndallization
35. An in-vitro method of pyrogen test based on the gelling or color development of pyrogenic preparation in
the presence of lysate on the amoebecytes of the horseshoe crab;
A. Qualitative fever response in rabbits C. Qualitative fever response in mice
B. Limulus method D. All of the above
36. Most biological are store at this temperature;
A. 2 – 8 °F C. 2 – 8 °C
B. 12 – 8 °F D. 12 – 8 °C
37. Parenteral products, which should be packed as single-dose medication;
A. Intraspinal C. Epidural
B. Intracisternal D. All of the above
38. Examples of primary packaging components;
A. Rubber stoppers C. Blister/strip packs
B. Cotton fillers D. Both A and B
39. A mechanism involved in the preparation of sustained release tablets, wherein the drug material is
applied with relatively thin coating material, ranging from several tenths of micron to 5000 microns in size;
A. Use of ion-exchange resins
B. Embedding the drug in a slowly eroding matrix
C. Embedding the drug in a plastic matrix, from which it is leached
D. Microencapsulation
40. A part of tablet press, which distributes the granulation material into the die cavities;
A. Hopper C. Upper and lower punches
B. Feed shoe/frame D. Auger
41. An ideal property of tablet granulations in which the material forms a stable, compact mass when
pressure is applied;
A. Compressibility C. Flow rate
B. Fluidity D. All of the above
42. The preferred bulking agent for chewable tablets, which provides an excellent mouth-feel, due to its
pleasant, cooling effect;
A. Sucrose C. Mannitol
B. Microcrystalline cellulose D. Lactose
43. This raw material can be used as a tablet diluents, disintegrant and binder;
A. Avicel C. Celutab
B. Lactose D. Cornstarch
44. The ff. statements are true for glidants/lubricants in tablet granulation;
A. Oppose the efficiency of the binder and the physical forces that act under compression
B. Cause the adhesion of powder to form granules
C. Causes a compressed tablet to break apart when placed in an aqueous medium
D. Reduce interparticulate friction, thereby improving the rate of flow of granulation
45. Carbowax 400, leucine, talc and colloidal silicon dioxide are employed as____.
A. Diluents C. Granulating agent
B. Lubricant D. Disintegrant
46. A method of preparation of tablets whose components are sensitive to moisture and elevated
temperatures, during drying, yet possess inherent cohesive properties;
A. Dry granulation method C. Pre-compression method
B. Direct compression D. All of the above
47. A method of preparing tablet granulations, wherein the powders are de-aerated and passes between two
rollers, forming a thin cake, which is screened to form granules;
A. Use of chilsonator C. Spheronization
B. Slugging D. Pelletization
48. An equipment, which alternatelycombine and draw apart the tablet material, as this equipment revolves.
Ideal for precise blending of dry-to-dry or dry-to-liquid materials, with short processing times;
A. Twin or V Shell Blender C. Conical Blender
B. Planetary Blade Mixer D. Horizontal Ribbon Mixer
49. An equipment, which delivers a reliable and uniformly mixed dried product, without the necessity for pre-
mixing. It produces a dry granulation from a wet powder mix;
A. Tray Dry Oven C. Granulator/Fluid Bed Dryer
B. Tablet Deduster D. All of the above
50. The critical operation in sugar coating process of tablets leading to a 50% to 100% increase in tablet
weight. This is the basis of an elegant tablet profile;
A. Sealing C. Subcoating
B. Smoothing D. Color coating
51. An enteric film-former material, which is not soluble in a slightly acid pH media;
A. Shellac flakes C. Cellulose acetate phthalate
B. Povidone D. Carboxymethylcellulose
52. It refers to the separation of the concentrated emulsified droplets from the discontinuous phase;
A. Flocculation C. Creaming
B. Coalescence D. Sedimentation
53. A type of gelatine blend, which contributes to plasticity and clarity to the blend, thus reducing haze or
cloudiness of the finished capsules;
A. Calf skin gelatine C. Pork skin gelatin
B. Calf bone gelatine D. Hydroxypropylmethylcellulose
54. The most common method of manufacture of hard gelatine capsules that uses completely automatic
machine, consisting of mechanisms for dipping, spinning, drying, stripping and joining the capsules;
A. Plate process C. Rotary Die method
B. Pin method D. Reciprocating Die method
55. The temperature at which empty hard gelatine capsules should be stored;
A. 100 °F C. 100 °C
B. 70 °C D. 70 °F
56. Aside from the property of fluidity, tablet granulations should also possess;
A. Flowability C. Solubility
B. Cohesiveness D. Compressibility
57. Pharmaceutical suspensions are evaluated by;
A. Particle size measurement C. Sedimentation volume
B. Viscosity D. Colloidal power
58. The coalescence of globules in an oil-in-water emulsion is an indication of;
A. Cracking C. Creaming
B. Flocculation D. Phase intervention
59. An adjunct used to prevent topical preparations from drying out of forming a “cruct” of the surface;
A. Sweetening agent C. Emollient
B. Preservative D. Humectant
60. Anteroom, which separates the sterile areas from non-sterile areas;
A. Laminar Flow enclosure C. Air curtain
B. Air lock D. HEPA filter
61. CGMP means;
A. Current Good Manufacturing Practice C. Current General Manufacturing Practice
B. Current General Manufacturing Program D. Current Good Manufacturing Program
62. Suppositories are made by;
A. Fusion or melt molding C. Cold compression
B. Rolling or hand-shaping D. Any of the above
63. USP requires that Dissolution Test should be carried out at;
A. 36.5 to 37.5 C C. 25 – 30 C
B. 39 C D. Any of the above
64. LAL stands for;
A. Limulus Antibiotic Lysate C. Limulus Amoebocyte Lysate
B. Lyophilized Antibiotic Lysate D. Lyophilized Amoebocyte Lysate
65. In real Time stability studies, the climatic conditions of the Philippines is classified as;
A. Mediterranean C. Hot and Dry
B. Temperate D. Hot and Humid
66. Long term stability studies, is also known as;
A. Accelerated stability studies C. Stress Tests
B. Real Time stability studies D. Validity studies
67. Directly Compressible grades of Lactose include;
A. Spray-Dried Lactose C. Anhydrous Lactose
B. Dehydrated Lactose D. All of the above
68. Sterilization technique. Which makes use of ethylene oxide-beta propiolactone or propylene oxide,
usually for plastic containers;
A. Steam sterilization C. Gas sterilization
B. Dry heat sterilization D. Surface Disinfection
69. Diluents of choice or chewable tablets;
A. Mannitol C. Lactose
B. Sorbitol D. Dextrose
70. Strip-sealed tablets are evaluated for;
A. Clarity C. Hardness
B. Thickness D. Leakers
71. An equipment associated with the maintenance of dust-free;
A. Laminar Flow Hood C. Ultra Violet Lamp
B. Autoclave D. Magnetic Resonance
72. Binder of choice for moisture-sensitive materials;
A. Ethylcellulose C. Gelatin solution
B. Starch paste D. Glucose solution
73. An adjunct necessity for oral liquids to prevent bacterial contamination;
A. Antioxidants C. Preservatives
B. pH stabilizers D. Buffers
74. “Rule of Thumb” is the principle applied for testing;
A. Ampules C. Vials
B. Implantations D. Compressed Tablets
75. Thermolabile products in solution is sterilized by;
A. Membrane filtration C. Autoclaving
B. Gas sterilization D. Gamma radition
76. A tablet formulation contains 2 actives, which are chemically incompatible. The best method to be used
is;
A. Dry granulation C. Wet granulation
B. Slugging D. Multiple-Layered compression
77. Freeze-drying is also known as;
A. Dessication C. Evaporation
B. Exsiccation D. Lyophilization
78. According to the USP, single dose containers of parenterals are limited to fill volume of;
A. 1000 ml C. 250 ml
B. 500 ml D. 1500 ml
79. For rapid disintegration of compressed tablets, the concentration starch to used is;
A. 1 to 5% C. 10 to 20%
B. 10 to 15% D. 20 to 25%
80. In the preparation of effervescent tablets, the component/s necessary for the effervescent effect is/are;
A. Sodium bicarbonate C. Tartaric acid
B. Citric acid D. All of the above
81. Manufacturing tanks of oral liquids are usually constructed of;
A. Glass C. Galvanized Iron
B. Aluminium D. Stainless Steel
82. Eggyolk, an emulsifier belongs to;
A. Synthetic group C. Finely Divided solid group
B. Natural group D. Non-ionic group
83. Uneven distribution of color on the surface of compressed tablets is called;
A. Peeling C. Mottling
B. Capping D. Lamination
84. Parenteral solutions intended to be freeze-dried should be;
A. Alcoholic C. Oleaginous
B. Aqueous D. Any of the above
85. A common lubricant added to tablet granulation;
A. Starch C. Magnesium stearate
B. Mannitol D. Acacia
86. Limulus amoebocyte lysate is obtained from;
A. Rabbits C. Albino mice
B. King crab D. Microorganism
87. A broad-spectrum preservative effective against bacteria and molds;
A. Parabens C. Sodium benzoate
B. Alcohol D. Glycerin
88. Inconsistent thickness of tablets could result to problems regarding;
A. Packaging C. Disintegration
B. Dissolution D. Hardness
89. Stoke’s Monsanto tester is used to measure___of tablets;
A. Friability C. Disintegration
B. Thickness D. Hardness
90. In the manufacture of emulsified semi-solids, the mixing of the oil aqueous phases should be at this
temperature to avoid breaking;
A. 30 to 40 °C C. 80 °C
B. 70 to 72 °C D. 40 to 43 °C
91. The bioavailabilty of a compressed tablet is dependent upon its;
A. Weight variation C. Content unifomity
B. Disintegration time D. Dissolution
92. An inert gas usually incorporated in filling ampoules;
A. Hydrogen C. Nitrogen
B. Oxygen D. Ethylene oxide
93. The normal moisture content of hard gelatine capsules;
A. 2 to 5% C. 20 to 24%
B. 12 to 16% D. 25 to 30%
94. This statement is tru of the FIFO Policy;
A. Contains information regarding the activity of the component
B. Prevents contamination and mix-ups
C. Assure that the oldest stock of material is used first
D. All of the above
95. Which of these is the adverse effect of a product recall?
A. A function of biological testing in a laboratory
B. Should be filed by a dissatisfied customer
C. Inflicts damage on the reputation and good standing of the company
96. Which of the ff. Is the function of Research and Product Development Department?
A. Pilot Batch production C. Manufacture and packaging
B. In-process quality testing D. Clinical testing
97. Pyrogens contaminating glasswares can be destroyed at this setting;
A. 121 C for 20 minutes C. 200 C for 1 minute
B. 180 C for 1 hour D. 650 C for 1 minute
98. Water soluble bases for medicated application are prepared from;
A. Polyethylene glycol C. Petroleum jelly
B. Sorbitol D. Mineral oil
99. A solid dosage form, which does not need to conform to USP disintegration time;
A. Film-coated tablets C. Enteric-coated tablets
B. Sugar-coated tablets D. Chewable tablets
100. An instrument used to check the tightness of the caps/closure;
A. pH meter C. Crimper
B. Torque tester D. Implinger
101. A type of compressed tablet which produce equilibrium blood levels of the drug without the need for
repeated administration of dosage units;
A. Chewable tablet C. Sublingual tablet
B. Sustained-release tablet D. Lozenges
102. The most widely used method of tablet granulation preparation, due to the greater probability that the
granulation will meet all the physical requirements for the compression of good tablets;
A. Wet Granulation method C. Dry Granulation method
B. Slugging D. Direct compression
103. A tablet hardness tester containing a compressible spring held between two plungers. The lower plunger
is in contact with the tablet, while the upper plunger is forced against the spring by a threaded bolt and
the breaking force is transmitted against a tablet;
A. Pfizer C. Strong-Cobb
B. Stokes-Monsanto D. Eureka
104. An equipments used to produce fine emulsion droplets, by first compressing the liquid with a high
pressure and then allowing the liquid to escape radically past a flat disc, held by strong spring
mechanism;
A. Rotor-Stator C. Ultrasonifier
B. Mechanical Stirrer D. Homogenizer
105. A unit operation in which a mixture of liquids and solids,slurry or feed is forced through a porous medium,
in which the solids form a cake on the surface and the clear liquid is collected;
A. Decantation C. Filtration
B. Extraction D. Separation
106. High resistant borosilicate glass is also referred to as;
A. Type NP C. Type II
B. Type III D. Type I
107. Parenteral adjuvant which contribute to the isotonicity of the product, as well as reduce the pain of
injection in areas with sensitive nerve ending;
A. Antioxidants C. Buffers
B. Tonicity contributors D. pH stabilizers
108. The USP states that this adjuvant must be added to parenteral preparation contained in multiple dose
containers;
A. Antimicrobial agents C. Antioxidants
B. Coloring agents D. Buffers
109. A glass type, which is treated with sulphur dioxide and is suitable for buffered parenteral solutions, has a
pH of below 7, and is not reactive with glass;
A. Type 1 C. Type 3
B. Type 2 D. NP
110. The officially recognized filter media for parenteral solutions, since it provides the best flow rate. It also
retains microorganisms on the surface of the filter;
A. Asbestos Pad C. Unglazed porcelain candles
B. Diatomaceous earth candles D. Cellulose Ester Membrane
111. A method wherein ampoules are sealed by heating the neck of the ampoules, below the tip, leaving just
enough of the tip from grasping with forceps or other mechanical device;
A. Pull seal Method C. Tip seal method
B. Grasp seal method D. Both A and C
112. A finishing procedure for gelatine capsules wherein the bulf-filled capsules are rubbed with an oil-
impregnated cloth. It imparts gloss to the capsules as it removes resistant materials;
A. Pan polishing C. Salt polishing
B. Brushing D. Cloth dusting
113. A system for ensuring that products are consistently produced and controlled according to quality
standards. It is designed to minimize the risks of errors involved in any pharmaceutical production, which
cannot be eliminated through the final testing of the products;
A. First in-First out Policy C. Current Good Manufacturing Practice
B. Quality Control D. Safety First Policy
114. An ointment base prepared from mixtures of high and low molecular weight polyethylene glycol. It is
greaseless by nature and no additional water is required in its preparation;
A. Water-Removable base C. Hydrocarbon base
B. Water-soluble base D. Absorbable base
115. An ointment base, which act as occlusive dressings. Producing a warm sensation and insensible
perspiration is inhibited;
A. Lanolin C. White petroleum
B. Polyethylene glycol D. Cold cream
116. A tablet compressing machine, which contains a head that carries a number of sets of dies and
upper/lower punches, which revolve continuously;
A. Single punch machine C. High Speed Rotary tablet machine
B. Multi layer tablet machine D. Multi Station Rotary tablet machine
117. Substances of varying densities, which make up the major portionof the tablet, making the compression
cycle possible;
A. Disintegrants C. Glidants
B. Bulking agents D. Granulating agents
118. A tablet processing problem characterized by the separation of the tablet into several distinct layers;
A. Lamination C. Capping
B. Chipping D. Mottling
119. The most commonly used class of aerosol propellant which is composed of butane, iso-butane and
propane gasses. It has excellent solvent powers;
A. Hydrocarbon propellants C. Hydrofluroalkanes
B. Chlorofluorocarbons D. Compressed Gas propellants
120. A class of aerosol propellants, which require the use of a non-volatile co solvent. It produces only coarse
droplets and is applicable only to surface and topical sprays;
A. Hydrofluroalkanes C. Hydrocarbon propellants
B. Compressed Gas propellants D. Chlorofluorocarbons
121. It is a Zwitterionic type of an aerosol propellants;
A. Oleic acid C. Cetyl pyridinium chloride
B. Phosphatidylcholine D. Sorbitan trioleate
122. An aerosol container material, which is lightweight and seamless. And is mostly used for inhalation and
topical aerosols;
A. Three-piece tin plate C. Plastic coated glass
B. Plastic D. Plastic
123. An aerosol container material, which can be pressurized from the base with compressd gasses. Visible
seams make this container visually less appealing;
A. Aluminium glass C. Plastic coated glass
B. Three-piece tin plate D. Plastic
124. A special technique for hard gelatine capsules which provides a tamper-proof feature to filled capsules, to
prevent its unjoining;
A. Imprinting C. Sealing/Banding
B. Locking D. Special purpose
125. A finishing method for hard gelatine capsules, wherein a polyurethane or cheese cloth material lines the
polishing pan. The liner is used to trap removed dust, imparting gloss to capsules;
A. Salt polishing C. Brushing
B. Pan polishing D. Cloth dusting
126. It measures the time it takes for a tablet to reach a state wherein any tablet residue remains on the
screen, resulting to a mass with no palpably visible core;
A. Dissolution test C. Content Uniformity
B. Disintegration test D. Abrasion test
127. It determines the homogeneity of distribution of the active/s in the batch of finish tablets;
A. Content uniformity C. Stability test
B. Weight variation D. Quantitative assay
128. Tablet adjuvants with cohesive properties, capable of gluing powders together, causing the formation of
granules;
A. Binder C. Disintegrant
B. Diluents D. Lubricant
129. A part of tablet compressing machine which control the sizes and shapes of the finished tablets;
A. Hopper C. Auger
B. Feed shoe D. Die cavities
130. The reverse of creaming, wherein less concentrated emulsified droplets separate from the internal phase;
A. Coalescence C. Sedimentation
B. Creaming D. Flocculation
131. A biological product obtained from poisonous bacterial products that act as antigens and causes the
human body to produce specific antibodies to combat its presence;
A. Toxins C. Toxoids
B. Antitoxins D. Vaccines
132. Fever-producing organic substances arising from microbial contamination and mostly occur in patients
following intravenous injection;
A. Microorganisms C. Foreign bodies
B. Pyrogens D. Antigens
133. Impalpable powders have a particle size of less than;
A. 74 microns C. Less than 1 microns
B. 1 microns D. 50 microns
135. Non-ionic surfactants composed of higher molecular weight PEG compound are referred to as;
A. Tweens C. Spans
B. Carbowax D. All of the above
136. A suspension that appear as masses of gels, consisting of floccules of small distinct particles;
A. Lotions C. Mixtures
B. Magmas and Milk D. Gels
137. A filter aid which forms a fine surface deposit to screen out all solid, preventing the clogging of the
supporting filter media;
A. Infusorial earth C. Membrane filter
B. Kraft paper D. Nylon
138. A filter aid which is used for straining syrupy liquids, and is unaffected by molds and fungus;
A. Bonded fabrics C. Nylon
B. Talc D. Activated charcoal
139. It refers to the binding of drug molecules to the polymer material of the plastic container;
A. Sorption C. Adsorption
B. Absorption D. Leaching
140. Type III glass is referred to as;
A. General purpose soda lime glass C. Treated soda lime glass
B. Soda lime glass D. Borosilicate glass
141. It refers to any distinctive combination of letters and/or numbers or both, by which the complete history of
the manufacture, control, packaging and distribution of a batch or lot of drug is determined;
A. Drug Registration Number C. Manufacturing Order Number
B. Lot number D. Finishing Order Number
142. Any substance of a drug, which is intended to furnish pharmacological activity or other effect in the
diagnosis, cure, mitigation, treatment or prevention of a disease or to affect any structure of function of
the body;
A. Inactive ingredient C. Active ingredient
B. Drug excipient D. Drug adjuvant
143. It refers to the release or movement of the components of the plastic container into the contents;
A. Sorption C. Adsorption
B. Absorption D. Leaching
144. A section of the plant department consist of products which have been stripped, bottled or packed, but not
yet labelled nor packed into boxes and cartons. As it waits the results of quality control test and assays;
A. Finished Good Section C. Raw Materials Section
B. In-Process Section D. Returned Goods Section
145. The most useful preservatives in the manufacture of oral liquids, because of its neutral pH and it possess
both antifungal and antibacterial properties;
A. Parabens C. Sodium benzoate
B. Cetyl Pyridinium Chloride D. Ethyl alcohol
146. A method of filling viscous liquid preparations in a very large containers;
A. Volumetric C. Gravimetric
B. Constant Level D. All of the above
147. A class of suspensions which contain finely powdered substances that are insoluble in the dispersion
medium, are intended for external applications;
A. Lotions C. Creams
B. Ointments D. Gels
148. Which of the following statements is true for protective colloids?
A. Protective colloids do not form a mechanical sheath around each particle of suspensions
B. Protective colloids differ in viscosity and are used in lower concentrations to produce an increase in
the viscosity of suspensions
C. Protective colloids do not reduce interfacial tension
D. All of the above
149. A method of particle size reduction in suspensions, wherein the particles are subjected in a turbulent air
chamber, thus colloiding with each other to fracture and produce particles with sizes 5 microns and
below;
A. Micronization C. Spray-drying
B. Freeze-drying D. Homogenization
150. It is the reverse of creaming, wherein less concentrated emulsified droplets separates from the internal
phase. It usually settles at the bottom of the external phase of the container;
A. Coalescence C. Sedimentation
B. Flocculation D. Separation
151. Which of the following is/are official sources of Starch USP?
I. Zea mays
II. Triticum aestivum
III. Manihot esculenta
A. I only
B. I and II
C. III only
D. I and III
E. I, II and III
152. Which of the following is/are uses of starch in pharmaceutical formulation?
I. Lubricant
II. Diluent
III. Disintegrant
A. I only
B. III only
C. I and II
D. I and III
E. I, II and III
153. What is the allowable limit of silicon dioxide in gelatin?
A. 2%
B. 1%
C. 0.5%
D. 0.25%
E. 0.15%
154. What is a pharmaceutical glaze?
A. Denatured alcoholic solution of PVP
B. Denatured alcoholic solution of Shellac
C. Hydroalcoholic solution of NaCMC
D. Hydroalcoholic solution of starch
E. Aqueous solution of glucose
155. Which of the following can be considered as use/s of Directly Compressible Strach?
I. Binder
II. Diluents
III. Disintegrant
A. I only
B. I and II
C. II only
D. I and III
E. I, II and III
156. Which of the following is obtained by incomplete partial hydrolysis of starch and consists mainly of
dextrin, maltose and water?
I. Binder
II. Diluents
III. Disintegrant
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
157. Lactose is relatively inexpensive tablet bulking agent. Which of the following types of drug or excipients
is/are incompatible with lactose?
I. Amine drugs
II. Water-based binding solutions
III. Alcohol-based binding solutions
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
158. Maillard Reactions is a documented incompatibility of certain excipients with acetates, phosphates and
lactates. Which of the following excipients can manifest such reaction?
I. Anhydrous lactose
II. Pregelatinized starch
III. Spray-dried lactose
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
159. Moisture content of excipients and active drug can affect the properties and production of compressed
tablet. Which of the following excipients has the smallest moisture content?
A. Dicalcium phosphate
B. Monocalcium phosphate
C. Sorbitol
D. Mannitol
E. Sucrose
160. Sodium starch glycollate and croscarmelose are primarily used in tablet formulation as;
A. Lubricants
B. Disintegrants
C. Diluents
D. Binders
E. Glidants
161. Which of the following excipients is expected to possess the greatest adhesive property?
A. Acacia C. Starch E. Simple syrup
B. Gelatine D. Glucose
162. Which of the following excipients can be used for direct compression?
I. Pregelatinized starch
II. Anhydrous lactose
III. Mannitol
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
163. Which of the following is/are sucrose based tablet diluents-binder?
I. Nutab
II. Avicel
III. Cab-o-sil
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
164. What is the concentration of Starch in Starch paste used as a binder solution?
A. 0.5 – 1%
B. 1 – 5%
C. 5 – 10%
D. 10 – 15%
E. 15 – 25%
165. Which of the following principled is/are employed in the use of lubricants in tablet formulation?
I. Higher concentrations of lubricants are employed when active drugs and other excipients use
have bigger particle sizes
II. Lubricants are added together with the rest of the excipients in the initial steps in production
III. Lubricants generally increase the disintegration time and reduce dissolution rate
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
166. Double compression method of tablet manufacture is the preferred method in which of the following
conditions?
I. When the initial powder blend has a significant quantity of fine powders
II. When the active ingredients are sensitive to moisture or elevated temperature
III. When the active ingredients and the excipients are free-flowing
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
167. Which of the following mechanisms explain the use of glidants in tablet formulations?
A. Reduce interparticulate tension leading to improved flow of particles
B. Surface active agents that reduce friction between the inner die walls and the tablet
C. Reduce sticking of particles to the wall of the die and the contact surface of the punches
D. By capillary action, improve uptake of water into the interior of the tablet
E. Increase interparticulate attraction achieved during the process of
168. Which of the following precautions are observed during addition of tablet lubricants in formulations
I. Add lubricants rprior to wetting of powder blends or slugging, as applicable
II. Add lubricants at concentrations consisiting of about 20-25% of final tablet weight
III. Mix lubricants with the rest of the granules for about 2-5 minutes only
A. I only
B. I and II only
C. III only
D. I and III
E. I, II, III
169. Sterotex, Magnseium stearate, and the high melting point waxes can be categorized as
I. Water-soluble lubricants
II. Glidants
III. Water-insoluble lubricants
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
170. Talc in tablet formulations is generally used as
I. Glidant
II. Lubricant
III. Anti-adherent
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
171. An internal disintegrant is used in which of the following methods of manufacture?
I. Wet granulation
II. Dry granulation
III. Direct compression
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
172. What is a “Running powder”?
A. Powder blend with improved lubrication
B. Combination of a disintegrant and a lubricant
C. Combination of a disintegrant and binder
D. Powder combination to improve flow
E. Combination of a glidant and a binder
173. What are referred to “lakes” in pharmaceutical manufacturing?
A. Binder solutions
B. Wetted powder blends in wet granulation
C. Magmas and suspensions
D. Flavours in hydroalcoholic mixtures
E. Dyes absorbed on aluminium hydroxide
174. Flavours for pharmaceutical oral liquids or chewable tablets are chosen based on the baseline taste of
the active ingredient. Which of the following flavours are recommended for drugs with a sour baseline
taste?
I. Cherry
II. Citrus
III. Strawberry
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
175. Which of the following is/are disadvantage of wet granulation method of tablet manufacture?
I. Good color distribution
II. Uniform composition of granules during processing, transport and handling
III. Useful for heat-sensitive materials
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
176. A method of tablet production wherein a granulation solution is sprayed onto the suspended particles
which would then be dried rapidly in the suspending air
A. Wet granulation
B. Fluid bed granulation
C. Dry granulation
D. Direct compression
E. Double compression
177. This granulation process involves the direct formation of granules from a wet granulation using a machine
where initially extruded rod-shaped cylindrical particles with size range of 0.5-12mm are passed through
appropriate an extruder screen. The extruded segments are then shaped into idealized granules by
centrifugal and frictional forces.
A. Spray-drying
B. Spray congealing
C. Precompression
D. Spheronization
E. Fluid granulation
178. Which of the following sequence in tablet manufacture correctly illustrates wet granulation method of
manufacturing tablets?
A. Initial dry mixing → Wet mixing → Wet screening → Drying → Dry screening → Final dry mixing →
Compression
B. Initial dry mixing → Wet mixing → Wet screening → Drying → Final dry mixing → Compression
C. Initial dry mixing → Wet mixing → Wet screening → Drying → Slugging → Granulation → Final dry
mixing → Compression
D. Initial dry mixing → Wet mixing → Wet screening → Drying → Dry screening → Final dry mixing →
Compression
E. Initial dry mixing → Wet mixing → Drying → Dry screening → Final dry mixing → Compression
179. Which of the following diluents is/are appropriate choices when producing tablets that are dissolved in
solution prior to oral administration?
I. Mannitol
II. Lactose
III. Microcrystalline cellulose
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
180. Consider the following formulation:
Ingredients Amount/Tablet
Aluminium OH & Carbonate CO-dried gel 325.0 mg
Mannitol USP Granular 675.0 mg
Microcrystalline cellulose 75.0 mg
Starch 30.0 mg
Calcium Stearate 22.0 mg
Flavor qs
This tablet formulation is most likely manufactured by what method?
A. Wet granulation C. Direct compression
B. Fluid bed granulation D. Dry granulation
181. A tablet formulation contains the following: aspirin, sodium carbonate, fumaric acid and citric acid. What
is/are the use/s of sodium carbonate, fumaric acid, and citric acid in the formulation?
I. Diluents
II. Binder
III. Disintegrant
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
182. Capping and splitting of tablets can be caused by which of the following conditions?
I. When there is an excessive quantity of water in the formulation
II. When there is an excessive quantity of fines or powder
III. When the dies are worn and the punches are imperfect
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
183. When the capping and splitting are encountered during tablet compression, which of the following may be
employed as remedy/remedies?
I. Slowing the rate of tablet compression
II. Use of tapered dies
III. Increasing the quantity of fines or powder
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
184. Which statement is/are correct regarding film tablet coating?
I. The Wurster spray coating method provides uniform coating coverage while preventing adjacent
tablets from adhering together
II. Cellulose acetate phthalate, hydroxypropylmethyl cellulose, and PVP are pH dependent enteric
coats
III. Nonaqueous film coating solutions consist of a film former, an alloying substance, opaquants,
colorants, a glossant and a volatile solvent
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
185. What is the correct order of the steps involved in Sugar-coating?
A. (1) Subcoating, (2) Waterproofing and Sealing, (3) Smoothing and Final rounding, (4) Finish and
coloring coats, (5) Imprinting, and (6) Polishing
B. (1) Subcoating, (2) Smoothing and Sealing, (3) Final rounding, (4) Finish and Coloring coats, (5)
Polishing, and (6) Imprinting
C. (1) Waterproofing and Sealing, (2) Subcoating, (3) Smoothing and Final rounding, (4) Finish and
Coloring coats, (5) Imprinting, and (6) Polishing
D. (1) Waterproofing and Sealing, (2) Smoothing and Sealing, (3) Subcoating, (4) Polishing, (5) Finish
and coloring coats, and (6) Imprinting
186. Uneven distribution of color in tablet coating is due to
A. Bridging C. Orange Peel Affect
B. Erosion D. Mottling
187. What problem in film coating arises when the fluid delivery rate exceeds the drying capacity of the
process?
A. Bridging C. Picking E. Mottling
B. Erosion D. Orange Peel Affect
188. An assay of the active ingredient revealed a concentration of 98.5% nitrofurantoin raw material. The USP
monograph specifies limit of 90-110%. What is the maximum amount of nitrofurantoin raw material to be
used in preparing a 34.2 kilo batch size to accommodate a 5% production overage if a 342 mg tablet
contains 100 mg of the drug?
A. 11.675 kilos C. 11.168 kilos E. 10.000 kilos
B. 11.500 kilos D. 11.000 kilos
189. In sugar coating of tablets, the greatest increase in the size of the tablet occurs at what stage of the
process?
A. Sealing C. Color coating E. Polishing
B. Smoothing D. Subcoating
190. Which of the following materials is/are suitable for producing sustained-release film coating?
I. Acrylic resins
II. Cellulose elastomers
III. Silicone elastomers
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
191. Which of the following mechanisms can explain the effects of controlled drug delivery system?
I. Achievement of sustained drug action at a predetermined rate
II. Spatial placement of a controlled release system adjacent t or in the diseased tissue or organ to
achieve a systemic drug action
III. Rate and amount of drug release being determined by the physiologic and therapeutic need of
the patient
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
192. It is defined as the load in grams required to push a standard a set distance into a prepared gelatine gel
(6.66% solution at 10 degree Celsius)
A. Bloom strength C. Viscosity E. Recovery rate
B. Tensile strength D. Compressibility index
193. Which of the following is the source of gelatine?
A. Carageenan C. Starch E. Glucose
B. Galageenan D. Collagen
194. Given the following formulation:
Nitrofurantoin 100 mg
Lactose 152 mg
PVP 15 mg
Microcrystalline cellulose I 15 mg
Syloid 2 mg
Sterotex 1 mg
Which of the given ingredients is the disintegrant?
A. Nitrofurantoin C. PVP E. Syloid
B. Lactose D. Microcrystalline cellulose
195. Given the following formulation:
Nitrofurantoin 100 mg
Lactose 152 mg
PVP 15 mg
Microcrystalline cellulose I 15 mg
Syloid 2 mg
Sterotex 1 mg
Which of the given ingredients is the binder?
A. Nitrofurantoin C. PVP E. Syloid
B. Lactose D. Microcrystalline cellulose
196. Plasticizers are useful in which of the following?
I. Film coating
II. Manufacture of soft-gel capsules
III. Manufactured of hard-gelatin capsules
A. I only
B. I and II
C. III only
D. I and III
E. I, II, III
197. What is the amount of moisture present in soft gelatine capsules?
A. 1-5% C. 10-15% E. 12-20%
B. 6-10% D. 15-18%
198. What is the maximum particle size that can be found in True solutions
A. 10 um C. 1 um E. 1 millimicrometer
B. 5 um D. 0.1 um
199. Protective colloids classified as clays include which of the following:
A. Casein C. Gum E. Attapulgite
B. Acacia D. CMC
200. Ionamin capsules which contain Phentermine utilize which of the following controlled release systems?
A. Osmotic system C. Prodrugs E. Dissolution system
B. Ion exchange D. Diffusion system
201. A batch or any portion of a batch of drug produced by a continuous process is:
A. Lot C. Inert substances E. Product
B. Component D. Active ingredient
202. The records to be controlled by Quality Control should be:
A. Master formula C. Returned goods E. In-process records
B. Inventory records D. Production records
203. A semisolid vehicle recognized by the USP/NF is:
A. Glycerogelatin base C. Alcohol soluble fats E. Fats and oils
B. Water-soluble base D. Non-absorption base
204. Fever producing substances arising from microbial contamination are:
A. Bacteria C. Pyrogens E. Coliform organisms
B. Fungi D. Yeast
205. Classified as sterile product although not injected into the body is:
A. Ophthalmic preparation C. Ointment E. Dextrose injection solution
B. Biological product D. Gargle
206. Sealing of ampoules is done by:
A. Heating the neck of the ampoules
B. Pull sealing
C. Pressing the ampoule tip
D. Gas sealing
E. Alcohol-flame seal
207. A tablet processing problem where a partial or complete separation of the top or bottom of the table is
termed:
A. Elimination C. Picking E. Breaking
B. Capping D. Sticking
208. To control microorganisms in the air is to:
A. Install UV lamps in several areas
B. Install IR lamps in the areas
C. Provide ETO gas around the room
D. Close the door tightly
E. Spray insecticide inside the room
209. Products which have been bottled or stripped-packed but not yer labelled or packed into boxes or
barbons are termed:
A. Finished products
B. Releasable for sale
C. In-process
D. Rejected products
E. For processing
210. Advantage of plastic containers over glass is:
A. Permeability
B. Susceptible to microorganisms growth
C. High transportation cost
D. Lightness in weight
E. Light can penetrate easily
211. Egg yolk is an example of an emulsifier belonging to:
A. Non-ionic type C. Synthetic group E. Natural group
B. Finely divided liquid D. Ionic type
212. Lyophilized products are manufacture by series of processes as:
A. Freezing C. Cooking E. Mixing
B. Melting D. Compression
213. A HEPA filter is used to filter air entering a:
A. Gas chamber C. Fume hood E. Clean room
B. Laminar flow hood D. Sterile room
214. The size of a single-dose container for injection is limited to:
A. 30 ml C. 1000 ml E. 60 ml
B. 50 ml D. 20 ml
215. An indicator employed in sterilization process is:
A. Methyl red TS C. Phenolphthalein TS E. Colored paper strips
B. Litmus paper D. Colored cloth
216. Coating of tablets that allow disintegration in the intestines is:
A. Sugar C. Film E. Gelatine
B. Enteric D. Chocolate
217. To protect the contents of a bottle from the action of light id to use:
A. Flint glass C. Colorless glass E. Plastic coated glass
B. Green colored glass D. Amber colored glass
218. A lyophobic substance is easily wet by:
A. Polar solvents C. Non-polar solvents E. Alcohol-water mixture
B. Water D. Hydroalcohol
219. In tablet compression, the large, poorly formed, compacted mass of powder is referred to as:
A. Slugs C. Vaginal tablets E. Lozenges
B. Buccal tablets D. Compressed tablets
220. Content uniformity test for tablets, USP/NF limit is:
A. 90-110% C. 90-100% E. 85-115%
B. 95-105% D. 85-105%
221. The best choice of disintegrant by the formulators is:
A. Lactose C. Stearic acid E. Sucrose
B. Starch D. Talc
222. The dispensing division of the warehouse requires a:
A. Licensed chemist C. Licensed pharmacist E. Male engineer
B. Experienced scientist D. Any skilled technician
223. Room temperature recognized by USP/NF is:
A. 20 °C C. Temp. Of the working area E. 30 °C
B. 15-20 °C D. 25 °C
224. A protective colloid added to a suspension formulation is to:
A. Allow for fast sedimentation
B. Allow active constituent to easily separate
C. Allow solution of the sediment
D. For easy measurement of final volume of the preparation
225. Effervescent tablets when added to water releases:
A. Oxygen
B. Hydrogen
C. Nitrogen
D. Gas
E. Carbon dioxide
226. In labelling of a product, an unlabelled portion is provided for:
A. Viewing the contents
B. Elegance
C. Save cost of label
D. Art design
E. Saving of glue applied
227. Property of IV solutions:
A. Hypotonic
B. Isotonic
C. Non-aqueous vehicle
D. Hypertonic
E. Hydroalcoholic vehicle
228. The material present in both enteric and film coating is:
A. Wax C. Cellulose acetate phthalate E. Sugar
B. Paraffin wax D. Vaseline
229. A process of placing a thin coatings to small particles of solids or to droplets of liquids is:
A. Film coating C. Microencapsulation E. Lactose coating
B. Sugar coating D. Chocolate coating
230. The bar marks found in labels of products serve to:
A. Impart elegance
B. Meet BFAD requirement
C. Increase marking in labels
D. Distinguish one product from the other
231. The Inspection and Checking section of Quality Control is responsible for:
A. Checking sterility of materials
B. Doing pyrogen testing
C. Chemical assaying
D. Analyzing finished products sampled
E. Sampling of raw materials delivered by suppliers
232. To determine whether the product has undergone stability studies, the label indicates the:
A. Expiry date C. DR. No. E. Lot number
B. Bar marks D. Control number
233. Required characteristic of surfaces of equipments used in production:
A. Reactive with substances of the formulation
B. Non-absorptive
C. Absorbs the excipients of the formulation
D. Turns dark with some constituents
E. Made of plastic covering
234. The water used to prepare parenteral products must be:
A. Water, USP
B. Distilled water
C. Water for injection
D. Demineralised water
E. Purified water
235. To control raw materials and finished products in the warehouse, the practice of:
A. First in-last out
B. Last in-last out
C. Last in-first out
D. First in-first out
E. As decided by the supervisor
236. Uneven distribution of color on the surface of tablets:
A. Peeling
B. Mottling
C. Capping
D. Lamination
E. Picking
237. To remedy the irritating effects of UV radiation is to:
A. Wear UV goggles
B. Wear mask
C. Wear any type of eyeglass to cover the eyes
D. Wear head cap
E. Wear contact glasses
238. Part of a tablet machine which controls the size and shape of a tablet is:
A. Hopper
B. Punches
C. Cam
D. Die
E. Upper punch
239. Moist heat sterilization is more effective than dry heat oven at a lower temperature due to:
A. Weakening of organisms by moist heat
B. Non-oxidation of organisms heat
C. Destruction of the carbohydrates of the cell wall of the organisms
D. Dissolution of the organisms in liquid form
E. Non-precipitation of the proteins
240. The more preferred type of suspension is the flocculated one due to:
A. Elegant in appearance
B. Forms a hard cake upon standing
C. No need of shaking before use
D. Not easy to resuspend
E. Easy resuspendability
241. A 50-kg ointment may be manufactured by:
A. Spatulation
B. Trituration
C. Fusion
D. Use of mixer
E. Use of big mortar and pestle
242. Strength of a product is expressed in terms of:
A. Potency
B. Activity
C. Toxicity
D. Therapeutic use
E. Lethal dose
243. The non-proprietary name of a drug product also refers to:
A. Common name
B. Official name
C. Brand name
D. Local name
E. Herbal name
244. Certified colorants used for drugs and cosmetics but not food is:
A. FD & C dyes
B. Internally D & C dyes
C. Eosin Y
D. D&C dyes
E. Fluorescin dyes
245. The part of the transdermal drug delivery system patch where the drug is stored:
A. Back strip
B. Membrane part
C. Peel strip
D. Gauze part
E. Reservoir
246. OTC labels of products indicate in front of the:
A. Expiry date
B. Formula
C. Pharmacologic category
D. Storage
E. Manufacturing date
247. Part of the tablet machine which holds the granules:
A. Punch
B. Cam
C. Die
D. Vessel
E. Hopper
248. The most useful preservative that is effective against bacteria and molds is:
A. Parabens
B. Sodium benzoate
C. Glycerine
D. Alcohol
E. Propanol
249. Solutions which are intended to be freeze-dried must be:
A. Hydroalcoholic
B. Oily
C. Aqueous
D. Combination of oil and alcohol
E. Ether-chloroform mixture
250. The building used for manufacturing of pharmaceuticals shall be of adequate space for:
A. Orderly placement of materials
B. Allowance of mix-ups of drugs
C. Allow-for cross-contamination of raw materials ad labels
D. Allowance of big quantities of products to mix raw materials
E. Use as rest area of some personnel
251. A biological indicator used during sterilization process consist of:
A. Killed microorganisms
B. Attenuated microorganisms
C. Inactivated microorganisms
D. Live microorganisms
E. Mixed live inactivated microorganisms
252. A characteristics of indicator paper strips used during sterilization process is:
A. Destroyed at 121.0 °C
B. Melts at 121.0 °C
C. Turns at 121.0 °C
D. Does not change color at high temperature
E. Changes color at 121.0 °C
253. Pharmaceutical aerosols may be in the form of:
A. Solutions in oil
B. Emulsions
C. Deffloculated suspensions
D. Granules
E. Small tablets
254. Hemodialysis is employed to remove toxins from the:
A. Peritoneal cavity
B. Kidney
C. Blood
D. Stomach
E. Intestines
255. Petroleum jelly is a semisolid belonging to the class:
A. Water soluble base
B. Absorption base
C. Water removable base
D. Hydrocarbon base
E. Alcohol soluble base
256. Antibiotics and insulin products can be released for distribution by:
A. BFAD
B. Q.C of the company
C. Production head
D. Marketing head
E. Plant manager
257. The Board of Trustees of a company functions as a:
A. Active planning
B. Preparer of policies
C. Owns the company
D. Stockholder’s money keepers
E. Helps in the marketing of products
258. Control records required in the manufacture of drugs:
A. Distribution records
B. Sales records
C. Master formula
D. Assay procedures
E. BFAD records
259. A product that is rubbed or sprayed on the body for cleansing and beautifying is:
A. Liniments
B. Poultices
C. Ointments
D. Therapeutic emulsions
E. Cosmetics
260. Method of tablet manufacture for easily compressible or adhesive ingredients is:
A. Direct compression
B. Slugging
C. Wet method
D. Dry method
E. Manual process
261. Gas used to sterilize plastic materials is:
A. Oxygen
B. Carbon dioxide
C. Ethane
D. Ethylene oxide
E. Carbon monoxide
262. Colorants are added to formulation for:
A. Meeting BFAD requirements
B. Trying which of them is suitable for the product
C. Satisfying the request of marketing department
D. Research during manufacturing
E. Aesthetic purpose
263. Practical methods of determining hardness of tablets is:
A. Eureka tester
B. Rule of the thumb
C. Pfizer tester
D. Roche tester
E. Pound with a pestle
264. Use of buffers in parenterals:
A. Tonicity contributor
B. To determine pH of the solution
C. Sterilizer
D. As diluents
E. To make hypotonic solution
265. The capsule shell is a basically composed of:
A. Gelatin
B. Wax
C. Plasticizer with alcohol
D. Water
E. Petrolatum
266. Humectant for creams is:
A. Distilled water
B. Oil
C. Sorbitol
D. Chloroform
E. Petroleum jelly
267. Characteristic of irrigation solutions to wash wounds and surgical opening may be:
A. Boiled for 30 minutes
B. With additives
C. Mixed with antibiotics
D. Pyrogen-free
E. With suspended fine particles
268. Plastic material used ophthalmic solutions as package and applicator is:
A. Polypropylene
B. Polyethylene
C. Polystyrene
D. PVC
E. Any fine plastic material
269. A colloid mill is used for:
A. Granulation
B. Tablet compressor
C. Produce fine granules
D. Microencapsulation
E. Homogenization of viscous emulsions
270. To control foam in emulsions is to:
A. Add polyethylene glycol
B. Add foaming agent
C. Apply compressed air
D. Mix or agitate rapidly
E. Add sorbitol
271. Thickness of tablets is controlled to avoid the problem in:
A. Packaging
B. Dissolution
C. Disintegration
D. Compression
E. Hardness
272. Tablets placed beneath the tongue in administration is:
A. Buccal
B. Troches
C. Chewable
D. Sublingual
E. Oral
273. Caps used to hold rubber closure in place for vials are made of:
A. Tin
B. Aluminium
C. Copper
D. Tin coated metal
E. Plastic coated tin
274. Quarantined materials delivered in the warehouse are:
A. Subject to test and assays
B. Releasable to production department
C. Rejectable
D. In-process products
E. For approval by the BFAD
275. Hard gelatin capsules are also referred to as:
A. Elastic capsule
B. Pork skin capsule
C. Dry-filled capsule
D. SEC type capsule
E. Soft capsule
276. Implantation pellets are those which contains:
A. Diluents
B. Base
C. Disintegrant
D. Active constituent
E. Lubricant
277. In the manufacture of semisolid emulsions, the mixing of the oil and the aqueous phases is done at a
temperature of:
A. 30-40°C
B. 80°C
C. 90-100°C
D. Just to melt
E. 70-72°C
278. Water can be purified by:
A. Chemical reaction
B. Distillation
C. Solution by boiling
D. By freezing
E. By adding preservative
279. An emulsifier suitable for water in oil emulsion should have an HLB value of:
A. 8-18
B. 3-6
C. 5-6
D. 10-20
E. 9-10
280. Property of a tablet granulations to obtain good tablets:
A. Fine granules
B. Well-mixed with lubricant
C. Contain large quantities of fines compressibility
D. Compressibility
E. Uneven sized particles
281. Stokes Monsanto tester of tablets is to measure:
A. Thickness
B. Friability
C. Hardness
D. Disintegration
E. Dissolution
282. In ampul sealing, excessive heating of the ampul after it is closed will result to:
A. Fragile bubble
B. Fracture at the neck
C. Leaker
D. Deposit of carbon
E. Ampul-break up
283. Substances that prevent bacterial and fungal growth are:
A. Coloring agents
B. Flavorants
C. Sweeteners
D. Antioxidants
E. Preservative
284. To assist in assuring the stability of the dosage forms during transport and storage, the label shall
indicate:
A. Expiry date
B. Storage caution
C. Concentration of drug substance
D. Bar marks
E. Transport caution
285. Pyrogens may come from:
A. Water
B. Pure solute
C. Sterile container
D. Gowns which has been sterilized
E. Air
286. Temperature that can destroy pyrogens is:
A. 180°C
B. 250°C
C. 650°C for 60 seconds
D. 150°C for 1 hour
E. 500°C for one minute
287. Insoluble powders for ophthalmic preparations must be:
A. Less than 20 microns in particle size
B. Pyrogen-free
C. Give preservative action
D. Impalpable to the touch
E. Less than 100 microns size
288. Dialysis solutions as life-saving preparations had the following characterisitics:
A. Requires semi permeable membrane to separate one substance to one another
B. Contains several active ingredients
C. Used to separate red blood cell from white corpuscles
D. Used to individuals with lung diseases
E. Used for any other ailments
289. Large volume parenterals are employed for:
A. Prophylactic therapy
B. Nutritional use
C. Heart diseased patients
D. For children’s needs
E. Replacement therapy
290. In semisolid preparations, petrolatum is a common hydrocarbon base due to its:
A. Property of being easily washed by water
B. Consistency
C. Low cost
D. Can be used for other purposes
E. Easily available
291. To increase viscosity of the aqueous phase of an emulsion is to:
A. Add more oil
B. Add more water
C. Add more emulsifier
D. Stir vigorously
E. Use mixer to stir well
292. LAL method of test is specified for:
A. Bacteria
B. Molds
C. Virus
D. Yeast
E. Pyrogens
293. Sterilization process for heat sensitive parenterals is by:
A. Dry heat
B. Membrane filtration
C. Tyndallisation
D. Inspissations
E. Add preservatives
294. Advantage of multilayered tablets:
A. High cost but effective
B. May be coated
C. 2 incompatibe drugs may keptseparate
D. May separate in 2 layers
E. Lamination may occur
295. This is a common lubricant for tablets:
A. Magnesium stearate
B. Acacia
C. Talc
D. Starch
E. Mannitol
296. A container which holds the drug and is in direct contact with the preparation is:
A. Secondary container component
B. Packaging container
C. Tertiary container component
D. Primary container
E. Plastic container
297. Uniformity of dosage units of suspensions is determined by performing the:
A. Weight variation test
B. Fill volume
C. Content uniformity
D. Viscosity determination
E. Assay process
298. Filter aids for clarification of liquids include:
A. Starch
B. Fuller’s earth
C. Aorbitol
D. Sugar
E. Lactose
299. Synthetic drug carrier system include:
A. Injectable particulate
B. Ophthalmic ointment
C. Transdermal delivery systems
D. Lozenges
E. Poultices
300. Implantation tablets which are administered:
A. Orally
B. Rectally
C. Insertion into body tissues
D. Through the vagina
E. Under the tongue
1. It is one of the tools of organization.
A. Chart
B. Division of responsibility
C. Both A and B
D. Both A and C
2. It is an element of organization.
A. Manangement guide
B. Organizational Planning
C. Product manual
D. Both A and B
3. It is one of the tools of organization.
A. Delegation of the authority
B. Management guide
C. Division of responsibility
D. Production guide
E. Employee manpower guide
4. It is an element of organization.
A. Determination of inter relationship among function
B. Position description
C. Organizational manual
D. All of the above
5. It is the disadvantage of tool of organization.
A. Does not reveals companies objective
B. Limiting the objectives
C. Have structure objectives none of the above
D. None of the above
E. All of the above
6. Stage of Research & product development
A. Preliminary stage
B. Planning stage
C. Schedule stage
D. Both A and B
E. Both A and C
7. Section of Quality Control of Division
A. Central release section
B. Chemical control section
C. Production section
D. Both A and B
8. Section of Quality Control of Division
A. Micro-biological section
B. Plant inspection section
C. Specification and assay
D. All of the above
9. Section of the Plant Department
A. Planning and Scheduling
B. Rejected area
C. Quarantine area
D. Approved area
10. Section in Warehousing Department
A. Dispensing section
B. Finishing goods area
C. Quality Control area
D. Both A and B
E. Both A and C
11. Which is not section of Plant Departrment.
A. Finished good area
B. Engineering & maintenace
C. Inventory section
D. Manufacturing of drugs
12. Which is not a stage of research & Product Development.
A. Preliminary stage
B. Research stage
C. Pharmaceutical reseach
D. Both A and B
E. Both A and C
13. Which is not section of warehousing department.
A. Returned goo section
B. Approved for use section
C. Approved for use section
D. Inventory section
14. It is not a section of Quality control
A. Micro-biological section
B. Approved for use section
C. Chemical control section
D. All of the above
15. It is not a division of Research & Product development
A. Pharmaceutical research
B. Microbial section
C. Chemical section
E. All of the above
16. It is section of Research and Production Development Division.
A. Approved for Use section
B. Returned Goods Section
C. Pharmaceutical Research
D. Chemical Research
17. It is part of Research & Product Development
A. Quarantine area
B. Clinical Research stage
C. Chemical control Section
D. Engineering & maintenance
E. Approved Area
18. It is a section of Quality control Division
A. Quarantine area
C. Chemical Control section
D. Engineering & maintenace
19. It is a section of Plant department
A. Quarantine area
C. Chemical Control Section
E. Quality control area
20. It is one section of warehouse division
A. Quarantine area
C. Chemical Control Section
E. Quality control
21. It is a combination of people, money & machines.
A. Plants dept
B. Finance dept organization
C. Line
D. All of the above
22. Identified as “ Chain of command” from top to bottom
A. Plant department
B. Finance department
C. Organization
D. Line
E. All of the above
23. Involves payment & fix price of expenses.
A. Plant department
C. Organization
D. Line
24. Overall composition of the company
A. Plant department
C. Organization
D. Line
25. This watches closely and records all materials used in the production.
A. In process Section
B. Dispensing pharmacist
C. Inventory control
D. Production control
E. All of the above
26. Consist of the products which have been bottled or stripped, packed but not yet labeled.
E. All of the above
27. Who prepares the manufacturing order based on the master formula.
E. All of the above
28. Who weighs & measure the ingredients & transfer them to the respective mfg. area.
E. All of the above
29. In charge of the preparation of the master formula if the copy was sent without the actual amount.
A. Batch
B. Lot number
C. Component
D. QC Head
30. Where do the copies of manufacturing order goes to?
A. Batch
B. Lot number
C. Component
D. QC Head
31. A specific homogenous quantity of a drug produced accdg. To a single M.O.
A. Batch
B. Lot number
C. Component
D. QC Head
32. Any distinct combination of letters or both w/c the complete history of the mfr, control, packing & distribution
of a batch or lot of a drug is determined.
A. Batch
B. Lot number
C. Component
D. QC Head
33. Ingredient intended for the use in the manufacture .
A. Batch
B. Lot number
C. Component
D. QC Head
34. Responsibility of an organization to determine that system, facilities & written procedures.
A. Technology element
B. Aesthetic element
C. Quality Control
D. Quality assurance
35. Where random spot checking instead of 100% examination of the work process & product is performed.
B. Aestetic element
C. Quality Control
36. The element of quality that indicates that the possesses an attractive design.
B. Aestetic element
C. Quality Control
37. Element of quality that means that product can withstand the surrounding conditions.
B. Aestetic element
C. Quality Control
38. Dishonesty & fatigue is one cause of variation of:
A. Materials
B. Machines
C. Methods
D. Man
E. All of the above
39. Variation between supplies of the same substance for:
A. Materials
B. Machines
C. Methods
D. Man
E. All of the above
40. Aging & improper care is one cause of variation of:
A. Materials
B. Machines
C. Methods
D. Man
E. All of the above
41. Negligence by chance is one variation of:
A. Materials
B. Machines
C. Methods
D. Man
E. All of the above
42. Difference in adjustment of equipment is one variation of:
A. Materials
B. Machines
C. Methods
D. Man
E. All of the above
43. Variation w/n a batch is for:
A. Materials
B. Machines
C. Methods
D. Man
E. All of the above
44. Variation of equipment for the same process if for:
A. Materials
B. Machines
C. Methods
D. Man
E. All of the above
45. Inadequate training & understanding is one cause of variation for:
A. Materials
B. Machines
C. Methods
D. Man
E. All of the above
46. Inexact & inadequate procedure is one cause of variation for:
A. Materials
B. Machines
C. Methods
D. Man
E. All of the above
47. Variation between batches from the same supplies is for:
A. Materials
B. Machines
C. Methods
D. Man
E. All of the above
48. Improper working conditions is one cause of variation of:
A. Materials
B. Machines
C. Methods
D. Man
E. All of the above
49. Partial or complete separation of the top or bottom of a tablet from the main body.
A. Picking
B. Capping
C. Lamination
D. Chipping
E. Mottling
50. Separation of tablet 2 or more distantn layer.
A. Picking
B. Capping
C. Lamination
D. Chipping
E. Mottling
51. Removal of edges of edges of tablets.
A. Picking
B. Capping
C. Lamination
D. Chipping
E. Mottling
52. Removal of material from the surface of the tablets
A. Picking
B. Capping
C. Lamination
D. Chipping
E. Mottling
53. Adhesion of granulation to the die wall.
A. Weight variation
B. Mottling
C. Double impression
D. Sticking
54. Unequal distribution of color on the surface of the tablet with light or dark areas.
A. Weight variation
B. Mottling
D. Sticking
E. Picking
55. Imprinting twice which is unnecessary
A. Weight variation
B. Mottling
D. Sticking
E. Picking
56. Migration of dye during drying of granulation.
A. Weight variation
B. Mottling
D. Sticking
E. Picking
57. Caused by poor mixing
A. Weight variation
B. Mottling
D. Sticking
E. Picking
58. Tablets w/c is recommended to speed up disintegration by breaking up starting from the mouth.
A. Chewable tablet
B. Sublingual tablet
C. Buccal tablet
D. Vaginal tablet
E. Troches
59. It is placed beneath the tongue, which contain drugs to be absorbed through the oral mucosa because they
are destroyed in the GIT.
A. Chewable tablet
C. Buccal tablet
D. Vaginal tablet
E. Troches
60. It placed at the side of the cheek or between the lip gum, which contain drugs to be absorbed through the
oral mucosa because they are destroyed in the GIT
A. Chewable tablet
C. Buccal tablet
D. Vaginal tablet
61. It is consist of small tablets of compressed drug without excipient.
A. Chewable tablet
C. Buccal tablet
D. Vaginal tablet
62. Specially formulated and shaped tablet intended to be placed in the vagina by special inserters.
A. Vaginal tablets
B. Implantation tablets
C. Insert
D. Both A and B
E. Both A and C
63. It is designed so that the administration of a single dosage unit provides the immediate release of an amount
that promply produces the desired therapeutic effect.
A. Sugar-coated tablet
B. Enteric coated tablet
C. Sustained release tablet
D. Hypodermic tablet
E. All of the above
64. It is also referred as dry-filled capsule consisting of two section, one slipping over the counter.
A. Hard capsule
B. Hard gelatin capsule
C. Hard gel capsule
D. Both A and B
E. Both A and C
65. It is defined as a colloidal system consisting of very fine subdivided liquid or solid particles dispersed in and
surround by a gas.
A. Capsules
B. Tablets
C. Aerosol
D. Cosmetics
E. Solutions
66. It is a branch of science dealing with the external embellishment.
A. Cosmetic surgery
B. Cosmetology
C. Cosmetic art
D. Cream
67. It is employed to produce carbon dioxide by chemical reaction of the components upon addition of water.
B. Hygroscopic tablet
C. Eutetic tablet
D. All of the above
68. What type of cosmetic is deodorant cream?
A. Hair care
B. Skin care
C. Teeth care
D. Nail care
69. What type of cosmetic is lipstick?
A. Hair care
B. Skin care
C. Teeth care
D. Nail care
70. What type of cosmetics is depilatories?
A. Hair care
B. Skin care
C. Teeth care
D. Nail care
71. What is the use of alkyl esters of p-hydroxy benzoic acid in the preparation?
A. Type of ointment base
B. Preservatives
C. Emulsifiers
D. Filter aids
E. Flavour
72. What is the use of benzalkonium chloride in the preparation?
B. Preservatives
C. Emulsifiers
D. Filter aids
E. Flavour
73. What is the use of petrolatum in the preparation?
B. Preservatives
C. Emulsifiers
D. Filter aids
E. Flavour
74. What is the use of casein in the preparation?
B. Preservatives
C. Emulsifiers
D. Filter aids
E. Flavour
75. What is the use of acacia in the preparation?
B. Preservatives
C. Emulsifiers
D. Filter aids
E. Flavour
76. What is the felt in the preparation?
B. Preservatives
C. Emulsifiers
D. Filter aids
E. Flavour
77. What is the use of membrane filter in the preparation?
B. Preservatives
C. Emulsifiers
D. Filter aids
E. Flavour
78. What is the use of diatomite in the preparation?
B. Preservatives
C. Emulsifiers
D. Filter aids
79. What is the use of anhydrous lanolin in the preparation?
B. Preservatives
C. Emulsifiers
D. Filter aids
80. What is the use of veegum in the preparation?
B. Preservatives
C. Emulsifiers
D. Filter aids
81. What is the use of sodium lauryl sulfate in the preparation?
B. Preservatives
C. Emulsifiers
D. Filter aids
82. What is the use of Steric acid in the preparation?
B. Preservatives
C. Emulsifiers
D. Filter aids
83. What is the use of cotton cloth in the preparation?
B. Preservatives
C. Emulsifiers
D. Filter aids
84. What is the use of kraft paper in the preparation?
B. Preservatives
C. Emulsifiers
D. Filter aids
85. What is the use of mineral oil in the preparation?
B. Preservatives
C. Emulsifiers
D. Filter aids
86. It is not process of capsules production.
A. Dipping
B. Pinning
C. Drying
D. Homogenizing
87. It is not a part of capsule filling equipment.
A. Hopper for empty capsules
B. Punch
C. Hopper for powder with auger
D. Closing plate
88. It is not a part of Transdermal drug delivery system.
A. Backing layer
B. Drug containing layer
C. Release control layer
D. Anti-adhesive
89. It is not a part of aerosol container.
A. Hopper
B. Housing
C. Mounting cap
D. Actuator
90. What is the use of polyethylene glycol in film coating of tablets?
A. Surfactant
B. Opaquant
C. Water permeability
D. Plasticizer
91. What is the use o castor oil in film coating of tablets?
A. Surfactant
B. Opaquant
D. Plasticizer
92. What is the use of polyoxyethylene sorbitol in the film coating of tablets?
A. Surfactant
B. Opaquant
D. Plasticizer
93. What is the use of titanium dioxide in film coating of tablets?
A. Surfactant
B. Opaquant
D. Plasticizer
94. What is the use of beeswax in film coating of tablets?
A. Plasticizer
B. Glossant
C. Allow rapid evaporation
D. Volatile solvent
95. What is the use of cellulose acetate phthalate in film coating of tablets?
A. Plasticizer
B. Glossant
D. Volatile solvent
96. What is the use of plasticizer in film coating of tablets?
A. To produce smooth thin film
B. For elasticity
D. All of the above
97. What is the use of polyester in the preparation of transdermal drug delivery
A. Backing layer
B. Adhesive
C. Peel strip
D. Packaging
98. What is the use of heat sealed foil pouches in TDD?
A. Backing layer
B. Adhesive
C. Peel strip
D. Packaging
99. What is the use of polyethylene in the preparation of TDD?
A. Backing layer
B. Adhesive
C. Peel strip
D. Packaging
100. What is the use of silicone based in the praparation of TDD?
A. Backing layer
B. Adhesive
C. Peel strip
D. Packaging
101. What is the use of acrylic based in the preparation of TDD?
A. Backing layer
B. Adhesive
C. Peel strip
D. Packaging
102. What is the use of foil in the preparation of TDD?
A. Backing layer
B. Adhesive
C. Peel strip
D. Packaging
103. What is the use of metallixed laminates in the preparation of TDD?
A. Backing layer
B. Adhesive
C. Peel strip
D. Packaging
104. What is the use of plastic pouches in the preparation of TDD?
A. Backing layer
B. Adhesive
C. Peel strip
D. Packaging
105. What is the use of polyisobutylene in the preparation of TDD?
A. Backing layer
B. Adhesive
C. Peel strip
D. Packaging
106. What is the coextruded films in the preparation of TDD?
A. Backing layer
B. Adhesive
C. Peel strip
D. Packaging
107. Monosodium glutamate can be used as flavor in drugs.
A. Statement is True
B. Statement is False
C. Can be
D. Should not be
108. Partition coefficient of the drug substance can influence absorption of drugs on the skin.
C. Can be
D. Should not be
109. Creaming is one problem of suspension
C. Can be
D. Should not be
110. The transdermal route of administration is unsuitable for drugs that irritate the skin
C. Can be
D. Should not be
111. What is the use of acacia in the preparation of tablet?
A. Diluent
B. Binders
C. Disintegrants
D. Opaquant
112. What is the use of agar in the preparation of tablet?
A. Diluent
B. Binders
C. Disintegrants
D. Opaquant
113. What is the use of Starch in the preparation in tablets?
A. Diluent
B. Binders
C. Disintegrants
D. Opaquant
114. What is the use of sodium carboxy methyl cellulose in the preparation in tablets?
A. Diluent
B. Binders
C. Disintegrants
D. Opaquant
115. What is the use of sucrose in the preparation in tablet?
A. Diluent
B. Binders
C. Disintegrants
D. Sweetener
E. Flavor
116. What is the use of mannitol in the preparation in tablet?
A. Diluent
B. Binders
C. Disintegrants
D. Sweetener
E. Flavor
117. What is the use of lactose in the preparation in tablet?
A. Diluent
B. Binders
C. Disintegrants
D. Both A and C
E. Both A and B
118. What is the use of polyvinyl pyrrolidone in the preparation in tablet?
A. Diluent
B. Binders
C. Disintegrants
D. Both A and C
E. Both A and B
119. What is the use of tragacanth in the preparation in tablet?
A. Diluent
B. Binders
C. Disintegrants
D. Both A and C
E. Both A and B
120. What is the use of methyl cellulose in the preparation in tablet?
A. Diluent
B. Binders
C. Disintegrants
D. All of the above
121. What part of machine is hopper.
A. Tabletting machine
B. Capsulating machine
C. Aerosol assembly
D. Both A and B
E. Both A and C
122. What part of machine is the rectification unit.
C. Aerosol assembly
D. Both A and B
E. Both A and C
123. What part of machine is the feed frame
C. Aerosol assembly
D. Both A and B
124. What part of the machine is the valve assembly
C. Aerosol assembly
D. Both A and B
E. Both A and C
125. What part of machine is the cam
C. Aerosol assembly
D. Both A and B
E. Both A and C
126. What part of machine is the peg-ring
C. Aerosol assembly
D. Both A and B
E. Both A and C
127. What part of the machine are the dies
C. Aerosol assembly
D. Both A and B
E. Both B and C
128. What part of machine is the closing plate
C. Aerosol assembly
D. Both A and B
E. Both B and C
129. What part of machine are the punches
C. Aerosol assembly
D. Both A and B
E. Both B and C
130. What part of the machine is dip tube
C. Aerosol assembly
D. Both A and B
E. Both B and C
131. Titanium dioxide is a substance to be used as:
A. Composition of hard gelatin capsule
B. Propellants in aerosol
C. Component of aerosol package
E. All of the above
132. Sulfur dioxide is a substance to be used as:
E. All of the above
133. Pork skin is a substance to be used as:
E. Both A and B
134. Bone of alligator is a substance to be used as.
E. Both B and C
135. Flourinated Chlorinated Hydrocarbons is a substance to be used as:
E. Both B and C
136. Nitrogen is a substance to be used as:
E. Both A and B
137. Carbon monoxide is a substance to be used as:
E. Both A and C
138. Nitrous oxide is a substance to be used as:
E. Both A and B
139. Propellant is a substances to be used as:
E. Both A and B
140. Container is a component of:
E. Both B and C
141. Actuators are parts of a component of:
E. Both A and B
142. Punches are parts of a component of:
E. All of the above
143. A natural gum best used as a tablet binder when dry since it is difficult to disperse and forms a very heavy
mucilage in water.
A. Acacia
B. Tragacath
C. Psyllium
D. Gelatin
E. Alginic acid
144. Milling action for friable materials which tend to fracture along well defined planes.
A. Attrition
B. Impact
C. Pressure
D. All of the above
145. Additives used in thermostatic formulations as part of packaging materials for pharmaceutical preparation
which are added to reduce the coefficient of friction of the plastic material.
A. Plasticizers
B. Lubricants
C. Slip agents
D. Stabilizers
146. Optical property in plastic packaging materials which is a measure of milkiness caused by light scattering by
surface imperfection of film in homogeneities.
A. Clarity
B. Haze
C. Gloss
D. Light transmission
147. A type of novel delivery system which has the capacity of adhering to a _____ biological substrate and
remain there for an extended period of time.
A. Bioadhesive
B. Intelligent polymers
C. Block copolymer micelles
D. Biomucoadhesive
148. A type of tablet coating which is a modified form of film coating, differing only in the size of the particles to be
coated and the method used.
A. Compression coating
B. Microencapsulation
C. Enteric coating
D. Specialized film coating
E. All of the above
149. Sugar coating problem encountered when moisture become trapped in the coating.
A. Sweating
B. Blistering
C. Peeling
D. Flaking
150. The following are the factors which may cause tablets to cap or split except:
A. Excess fines or powders
B. Deep marking on punches
C. Worm dies
D. Unsuitable formula
151. The following statements are TRUE about granules:

1 - Granules are more stable to the effects of atmospheric humidity.
2 - Granules are more likely to harden upon standing.
3 - Granules are easily wetted by liquids.
4 - Granulations flow less freely into tablet presses.
A) 1 only D) 1 & 3 are true

B) 2 only E) 2 & 4 are true
C) 3 only
152. These are dosage forms that must be left intact upon swallowing.
1- Enteric-coated tablets
2- Sublingual tablets
3- Chewable tablets
4- Extended-release dosage forms
A) 1 & 2 only D) 3 & 4 only

B) 1, 2 & 4 E) 2 & 3 only
C) 1, 2 & 3
153. Hard gelatin capsule shells may be colored with dyes ad made opaque by adding ________.
A) Coal tar D) Gelatin

B) Cupric sulphate E) Talc
C) Titanium dioxide
154. A pH- sensitive, non-digestible radiofelemettric device used as a nonradioactive means of measuring gastric
pH, gastric residence time and gastric emptying time of solid dosage forms is called________.
A) Gamma Scintigraphy D) Silica gel

B) Heidelberg capsule E) Cellulose
C) Gelatin
155. A size “0” capsule has a volume of________.
A) 0.37 mL D) 0.68 mL
B) 0.95 mL E) 0.75 mL
C) 0.50 mL
156. It is an optional step in the preparation of filled hard gelatin capsules.
A) Filling the capsule shells.

B) Cleaning and polishing the filled capsules
C) Developing and preparing the capsule formulation
D) Capsule sealing
E) None of the above
157. When a pharmacist is developing a capsule formulation, she aims to prepare one with the following
characteristics, EXCEPT
A) Ease of swallowing D) Good bioavailability

B) Ease of filling E) None of the above
C) Elegance
158. Sodium starch glycolate is a ______ included in a capsule formulation to assist the breakup and distribution
of its contents in the stomach
A) Diluent D) Binder
B) Filler E) None of the above
C) Disintegrant
159. The addition of ______ % of a lubricant or glidant to the capsule powder mix enhances flow properties.
A) 0.5- 1.0 % D) 0.5- 10.0 %

B) 0.25- 1.0 % E) 0.3- 0.5 %
C) 0.1- 0.2 %
160. Liquids that may be encapsulated into soft gelatin capsules include the following, EXCEPT
A) Ketones D) Ethers
B) Aromatic oils E) None the above
C) Polyethylene glycols
161. Determination of the amount of active ingredients by assay for capsules must fall within the range of _______
of the label claim for 9 out of 10 dosage units assayed.
A) 85%- 115% D) 90%- 110%

B) 100%- 120% E) 70%- 100%
C) 70%- 125%
162. It creates the desired bulk, flow properties and compression characteristics of tablets and capsules.
A) Lactose D) Sodium alginate

B) Methylcellulose E) All of the above
C) Liquid glucose
163. A pharmaceutic ingredient used for enteric coating tablets.
A) Methylcellulose D) Shellac
B) Gelatin E) Talc
C) Liquid glucose
164. A type of tablet inserted into capsules or dissolved in liquid to provide accurate amounts of potent drug
substances is called _______.
A) Coated tablet D) Tablet triturate
B) Multi- layered tablet E) Hypodermic tablet
C) Compressed tablet
165. An example of a rapidly disintegrating tablet is _____.
A) Triaminic D) Tempra
B) Benadryl E) Diazepam
C) Loratadine
166. The following are the factors that need to be controlled during production to ensure that established product
quality standards are met, EXCEPT
A) Content uniformity D) Weight Variation

B) Tablet shape E) None of the above
C) Dissolution
167. The thickness of a tablet is determined by the following factors, EXCEPT
A) Shape of the punches D) Pressure applied during compression

B) Diameters of the die E) None of the above
C) Amount of fill entering the die cavity
168. Which of the following statements is not true for tablet hardness and friability?
A) The greater pressure applied, the harder are the tablets.

B) Tablets intended to dissolve slowly are made hard.
C) Tablets intended to dissolve slowly are compressed with minimal pressure.
D) Tablets should be soft enough to disintegrate properly after swallowing.
169. The accepted maximum weight loss of not more than 1% is a requirement for ______.
A) Tablet dissolution D) Tablet hardness

B) Tablet disintegration E) Tablet weight variation
C) Tablet friability
170. The process by which the powder mixture is compressed into large flat tablets or pellets about 1 inch in
diameter.
A) Fluid bed process D) Slugging

B) Dry granulation E) Sifting
C) Direct compression
171. An optional step in the sugar coating of tablets is the _______.
A) Subcoating D) Polishing
B) Waterproofing & sealing E) None of the above
C) Smoothing & final rounding
172. It is the recommended alcohol content limit for OTC oral products intended for children under 6 years of age.
A) 10% D) 0.5%
B) 5% E) 1.5%
C) 0.1%
173. When a solvent at a given temperature has dissolved all of the solute it can, it is said to be ________.
A) Homogenous D) Clear solution

B) Saturated E)Soluble
C) Totally dissolved
174. Solutions of aromatic materials are called ________ if the solvent is alcoholic.
A) Elixirs D) Aromatic waters

B) Spirits E) Solutions
C) Syrup
175. It provides a pleasant means of administering a liquid form of a disagreeable-tasting drug.
A) Syrup D) Juice
B) Sucrose E) Magmas
C) Sorbitol solution
176. In the preparation of elixirs, the best remedy to the formation of cloudiness due to separation of flavouring
oils is
1- The pharmacist may filter the solution to remove the cloudiness
2- The elixir is allowed to stand for a certain number of hours to ensure saturation of the hydroalcoholic
solvent
3- Make use of low heat to permit the dissolution of undissolved particles causing the cloudiness of the
solution
4- Add talc to absorb the excessive amounts of oils and provide ease in their removal from the solution
The pharmacist may:
A) 1 only D) 1 & 3
B) 2 only E) 1 & 2
C) 2&4
177. Diluted acids are aqueous solutions prepared by diluting the corresponding concentrated acids with purified
water. Most diluted acids have a strength of 10% w/v with the exception of Diluted Acetic Acid, which is _____
w/v.
A) 6% D) 5%
B) 8% E) 20%
C) 10%
178. These are concentrated preparations of vegetable or animal drug which are more potent on a weight basis as
the crude drug.
A) Fluidextracts D) Extractive
B) Percolate E) All of the above
C) Extracts
179. Dispersions containing 10-50 µm particles include
1 - Suspensions 3 - Magmas
2 - Emulsions 4 - Gels
A) 1&4 D) 3 & 4
B) 2&3 E) 2 & 4
C) 1&2
180. The following are reasons for preparing a suspensions, EXCEPT
A) Some drugs are chemically unstable in solution.

B) Solid forms of drugs are preferred to the liquid form because of the ease of swallowing.
C) Suspensions allow flexibility in administration of a range of doses.
D) Some poor- tasting drugs are developed to prepare a palatable liquid dosage form.
181. According to Stoke’s equation the reduction in particle size produce _____.
A) Smaller particles, faster settling rate

B) Slow, more uniform rates of settling
C) Bigger particles, slower settling rate
D) Finer particles and slower settling rate
E) All of the above
182. The theory of emulsification wherein the emulsifying agent is preferentially soluble in one of the phases and
is one embedded more deeply in that phase than the other is the _____.
A) Surface Tension theory D) interfacial Fil Theory

B) Plastic Film theory
C) Oriented-Wedge theory
183. The initial step in the preparation of an emulsion is the _____.
A) Preparation of the raw material. D) Selection of the type of emulsion.

B) Selection of the emulsifier.
C) Mixing of the ingredients.
184. Finely divided solids such as the following generally form O/W emulsion when the insoluble material is added
to the aqueous phase.
1- Acacia 3- Magnesium hydroxide
2- Bentonite 4- Aluminum hydroxide
A) 2, 3 & 4 D) 3 & 4 only

B) 2 only E) 2 & 3 only
C) 1, 2 & 3
185. Surface active agents with HLB values between 8-18 produce _____ type of emulsion.
A) Oil- in- Water D) Water- in- Oil-in- Water

B) Oil- in- Water- in- Oil E) None of the above
C) Water- in- Oil
186. When the emulsifying agent is added to water first to form a mucilage and the oil is slowly incorporated, the
method used in preparing the emulsion is called_____.
A) In situ method D) English method

B) Forbes bottle method E) None of the above
C) Continental method
187. These are thermodynamically stable and optically transparent isotropic mixture of a biphasic O/W system
stabilized with surfactants.
A) Floccules D) Magmas
B) Microemulsions E) Micelles
C) Gels
188. It takes place in unstable emulsions in which the internal phase has a lesser density than the external phase.
A) Bleeding D) Downward creaming

B) Coalescence of globules of the E) Syneresis
internal phase
C) Upward creaming
189. The reversible gel-sol formation with no change in volume or temperature is referred to as_____.
A) Imbibition D) Thixotrophy
B) Swelling E) Rheopexy
C) Syneresis
190. Coloring agents are used in pharmaceutical preparations for aesthetic effects. About 90% of the dyes used in
products regulated by the FDA are synthesized from a single colorless derivative of benzene called_____.
A) Cupric sulphate D) Aniline

B) Sulfur E) None of the above
C) Coal Tar
191. The introduction of diet softdrinks in the 1950’s provided the spark for the widespread use of artificial
sweeteners today. The particular sweetener used by persons with phenylketonuria (PKU) is called_____.
A) Aspartame D) Acesulfame potassium

B) Cyclamate E)None of the above
C) Saccharin
192. Moisture tackiness is a sign of degradation for _____.
A) Tablets D) Creams
B) Capsules E) Ointments
C) Oral powders
193. The dye component contained in FD & C yellow No. 5 which causes allergic-type reactions in many people.
A) Sulfur D) Riboflavin
B) Red mercuric iodide E) Eosin
C) Tartrazine
194. the preservative with the required proportion of 15%-20% concentration commonly employed in
pharmaceutical preparations.
A) Benzoic acid D) Propylparaben

B) Alcohol E) Glycerin
C) Sodium benzoate
195. It is a commercial water- based colloidal dispersion that contains a 30% ethyl cellulose pseudolatex.
A) Aquacoat D) Shellac
B) Cellulose acetate phthalate E) None of the above
C) Polyoxyethylene sorbitan
196. It means the tablet is imprinted with a code that is cut into its surface during production.
A) Laminated D) Debossed
B) Engraved E) All of the above
C) Embossed
197. It is a film-coating problem which shows a filling-in of the score line or an indented logo on the tablet caused
by the film.
A) Mottling D) Bridging
B) Erosion E) Sticking
C) Picking
198. It describes dosage forms which are designed to release the drug at a time other than promptly after
administration.
A) Modified release D) Targeted release

B) Extended release E) None of the above
C) Delayed release
199. The following are the characteristics of drugs commonly incorporated into an extended-release product,
EXCEPT
A) Administer in relatively large D) Possess a good margin of safety.

doses.
B) Exhibits very slow or very fast rates E) None of the above
of absorption and excretion.
C) Uniformly absorbed in the GIT
200. It is a free-flowing powder commonly used to provide the hydrophilic matrix for extended – release tablets.
A) Hydroxypropyl methylcellulose D) Polyethylene

B) Polyvinyl acetate E) PEG 400
C) Polymethacrylate
201. These are semisolid preparations which are intended for external application to the skin or mucous
membranes.
A) Creams D) Gels
B) Pastes E) Magmas
C) Ointments
202. Hydrophilic Ointment, USP is an example of a ____ ointment base.
A) Oleaginous base D) Water- soluble base

B) Absorption base E) none of the above
C) Water- removable base
203. The preparation of ointments having an emulsion base is done chronologically in the following manner:
1 - Preparation and heating of an aqueous solution of the heat-stable, water- soluble components to the
same temperature as the oleaginous components.
2 - The water-immiscible components (oils and waxes) are melted together at 70-75ºC.
3 - The mixture is slowly cooled while maintaining the temperature for 5-10 mins. and stirred until congealed.
4 - The aqueous solution is slowly added to the melted mixture with continuous stirring.
A) 2- 3-1-4 D) 3- 4-1- 2
B) 1- 2- 3- 4 E) 3- 2- 4-1
C) 2- 1-4- 3
204. The following are ointment bases specifically used for ophthalmic ointment preparations, EXCEPT
A) White petrolatum + Liquid D) PEG+ Mineral Oil

petrolatum
B) Hydrophilic ointment E) None of the above
C) White petrolatum+ Liquid
petrolatum + Lanolin
205. Enhanced percutaneous absorption of drugs are affected by the following factors, EXCEPT
A) Drug concentration D) Drugs with 100 - 800 molecular weights

B) Dehydration of the skin E) None of the above
C) Large area of application
206. A physical method that is used to enhance transdermal drug delivery and penetration wherein a charged
chemical compound is delivered across the skin membrane with the use of an electrical field.
A) Use of penetration enhancers D) Iontophoresis

B) Use of percutaneous absorption E) None of the above
enhancers
C) Sonophoresis
207. The rate of drug transport in all transdermal drug delivery systems, both monolithic and membrane, is
controlled by the_____.
1 - Drug delivery device 3 - Skin
2 - Concentration of the drug 4 - Environmental factors
A) 1&2 D) 2 & 4
B) 1&3 E) 1& 4
C) 2&3
208. A disadvantage of TDDSs is
A) Only relatively potent drugs are used. D) It can avoid GI drug absorption difficulties.
B) It avoids the first- pass effect. E) None of the above
C) It rapidly terminates drug therapy.
209. It is used as an adjunct in smoking cessation programs.
A) Catapres TTS D) Scopolamine TDDSs

B) Nitroglycerin-containing TDDSs E) None of the above
C) Nicotine TDDSs
210. Pessaries is a term also referring to _____.
A) Rectal suppositories D) All of the above

B) Vaginal suppositories E) None of the above
C) Urethral suppositories
211. When made with cocoa butter, male urethral suppositories usually weighs about _____.
A) 2g D) 5g
B) 3g E) 6g
C) 4g
212. Long-acting or slow-release suppositories such as Morphine Sulphate is prepared with a base that contains
_____ to prolong the release of the drug over several hours.
A) Alginic acid D) Stearic acid

B) Polyethylene glycol E) All of the above
C) Glycerinated gelatin
213. Glycerinated gelatin suppositories may be prepared by dissolving the following components in their required
proportions:
A) Gelatin (20%), glycerine(70%),suspension of the medication (10%)

B) Gelatin (60%), glycerine(20%),suspension of the medication (20%)
C) Gelatin (20%), glycerine(40%),suspension of the medication (40%)
D) Gelatin (50%), glycerine(30%),suspension of the medication (20%)
214. Suppositories are prepared by the three general methods, EXCEPT
A) Compression D) Congealing
B) Molding E) None of the above
C) Hand-rolling
215. Cocoa butter suppositories must be maintained and stored in a cool place with a temperature of _____.
A) Below 2ºC D) 2-8º C

B) Above 30º C E) None of the above
C) Room temperature
216. Cross-flow membrane filtration is one of the man methods used in the preparation of purified water and is
referred to as _____.
A) Distillation D) Electrophoresis
B) Ion exchange E) None of the above
C) Reverse osmosis
217. Fluid energy grinding produces finer particles of _____ size for the dispersed phase of suspensions.
A) 1 - 50 µm D) 100 µm
B) 10 - 50 µm E) none of the above
C) Less than 10µm
218. Loose aggregation of suspension particles is called_____.
A) Micronization D) All of the above

B) Flocculation E) None of the above
C) Redispersion
219. Semisolid, semi- rigid systems consisting of dispersions made up of small inorganic particles or large organic
molecules enclosing and interpenetrated by a liquid.
A) Emulsions D) Magmas
B) Gels E) Colloidal dispersion
C) Suspensions
220. It is a form of instability seen in aqueous and non-aqueous gels where there is separation of the solvent
phase due to the elastic contraction of the polymeric molecules.
A) Syneresis D) Thixotropy
B) Imbibition E) Bleeding
C) Swelling
221. It is a semisolid gel consisting of a liquid component together with a protosubstance and a crystalline waxy
fraction.
A) Plastibase D) Organogels
B) Carbowaxes E) Bentonite
C) Petrolatum
222. It is a gelling agent capable of adsorbing large quantities of water without liquefying and is used to prepare
transparent gels.
A) Bentonite D) Colloidal silicon dioxide

B) Carbomer 934 E) Veegum
C) Carboxymethylcellulose sodium
223. Plastibase, a gelling agent that contains a mixture of 5% low molecular weight polyethylene and 95% mineral
oil, is also called_____.
A) Poloxamer D) Povidone
B) Jelene E) Vaseline
C) Veegum
224. The gelatin temperature or gel point of gelatin is highest at its _____.
A) Melting point D) Freezing point

B) Congealing point E) None of the above
C) Isoelectric point
225. Aerosols which are used to provide an airborne mist are called_____.
A) Foam sprays D) Dermatologic sprays

B) Space sprays E) Suntan sprays
C) Surface sprays
226. Freon 12 is a fluorinated hydrocarbon which forms a liquid when cooled to -30º C. It is referred to chemically
as_____.
A) Dichlorofluoromethane D) Difluoroethane
B) Trichloromonofluoromethane E) Trinitrophenol
C) Dichlorotetrafluoroethane
227. Foam aerosols contain _____ % propellant.
A) 85% D) 5%
B) 30%- 70% E) 20%
C) 6%- 10%
228. The following are the main components of a three-phase aerosol system, EXCEPT
A) Valve assembly D) Vapor phase

B) Liquid propellant E) None of the above
C) Product concentrate
229. The part of the aerosol valve assembly which brings the formulation from the container to the valve is
the____.
A) Actuator D) Dip tube

B) Gasket E)Pressurized stem
C) Stem
230. The filling process used for most pharmaceutical aerosols is _____.
A) Cold filling D) None of the above

B) Pressure filling E) All of the above
C) Manual filling
231. Exposure to temperatures above_____ may cause an aerosol container to burst or explode.
A) 49ºC D) 100ºC
B) 37ºC E) 150ºC
C) 60ºC
232. It is a sterile solution of NaCl, KCl, and CaCl2 in Water for Injection.
A) Sodium Chloride Injection, USP D) Bacteriostatic NaCl Injection, USP

B) Ringer’s Injection, USP E) Water for Injection, USP
C) Lactated Ringer’s Injection, USP
233. The following are the general methods used to sterilize pharmaceutical products, EXCEPT
A) Steam sterilization D) Boiling

B) Filtration E) None of the above
C) Ionizing radiation
234. To validate the sterility of pharmaceutical products, biologic indicators are used. In steam and ethylene oxide
sterilization, spores of suitable strains of _____ are commonly employed.
A) Bacillus punulus D) All of the above

B) Bacillus subtilis E) None of the above
C) Bacillus stearothermophilus
235. The animal source of the Limulus Amoebocyte Lysate (LAL) test is the_____.
A) Rabbit D) Horse
B) Horseshoe crab E) Guinea pigs
C) Monkey
236. One of the prime requisites for parenteral solutions is _____.
A) Freshness D) Safety
B) Clarity E) Convenient
C) Availability
237. Labels on containers of parenteral products must state the following information, EXCEPT
A) Lot number D) Storage conditions and expiry date

B) Name of the preparation E) None of the above
C) Amount of inactive components
238. The risk level of compounded sterile preparations (CSPs) which include non-sterile components and
therefore, must sterilized before being administered is the_____.
A) Low-risk level D) None of the above

B) Medium-risk level E) All of the above
C) High-risk level
239. Injectable sterile products formulated with no binders, diluents or excipients to permit total dissolution and
absorption from the site of implantation is called _____.
A) Implants D) Pills
B) Pellets E) None of the above
C) Hypodermic tablets
240. Ophthalmic solutions and suspensions are sterilized using _____.
A) Autoclave D)High temperatures

B) Bacterial filtration E) All of the above
C) Ionizing radiation
241. Soft contact lenses contain _____% water to enhance its permeability to oxygen.
A) 10% - 20% D) 30% - 80%

B) 50% - 100% E) None of the above
C) 0.1% - 0.2%
242. It is a sample chosen in such a manner that one objective has a good chance of being selected as another.
A) QC sample D) Retention sample

B) Sample for monitoring E) In- process
C) Random sample
243. It is referred to as a step-by-step method on how to go about a job.
A) Specifications D) Formulation
B) Standard operating procedure E) None of the above
C) Official standards
244. This is a concise and precise statement of the ingredients that comprise the product, together with the %
and/or weight of each.
A) Formula D) Materials control

B) Standards E) Concentration
C) Specifications
245. A kind of product defect which may affect the function of the object and thus rendering the product useless
such as the presence of a crack in a bottle.
A) Critical defect D) Internal defect

B) Minor defect E) None of the above
C) Major defect
246. The following are factors that accelerate product instability, EXCEPT
A) Viscosity D) Method of manufacture

B) Moisture E) None of the above
C) Light
247. What is TRUE about expiration date?
1 - It is calculated by using the Arrhenius equation.
2 - It is a direct application and interpretation of the knowledge gained from stability testing.
3 - It does not limit the period during which a preparation is expected to have its labeled potency.
4 - It refers to the first day of the indicated month when it appears on the product label as month and year.
A) 4 only D) 3 & 4
B) 1&2 E) 3 only
C) 2 only
248. The following are chemical causes of product deterioration, EXCEPT
A) Racemization D)Decarboxylation
B) Dissolution E) None of the above
C) Precipitation
249. The problem of declining potency in an unstable preparation can be remedied by_____.
A) Reformulating the formulation. D)Add another ingredient to enhance the potency.

B) Change the active ingredient. E) Increase the concentration of the inert substance.
C) Addition of an overage of the active
ingredient.
250. A 15% decrease in potency of antibiotic products is considered admissible for unstable antibiotics, therefore,
addition of this overage to dry dosage forms should not be exceeded.
A) 15% D) 10%
B) 20% E) 30%
C) 25%
251. If the test results indicate that the raw material meets monograph specifications, the material is_____.
A) Submitted for quarantine D) Kept for storage

B) Returned to the warehouse E) Return to supplier
C) Approved for use
252. Approved raw materials are audited to assure that they are utilized in such a manner that the oldest stock is
used first. The policy employed is called_____.
A) In- process D) First in first out

B) Quarantine E) Random sampling
C) For sampling
253. These packaging materials come in direct contact with the product itself, EXCEPT the
A) Caps D) Seals
B) Plungers E) None of the above
C) Labels
254. Physical inspections for containers include the following criteria, EXCEPT
A) Extractable substances D) Light transmission

B) Finish E) None of the above
C) Leak
255. To check cap tightness, the_____ tester is used.
A) Pressure tester D)None of the above

B) Torque tester E) All of the above
C) Closure tester
256. It is the original document that is used as key in the production of products.
A) Monograph D) Standard operating procedure

B) Master Formula record E) Approved Quarantine Record
C) Batch Production Record
257. Which is not a control test for semisolid preparations?
A) Homogeneity D) Clarity
B) Softening range E) None of the above
C) Viscosity
258. Liquid preparations are subjected to the following control tests:
1- Texture, humidity effect, moisture content
2- Viscosity, isotonicity, pourability
3- Crystallization, precipitation, surface tension
4- Consistency, homogeneity, loss of water
A) 2&3 D) 2 & 4
B) 1&3 E) 1 & 2
C) 3&4
259. Which one of these is not a finely divided solid used as an emulsifying agent?
A) Aluminum hydroxide D) Magnesium trisilicate

B) Bentonite E) None of the above
C) Chondrus
260. These are aqueous liquid preparations which contain suspended, insoluble solid substances and which are
intended for internal use.
A) Mixtures D) Lotions
B) Milks E) Creams
C) Magmas
261. If the parts of a solvent required for one part of solute is from 30-100, the solute is said to be _____.
A) Soluble D) Sparingly soluble

B) Very slightly soluble E) Freely soluble
C) Slightly soluble
262. Which is NOT an advantage of tablets over the oral medications?
A) Precision of dosage D) Convenience of administration

B) Durability E) None o f the above
C) Unbreakability
263. The following are the essential components of a compressed tablet, EXCEPT
A) Bulking agent D) Disintegrant

B) Lubricant E) None of the above
C) Binder
264. The basic elements of a tablet press Are the following, EXCEPT
A) Hopper D) Ejector
B) Feed frame E) None of the above
C) Cam
265. A tablet processing problem wherein the tablet is separated into two or more distinct layers.
A) Chipping D) Picking
B) Capping E) Sticking
C) Lamination
266. It describes the adhesion of the granulation to the die wall.
A) Sticking D) Capping
B) Picking E) Lamination
C) Chipping
267. Variation in the weights of tablets during compression may be caused by
1- The size and distribution of the granules being compressed.
2- Poor flow resulting in incompletely-filled dies.
3- Poor mixing of the granulation.
4- Unequal length of the lower punches.
A) 1 only D) 1, 2 & 3
B) 1&2 E) 1, 2, 3 & 4
C) 2&3
268. The following are reasons for coating solid dosage forms, EXCEPT
A) To compressed reactive ingredients D) To delay or prolong absorption.

together.
B) To mask unpleasant taste. E) None of the above
C) For surface modification.
269. The basic processes used in the application of tablet coatings are the following, EXCEPT
A) Pan coating D) Tablet compression coating

B) Electrostatic coating E) None of the above
C) Dip coating
270. It is a type of suppository that is tapered at one end or both and which resembles a torpedo.
A) Vaginal suppositories D) Pessary suppositories

B) Rectal suppositories E) All of the above
C) Urethral suppositories
271. Which of the following is NOT a specification for an ideal suppository base?
A) Dissolves outside the body cavity D) Stable on storage

B) Nontoxic and non irritating to the E) None of the above
mucus membrane
C) Compatible with a variety of drugs
272. The most commonly used method for producing suppositories where the emulsified ingredients are poured in
a mould and allowed to cool in a refrigerator.
A) Hand moulding D) Compression in a tablet press

B) Cold compression E) Lyophilization
C) Melt moulding
273. The color of the skin is determined by the following factors:
1- The amount of melanin pigment in the epidermis
2- The presence of carotene in the epidermis
3- The proportion of reflected and scattered light
4- The amount of blood in the dermal and subcutaneous blood vessels
A) 1&2 D) 1, 2 & 3
B) 2&3 E) 1, 2, 3 & 4
C) 3&4
274. A class of cosmetic preparations which make water available to the stratum corneum and regulate the rate
and quantity of water uptake by the said layer are referred to as_____.
A) Emollient creams & lotions D) Suntan creams and lotions

B) Hand creams and lotions E) Body creams and lotions
C) Cleansing creams and lotions
275. Which type of creams and lotions that function to ameliorate skin complexion where the skin has become
mottled due to age or drug therapy?
A) Suntan cream D) Hand lotion

B) Skin lightener E) Body cream
C) Emollient cream
276. A cream and lotion preparation that prevents melanogenesis.
A) Suntan cream D) Hand lotion

B) Skin lightener E) Body cream
C) Emollient cream
277. Beeswax contributes to cream consistency and has the lowest melting points which generally form the
softest emulsions. Its melting range is_____.
A) 30º- 50º C D) 10º- 50º C

B) 70º- 100º C E) None of the above
C) 62º- 65º C
278. These ingredients are used to stiffen creams and prevent the bleeding of oils when the oil content is high.
1- Pilomotor agents 3- Ceresin
2- Ozokerite 4- Beeswax
A) 1 & 2 D) 3 & 4
B) 2 & 3 E) 2 & 4
C) 1 & 3
279. The ability to impart a velvety, peach like finish to the face is called____.
A) Bloom D) Absorbency
B) Covering power E) All of the above
C) Slip
280. For compact face powders, the type of binder represented by the following materials such as metallic
stearates may be used.
A) Water-soluble binder D) Dry binder

B) Emulsion binder E) None of the above
C) Oil binder
281. An eye makeup which may be manufactured in the form of cream, stick, liquid powder or pressed cake, and
may be applied dry or wet.
A) Mascara D) Eye cream

B) Eye shadow E) None of the above
C) Eyeliner
282. The basic ingredients of eye makeup include the following, EXCEPT
A) Carnauba wax D) Petrolatum

B) Wax rosin E) None of the above
C) Isopropyl myristate
283. Mouth preparations which are intended for use with a toothbrush for the purpose of cleaning the accessible
surfaces of the teeth are called_____.
A) Gargles D) All of the above

B) Mouthwash E) None of the above
C) Dentifrices
284. It is known as the process of removing relatively intact hair by uprooting.
A) Laser removal D) Depilation

B) Shaving E) None of the above
C) Epilation
285. Shampoo additives were developed to enhance acceptance and performance of shampoos. Antidandruff
agents are added which contain the following ingredients:
1- Sarcosinates 3- Lanolin derivatives
2- Selenium sulphide 4- Zinc pyrithrone
A) 2&4 D) 3 & 4
B) 1&2 E) 1& 4
C) 1&3
286. Shampoos are evaluated by the following performance properties, EXCEPT
A) Foam stability D) Consistency

B) Detergency and cleaning action E) None of the above
C) Body texture and set retention
287. The primary film former used in nail lacquers is _____.
A) Resin D) Nitroparaffins
B) Dioctyl phthalate E) None of the above
C) Nitrocellulose
288. Quality control checks for nail lacquers involve in the following, EXCEPT
A) Drying time D) Water resistance

B) Smoothness of flow E) None of the above
C) Fragrance blend
289. Perfume raw materials may be obtained from
1- Flower oils 3- Animal secretions
2- Resins 4- Isolates from plant materials
A) 1&2 C) 1 only
B) 2&3 D) 1, 2, 3 & 4
290. A fragrance type which is described to be a harmonious combination of two or more floral notes.
A) Bouquet D) Cologne blend

B) Floral E) None of the above
C) Fougere
291. It is the process of verifying, by data and analysis, that the design objectives of a given facility, a system
apparatus or procedures are reliably fulfilled in routine operation.
A) Inspection D) None of the above

B) Validation E) All of the above
C) Evaluation
292. It is the gathering and documentation of sufficient evidence to give reasonable assurance that the process
under review does what it purports to do.
A) Assay validation D) Validation of existing products

B) Process validation E) None of the above
C) Clearing validation
293. Non-compliance to CGMP can result in the following, EXCEPT
A) Quality variation D) All of the above

B) Contamination E) None of the above
C) Mix- ups and errors
294. Current Good manufacturing practice in manufacturing, processing, packing, or holding in the subject
of_____.
A) R.A. 3720 D) A.O. 60 series 1968

B) A.O. 150 series 1971 E) None of the above
C) A.O. 220 series 1974
295. What is NOT TRUE about cleanrooms?
1- Cleanrooms are sterile.
2- The air inside is constantly recirculated through HEPA and ULPA filters to remove internally generated
contaminants.
3- The equipment inside is designed to generate minimal air contamination.
4- Cleanrooms are kept at a positive pressure.
A) 1 only D) 3 & 4
B) 2 only E) 1, 2, 3 & 4
C) 1&3
296. According to the US FED Cleanrooms Standards, the maximum particles/ ft3 of ≥ 0.5 µm for a Class 100
room is_____.
A) 300 D) 1000
B) 750 E) 3000
C) 100
297. It is the process which involves finding the target ( receptors or enzymes) that causes or leads to the disease
with the use of new scientific approaches.
A) Drug discovery D) Drug manufacture

B) Drug development E) All of the above
C) Clinical trials
298. In the development stage or phase of drugs, the lead compounds are modified and synthesized to perform
the following tasks, EXCEPT
A) To improve their interactions with D) To satisfy the performance criteria

the targets
B) To reduce toxicity E) None of the above
C) To improve pharmacokinetic
performance
299. Which of the following are trends in drug discovery & development?
1- Irrational approach
2- Antisense approach
3- Molecular approach
4- Gene therapy
A) 1&2 D)1, 2, & 4

B) 3 only E) 1, 2, 3 & 4
C) 1, 2 & 3
300. Through the Human Genome project, many novel disease targets have been discovered, which can be
utilized to develop better and more effective drugs. Technologies to discover new drugs include the following,
EXCEPT:
A) High throughput screening D) None of the above

B) Genomics and proteomics E) All of the above
C) Nanotechnology
JURISPRUDENCE
ANSWER KEY:
1. It is the science of philosophy of laws.

a. Ethics
b. Jurisprudence
c. Morality
d. Rules &regulations
2. It is the science of morality
a. Ethics
b. Jurisprudence
c. Morality
3. They ensure the provision of safe, effective and quality drugs, for improved patient care and quality of life by
helping individual protect themselves against diseases, maintain good health and make the best use of their
medication.
a. Teachers
b. Pharmacists
c. Medical technologists
d. Veterinarians
4. It is identified by the willingness of individual practitioners to comply with ethical and professional standards
w/c exceeds minimum legal requirements.
a. Jurisprudence
b. Ethics
c. Both a & b
d. Profession
5. It refers to the ability to discern between right or wrong.
a. Ethical awareness
b. Laws
c. Ethical competency
d. Jurisprudence
6. It pertains to the ability to engage in sound moral reasoning and consider carefully the implications of
alternative actions.
a. Ethical awareness
b. Laws
c. Ethical competency
d. Jurisprudence
7. An establishment where pharmaceuticals, proprietary medicines or pharmaceutical specialists are prepared,
compounded, standardized, and distributed or sold.
a. Botica
b. Pharmaceutical laboratory
c. Pharmaceutical manufacturing lab
d. Both b and c
8. It is a method of secret writing that substitutes others letters or characters for the letter intended.
a. Code
b. Secret keys
c. Secrets clues
d. Cipher
9. It refers to viruses, sera, toxins and analogous products used for the preventions or cure of human diseases.
a. Biologic products
b. Poison
c. Device
d. Both a & c
JURISPRUDENCE
10. It is any drug, active principle or preparation of the same, capable of destroying life or seriously engaging
health when applied externally to the body or introduced internally in moderate doses.
a. Biologic products
b. Poison
c. Abortive drugs
d. All of the above
11. It means a system of words or others system arbitrarily used to prevent words.
a. Code
b. Secret keys
c. Secrets clues
d. Cipher
12. Characteristics styles or symbols kept from the knowledge of others or disclosed confidentially to only one or
a few.
a. Code
b. Secret keys
c. Secrets clues
d. Cipher
13. An articles used for food or drink for man.
a. Device
b. Drug
c. Food
d. poison
14. Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or
other animals.
a. Device
b. Drug
c. Cosmetics
d. Poison
15. Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the
human body or any part thereof for cleaning, beautifying, promoting attractiveness, or altering the
appearance.
a. Device
b. Drug
c. Cosmetics
d. Poison
16. An instrument, apparatus, or contrivances, including their components, parts, and accessories, intended for
use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.
a. Device
b. Drug
c. Food
d. Poison
17. A quality of any drug or device produced during a given cycle of manufacture.
a. Batch
b. Lot
c. Batch number
d. Lot number
18. The stated in the label of a drug or device after w/c the drug is not expected to retain its claimed safety,
efficacy, and quality or potency or after w/c it is not permissible to sell the drug or device.
a. Manufacturing date
b. Registration date
c. Production date
JURISPRUDENCE
d. Expiration date
19. Drugs intended for use for animals.
a. Poison
b. Antibiotics
c. New drugs
d. New veterinary drugs
20. Any drug intended for use by man containing of any chemical substance w/c is produced by microorganism
and w/c has the capacity to inhibit or destroy microorganism in dilute solution.
a. Poison
b. Antibiotics
c. New drugs
d. New veterinary drugs
21. Any ingredient intended for use in the manufacturing of drug including those that may not appear in the
finished product.
a. Component
b. Raw materials
c. New drug
22. Any substance other than “active ingredient” present in a drug.
a. Raw material
b. Minute organism
c. Microorganism
d. Inactive ingredient
23. The concentration of known active drug substance in formulation.
a. Strength
b. Net content
c. Component
d. Stability
24. Articles (other than food) intended to affect the structure or any function of the body of man and recognized
in the Philippine National Formulary.
a. Medical plants
b. Brand name
c. Both a & b
d. Generic name
25. It refers to the proprietary name assigned to the product by the drug establishment.
a. Trade name
b. Brand name
c. Both a & b
d. Generic name
26. It refers to the identification of drugs and medicines by their scientifically and internationally recognized
active ingredient as determined by the BFAD of the Department of Health.
a. Trade name
b. Brand name
c. Both a & b
d. Generic name
27. Refers to the name/s and amount/s of active ingredients per dosage unit expressed in metric system.
a. Net content
b. Formulation
c. Strength
d. Potency
JURISPRUDENCE
28. It refers to the classification of the product based on its therapeutic action as specified in the product
registration.
b. Indication
c. Dosage form
d. Dosage formulation
29. It refers to the approved clinical use of the product based on substantial and scientifically supported
evidence of the safety and efficacy of the drug in the given dosage form.
b. Indication
c. Dosage form
30. It is the pharmaceutical form of the preparation based on official pharmacopoeia.
b. Indication
c. Dosage form
31. It refers to the site and manner the product is to be introduced into or applied on the body.
a. Device
b. Direction for use
c. Mode of administration
d. Route of administration
32. It refers to the statements regarding the occurrence of potential hazards and side effects associated with the
use of the product and the limitations of its use.
a. Contraindications
b. Warning
c. Precautions
d. Indication
33. It refers to the statements regarding the condition wherein the use of the product may cause harm to the
patient.
b. Warning
c. Precautions
d. Indication
34. It refers to the instructions and special care required in the use of product to avoid undesired effects and to
ensure the safe and effective use of the drug.
b. Warning
c. Precautions
d. Indication
35. It refers to the total amount/ quantity/ number of the dosage form in a certain container of a product
expressed in metric system.
a. Volume
b. Strength
c. Net content
d. Potency
36. Refers to the part of the label that is most likely to be displayed, presented, shown or examined under
customary condition of display for retail use.
a. Principal display panel
b. Primary pack
c. Area of the principal display panel
JURISPRUDENCE
d. Inserts
37. The first pack containing the individually wrapped products, strip, or blister packs.
a. Wrapper cartons
b. Inserts
c. Primary pack
d. Leaflets
38. Any establishment w/c is a registered owner of the drug product, procures the raw materials and packing
components, and provides the production monographs, quality control standards and procedures, but
sub-contracts the manufacturer of such product to a licensed manufacturer.
a. Drug Manufacturer
b. Drug trader
c. Drug Importer
d. Drug Exporter
39. The process of approval for the manufacture, importation, exportation, sale, offer for sale, distribution or
transfer of pharmaceutical products containing active ingredient/s of known chemical structure and
properties determined to be safe, efficacious, and of good quality according to standards of BFAD.
a. CGMP
b. Registration
c. Assay
d. Drug Evaluation
40. A drug approved for sale to the general public under certain conditions.
a. Drug for Restricted Use
b. Drug for General Use
c. Drug for Limited Use
d. Drug for Registration
41. A drug which has been used for at least five years and involving at least 5,000 patients.
a. Investigational drugs
b. Established drugs
c. New drugs
d. Tried & tested drugs
42. It is a drug, the safety and efficacy of which has been demonstration through long years of general use and
can be found in the current official USP-NF, and other internationally recognized pharmacopeias.
a. Investigational drugs
b. Established drugs
c. New drugs
d. Tried & tested drugs
43. In Human Studies- Clinical Pharmacology Phase III.
a. Controlled Clinical Trials
b. Safety and Efficacy
c. Tolerance and Safety
d. Post marketing Surveillance
44. It is certification issued after a batch of antibiotics has been found to comply with the characteristics of
identity, strength, quality and purity.
a. Certification of Good Standing
b. Batch Certification
c. Certification of Product Registration
d. CGMP
45. It refers to standards and procedures whereby the laboratory achieves a defined, consistent and reliable
standard in performing laboratory tests and activities.
a. GMP
b. GCP
JURISPRUDENCE
c. GLP
d. CPR
46. It is a document issued by the BFAD for the purpose of marketing, use or free distribution of a product in the
Philippines.
a. Certification of Good Standing
b. Batch Certification
c. CGMP
d. CPR
47. It refers to the standards and procedures for clinical trials that encompasses the design, protocol approval,
conduct, monitoring, termination, audit, analyses, reporting and documentation of human studies.
a. GMP
b. GCP
c. GLP
d. CPR
48. It means the label on or affixed to an immediate container.
a. Outer label
b. Inner label
c. Immediate label
d. Packaging display panel
49. It means a display of written, printed or graphic matter upon any article or any of its containers or wrappers
or attached to or accompanying such articles.
a. Principal display panel
b. Leaflets
c. Labels
d. Packaging material
50. It is a drug which contains no amount of, or a different active ingredient, or less than 80% of the active
ingredient it purports to possess, as distinguished from an adulterated drug including reduction or loss of
efficacy due to expiration.
a. Counterfeit drug
b. New drug
c. Investigational drug
d. Tried and tested drug
51. It refers to drug products indicated for life threatening conditions.
a. Lifesaving drugs
b. Counterfeit drugs
c. Drugs for limited used
d. Drugs for restricted use
52. It is a policy and program of the national government to ensure that safe and effective drug are made
available to all Filipino at any time and place and at a reasonable and affordable cost.
a. National Drug Policy
b. National Drug Formulary
c. National Drug Committee
53. It is composed of a sore list of medicines essential and a complementary list of drugs considered useful if
not essential.
54. It is a team of pharmacologists, pharmacists, and clinicians whose main tasks are to prepare the National
Drug Formulary and recommend to the BFAD the drug for delisting.
JURISPRUDENCE

55. It is the description of the chemical structure of the drug or medicine and serves as the complete
identification of a compound.
a. Chemical name
b. Generic name
c. INN
d. Both b and c
56. It is the finished product from that certain the active ingredients, generally but not necessarily in association
with inactive ingredient.
a. Drug product
b. Generic drug
c. Essential drug
d. Drug innovator
57. It is a list of drug that meets the care needs of majority of the population.
a. EDL
b. Complementary list
c. NDF
d. Core list
58. It is the written order and instruction of a validly registered physician, dentist or veterinarian for the use of a
specific drug product for a specific patient.
a. Prescription
b. Medical chart
c. Purchase slip booklet
59. It is the act by a validly registered pharmacist of filling a prescription or doctor’s order on the patient chart.
a. Delivering
b. Selling
c. Dispensing
d. Trading
60. It refers to either prohibited or regulated drugs which require a special prescription form.
a. Ethical drugs
b. OTC drugs
c. Prescription drugs
d. Dangerous drugs
61. These drugs may be dispensed even without a written order of a validly registered physician, dentist or
veterinarian in duly licensed drug outlets.
a. Ethical drugs
b. OTC drugs
c. Prescription drugs
d. Dangerous drugs
62. Any resident citizen of the Philippines at least sixty years old.
a. Senior citizen
b. Neonates
c. Elderly
d. Both a and c
63. Any person whether related to the senior citizens or not who takes care of him/her as a dependent.
a. Head of the family
b. Benefactor
JURISPRUDENCE
c. Beneficiary
d. Protector
64. It refers to the branch of medical science devoted to the study to the biological and physical chances and the
diseased of old age.
a. Pediatrics
b. Pharmacy
c. Geriatrics
d. Orthodontics
65. It means a natural person who is a purchaser, lessee, recipient or prospective, purchaser, leaser or
recipient of consumer products, services or credit
a. Creditor
b. Consumer
c. Customer
d. Owner
66. It means any substance w/c on contact with living tissue will cause destruction of tissue by chemical action.
a. Corrosive
b. Poison
c. Antibiotics
d. Biological
67. ----
a. -
b. -
c. -
d. -
68. It means any device, written, printed, affixed or attached to a consumer product or displayed in a consumer
repair or service establishment for the purpose of indicating the retail price per unit or service.
a. Label
b. Price tage
c. Sticker
69. Any person engaged in the business of selling consumer products directly to consumers.
a. Supplier
b. Exporter
c. Telemarketing
d. Retailer
70. It means a set of conditions to be fulfilled to ensure quality and safety of a product.
a. Standard
b. Services
c. Labor
71. It includes rice, corn, bread, fish and drugs classified as essential by the department of health.
a. Basic necessities
b. Prime commodities
c. Primary needs
72. It is contingent fund in the budget of the implementing agency w/c shall not be used in normal or regular
operation.
a. Petty cash
b. Buffer fund
c. Both a and b
d. Nota
JURISPRUDENCE
73. It is the abnormal phenomenon where consumers buy basic necessities and prime commodities grossly in
excess of their normal requirement resulting in undue shortages of such goods to the prejudice of less
privileged consumers.
a. Hoarding
b. Panic buying
c. Cartel
d. Profiteering
74. It is the maximum price at which any basic necessities or prime commodities may be sold to the general
public.
a. Prevailing price
b. Price ceiling
c. Discounted price
d. 50% off of the original price
75. It is the undue accumulation by a person or combination of person of any basic necessity beyond his or their
normal inventory levels.
a. Hoarding
b. Panic buying
c. Cartel
d. Profiteering
76. The sale or offering for sale of any basic necessity or prime commodity at a price grossly in excess of its true
worth.
a. Hoarding
b. Panic buying
c. Cartel
d. Profiteering
77. It is any combination of or agreement between two or more persons engaged in the production,
manufacture, processing, storage, supply, distribution, marketing, sale or disposition of any basic necessity
or prime commodity design to artificially and unreasonably increased or manipulate its price.
a. Hoarding
b. Panic buying
c. Cartel
d. profiteering
78. An analytical test using a device, tool or equipment with a different chemical or physical principle that is
more specific which will validate and confirm the result of the screening test.
a. Confirmatory test
b. Drug test
c. Drug analysis
79. Any act of knowingly planting, growing, raising, or permitting the planning of any plant which is the source of
dangerous drugs.
a. Cultivate
b. Culture
c. Pusher
d. Both a and b
80. Any act of knowingly passing a dangerous drug to another, personally or otherwise, and by any means, with
or without consideration.
a. Cultivate
b. Deliver
c. Culture
d. Both a and c
JURISPRUDENCE
81. The illegal cultivation, culture, delivery, administration, dispensation, manufacture, sale, trading,
transportation, distribution, importation, exportation and possession of any dangerous drugs and dangerous
drugs and/or controlled precursor and essential chemical.
a. Illegal trafficking
b. Illegal cultivation
c. Illegal selling
d. Illegal possession
82. Indian hemp.
a. Marijuana
b. Hashish
c. Bhang
d. All of the above
83. Ecstasy.
a. Methylenedioxymethamphetamine
b. Methyldioxymethamphetamine
c. MMCA
d. Methamphetamine Hydrochloride
84. Shabu.
a. Methylenedioxymethamphetamine
b. Methyldioxymethamphetamine
c. MMCA
d. Methamphetamine Hydrochloride
85. A rapid test performed to establish potential/ presumptive positive result.
a. Confirmatory test
b. Screening test
c. Test analysis
d. Laboratory test
86. Any person who is licensed physician, dentist, chemist, medical technologist, nurse, midwife, veterinarian or
pharmacist in the Philippines.
a. Practitioner
b. Coddler
c. Test analysis
d. Laboratory test
87. Any person, who sells, trades, administers, dispenses, delivers, or gives away to another, on any terms
whatsoever, or distributes, dispatches in transit or transport dangerous drugs or who act as a broker in any
such transactions.
a. Practitioner
b. Coddler
c. Protector
d. Pusher
88. It is a license issued by the Director General of the Intellectual Property Office (IPO) to exploit a patented
invention without the permission of the patent holder, either by manufacture or through parallel importation.
a. Certificate of Product Registration
b. Compulsory license
c. Batch certificates
d. NOTA
89. It refers to drugstores, pharmacies, and other business establishment which sell drugs and medicines.
a. Drug Outlet
b. Drug Establishment
c. Drug laboratory
d. Both a and c
JURISPRUDENCE
90. It refers to pharmaceutically equivalent or pharmaceutically alternative products that may or may not be
therapeutically.
a. Multisource pharmaceutical products
b. Multi-pharmaceutical products
c. Source pharmaceutical products
d. Pharmaceutical products
91. It refers to the international agreement administered by the WTO that sets down minimum standards for
many forms of intellectual property regulations.
a. TRIPS Agreement
b. WTO agreement
c. Agreement on Trade-Related Aspects of Intellectual Property Rights
d. Both a and c
92. Any change in law can be done by passing a/an.
a. Memorandum order
b. Amendments
c. Bill
d. Administrative order
93. If the entire batch of products is marketed under one company, only the lot number needs to be indicated.
a. The statement is incorrect
b. The statement is correct
c. Both the batch and the lot number should be indicated
d. Only the registration number is needed
94. The minimum age requirement to practice pharmacy in the Philippines.
a. 18
b. 19
c. 20
d. 21
95. The book kept for the purpose of recording the sale of violent poisons should be preserved for a period of.
a. 1 year
b. 2 years
c. 4 years
d. 5 years
96. Ordinary prescription shall be retained by the pharmacist for a period of.
a. 1 year
b. 2 years
c. 4 years
d. 5 years
97. Dangerous drug prescription shall be retained by the pharmacist for a period of.
a. 1 year
b. 2 years
c. 4 years
d. 5 years
98. The Rx symbol is required in the label of.
a. Ethical drugs
b. Over the counter drugs
c. Prescription
d. Both a and c
99. Applicable S-tax for prescription of dangerous drugs.
a. S-1
b. S-2
c. S-3
JURISPRUDENCE
d. S-4
100. Drug Registration of Herbal and/or Traditional Drugs (Local & Imported).
a. A.O. 63
b. A.O. 62
c. A.O. 42
d. A.O. 55
101. Revised Rules and Regulations to Implement Dispensing Requirement under the Generics Act of 1988.
a. A.O. 63
b. A.O. 62
c. A.O. 42
d. A.O. 55
102. Revised Rules and Regulations to Implement Prescribing Requirement under the Generics Act of 1988.
a. A.O. 63
b. A.O. 62
c. A.O. 42
d. A.O. 55
103. Amendment to A.O. 62.
a. A.O. 55
b. A.O. 90
c. A.O. 42
d. A.O. 56
104. Requirements for Labeling Materials of Pharmaceuticals Products.
a. A.O. 55
b. A.O. 90
c. A.O. 42
d. A.O. 56
105. Revised Regulations for Licensing of Drug Establishments and Oulets.
a. A.O. 42
b. A.O. 90
c. A.O. 64
d. A.O. 56
106. Amendments of A.O. 55.
a. A.O. 67
b. A.O. 90
c. A.O. 64
d. A.O. 56
107. Revised Rules and Regulation of Registration of Pharmaceutical Products.
a. A.O. 67
b. A.O. 90
c. A.O. 64
d. A.O. 56
108. The University Accessible Cheaper and Quality Medicines Act of 2008 is known as R.A.
a. 9257
b. 9502
c. 9165
d. 9205
109. The Comprehensive Dangerous Drug Act of 2002 known as R.A.
a. 9257
b. 9502
c. 9165
d. 9205
JURISPRUDENCE
110. The Expanded Senior Citizens Act of 2003 known as R.A.

a. 9257
b. 9502
c. 9165
d. 9205
111. The Pharmacy Law is known as R.A.
a. 5921
b. 6675
c. 3720
d. 8205
112. The Special Law on Counterfeit Drug is known as R.A.
a. 5921
b. 6675
c. 3720
d. 8203
113. The Generics Acts of 1988 is known as R.A.
a. 5921
b. 6675
c. 3720
d. 8203
114. The Foods, Drugs, Devices and Cosmetics Acts is knows as R.A.
a. 5921
b. 6675
c. 3720
d. 8203
115. The Price Act is Known as R.A.
a. 7432
b. 7581
c. 8293
d. 7394
116. The Consumers Act of the Philippines is known as R.A.
a. 7432
b. 7581
c. 8293
d. 7394
117. The Intellectual Property Code of the Philippines is known as R.A.
a. 7432
b. 7581
c. 8293
d. 7394
118. The Senior Citizens Act is known as R.A.
a. 7432
b. 7581
c. 8293
d. 7394
119. Filling and refilling of prescription shall be done by.
a. Intern with the supervision of the registered pharmacist
b. RPh
c. pharmacist
d. supervisor
JURISPRUDENCE
120. A certain drug is considered counterfeit if it contains less than how many percent of the active ingredient it
purports to possess?
a. 10
b. 40
c. 80
d. 95
121. The principal Display Panel comprises __% of the total surface of the container.
a. 10
b. 40
c. 80
d. 95
122. The test for alcohol content for registration of herbal and/or tradition drug should not be more than __%.
a. 10
b. 40
c. 80
d. 95
123. Amount of marijuana subject to life imprisonment to death and a fine ranging from 500,000 pesos to 10M
pesos.
a. 500 g
b. 10 g
c. 50 g
d. 40 g
124. Amount of shabu subject to life imprisonment to death and a fine ranging from 500,000 pesos to 10M pesos.
a. 500 g
b. 10 g
c. 50 g
d. 40 g
125. Amount of opium subject to life imprisonment to death and a fine ranging from 500,000 pesos to 10M pesos.
a. 500 g
b. 10 g
c. 50 g
d. 40 g
126. Amount of heroin subject to life imprisonment to death and a fine ranging from 500,000 pesos to 10M pesos.
a. 500 g
b. 10 g
c. 50 g
d. 40 g
127. The confiscated or seized dangerous drug, plant sources, controlled precursor and essential chemicals shall
be submitted to the PDEA Forensic Laboratory for a quantitative examination within.
a. 12 hour
b. 48 hour
c. 24 hour
d. 16 hour
128. If the seized drug was found to be counterfeit, the business establishment must be directed for preventive
closure for a period of.
a. 12 days
b. 15 days
c. 60 days
d. 30 days
129. Duration of the conduct of examination in determining the genuineness and authenticity of the product by the
bureau:
JURISPRUDENCE
a. 10 working days
b. 20 working days
c. 16 working days
d. Within 24 hours
130. The senior citizen shall be entitled the grant of ___discount for the consumption of electricity, water and
telephone by the senior citizens center and residential care/group homes that are non-stock, non-profit
domestic corporation:
a. 20%
b. 50%
c. 10%
d. 5%
131. The senior citizens shall be entitled the grant of ___ discount from all establishments relative to the
utilization of transportation services, restaurants and purchase of medicines anywhere in the country,
including funeral and burial services for the death of the senior citizens:
a. 20%
b. 50%
c. 10%
d. 5%
132. Re-application of the LTO after revocation may be done within ___ year/s:
a. 2
b. 3
c. 1
d. 5
133. The decision of the Board of Pharmacy in administrative cases involving a pharmacist becomes final and
executor after the lapses of:
a. 15 days
b. 60 days
c. 30 days
d. NMT 6 months from notice to respondents
134. Number of years of pharmacy practice for the pharmacist to qualify as board examiner:
a. 5 years
b. 10 years
c. 15 years
d. 20 years
135. R.A. 9165 was signed into law on:
a. June 7, 2002
b. February 26, 2004
c. June 23, 1969
d. June 23, 1963
a. June 7, 2002
c. June 23, 1969
d. June 23, 1963
a. June 7, 2002
c. June 23, 1969
d. June 23, 1963
a. June 7, 2002
JURISPRUDENCE

c. June 23, 1969
d. June 22, 1963
139. R.A. 7394 was signed into law on :
a. April 13, 1992
c. February 7, 1992
d. September 13, 1988
a. April 13, 1992
c. February 7, 1992
a. April 13, 1992
c. February 7, 1992
142. This is the division of the BFAD that provides assistance to person/establishment in complying with BFAD
legal requirements:
a. Product services
b. Laboratory services
c. Legal, information and compliance
d. Administrative
143. The division of BFAD that certifies batches of antibiotics:
a. Product services
d. Administrative
144. The division of BFAD that is involve in cash collection:
a. Product services
d. Administrative
145. The permanent consultant/s of the Dangerous Drug Board:
a. PNP chief
b. NBI director
c. Both a and b
d. Secretary of Health
146. The Board of Pharmacy is composed of a Chairman and ___ members:
a. 4
b. 3
c. 2
d. 5
147. A complete pharmacy internship program based on R.A 5921 article III sec 18c shall consist of:
a. 480 hours
b. 640 hours
c. 960 hours
d. 980 hours
148. Upon finding that the drugs are counterfeit, the Bureau shall file an appropriate proceeding against the
registered pharmacist with the PRC for the ____ of professional license:
JURISPRUDENCE
a. Suspension
b. Cancellation
c. Revocation
d. Both a and b
149. Executive order which is responsible in reorganization of the BFAD:
a. 175
b. 851
c. 119
d. 174
150. The following are list of drugs that are subject to price regulations under R.A. 9502, except:
a. Drugs for the treatment of PTB
b. Drugs for the treatment of SLE
c. Drugs for the treatment of BSE
d. Drugs for the treatment of HIV-AIDS
151. Drug test certificates issued by accredited drug testing centers shall be valid for __ period from the date of
issue:
a. 2 years
b. 1 year
c. 3 months
d. 6 months
152. Responsible in granting a license to exploit a patented invention, even without the agreement of the patent
owner, in favor of any person who has shown the capacity to exploit the invention:
a. Director General of the IPO
b. Director General of PDEA
c. Director of NBI
d. Director of BFAD
153. Additional label to be attached to poisons:
a. Warning: may be habit-forming
b. Warning: it is Toxic
c. A vignette of skull and bones
d. For internal use
154. The designated person of a manufacturing company who will transact officially with the Bureau:
a. Branch pharmacist
b. Liaison officer
c. Detailman
d. Supervisor
155. The net content of the liquid dosage form must be expressed using
a. Arabic numerical and Avoirdupois system
b. Metric
c. Arabic numeral and metric system
d. Roman numeral and Avoirdupois system
156. Which of the following statement indicates that product is a prescription drug?
a. RX symbol
b. For external use
c. A vignette of skull and bones
d. “shake well”
157. In the labeling requirements, the generic name must be:
a. Enclosed by an outline circle
b. Smaller font size than the brand name
c. Written after the brand name
d. Printed in full and not abbreviated
JURISPRUDENCE
158. According to A.O. 55, under the formulation, drugs with multiple components must be arrange in order of:
a. Decreasing pharmacologic activity
b. Increasing pharmacologic activity
c. Alphabetically
d. According to use
159. Authorized to established and initiate a price monitoring and regulation system for drugs and medicines:
a. Secretary of the DOH
b. Secretary of the DTI
c. Secretary of the DENR
d. Both b and c
160. The one responsible in ensuring that all drugs authorized for marketing in the country conform to
international standards for the content, purity and quality of pharmaceutical products as established in the
International Pharmacopoeia is :
a. BFAD
b. DTI
c. DOH
d. DOST
161. For products containing 3 or more active ingredients, the official name for the combination shall be
designated by:
a. DOST
b. DTI
c. DOH
d. BFAD
162. The potency of biological product must be expressed in :
a. Metric system
b. Apothecary
c. International unit
d. Avoirdupois
163. The word “single use” must be included in the label of :
a. Biological products
b. Small containers
c. Individually wrapped products
d. Large volume injection
164. The BFAD must be notified of such change in the establishment:
a. Change the manager
b. Change of pharmacist-in-charge
c. Change of product arrangement
d. Change of supervisor
165. The following must be displayed conspicuously inside the drug outlet:
a. Certificate of product registration
b. Diploma of the pharmacist-in-charge
c. Certificate of registration of the pharmacy
d. Certificate of registration of the pharmacist-in-charge
166. Basis for non-renewal of LTO of Drug Outlet and Drug Establishment:
a. Failure to comply with PRC standards and requirements
b. Serious repeated or rampant violation of existing laws, rules and regulation
c. Persistent performance that assures the safety, efficacy and quality of drug products
d. Poor housekeeping
167. Grounds for suspension of LTO of Drug Establishment:
a. Lapses in record keeping of invoices
b. Sales of antibiotics without batch certification
JURISPRUDENCE
c. Selling of misbranded drug

d. Serious repeated or rampant violation of existing laws, rules and regulations
168. These are drugs found in the USP/NF and is considered safe and efficient through long years of general
use.
a. Investigational
b. Established
c. New
d. Tried and tested
169. Requirements for product registration, except:
a. Price
b. Brand identification
c. Prescribing and dispensing regulations applicable
d. Available scientific evidence
170. The source or circumstance of drug production is/are:
a. Imported as finished
b. Locally manufactured from local materials
c. Locally manufactured from imported materials
d. All of the above
171. Drug classification based on source:
a. Branded and patented
b. Imported as finished
c. Unbranded and off patent
d. Both a and c
172. In a drug establishment, personnel responsible for directing the manufacture and control must:
a. Be inadequate in number
b. Graduate of any 4 year course
c. Have capabilities to commensurate with assigned function
d. Experience is not necessary
173. The amount of reserve sample of all ingredients to be kept for all required tests in the laboratory to be
performed are:
a. 5x
b. 3x
c. 2x
d. 4x of the quantity needed
174. Raw materials must not be accepted if there is:
a. Breakage of seal
b. Damage on the counter
c. Contamination in transit
d. All of the above
175. Registration of herbal and/or traditional drugs must be renewed every:
a. Year
b. 2 years
c. 3 years
d. 5years
176. Heavy metals to be tested in the herbal and/or traditional drugs except:
a. Hg
b. Pb
c. As
d. Cu
177. Requirements for registration of local herbal and/or traditional drugs :
a. Technical specification of the ingredients used as components
JURISPRUDENCE
b. Government certificate of clearance

c. Free sale of drug
d. Certification of the importation of the drug
178. The discount privileges of the senior citizen shall be:
a. Transferable but limited sue only for the senior citizen
b. Non-transferable
c. Limited and exclusive for the benefits of the senior citizen
d. Both b and c
179. Violation of any provision of Senior Citizen Act is punishable by:
a. A fine not exceeding 2,000 pesos
b. Imprisonment of NLT 6 months but NMT 2 years for the first offense
c. Imprisonment not exceeding 2 months
d. A fine of 5,000 pesos but not exceeding 10,000 pesos
180. A drug product prescribed which is not registered at BFAD is considered a type of:
a. Impossible RX
b. Violate RX
c. Erroneous RX
d. Coded RX
181. The pharmacist received a prescription wherein the generic name does not correspond to the brand name,
the pharmacist:
a. Shall advise the prescriber of the problem
b. Must instruct the customer to get the proper prescription
c. Both a and b
d. May dispense of fill the said prescription
182. Under RA 6675, which of these prescriptions shall be filled:
a. Violative Rx
b. Erroneous Rx
c. Impossible Rx
d. Both a and c
183. Which among the agency given below has the power to reclassify, add to, or remove any drug from the list
of dangerous drugs?
a. DDB
b. PDEA
c. BFAD
d. NBI
184. Head of PDEA
a. NBI Chief
b. PNP Chief
c. Secretary of Health
d. Director General
185. First time minor offender is one who is:
a. Over 25 years but NMT 18 years old
b. Not below 12 but NMT 20 years old
c. Not below 10 but NMT 15 years old
d. Not below 25 but NMT 20 years old
186. Prescription for dangerous drugs are written in:
a. Duplicate
b. Triplicate
c. One copy
d. Any of the above
187. Absence of pharmacist in a drugstore on three inspections by BFAD inspection is ground for:
JURISPRUDENCE
a. Cancellation of the professional license of the said pharmacist

b. Suspension of the LTO
c. Revocation of the LTO
d. Temporary closure
188. Failure to properly record dangerous drugs as determined by the DDB in a drug outlet is a ground for:
189. Misinterpretation of any material fact in the application of LTO for a drug establishment is ground for:
190. Non-pharmacist may own and open a drugstore provided that there is a :
a. Supervisor
b. Pharmacist assistant
c. Pharmacy technician
d. Registered pharmacist
191. The sale of physician’s sample is prohibited under RA:
a. 3720
b. 5921
c. 6675
d. 9502
192. In order to pass the Pharmacy Board Examination, a candidate must obtain on the basis of 100% a general
average of 75% or over, with no ratings below 50% in
a. More than 2 subjects
b. More than 3 subjects
c. One subject
d. More than 4 subjects
193. The BOP, upon receipt of a formal complaint under oath against any pharmacist, shall furnish the latter copy
of the complaint which he shall answer within:
a. 30 days
b. 10 days
c. 60 days
d. 6 months from receipt
194. Any product that is not labeled in accordance with the requirements of A.O. 55 shall be deemed:
a. Misbranded
b. Conforms with the USP-NF standards
c. Both a and b
d. NOTA
195. The following are exempted from complying with the labeling requirements, except:
a. If the products are used solely for investigational use
b. If the products are compounded by the pharmacist
c. Established drugs
d. If the products are donated by foreign agencies
196. The BFAD shall be headed by a:
a. President
b. Secretary
c. Director
d. Commissioner
JURISPRUDENCE
197. Any person desiring to operate or establish a drug establishment shall file with the BFAD an application
supported by the following documents, except:
a. Red & white labels indicating the name of the drugstore
b. Proof of registration
c. List of products to be manufactures identified by its generic and brand names
d. Current PTR of the pharmacist-in-charge
198. Any herbal and/or traditional drug the registration of which is not intended to be renewed may be given an
extension of NMT
a. 30 days
b. 10 days
c. 60 days
d. 6 months after the expiry date of such registration
199. Example of diagnostic reagents required to be registered:
a. Skin traction kit
b. Pregnancy test kits
c. Plaster bags for blood transfusion
d. blood
200. Example of a medical device required to be registered:
d. blood
201. Example of a product not required to be registered:
d. blood
202. Unless otherwise declared by the President, prices of the basic necessities in an area shall automatically be
frozen at their prevailing prices of placed under automatic price control whenever that area is:
a. Declared to be in a state in rebellion

b. Is placed under martial law
c. Is under a state of calamity
d. All of the above
203. Based on RA 9165, sec. 15, the penalty imposed upon any person apprehended or arrested for the first
time, who is found to be positive for use of any dangerous drug, after a confirmatory test is:
a. A minimum of 6 months rehabilitation in a government center
b. Imprisonment ranging from 6 years and one day to twelve years
c. A fine of 50,000 pesos to 20,000 pesos
d. Both b and c
204. Based on RA 9165, sec. 15, the penalty imposed upon any person apprehended or arrested for the second
time, who is found to be positive for use of any dangerous drug, after a confirmatory test is:
a. A minimum of 6 months rehabilitation in a government center
b. Imprisonment ranging from 6 years and one day to twelve years
c. A fine of 50,000 pesos to 20,000 pesos
d. Both b and c
205. Serves as the implanting arm of the DDB:
a. BFAD
b. DOH
c. NBI
JURISPRUDENCE
d. PDEA
206. A food shall be deemed to be misbranded if:
a. It consists in whole or in part of any filthy or putrid substances
b. Its labeling is false or misleading
c. It contains any poisonous or deleterious
d. Both a and c
207. A food shall be deemed to be adulterated if:
a. It consists in whole or in part of any filthy or putrid substances
b. Its labeling is false or misleading
c. It contains any poisonous or deleterious
d. Both a and c
208. The members of the board of Pharmacy are appointed by the:
a. PRC commisioner
b. PACOP President
c. PPhA President
d. President of the Philippines
209. To recognize and accredit colleges and schools of pharmacy in the different colleges and universities is a
function of:
a. Board of Pharmacy
b. PRC
c. Council of Pharmaceutical Education
d. PPhA
210. To reprimand any erring pharmacist or to suspend or revoke his certificated of registration is a function of:
a. Board of Pharmacy
b. PRC
c. Council of Pharmaceutical Education
d. PPhA
211. The minimum mandatory requirements necessary for the opening and operation of drugstores and
pharmacies shall be in accordance with the rules and regulations prescribed by the:
a. BFAD
b. DOH
c. DDB
d. PDEA
212. An act regulating the practice of pharmacy and setting standards of pharmaceutical education in the
Philippines and for other purposes:
a. RA 3720
b. RA 5921
c. RA 9165
d. RA 9502
213. An act providing for cheaper and quality medicines, amending for the purpose RA 8293, RA 6675, and RA
5921, and for other purposes:
a. RA 9165
b. RA 9257
c. RA 9502
d. RA 8485
214. An act to promote, require, and ensure the production of an adequate supply, distribution, use, and
acceptance of drugs and medicines identified by their generic names:
a. RA 3720
b. RA 6675
c. RA 9165
d. RA 9502
JURISPRUDENCE
215. An act instituting the Comprehensive Dangerous Drugs Act of 2002, repealing RA 6425, as amended,
providing funds therefore, and for other purposes:
a. RA 3720
b. RA 6675
c. RA 9165
d. RA 9502
216. An act to ensure the safety & purity of foods & cosmetics, and the purity, safety, efficacy, and quality of drugs
and devices being made available to the publie, vesting the BFAD with authority to administer & enforce the
laws pertaining thereto, & for other purposes:
a. RA 3720
b. RA 6675
c. RA 9165
d. RA 9502
217. A candidate for Pharmacy board examination in the Philipines shall have the following qualification/sL
a. Natural-born Filipino citizen
b. Graduated with any four year course
c. Of good moral character
d. All of the above
218. What type of for was specified for printing the generic name if the name if the product is presented using a
special typeface exclusively designed for it?
a. Comic sans
b. Helvetica medium
c. Universe medium
d. Both b and c
219. Additional information for injections:
a. Recommended routes of administration
b. “Single use” or “Single dose”
c. Neither a nor b
d. Both a and b
220. In accordance to AO 56, s. 1989, the initial LTO has a validity of ___ years:
a. 5
b. 3
c. 2
d. 1
221. Under AO 56,s. 1989, the renewal of the LTO has a validity of ___ years:
a. 5
b. 3
c. 2
d. 1
222. Under RA 9165, the penalty of 12 years and one day to 20 years of imprisonment and a fine of
100,000 pesos to 500,000 pesos shall be imposed upon any person who acts as a:
a. coddler
b.
c. protector
d. either a or c
223. -
a. -
b. -
c. -
d. -
JURISPRUDENCE
224. -
a. -
b. -
c. Melting point
d. Dissolution
225. -
a. -
b. -
c. 222
d. 221
226. -
a. -
b. -
c. EO 175
d. EO 815
227. -
a. -
b. -
c. OSCA
d. PHILHEALTH
228. -
a. -
b. -
c. Any of the above
d. NOTA
229. -
a. -
b. -
c. Corazon C. Aquino
d. Ramon Magsaysay
230. CGMP means:
a. Current good manufacturing practice
b. Current good manufacturing process
c. Current good manufacture process
d. Current good manufacturing procedure
231. Which of the following is exempted in the labeling requirement?
a. Large volume injection
b. Product for external use
c. Products placed in small containers
d. Drugs for investigational purposes
232. Pharmacy Licensure Examination in the Philippines is held:
a. Once a year
b. Twice a year
c. Every other year
d. Every December
233. Refusal to allow entry of BFAD inspector is penalized by:
a. Suspension of LTO
b. Revocation of LTO
c. Temporary closure
JURISPRUDENCE
d. Cancellation of LTO
234. It is composed of a core list of medicines considered essential and a complimentary list of drugs considered
useful if not essential:
a. MIMS
b. PDR
c. Goodman & Gilman
d. Natianal Drug Formulary (NDF)
235. Monitors the treatment and rehabilitation of drug dependents and operation of drug rehabilitation and testing
centers:
a. PDEA
b. BFAD
c. NBI
d. DOH
236. Define as the delivery or sale of any drug or device for purposes of distribution in commerce, except that
such term does not include a manufacturer or retailer of such product.
a. Import
b. Distribute
c. Export
d. Manufacture
237. Quality control requirements for herbal and/or traditional drugs:
a. Test for the presence of heavy metals
b. Test for the presence of synthetic drugs
c. Test for alcohol content
d. All of the above
238. Pursuant to AO 55, all information required to appear on the label must be:
a. Written in english
b. Clearly and prominently displayed
c. Readable with normal vision with straining
d. All of the above
239. INN means:
a. International Non-Proprietary Name
b. International Proprietary Name
c. International Non-Proprietary
d. International Name
240. Based on the PNDF, the following are acting on the CNS except:
a. Anti-gout
b. Anti-schistosoma
c. Anti-parkinsonism
d. Anti-vertigo
241. Based on the PNDF, the following are Gastro-Intestinal drugs, except:
a. Anti-lipidemic
b. Anti-cholinergic
c. Spasmolytic
d. Antacid
242. The division in BFAD that evaluates and processes application for the registration of all products under
BFAD’s jurisdiction:
a. LSD
b. PSD
c. LICD
d. Regulation Division II
243. The division in BFAD that conducts all test analyses and trials of products under BFAD’s jurisdiction:
JURISPRUDENCE
a. LSD
b. PSD
c. LICD
244. The division in BFAD that conducts administrative or quasi-judical hearings and recommends, imposes
appropriate legal action:
a. LSD
b. PSD
c. LICD
245. The division in BFAD that calls upon erring manufacturer, distributor, or advertiser to desist from inaccurate
or misleading nutritional or medical claims in their advertising:
a. LSD
b. PSD
c. LICD
246. It refers to the prevailing specified range of temperature, humidity, and other environment factors within
optimal stability of the product:
a. Storage conditions
b. Temperature range
c. Stability
d. Expiry date
247. The expiry date of the product shall be expressed in terms of the:
a. Month and year
b. Month, date, & year
c. Year
d. Date and year
248. PRC means:
a. Philippine Regulation Commission
b. Professional Regulatory Commission
c. Philippine Regulatory Commission
d. Professional Regulation Commission
249. Requirement/s for registration of “Me-Too” or identical products includes:
a. Toxicology data
b. Pharmaceutical form of the drug
c. Clinical evaluation data
d. Mutagenicity
250. It is the current system of quality assurance aimed at ensuring that products are consistently manufactured
to a quality appropriate for intended use:
a. GLP
b. GCP
c. CGMP
d. CPL
251. Example/s of Cosmetic Specialty Qualified for Listing without Pre-Market Approval:
a. Lipsticks
b. After shave lotion
c. Perfumes
d. AOTA
252. President Corazon C. Aquino enunciated the National Drug Policy on:
a. May 30, 1987
b. April 30, 1987
JURISPRUDENCE
c. August 30, 1987

d. June 30, 1987
253. These are drugs are not covered by patent protection and which are labeled solely by their international
non-proprietary name.
a. Generic drugs
b. Innovator drugs
c. Branded drugs
d. Essential drugs
254. Any person who shall violate RA 6675, sec 6 (a) or 6 (b), for the first conviction shall suffer the penalty of
reprimand which shall be officially recorded in the appropriate books of the:
a. PRC
b. BOP
c. DDB
d. CPE
255. Regulated drugs includes:
a. LSD
b. Benzedrine
c. Heroin
d. Mescaline
256. Prohibited drugs includes:
a. Dexedrine
b. Amobarbital
c. Morphine
d. Phenobarbital
257. Elixir Paregoric:
a. Opium + Alcohol
b. Morphine + Alcohol
c. Codeine + Alcohol
258. All prescriptions dispensed in the drugstore, botica, or hospital pharmacy shall be kept on file for:
a. One year
b. 2 years
c. 3 years
d. 5 years
259. Partial filling of prescription for drugs to List A shall:
a. Be allowed
b. Not be allowed
c. Be allowed provided that the S-2 of the prescriber is indicated
d. Be allowed provided that a yellow prescription was presented
260. An act granting additional benefits and privileges to senior citizens amending for the purpose RA 7432:
a. RA 9165
b. RA 9257
c. RA 9502
d. RA 8485
261. The term “Drug Outlet” does not include:
a. Botica
b. Drugstore
c. Drug laboratory
d. Both a and b
262. Minumum penalty shall be imposed if the counterfeit drug product is:
a. Life-saving
JURISPRUDENCE
b. Not life-saving
c. Both a and b
d. None of the given choices
263. Government office where professionals register & where license is issued:
a. PRC
b. BFAD
c. PPhA
d. DDB
264. Acts as the policy formulation and sector monitoring arm of the Secretary of Health on matters pertaining to
foods, traditional medicines, cosmetics, and household products containing hazardous substances:
a. Director of PDEA
b. DDB Director
c. BFAD Director
d. President of PPhA
265. Collects samples of products in outlets under BFAD jurisdiction for laboratory analysis:
a. Regulation Division I
b. Regulation Division II
c. LSD
d. LICD
266. Assist in the development of the short/long range plan and prepares the budget estimates of BFAD:
a. Office of the director
b. LICD
c. Administrative Division
267. Coordinates the activities of the Drug Information Unit (DIU) for the purposes of information dissemination:
a. Office of the Director
b. Administrative Division
c. LICD
268. It is an act providing protection to consumers by stabilizing the prices of basic necessities & prime
commodities and by prescribing measures against undue price increases during emergency situations and
like occasions:
a. RA 7394
b. RA 7581
c. RA 7432
d. RA 3720
269. This order prescribes the conditions and requirements for good manufacturing practice applied to premises,
equipment, personnel, product and warehouse:
a. AO 220
b. AO 42
c. AO 56
d. AO 67
270. This order defines rules and regulations governing the registration and sale of herbal and/or traditional drugs
to ensure their quality and safety:
a. AO 220
b. AO 42
c. AO 56
d. AO 67
271. This order prescribes the activities involving drug products that need to be covered by a licensed from
BFAD:
a. AO 220
JURISPRUDENCE
b. AO 42
c. AO 56
d. AO 67
272. This order gives comprehensive guidelines on the registration of pharmaceutical products to be consistent
with RA 6675:
a. AO 220
b. AO 42
c. AO 56
d. AO 67
273. Laboratory controls are required for:
a. Finished products
b. components
c. In-process drug
d. All of the above
274. Ointments, creams, and other semi-solid preparations are tested for:
a. Melting point
b. Homogeneity
c. Impalpability
d. All of the above
275. Equipment used for manufacturing, processing, packing, labeling, testing and control of drugs must be:
a. Of suitable size
b. Absorptive
c. Impalpability
d. Both a and c
276. What is the color of the label for prescriptions used externally?
a. Pink
b. Red
c. Green
d. White
277. This is a proof that a person is a licensed pharmacist:
a. Certificate of registration
b. Transcript of record
c. Certificate of internship
d. All of the above
278. As defined in RA 8203, this refers to any entity, whether a single proprietorship, partnership, or corporation
engaged in or doing business in the Philippines:
a. residency
b. business establishment
c. brokering
d. ownership
279. Under RA 5921, administrative investigation shall be conducted by all members of the Board of pharmacy. In
case of suspension, it shall be for a period of NMT:
a. 1 year
b. 30 days
c. 6 months
d. 60 days
280. Which of the following statements is/are true for detailman?
a. An initial fee of twenty pesos is needed upon registration
b. He shall be, preferably a graduate of a College of Pharmacy
c. To be employed, he needs to possess the necessary credentials issued by the PRC.
d. Only a and b.
JURISPRUDENCE
281. For how many years shall the Chairman and members of the Board of Pharmacy hold office after
appointment?
a. 2
b. 3
c. 4
d. 5
282. Under RA 3720, if a drug’s strength differs or its safety, efficacy, quality or purity falls below the standards
set forth in the compendium, then the drug is deemed to be.
a. Adulterated
b. Mislabeled
c. Ineffective
d. All of the above
283. In order to manufacture, sell, offer for sale, import or distributed any drug or device, a license to operate
should be first secured from.
a. BFAD
b. DTI
c. PRC
d. DDB
284. Any person who shall be employed as detailmen by any pharmaceutical established shall be first secured
from.
a. BFAD
b. DTI
c. PRC
d. DDB
285. If found guilty of neglect of duty, incompetence, malpractice, unprofessional or dishonorable conduct, after
having been given been the opportunity to defend himself in a administrative, the chairman or members of
the Board of Pharmacy may be removed by.
a. President of PACOP
b. President of the Philippines
c. PRC Commissioner
d. Director of BFAD
286. R.A. 3720 was amended by EO no ____?
a. 851
b. 174
c. 175
d. 881
287. A certified true copy of the record of dangerous must be submitted to.
a. DDB
b. PDEA
c. 175
d. DOH
288. This refers to any facility used for the illegal manufacture of any dangerous drug/or controlled precursors
and essential chemical.
a. classrooms
b. clandestine laboratory
c. licensed establishment
d. all of the above
289. Maximum penalty shall be imposed if the sale, trading, administration, delivery or distribution of dangerous
drugs and/ or controlled precursor and essential chemicals transpires within __ meters from school.
a. 50
b. 100
JURISPRUDENCE
c. 101
d. 30
290. Penalty for unlawful prescription of dangerous drugs.
a. Fine of Php 100,000 to 50,000
b. Life imprisonment to death
c. Fine of Php 500,000 to 10 M
d. b and c
291. The term “elderly” shall mean:
a. Senior citizen
b. Any resident of the Philippines
c. At least 60 years old
d. All of the above
292. The term Secretary, in RA 3720, means:
a. Secretary of DOH
b. Secretary of the DTI
c. Secretary of Education
d. Secretary of the Drug establishment
293. Prescription for dangerous drugs are written in:
a. Triplicate
b. Duplicate
c. Five
d. Four copies
294. It refers to a licensed establishment carrying on the retail business of sale of drugs and medicines to
customers:
a. Exporter
b. Importer
c. Wholesaler
d. Retailer
295. It refers to any establishments that imports raw material, active ingredients and finished products for its own
use or for its own use or for distribution to other drug establishment or outlets:
a. Exporter
b. Importer
c. Wholesaler
d. Retailer
296. Penalty for illegal acts of price manipulation of any drug and medicine subject to price regulation:
a. Imprisonment of NLT 5 years nor more than 15 years
b. Fine of NLT 100,000 nor more than 10 M pesos
c. Imprisonment of NLT 10 years
d. a and b
297. Under RA 3720, Food means:
a. Chewing gum
b. Articles used for food or drink for man
c. a and b
d. NOTA
298. Every prescription for external use filled in the drugstore shall bear a red label showing in black ink the
components for such prescription and the word ______ at the bottom label:
a. “Warning: May be habit-forming”
b. “For External Use Only”
c. “For Internal Use Only”
d. “Flammable”
JURISPRUDENCE
299. Who shall take care and deliver to the Bureau the samples taken at random from every incoming shipment
of food, drugs, devices, and cosmetics which are being imported or offered for import into the Philippines?
a. Secretary of Health
b. BFAD Director
c. Commissioner of Custom
d. a and b
300. The provision of this act on warranty shall not apply to professional services of CPA, architects, engineers,
lawyers, veterinarians, optometrists, pharmacists, nurses, nutritionists, dietitians, physical therapists,
salesman, medical and dental practitioners and other professionals engaged in their respective professional
endeavors:
a. RA 7581
b. RA 7394
c. RA 7432
d. RA 8293
PHARMACEUTICAL JURISPRUDENCE
C 1. __________ denotes the date after which the product is not expected to retain its claim safety, efficacy and quality.
a. lot number c. expiration date
b. batch number d. control number
D 2. Equipment used for manufacture, processing, testing or control must meet the ff. criteria, except;
a. non reactive c. non absorptive
b. non additive d. non operational
B 3. Required tests for new drugs, except;

a. Phase IV Clinical Trial c. Phase III
b. Bioavailability d. Phase I
C 4. ________ determine the therapeutic index of drugs

a. pharmacodynamics c. clinical pharmacology
b. pharmacokinetics d. toxicity test
C 5. Government agency who issued national identification card and purchase slip booklet to senior citizen
a. BFAD c. OSCA
b. DILG d. DOLE
D 6. ____________ requires the representation of yellow prescription from a licensed doctor with S2 license number
a. List B c. OTC
b. Rx d. List A
A 7. __________ is a list of drug which cure the vast majority of illness, affordable and available to all persons
a. EDL c. USP/NF
b. NDF
A 8. __________ is the accredited professional pharmacy organization in the Philippines accepted by PRC
a. PPhA c. PAPPI
b. PSHP
B 9. Refers to the moral principles of practice in Pharmacy

a. Jurisprudence c. Law
b. Ethics d. NOTA
B 10. It is defined as a system of Laws or the Science or Philosophy of Laws

a. Pharmacy Law c. RA 5921
b. Jurisprudence d. Ethics
B 11. RA 3720 is the

a. Pharmacy Law c. Dangerous Drug Act
b. Food, Drug, Devices and Cosmetic Act d. Senior Citizen Act
D 12. RA 6425 is the

a. Narcotic Drugs Law c. Revenue Regulation
b. Pharmacy Law d. Dangerous Drug Act of 1972
C 13. This term refers to any person who sells, administers, delivers or gives away to another any dangerous drug without
any proper authority.
a. Pharmacist c. Pusher
b. Nurse d. Drug Agent
B 14. Includes opium and its active components and derivatives such as heroin and morphine,
coca leaf and its derivatives
a. Regulated Drugs c. Both a and b
b. Prohibited Drugs d. List B
B 15. Refers to any drug which produces insensibility, stupor, melancholy or dullness of mind with delusion
a. dangerous drug c. synthetic drug
b. narcotic drug d. regulated drugs
D 16. The only person/s authorized to issue a prescription

a. physician c. veterinarian
b. dentist d. AOTA
C 17. An act to promote, require and ensure the production of an adequate supply, distribution, use and acceptance of drug
and medicines identified by their Generic Names
a. RA 5921 c. RA 6625
b. RA 6425 d. PD 881
B 18. It is the chemical component responsible for the claimed therapeutic effect of the pharmaceutical product:
a. chemical name c. binder
b. active ingredient d. disintegrant
C 19. It is the identification of drugs and medicines by their scientifically and internationally recognized active ingredient as
determined by the Bureau of Food and Drugs
a. Brand name c. Generic name
b. label claim d. Both a and c
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A 20. Drug establishments is defined as:

a. any organization or company involved in the manufacture, importation, repacking, and or distribution of
drugs or medicines
b. drugstores, pharmacists and stores that sell drugs of medicines
c. both a and c
d. NOTA
B 21. It is the proprietary name given by the manufacturer to distinguish its product from those of their competitors
a. generic name c. common name
b. brand name d. AOTA
D 22. The objectives of RA 5921

a. The standardization and regulation of pharmaceutical education
b. The examination for registration and graduation of schools of pharmacy in the Philippines
c. The supervision, control and regulation of the practice of pharmacy in the Philippines
d. AOTA
D 23. This is/ These are created for the purpose of implementing Republic Act 5921
a. Council of Pharmaceutical Education c. Phil Pharmaceutical Association
b. Board of Pharmacy d. both a and b
A 24. The appointment of the Board of Pharmacy shall be approved by the:

a. President of the Philippines c. Commissioner of the PRC
b. Food and Drug Administrator d. AOTA
D 25. To be appointed member of the Board of Pharmacy, a person must be:

a. a natural born citizen of the Philippines
b. a duly registered pharmacist and has been in the practice of pharmacy for at least 10 years
c. a member of good standing of bonafide national pharmaceutical association in the Philippines
A 26. A complete pharmacy internship program based on RA 5921 Article III sec 18 shall consist of at least:
a. 960 hours c. 480 hours
b. 160 hours d. 980 hours
B 27. In order to pass the board examination, a candidate must obtain a general average of
a. 100% c. 50%
b. 75% d. 80%
C 28. Examination for registration to practice pharmacy in the Philippines shall be given:
a. once a year c. twice a year
b. thrice a year d. 5x a year
D 29. In order for somebody to practice pharmacy in the Philippines, he must be:
a. at least 21 years old
b. has satisfactorily passed the examination given by the board of pharmacy
c. holder of a valid certificate of registration duly issued to him by the Board of Pharmacy
d. AOTA
A 30. A food shall be deemed adulterated if:

a. it bears or contains any poisonous substance which may render it injurious to health
b. its labeling is false or misleading
c. both a and b
d. none of the above
B 31. A food shall be deemed misbranded:

a. it bears or contains any poisonous substance which may render it injurious to health
b. its labeling is false or misleading
c. both a and b
D 32. In R.A. no. 3720 Section 10, food means:

a. articles used for food or drink for man
b. chewing gum
c. articles used for components of any such article
d. all of the above
D 33. In R.A. no. 3720 Section 10, drug means:

a. any article recognized in the official Pharmacopeia and National Formulary
b. articles intended for use in the diagnosis, cure and mitigation, treatment or prevention of diseases
in man and other animals
c. articles intended for any function of the body of man
d. all of the above
A 34. It is the concentration of known active drug substance in the formulation:
a. strength c. batch size
b. percentage d. AOTA
C 35. In tablets, this/these test/s is/are usually performed:

a. weight variation, content uniformity, hardness
b. disintegration and dissolution for the active ingredients
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c. both a and b
d. NOTA
A 36. In the preparation of liquid or suspension one of the choices below is necessary:
a. viscometer c. particle counter
b. moisture balance d. leaker test
A 37. It is a drug which has been used for at least five years, involving at least 5,000 patients
a. tried and tested c. drug for general
b. established drug d. investigational drug
B 38. It is a drug the safety and efficacy of which has been demonstrated through long years of general use and can be
found in current USP-NF and other internationally recognized Pharmacopeia:
a. tried and tested c. drug for general use
b. established drug d. investigational drug
D 39. The source or circumstances of drug production is/are:

a. imported as finished
b. locally manufactured from imported materials
c. locally manufactured from local materials
d. AOTA
A 40. Products for external use bears:

a. red colored label
b. white colored label
c. any color as long as the statement “for external use only” is indicated
d. green colored label
A 41. Test for alcohol content should not be more than

a. 10% c. 75%
b. 20% d. 40%
D 42. All information required to appear on the label must be:

a. written in English or Filipino
b. clearly and prominently displayed
c. readable with normal vision without straining, the color contrast, the position and sparing of the information
must be taken into consideration in complying with labeling requirements.
d. AOTA
D 43. In the current good manufacturing practice, we usually consider the;

a. building c. equipment
b. personnel d. AOTA
C 44. A senior citizen who purchase his medicine for his personal needs is entitled to a minimum discount of:
a. 10% c. 20%
b. 30% d. 15%
C 45. The following statements are true, except;

a. Prescriber of Dangerous Drugs should have S2 license issued by the Dangerous Drug Board
b. Dangerous Drug prescriptions are accomplished in triplicate
c. Dangerous Drug prescriptions are issued by the Board of Pharmacy
d. The original copy of the Dangerous Drug Prescription should be kept by the pharmacist
D 46. License to operate (LTO)of a drugstore can be suspended except

a. Refusal to allow entry of BFAD inspector during business hours
b. Failure to properly record and keep of all prescriptions received in the last two years
c. Failure to produce invoices and receipts together with lot numbers, expiration dates for the drug on stocks
d. Absence of pharmacist on three (3) inspections by BFAD inspector
D 47. The ff. statements are incorrect, except;

a. Erroneous prescriptions should not be filled by pharmacist, Rx kept and reported to DOH
b. Violative Rx could be filled, Rx kept and reported to DOH
c. Impossible Rx could be filled, Rx kept and reported to DOH
d. Violative Rx should not be filled by pharmacist, Rx kept by pharmacist and reported to DOH
D 48. The ff. are violations under the Generic Act which a pharmacist may commit except:
a. imposing a particular brand on the buyer
b. failure to make accessible the required up-to-date information on drug products to the buying public
c. failure to report to the nearest DOH
d. failure to return the Rx to the patient
A 49. Requirement for drug store except:

a. minimum of 50 sq. m. floor area with concrete, tile of wooden flooring
b. adequate water supply
c. reference books and documents such as USP
d. prescription book
A 50. Product standardization is the responsibility of:

a. drug manufacturers c. whole
b. retailers d. importers
B 51. An act to ensure the safety and purity of foods, drugs, devices and cosmetics in the country
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a. RA 5921 c. RA 6425
b. RA 3720 d. RA 953
B 52. Drug product registration is regulated by:

a. Secretary of Health c. Multinational Companies
b. Bureau of Food and Drugs d. Local companies
D 53. Principal display label must contain the following, except:

a. pharmacologic category c. net content
b. dosage form and strength d. indications
C 54. Refusal to allow entry of BFAD inspectors is penalized by:

a. revocation of certificate of registration
b. temporary closure
c. suspension of license to operate
d. revocation of license to operate
B 55. That division in BFAD which is in charge of the inspection of manufacturers of foods, drugs and cosmetics
a. Regulation Division I c. Product Services
b. Regulation Division II d. Legal Division
A 56. BFAD is a regulatory agency of the national government under

a. DOH c. Office of the President
b. DDB d. Professional Regulation Commission
C 57. The presence of foreign matter inside the contents of a bottled syrup is a case of
a. misbranding c. adulteration
b. adultery d. mislabeling
B 58. All prescriptions dispensed in the drugstores shall be kept on file for:
a. one year c. three years
b. two years d. five years
C 59. When only the generic name is written but is not legible is a case of;
a. violative prescription c. impossible prescription
b. erroneous prescription d. NOTA
B 60. Where the brand name is not in parenthesis is a case of;

a. violative prescription c. impossible prescription
D 61. One of these is not a requirement for opening a drugstore

a. full time registered pharmacist
b. keeping of record books duly registered with BFAD
c. keeping of invoice indicating lot number or batch number of the manufacturer’s stock
d. keeping of list of patients who purchase drug in the drugstore
B 62. Prescription forms for dangerous drugs are issued by:

a. BFAD c. BIR
b. DDB d. PRC
B 63. Prescription for dangerous drugs are written in:

a. duplicate c. one copy
b. triplicate d. any of the above
A 64. The Board of Pharmacy is under the supervision of:

a. PRC c. CHED
b. Civil Service Commission d. DOH
A 65. The pharmacist should keep the copy of the original narcotic prescription for the period of
a. one year c. five years
b. two years d. four years
D 66. A permit to operate a retail drugstore is issued by;

a. DDB c. Board of Pharmacy
b. BIR d. BFAD
C 67. Government office where the professional register and where license is issued:
a. Bureau of Domestic Trade c. PRC
b. Bureau of Food and Drug d. BIR
D 68. A candidate for Board of Examination:

a. shall be a Filipino citizen of the Philippines
b. must be of good moral character
c. must have completed 960 hours of internship
d. AOTA
C 69. Grounds for reprimand, suspension or revocation of registration certificate, except:

a. insanity c. honesty
b. immorality
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B 70. Drugs which require batch certification before it can be released to the market:
a. anesthetics c. antineoplastics
b. antibiotics
B 71. The expiration date of the drug shall be expressed in terms of

a. day and year c. month and day
b. month and year
B 72. Poisonous preparation must bear

a. Rx symbol c. external use only
b. Vignette representing skull and bones
E 73. Counterfeit drugs refers to:

a. product with correct ingredients but not in the amount provided
b. product with wrong ingredients
c. product with insufficient quantity of active ingredients
d. drugs which is fraudently mislabeled
e. AOTA
D 74. Parties liable for violation of RA 8203 are, except:

a. manufacturer d. drugs which is fraudently mislabeled
b. pharmacist e. AOTA
c. processor of counterfeit drugs
B 75. Monitors the presence of counterfeit drugs

a. DOH c. CHED
b. FDRO’s d. DDB
D 76. Pharmacists are required to report record of sales of dangerous drugs twice a year to the
a. BFAD c. Municipal Health Officer
b. DOH d. DDB
D 77. Which of the violative acts will warrant closure of establishment

a. failure to record sales and purchases for dangerous drug
b. loss of Rx form for dangerous drug
c. failure to comply with filling of prescription for dangerous drug
d. illegal importation, distribution, manufacture
B 78. Which of the following drug preparation cannot be distributed as samples

a. OTC c. Rx Drug
b. Dangerous Drug d. AOTA
B 79. Supplies/medicines to be given to senior citizen should not exceed;

a. one day supply c. one month supply
b. one week supply d. one year supply
D 80. The following must be presented by senior citizens when buying drugs;
a. prescription c. OSCA identification card
b. Purchase slip booklet d. AOTA
C 81. BFAD requires all manufacturing company to designate a person who will transact officially with BFAD
a. medical director c. liaison officer
b. product manager d. quality control manager
C 82. Pharmacists are requested by law to be in drugstore

a. for 8 hours c. while the outlet is open for business
b. in the morning only d. when there is BFAD inspector
A 83. The following are record book except;

a. Republic Act Book c. Poison Book
b. Dangerous Drug Book d. Prescription Book
B 84. The minimum requirement necessary for the opening of retail drugstore must be in accordance with the rules and
regulations of:
a. DDB c. Board of Pharmacy
b. BFAD d. DOH
A 85 Sale of physician sample is a prohibited act under the:

a. Pharmacy Law c. Foods, Drugs, Devices, and Cosmetics law
b. Generics law d. Dangerous Drug Act
B 86. The latest amendments to RA 5921 is

a. EO 175 c. RA 3720
b. EO 174 d. PD L916
B 87. Drugstore, Pharmacy and other business establishment which sell drug or medicine is known as:
a. Drug Establishment c. Drug Trader
b. Drug Outlet d. Drug Manufacturers
C 88. Who has sole authority to remove a member of the Board of Pharmacy,, for cause provided in the laws?
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a. Chairman, PRC c. President of the Phil

b. Chairman, BOP d. President of Prof. Org.
A 89. The decision of the Board of Pharmacy in administrative cases involving a pharmacist becomes final and executory
after the lapse of:
a. 30 days c. 60 days
b. 15 days d. 90 days from notice to respondent
A 90 The Board of Pharmacy is under the supervision of:

a. PRC c. CHED
b. Civil Service Commission d. DOH
B 91. To be appointed as member of the Board of Pharmacy, a pharmacist must have practiced for at least;
a. 5 years c. 15 years
b. 10 years d. 2 years
C 92. Detailmen are requested to register with the:

a. Board of Medicine c. Board of Pharmacy
b.BFAD d. PRC
A 93. One of the functions of the Board of Pharmacy

a. examine applicants for the practice of pharmacy
b. to authorize opening of drugstore
c. to collect samples of drugs, medicines and cosmetics
d. to accredit colleges of pharmacy
D 94. RA 5921 was approved in:

a. 1965 c. 1960
b. 1970 d. 1969
B 95. Refers to the moral principles of the practice of pharmacy:

a. Jurisprudence c. Law
b. Ethics d. both a and c
B 96. How many years shall the chairman of the Board of Pharmacy hold office after appointment?
a. 2 yrs c. 4 yrs
b. 3 yrs. d. 1 yr
D 97. License to operate (LTO) a drugstore can be suspended EXCEPT

a. Refusal to allow entry of BFAD inspector during business hours
b. Failure to properly record and keep file of all prescriptions received in the last two years
c. Failure to produce invoices and receipts together with lot numbers, expiration dates for the drug stocks
d. Absence of pharmacist on three(3) inspections by BFAD inspector
C 98. The penalty for any person who falsely display within the establishment the certificate of registration of a pharmacist
not actually or regularly employed is:
a. a fine of more than P1000 or imprisonment of 6 mos
b. a fine of not less than P1000 but not exceeding P4000 or an imprisonment of not less than 4 yrs
c. a fine of not less than P1000 but not exceeding P4000 or an imprisonment of not less than 6 mos and one
day but not more than 4 yrs.
B 99. It is the proprietary name given by the manufacturer to distinguish its product from those of their competitors
a. generic name c. common name
b. brand name d. AOTA
C 100. Penalty imposed when the counterfeit drugs are not life saving drugs and the volume of the drug involved is not more
than one million
a. maximum penalty c. minimum penalty
b. medium penalty d. revocation of LTO
D 101. Penalty imposed when the counterfeit drugs are life saving and the volume of the drug involved is more than one
million
a. revocation of LTO c. minimum penalty
b. medium penalty d. maximum penalty
B 102 Products containing two or more active ingredients shall have a generic name/s as determined by the:
a. manufacturer c. DOH
b. BFAD d. drugstore owner
D 103. Major offenses under the Dangerous Drug Act warrant a penalty of:
a. reclusion perpetua to death
b. a fine ranging from 100,000 to 500,000
c. a fine ranging from 500,000 to 1,000,000
d. both a and b
d. both a and c
Administrative Sanctions. Shade A for closure; B for suspension of LTO; C revocation of LTO
B 104. Minor deficiencies in GMP such as inadequate storage facilities
C 105. For manufacturers: Lack of key technical and professional personnel

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C 106. Selling misbranded drugs.
B 107. Refusal to allow entry of BFAD inspector
A 108. Absence of pharmacist on three inspection of BFAD inspector
C 109 Inadequate or improper documentation of the production process
C 110. Lack of Pharmacist
B 111 Failure to properly record and keep a file of all prescriptions filed in the last two years
C 112. Sale of distribution of antibiotic products without batch certification by BFAD
B 113. Failure to produce invoices and receipts together with lot numbers, expiry dates for drugs in stock
C 114. Failure to properly record dangerous drugs as determined by DDB
C 115. Failure to take necessary remedial or corrective measures within the prescribed period as directed by BFAD
C 116. Violation by BFAD standards of quality, efficacy, purity, and safety of drug products
B 117. Lack of minor equipment in production or quality control
B 118. For manufacturers: Poor housekeeping
A 119. Applicable S-tax for dealers of exempt dangerous drugs preparation

a. S-1 d. S-4
b. S-2 e. S-5-C
c. S-3
B 120. Applicable S-tax for prescribers of dangerous drugs

a. S-1 d. S-4
b. S-2 e. S-5-C
c. S-3
C 121. Applicable S-tax for retailer of dangerous drugs

a. S-1 d. S-4
b. S-2 e. S-5-C
c. S-3
E 122. Applicable S-tax for producer/compounder of dangerous drugs

a. S-1 d. S-4
b. S-2 e. S-5-C
c. S-3
E 123. Prescriptions for poisons shall be retained by the pharmacist for:

a. 1 year d. 4 years
b. 2 years e. 5 years
c. 3 years
C 124. The registration of pharmacist shall be renewed every

a. 1 year d. 4 years
b. 2 years e. 5 years
c. 3 years
C 125. Demerol is classified as:

a. regulated drug c. prohibited drug
b. OTC drug d. exempt drug
A 126. Phenobarbital sodium is classified as:

b. OTC drug d. exempt drug
C 127. R.A. no. 5921 was first amended by:

a. P.D. no. 281 c. P.D. 1363
b. P.D. 223 d. P.D. 1926
B 128. The following are prohibited drugs, except:

a. LSD c. morphine
b. amphetamine d. cocaine
D 129. Lomotil is classified as:

b. OTC drug d. exempt DDP
D 130. The following is considered practice of pharmacy:

a. manufacture of pharmaceuticals
b. undertaking pharmaceutical research
c. teaching professional pharmacy subjects
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d. all of the above

e. none of the above
B 131. Drugs are considered adulterated if:

a. label is misleading c. differs from USP standards
b. it is an imitation
C 132. Establishments not requiring supervision of registered pharmacist:
a. drug importer c. plant management of laboratories
b. drug departments d. selling and distribution of drugs
A 133. The Pharmacy Law:

a. R.A. 5921 c. R.A. 6675
b. R.A. 3720 e. R.A. 8203
c. R.A. 6425
B 134. Food Drug Devices and Cosmetics Act:

a. R.A. 5921 c. R.A. 6675
b. R.A. 3720 e. R.A. 8203
c. R.A. 6425
C 135. Dangerous Drug Act:

a. R.A. 5921 c. R.A. 6675
b. R.A. 3720 e. R.A. 8203
c. R.A. 6425
D 136. Generics Act:

a. R.A. 5921 c. R.A. 6675
b. R.A. 3720 e. R.A. 8203
c. R.A. 6425
E 137. Special Law on Counterfeit Drugs:

a. R.A. 5921 c. R.A. 6675
b. R.A. 3720 e. R.A. 8203
c. R.A. 6425
A 138. Senior Citizens Act:

a. R.A. 7432 c. R.A. 6675
b. R.A. 3720 e. R.A. 8203
c. R.A. 6425
A 139. Consumer Act of the Philippines:

a. R.A. 7394 c. R.A. 7432
b. R.A. 7581 d. R.A. 5921
A 140. P.D. shortening the pharmacy course from 5 years to 4 years:

a. 1926 c. 223
b. 1363 d. 881
A 141. Executive Order amending R.A. 5921:

a. 174 c. 851
b. 175 d. 881
B 142. Executive Order amending R.A. 3720:

a. 174 c. 851
b. 175 d. 881
C 143. The Food and Drug Administration was abolished by this E.O. and created BFAD instead
a. 174 c. 851
b. 175 d. 881
B 144. Food Drug Devices and Cosmetics Act:

a. June 20, 1953 c. March 30, 1972
b. June 22, 1963 d. June 23, 1969
D 145. Pharmacy Law

a. June 20, 1953 c. March 30, 1972
b. June 22, 1963 d. June 23, 1969
B 146. Dangerous Drug Act:

a. June 20, 1953 c. June 22, 1963
b. March 30, 1972 d. June 23, 1969
B 147. Generics Act:

a. June 20, 1953 c. June 22, 1963
b. Sept. 13, 1988 d. June 23, 1969
B 148. Special Law on Counterfeit Drugs:

a. May 27, 1992 c. Sept. 13, 1988
b. Sept. 4, 1996 d. June 23, 1969
B 149. The permanent consultant of the DDB:

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a. Secretary of Justice c. BFAD Director

b. NBI Director d. Health Secretary
A 150. The product of diseased animal is considered as:

a. adulterated c. deteriorated
b. misbranded d. abuse
A 151. Where generic name is not written

a. violative Rx c. impossible Rx
b. erroneous Rx
B 152. Where the generic name is the one in parenthesis

b. erroneous Rx
C 153. When the generic name does not correspond to the brand name
b. erroneous Rx
B 154. Shall be filled:

b. erroneous Rx
D 155. Shall not be filled:

b. erroneous Rx d. a & c
A 156. Revised rules and regulations to implement prescribing requirements under the Generics Act:
a. AO no. 62 c. AO no. 64
b. AO no. 63 d. AO no.65
D 157. The following are classified as major offense, except:

a. possession of dangerous drugs c. manufacture of dangerous drugs
b. sale of dangerous drugs d. possession of opium pipe
B 158. Special forms of prescription of dangerous drugs are obtained from:

a. BFAD c. Board of Pharmacy
b. DDB d. BIR
D 159. The penalty for violation of R.A. no. 8203 about counterfeit drugs is:
a. permanent closure of the establishment
b. revocation of its license to operate
c. fine not less than P100,000 but not more than P500,000
d. all of the above
C 160. The street name for marijuana:

a. ice c. grass
b. honey d. moth
A 161. The following are regulated drugs, except:

a. elixir paregoric c. diazepam injection
b. valium tablet
A 162. These are classified as adulterated drugs, except:

a. label is smeared and dirty
b. potency of drug is below label claim
c. other components added are not stated on the label
d. substandard materials have been added
B 163. Retail establishments shall record all transaction of exempt preparations in the:
a. Dangerous Drug Book c. Prescription Book
b. Additional Opium book
B 164. Brand Name means:

a. description of the chemical structure of the drug or medicine
b. proprietary name given by the manufacturer
c. description of internationally recognized active ingredient
d. name of the manufacturer
A 165. Refer to the statement regarding the condition wherein the use of the product may cause harm to the patient:
a. contraindication c. warning
b. precaution d. indication
D 166. Government office where the professional register and where license is issued:
a. Bureau of Food & Drugs c. Bureau of Internal Revenue
b. Bureau of Domestic Trade d. Professional Regulation Commission
D 167. Government office where you obtain a business permit to open a drugstore, drug department as sole proprietor.
a. Bureau of Domestic Trade c. Professional Regulation Commission
b. Securities and Exchange Comm. d. Bureau of Food and Drugs
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B 168. Aspirin tablet with a brand name of Amopen:

a. erroneous prescription c. violative prescription
b. impossible prescription d. all of the above
A 169. BFAD is a regulatory agency of the national government under:

a. DOH c. PRC
b. Office of the President d. DDB
B 170. Selling of OTC drug is considered practice of pharmacy

a. False c. neither true nor false
b. True d. all of the above
B 171. The street name for LSD is:

a. Bottom c. Cactus
b. Acid d. Mushroom
B 172. Accreditation of colleges of pharmacy is a function of:

a. PRC c. Board of Pharmacy
b. Council of Pharmaceutical Education d. All of the above
D 173. Considered as Drug Establishment:

a. Department Store c. Supermarket
b. Botica sa Baryo d. Drug Manufacturer
A 174. Sale of physician sample is a prohibited act under the:

a. Pharmacy Law
b. Food, Drugs and Devices, and Cosmetics Act
c. Dangerous Drug Act
d. All of the above
B 175. Persons who are not practicing pharmacy:

a. teacher of the college of pharmacy
b. pharmacist-manager of a manufacturing company
c. pharmacist in a hospital
d. a & b
C 176. Order forms and yellow pad for prescriptions are secured from:
a. BFAD c. Dangerous Drug Board
b. Commissioner of Internal Revenue d. Bureau of Health
B 177. If a package does not bear the name and address of the manufacturer, the product is,
a. adulterated c. counterfeit
b. misbranded d. a & c
A 178. To implement the provisions of R.A. 3720, the agency created was,
a. BFAD c. Bureau of Customs
b. BIR d. DDB
D 179. R.A. 3720 was promulgated to:

a. ensure safety of foods, drugs and cosmetics
b. adopt measures to guarantee the purity and quality of food and drugs
c. allow BIR to set standards for food and drug
d. a & b
A 180. The laboratory division of the BFAD has the duty of:
a. testing, analyzing and doing trials on products submitted
b. inspection of manufacturing laboratories
c. taking samples from drug outlets
d. all of the above
B 181. A candidate for the board of pharmacy examination is required to be:

a. natural born citizen of the Philippines
b. completed an internship program of 960 hours
c. at least the age of 18 years old
d. a graduate of a pharmacy course of at least 3 years
D 182. A prerequisite for the practice of pharmacy is:

a. at least 21 years of age
b. holder of a valid certificate of registration from the board pf pharmacy
c. experienced in the practice of pharmacy for at least 2 years
d. a & b
D 183. Opium and its active components are included under:

a. dangerous drugs c. regulated drugs
b. prohibited drugs d. a & b
A 184. The act of introducing any dangerous drug into the body of any person refers to the term:
a. administer c. user
b. pusher d. deliver
B 185. Heroin is described as:

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a. regulated drug c. derivative of amphetamine

b. derivative of opium d. hypnotic drug
A 186. A pusher of dangerous drugs is one who:

a. sells or delivers dangerous drugs c. plants the source of the drug
b. smokes the drug d. importer
A 187. The ultimate objective of the PNDF is to provide:

a. low-cost drugs c. high quality but expensive drugs
b. free consultation from physicians d. a &b
D 188. In A.O. no.64 s. 1989 of the Generics Act of 1988, the caution “Food, Drugs, Devices and Cosmetics Act prohibits
dispensing without a prescription” should be indicated in the label of:
a. prescription drugs c. prohibited drugs
b. regulated drugs d. all of the above
D 189. The duties of a pharmacist towards the public under the Code of Ethics is:
a. to maintain USP/NF standards c. sell physicians’ sample at a low price
b. not to use inferior quality drugs d. a & b
C 190. Nitrobenzene as a poison is classified as:

a. prescription drug c. violent
b. dangerous drug d. a & c
C 191. The duty of a pharmacist towards a physician:

a. not to make a prescription or diagnose a disease
b. to substitute one article with another
c. not to discuss with the patient any error committed by the physician
d. all of the above
B 192. If a lipstick as a cosmetic contains a substance that caused the swelling of the lips of the user, it is considered:
a. misbranded c. formulated correctly
b. adulterated d. a & b
D 193. The Rx symbol is required in the label of:

a. prescription drugs c. dangerous drugs
b. over the counter drugs d. a & c
C 194. The maximum volume of a cough syrup to be sold:

a. 60 mL c. 120 mL
b. 240 mL d. 250 mL
C 195. A wholesaler of narcotics must obtain:

a. S-5 c. S-4
b. S-1 d. S-2
B 196. Hospital pharmacies should be accredited by:

a. Board of Pharmacy c. Council of Pharmaceutical Education
b. BFAD d. DOH
C 197. A pharmacy intern is required to practice in:

a. BFAD c. hospital pharmacy
b. college teaching d. none of the above
C 198. A drug or medicine containing correct ingredients but not in the amount provided is:
b. misbranded d. b & c
A 199. The administrative designation assigned as S-3 is applicable to:

a. practicing professionals in narcotics c. sell physicians’ sample at low prices
b. not to use inferior quality drugs d. a & b
D 200. Administrative designation assigned to persons using narcotics in research, analysis and instruction is:
a. S-1 c. S-6
b. S-5 d. S-7
D 201. The regulation of the labeling, sale and distribution of hazardous substances is:
a. RA 953 c. Regulation Revenue 16-67
b. PD 881 d. PD 280
D 202. In the application for a new drug, the ff are the requirements:
a. components list c. investigation about its safety
b. specimens of the labeling d. AOTA
D 203. An adulterated cosmetic is:

a. contains filthy substance c. if the labeling is false
b. packed under unsanitary conditions d. a and b
A 204. Heroin is described as:

a. derivative of opium c. derivative of amphetamine
b. regulated drug d. hypnotic drug
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B 205. The original copy of the records of prescription of drugs is retained by:
a. physician c. buyer of the drug
b. pharmacist who filled it d. a&b
C 206. The certification of batches of antibiotics is a specific function of the:

a. Board of Pharmacy c. BFAD
b. Bureau of Health d. NOTA
D 207. According to the international code of ethics, a pharmacist has the responsibility to:
a. show the same dedication to all
b. to promote the individual’s right to access to safe and effective treatment
c. to be sure the buyer-customer can pay for the medicine purchased
d. a&b
B 208. The duty of fixing the date of the Board of Examination for all professions is done by:
a. Board Examiner c. BIR
b. PRC Commissioner d. Any of the above
C 209. Prohibited Acts under Ra 3720:

a. manufacture of adulterated drugs
b. sale or offering of any drug beyond its expiry date
c. selling of OTC drugs in a drugstore
d. Forging or counterfeiting
A 210. If a device like a contraceptive contains a substance that reduces its safety and quality, it is considered to be:
a. adulterated c. not adulterated
b. misbranded d. not misbranded
D 211. Example of outlets under the responsibility of the Regulation Division I is:
a. Hospital Pharmacy c. Manufacturing Drug Laboratory
b. retail drugstores d. a&b
C 212. The meaning of the term “food” includes the ff, except:
a. chewing gum c. lozenges like Strepsils
b. candies d. a&b
B 213. Can a member of the pharmacy board teach in a school where a pharmacy course is offered?
a. Yes c. doubtful
b. No d. if permitted by the school
C/A 214. These sections are under the Product Services Division
a. Food Product Section
b. Physicochemical Section
c. Household hazardous substances
d. Research Section
D 215. These are sections under the Laboratory Services Division, except
a. Microbiology Section c. Toxicology Section
b. Research section d. Inspection Section
B 216. Under CGMP, buildings should provide adequate space for:

a. Storage of equipment c. packing operations
b. The holdings of rejected components d. Administrative offices
D 217. Sections under the Legal, Information and Compliance Division

a. Advertising and Promotion Section
b. Public Assistance Information and Compliance Section
c. Legal Research and Investigation Section
d. Licensing section
A 218. Batch record should include

a. all lot or control# appearing on the labeling of drugs from batch
b. label of component used
c. report of mix up errors
d. endorsement of the Administrative Officer
C 219. Prohibited acts on the labeling include

a. the manufacture of misbranded products
b. the use of any reference to any BFAD product
c. mutilation of the whole or any part of the labeling of the product while held for sale
d. using marks required by the regulation
C 220. Additional labeling requirements for biological products, except;

a. name of the species of animal or organism on where the product is tested
b. name and proportion of antibiotics in the preparation
c. name and quantity of all excipients
d. the potency of the product
E 221. Exemptions in labeling requirements include

a. Investigation Drugs d. Donated Drugs
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b. Extemporaneous Preparation e. AOTA

c. Drugs with transparent covering
C 222. It plans, directs, and supervises the implementation of rules and regulations and SOP in inspection and licensing of
establishment
a. Regulation Division I c. Regulation Division II
b. Administrative Division d. Legal, Info and Compliance Div
A 223. Product container should

a. be unadsorptive c. suitable for intended use
b. should provide adequate protection d. store in a common area
D 224. Functions of the Laboratory Services Division, except:

a. Conducts all test analysis and trials of products under jurisdiction
b. Appears in investigational hearings as may be necessary
c. Certifies batches of antibiotics and antibiotic preparation
d. Obtain data on ADR from different resources
A 225. It is an example of a regulated drug:

a. Amytal Na c. Sublimate injection
b. Brown mixture d. Valium
C 226. The one responsible for the quality and purity of drugs sold in their original packaging is:
a. retailer c. manufacturer
b. wholesaler d. all
D 227. Counterfeit drugs refer to

a. medicinal products with correct ingredient but not in amount
b. medicinal products with insufficient quantity
c. drug deliberately and fraudulently mislabeled
d. all of the choices
C 228. Grounds for revocation of license to operate in a drugstore or pharmacy

a. the owner is not a pharmacist
b. pharmacist is absent during the time of inspection
c. no pharmacists
d. AOTA
C 229. The ff statements are true, EXCEPT

a. prescriber of Dangerous Drugs should have S-2 license issued by DDB
b. Dangerous drug prescriptions are accomplished in triplicate
c. Dangerous drug prescriptions are issued by the Board of Pharmacy
d. The original copy of Dangerous drug prescriptions should be kept by the Pharmacist
B 230. The product of diseased animal or animal which has died otherwise then by slaughter is considered as:
a. misbranded c. deteriorated
b. adulterated d. abused
C 231. The office which supervises the Board of Pharmacy is:

a. Civil Service Commission c. Professional Regulation Commission
b. Office of the President
B 232. Under BFAD regulation, minor deficiencies in GMP is a ground for:

a. revocation of LTO c. reprimand
b. suspension of LTO d. AOTA
B 233. Drug product marketed “sample”, “not for sale” may be sold to the public provided the price is lower than the
commercial ones:
a. Yes c. depends on the discretion of the pharmacist
b. No d. NOTA
C 234 Filling and refilling of a prescription should be done by:

a. registered nurse c. registered pharmacist
b. pharmacy aide d. pharmacy intern
B 235 If a package does not bear the name and address of the manufacturer, the product is:
b. misbranded d. a&c
C 236. Who can suspend or revoke the certificate of registration of an erring pharmacist?
a. DECS c. Board of Pharmacy
b. BFAD d. DOH
A 237. The function of providing consultative, training and advisory services to all agencies involved in food and drug
manufacturing is the function of:
a. BFAD c. BIR
b. DOH d. Bureau of Customs
A 238. Poison book is maintained after the last entry it has been made:
a. 5 yrs c. 3 yrs
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b. 2 yrs d. 1 yr
B 239. The BFAD Division that certifies batches of antibiotics is:

a. Inspection and Licensing c. Licensing Of New Products
b. Laboratory d. Regulation Division
A 240. The term “secretary” under RA 3720 means:

a. Secretary of Health c. Sec of Customs
b. Sec. of BFAD d. AOTA
D 241. The term “new drug” refers to:

a. not yet recognized by the expert c. containing discovered drug
b. intended for new disease d. AOTA
C 242. Prescription without specification on the Generic Name of the prescribed product is a violation of RA:
a. 5921 c. 6675
b. 3720 d. 6425
C 243. An amendment to the pharmacy Law which gives all Filipinos, regardless how his citizenship was acquired, the
opportunity to take the board examination:
a. PD No. 1926 c. PD No. 1363
b. EO 174 d. Board Resolution No. 112
D 244. If a face powder caused redness and itchiness in a person, it is deemed to be:
a. misbranded c. imitation
b. still be allowed to be used d. adulterated
B 245. The power to submit and recommend to the President the nominees for the members of the various boards is given to:
a. President of the Phil. Pharmaceutical Association
b. PRC Commissioner
c. PACOP President
d. Secretary of Health
A 246. Where more than one drug product is prescribed in one prescription is a case of:
a. violative prescription c. impossible
C 247. Indian hemp is known as:

a.. Papaver somniforum L. c. Cannabis sativa L.
b. Opium poppy d. amphetamine
D 248. Section under Regulation Division II (Manufacturers) is:

a. Inspection c. Licensing
b. Analysis d. a&c
B 249. RA 5921 requires all detailmen to be preferably:

a. physicians c. dentists
b. pharmacists d. nurses
A 250. The books kept for the purpose of recording the sale of poisons should be preserved for a period of:
a. 2 yrs c. 3 yrs
b. 5 yrs d. 1 yr
B 251. A registered pharmacist is one who:

a. graduated from the college of pharmacy
b. Passed the Pharmacy Board Exam
c. reached the age of 18
d. Experienced in the practice of pharmacy
B 252. A practicing physician can be allowed to open a retail drugstore:

a. Yes c. depends on the discretion of the PPhA
b. No
A 253. An application to open a retail drugstore must be signed by

a. Filipino registered pharmacist c. Chinese druggist
b. American registered Pharmacist d. a&b
A 254. A rating below 50% in three sets of subjects:

a. disqualify the candidate from passing the Pharmacy Board Examination
b. pass the Board Examination if the average is 75%
c. conditional situation
d. NOTA
B 255. A drug trader is considered under:

a. drug outlet c. retailer
b. drug establishment d. b&c
C 256. Mandatory info. that shall be included in the labeling materials on pharmaceutical products as specified by RA 3720,
except;
a. name of the product c. assay procedure

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b. storage condition d. generic form and strength
B 257. The incoming shipment of food, drugs and cosmetics which are being imported are sampled and submitted for the
examination to the Bureau of:
a. Customs c. Health
b. Food and Drugs d. Internal Revenue
B 258 List of core and complementary drugs officially recognized by the DOH:
a. Drug Reference Manual c. PIMS
b. NDF d. AOTA
B 259. The size of the Rx symbol in a prescription label should be what proportion of the label:
a. ½ c. ¼
b. 1/5 d. 1/3
B 260. If a label for drugs has no Net Content that makes it misleading, it is considered:
a. adulterated c. poisonous
b. misbranded d. a&b
B 261. The principal display panel of the label of a dosage form is:
a. the side part c. back portion
b. most shown in front part d. any of the above
D 262. Requirement for approval of License to Operate (LTO) of an establishment

a. attendance to a BFAD seminar
b. certificate of registration of a Filipino Pharmacist
c. attendance to a CPE seminar
d. a&b
C 263. After the date, drug is not permissible to be sold refers to:
a. stability studies c. expiry date
b. shelf life d. a&b
C 264. A system of words or other system arbitrarily used to represent words:

a. secret key c. code
b. cipher d. NOTA
C 265. A pharmacist after filling a prescription containing a poison shall record the ff. except:
a. date of sale c. contraindication
b. name and quantity of poison sold d. purpose of the purchase
A 266. Poisons classified as violent

a. atropine c. Na hypochlorite
b. Aspirin d. Na phosphate
C 267. One of the ff. is not an objective of RA 5921

a. standardization of pharmaceutical education
b. control practice of pharmacy
c. adopt measures to ensure safe supply of foods and drugs
d. examination of graduate pharmacists
B 268. An act which provides for the registration and imposition of fixed and special taxes on all habit-forming drugs:
a. Dangerous Drugs Act c. Opium Law
b. Narcotic Drug Law d. Pharmacy Law
D 269. Member dean of the Council of Pharmaceutical Education

a. Dean of UP College of Pharmacy c. of a private college of pharmacy
b. of College of Medicine d. a & c
B 270. The Council of Pharmaceutical Education was created by:

a. PD 223 c. RA 3720
b. RA 5921 d. PD 1363
D 271. Required in labels for injection

a. statement of route of administration c. toxic dose
b. strength in units of potency d. a&b
B 272. The pharmacist may allow his certificate of registration rented provided he visits drugstores frequently?
a. Yes c. Doubtful
b. No d. depends on the discretion of the school
D 273. An adulterated food:

a. contains poisonous or deleterious substance
b. if packed under unsanitary conditions
c. without a DR number
d. a & b
C 274. If the standard of fill amount of container for food has not been complied with the manufacturer, the violation is:
a. adulteration c. misbranding
b. imitation d. a&c
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D 275. Barbiturates are considered

a. dangerous c. prohibited
b. regulated d. a&b
B 276. In the label of a dosage form, the brand name is on top of the generic name:
a. correct c. allowed in emergency cases
b. wrong d. a&c
D 277. The price of medicines allowed for Senior citizens with a discount can be granted upon presentation of:
a. OSCA approved ID card c. Prescription of a physician
b. any ID card d. a&c
B 278. Drug samples for manufacturer should be:

a. sold to the patients c. given free to anyone
b. given to the patients by the physician d. a and b
B 279. Who prepares the question for licensure examination

a. PRC Commissioner c. BFAD Officer
b. Board of Pharmacy member d. CHED representatives
D 280. One of this is not a pharmaceutical legislation

a. RA 6675 c. RA 6425 as amended
b. RA 5921 as amended d. RA 593
D 281. An additional requirement for approval of an LTO for an outlet s:

a. drug steal containing the name and address
b. rubber stamp with the name and address with name and address
c. accounting record book
d. a&b
A 282. Display of certificate of registration of pharmacist is done where:

a. place in conspicuous area in the drug outlet
b. inside the prescription room
c. at home
d. AOTA
C 283. In the case of drug recall, the responsibility for the quality of drug in original sealed container rests with the:
a. Pharmacists in-charge of the drugstore or hospital
b. drug distributor
c. drug manufacturer
d. delivery man
B 284. The Pharmaceutical manufacturer can sell their products directly to the:
a. public c. physician
b. wholesaler d. NOTA
C 285. Which RA prohibits the refusal of a drugstore owner to allow samples of his drugs to be collected by an authorized?
a. RA 953 c. RA 3720
b. RA 6425 d. RA 5921
A 286. Persons who are not considered to be practicing pharmacy:

a. detailmen c. faculty of a college of pharmacy
b. drugstore pharmacist d. b&c
A 287. The inspection of the food, drug and cosmetics establishments for compliance with Current Good Manufacturing
Practices is the duty of:
a. BFAD c. BIR
b. Board of Pharmacy d. CHED
A 288. Selling OTC drugs is a practice of pharmacy:

a. True c. doubtful
b. False d. depends on the location of the store
C 289. The Chairman of the Council of Pharmaceutical Education is:

a. PACOP President c. Secretary of Education
b. Dean of UP College of Pharmacy d. Any of the above
A 290. All prescriptions should have on the label “Warning: may be habit-forming”
a. False c. Sometimes
b. true d. Depending on the kind of prescription
A 291. DOH administrative order no. 56, 1989 regarding regulations, for licensing of establishments and outlets, the reference
books required for submission to the BFAD is:
a. USP/NF, Remington’s Pharmaceutical Science
b. PIMS
c. MERCK
d. All of the above
B 292. Pharmacist who substituted drugs called for in a prescription, without prior consultation with the prescriber violates:
a. RA 6675 c. PD 881
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b. RA 88, 3720 d. PD 1363
B 293. Right of the respondents means:

a. to inform the public c. to have a slow trial
b. to be represented by counsel d. none of the above
D 294. Mandatory information that shall be included in the front display panel of labels:
a. precautions c. warning
b. contraindications d. name of product in generics
C 295. Pharmacy means:

a. any drug preparation or mixtures of drugs
b. article intended for use in the diagnosis, cure, mitigations, treatment or prevention of disease in man or
animals
c. place of establishment where drugs, chemical products, active principles of drugs, pharmaceutical
proprietary medicine and poisons are sold at retail and where medical, dental , veterinary prescriptions are
compounded and dispense.
e. AOTA
C 296. All of these are true for yellow prescription forms, except;
a. they shall be used exclusively by the physician and other practitioner
b. it is not transferable
c. it is transferable
d. none of these
D 297. Which agency answers the functions of the former Food and Drug Administration?
a. Food and Drug Office
b. Bureau of Foods
c. Drug Administration of the Philippines
d. Bureau of Food and Drugs
C 298. All of these are correct for NDP, except;

a. NDP is enunciated on April 30, 1987
b. it ensure the safe and effective drugs are made available to all Filipinos
c. it is composed of core lists of drugs only
d. it is formulated through local research
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JURISPRUDENCE
1. The special law on counterfeit drug is known as RA__________

A.7394
B.3720
C.8203
D.5921
E.NOTA ( none of the above )
2. Counterfeit drug refer to the mdicinal products.
A. recognized in USP/NF
B. article intended for use in diagnosis, cure, mitigation and treatment of disease.
C. without active ingredient results in the reduction of drugs safety, efficacy, quality or strength
D. A & C only
E. AOTA ( all of the above )
3. Which of the following is a prohibited act under the special law on counterfeit drugs?
A. possession of the drug
B. manufacture, sale, offer for sale, donation, trafficking or importation of drug
C. unregistered imported drug products
D. A & B only
E. AOTA
4. The parties liable in RA 8203 include:
A. the pharmacist
B. inspector
C. manufacturer
D. customer
E. A & C
5. If the seized drug was found to counterfeit, the business establishment must be directed for preventive
closure for a period of :
A. 15 days
B. 10 days
C. 30 days
D. 20 days
E. 60 days
6. Administrative sanctions for any violators of special law on counterfeit drugs:
A. fine NLT 100,000 pesos and NMT 500,000 pesos
B. permanent closure of establishment and revocation of its license to do business
C. forfeiture, confiscation and destruction of products found to be counterfeit
D. A & C only
E. AOTA
7. RA 8203 was signed into law on:
A. Sept. 4, 1996
B. Sept. 13, 1988
C. Oct. 4, 1996
D. Sept. 13, 1986
E. Sept. 4, 1992
8. Drugs, as defined in RA 8203, refer to:
A. any article recognized in the official USP/NF
B. any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man
or animals
C. herbal and/ or in traditional drugs which are articles of plant or animal origin used in folk medicine
D. A & B only
E. AOTA
9. A certain drug is considered counterfeit if it contains less than how many percent of the active ingredient it
purports to possess?
A.80
B. 75
C. 60
D. 85
E. 90
10. As defined in RA 8203, this refers to any entity, whether a single proprietorship, partnership or
corporation engaged in or doing business in Philippines.
A. brokering
B. business establishment
C. residency
D. ownership
E. NOTA
11. Any person in possession of counterfeit drugs shall be exempted from liability after:
A. presentation of sales invoices, official receipts or legally acceptable document evidencing his
purchase from a drugstore an indicating therein the batch and lot numbers and expiry dates of such drugs
B. presentation of certificates evidencing the importation and exportation of drugs
C. presentation of duplicates legally acceptable documents evidencing the purchase and importation or
exportation of the drugs
D.A & B only
E. AOTA
12. Upon finding that the drugs examined are counterfeit, the Bureau shall file an appropriate proceeding
against the registered pharmacist with the PRC for the___________ of professional license.
A. revocation
B. suspension
C. cancellation
D. A or B
E. NOTA
13. The commission of the acts prohibited in RA 8203 shall be punished by:
A. imprisonment of NLT 6 months and one day but NMT 1 year if the counterfeit drug is intended for
animals
B. imprisonment of 6 years and one day but NMT 10 years
C. fine of NLT 100,000 pesos but NMT 500,000 pesos
D. B or C
E.AOTA
14. If the counterfeit drug is proximate cause of death of victim who unknowingly purchased and took the
counterfeit drug, the penalty to be imposed shall be:
A. life imprisonment
B. fine of 500,000 pesos to 5M pesos
C. fine of 100,000 pesos to 10M pesos
D. A & B only
E. A & C only
15. If the illness sought to be cured is aggravated by the use of the counterfeit drug, the punishment to be
imposed shall be:
A. imprisonment from 12 years to 15 years
B. life imprisonment
C. fine of 100,000 pesos to 500,000 pesos
D. A & C only
E. B & C only
fine of 100,000 pesos to 500,000 pesos
A. June 23, 1969
B. June 23, 1963
C. June 22, 1969
D. June 22, 1963
E NOTA
17. A complete pharmacy internship are based on RA 5921 article III section 18c shall consist of at least:
A. 480 hours
B. 960 hours
C.160 hours
D. 980 hours
E. 940 hours
18. RA 5921 provides for and shall govern:
A. standardization and regulation of pharmaceutical education
B. examination and registration of graduates of schools of pharmacy
C. supervision, control and regulation of the practice of pharmacy in Philippines
D. A & C only
E. AOTA
19. For the purpose of implementing RA 5921, this/these was/were created:
A. Board of Pharmacy
B. Council of Pharmaceutical Education
C.PRC
D. A & B only
E. AOTA
20. The Council of Pharmaceutical Education was created for the implementation of RA 5921. This council is
composed of:
A. Secretary of Education
B. BFAD administrator
C. Chairman of Board of Pharmacy
D. A & C only
E. AOTA
22. The Board of Pharmacy was created for the implementation of RA 5921. This Board is composed of a
chairman and _______ members.
A. 2
B. 3
C. 4
D. 5
E. 6
23. Who shall appoint the chairman and the members of the Board of Pharmacy?
A. BFAD director
C. President of the Philippines
D. Sec. of Department of Education
E. Commissioner of Civil Service
24. To be appointed member of the Board of Pharmacy, a person shall be a duly registered pharmacist and
has been in the practice of Pharmacy for at least _________ years.
A. 5
B. 7
C. 8
D. 10
E. 12
25. According to RA 5921, the qualifications of members of the Board of Pharmacy include:
A. natural born citizen in Philippines
B. of good moral character and of recognized standing in the pharmaceutical profession
C. a member of good standing of any bona fide national pharmaceutical association of the Philippines
D. A & B only
E. AOTA
26. For how many years shall the chairman and members of the Board of Pharmacy hold office after appointment?
A. 3
B. 4
C. 5
D. 6
E. 2
27. Which of the following statement is/are correct about the tenure of office and fees of board members?
A. The chairman or member may be reappointed for another term of 3 years but in no case shall he serve
continuously for more than 6 years
B. The most senior of the Board shall automatically be the chairman
C. The chairman and members shall receive the sum of 60 pesos for each applicant examined
D. A & B only
E. AOTA
28. If found guilty and neglect duty, incompetence, malpractice, unprofessional or dishonorable conduct, after
having been given the opportunity to defined himself in an administrative investigation, the Chairman or Members of
the Board may be removed by:
A. President of the Philippines
B. Chairman of the Council of Pharmaceutical Education
C. BFAD administrator
D. PRC Commissioner
E. Civil Service Commissioner
29. According to RA 5921, who shall be the Executive Officer of the Board?
B. Chairman of the Council of Pharmaceutical Education
C. BFAD Administrator
D. PRC Commissioner
E. Civil Service Commissioner
30. The Board of Pharmacy is vested with the authority to:
A. examine applicants for the practice of pharmacy
B. issue certificates of registration of pharmacists
C. study the conditions affecting the practice of pharmacy in the Philippines
D. A & B only
E. AOTA
31. Any person who shall be employed as detailman by any pharmaceutical establishment shall be required to
register with the:
A. PRC
B. BFAD
C. Board of Pharmacy
D. DOH
E. Council of Pharmaceutical Education
32. As defined in RA 5921, he is the one who represents any duly authorized manufacturer, dealer, distributor,
representative or wholesaler of drugs, pharmaceutical and biologic products whose primary duty is to introduce the
product made by the manufacturer.
A. broker
B. owner
C. detailman
D. retailer
E. wholesaler
33. Which of the following statement is/are true for detailman?
A. he shall be, preferably, a graduate of a college of Pharmacy
B. an initial fee of 20 pesos is needed upon registration
C. to be employed, he needs to possess the necessary credentials issued by the PRC
D. A & B only
E. AOTA
34. Any of the following shall be sufficient ground for reprimanding a pharmacist, or for suspending or revoking his
certificate of registration:
A. immoral or dishonorable conduct which includes conviction by a competent court of any criminal offense
B. fraud or deceit in the acquisition of the certificate of registration
C. insanity
D. A & B only
E. AOTA
35. Any of the following shall be sufficient ground for reprimanding a pharmacist, or for suspending or revoking his
certificate of registration:
A. acting as dummy of an alien or a person who is not a qualified to establish or operate a retail drugstore
B. gross negligence, or ignorance or incompetence in the practice of his profession resulting in the injury or
death of another
C. violations of any provisions of the code of ethics
D. A & B only
E. AOTA
36. Under RA 5921, administrative investigation shall be conducted by all members of the Board of Pharmacy. In
case of suspension, it shall be for a period of not more than:
A. 60 days
B. 6 months
C. 30 days
D. 3 months
E. 1 year
37. The Board of Pharmacy, upon receipt of a formal complaint under oath against a pharmacist, shall furnish the
latter a copy of the complaint which he shall answer within _______ days from receipt.
A. 15
B. 5
C. 10
D. 30
E. 60
38. A candidate for Board examination in pharmacy shall have the following qualification/s:
A. shall be a citizen of the Philippines
B. shall be of good moral character
C. shall have graduated with the degree of Bachelor of Science in Pharmacy or with an equivalent degree from a
school, college or university duly accredited by the Council of Pharmaceutical Education, completing a standard
pharmacy course of not less than 4 academic years.
D. A & C only
E. AOTA
39. The Pharmacist Examination shall consist of theoretical examination on the subjects in:
A. Chemistry
B. Biological science
C. Pharmacy
D. A & C only
E. AOTA
40. A person is deemed to be practicing pharmacy within the meaning of Article IV of RA 5921, if he:
A. prepares or manufactures, analyzes, assays, preserves, stores, distributes, or sells any medicine, drug,
chemicals, cosmetics and pharmaceuticals
B. renders pharmaceutical service in any office or drug and cosmetic establishment where scientific,
technological or professional knowledge of pharmacy is applied
C. engages in teaching scientific, technological or professional pharmacy subject in the college of pharmacy
D. A & B only
E. AOTA
41. Filling and refilling of prescription shall be done by:
A. registered pharmacist
B. intern with the supervision of a registered pharmacist
C. nurse
D. pharmacy aide
E. A & B only
42. Every prescription for external use filled in the drugstore shall bear what label?
A. red label
B. white label
C. red label showing in blank ink the components and the word “For external use only”
D. white label showing in red ink the word “For external use only”
E. NOTA
43. All prescription dispensed in the drugstore shall be recorded in the books kept for the purpose indicating:
A. name of the manufacturer
B. address of the manufacturer
C. lot and control numbers of the main ingredients of the prescription
D. A & C only
E. AOTA
44. The following substances are included in the list of violent poisons stated in RA 5921:
A. atropine
B. nitrobenzene
C. strychnine
D. B & C only
E. AOTA
45. If a pharmacists dispenses or sells any of the violent poisons intended for medicinal use, he shall enter into a
separate book detail such as:
A. name and address of purchaser
B. date of sale
C. purpose of purchase
D. name and quantity of poison
E. AOTA
46. The pharmacist shall affix to every box, bottle or other package containing any dangerous or poisonous drug the
following:
A. a label of white paper with the word POISON in red ink
B. a label of red paper
C. the word ‘Poison’ in large letters
D. a vignette representing skull and bones
E. B, C and D only
47. The book kept for the purpose of recording the sale of poisons shall be open at all times for inspection and shall
be preserved for a period of at least________ years after the last entry.
A. 1
B. 2
C. 3
D. 5
E. 7
48. The pharmacist in charge of a drugstore after filling a prescription containing abortive or anti- conception
substances or devices shall record in a separate register book for abortive and anti- conception the following data:
A. number and date of prescription
B. name and address of physician
C. date of filling a prescription
D. name, quantity and manufacturer of drug
E. AOTA
49. Any person who shall make false representation to procure a registration certificate as pharmacist for himself or
for another shall be sentenced to:
A. A fine of NLT 1000 pesos but not exceeding 4000 pesos
B. An imprisonment of NLT 6 months and one day but NMT 4 years
C. An imprisonment of NLT 4 months and one day but NMT 4 years
D. A & B only
E. A & C only
50. This means a method of secret writing that substitutes other or characters for the letter intended, or transposes
the letter after arranging them in blocks or squares.
A. code
B. cipher
C. secret keys
D. substitution
E. NOTA
51. This means a system of words or others system arbitrarily used to present words.
A. Code
B. Cipher
C. Secret keys
D. Substitution
E. NOTA
52. This means characteristic styles or symbols kept from the knowledge of others or disclosed confidentially to only
one or few.
A. Code
B. Cipher
C. Secret keys
D. Substitution
E. NOTA
53. It is any drug, active principle or preparation of the same, capable of destroying life or seriously endangering
health when applied externally to the body or introduced internally in moderate doses.
A. Adulterated drug
B. Misbranded drug
C. Counterfeit drug
D. Poison
E. AOTA
54. This term means any drug, preparation or mixture of drugs marked under a trade name and intended for the
cure, mitigation, treatment or prevention of disease in man or animals.
A. Pharmaceuticals
B. Proprietary medicines
C. Pharmaceuticals specialties
D. A & C only
E. AOTA
55. Under Ra 5921, Drug means:
A. article in the current official USP/NF
B. articles other than food, intended to affect the structure or any function of the body of man and animals
C. herbal and/or traditional drugs which are articles of plant or animal origin used in folk medicine
D. A & B only
E. AOTA
56. RA 3720 is also known as:
A. Pharmacy Law
B. Consumer Act of the Philippines
C. Food, Drugs and Cosmetics and Devices Act
D. Senior Citizens Act
E. Special Law on Counterfeit Drugs
A. June 22, 1963
B. June 22, 1969
C. June 23, 1969
D. July 22, 1969
E. July 22, 1963
58. In accordance with the provision of RA 3720, the Government through the DOH shall:
A. establish standards and quality measures for foods, drugs and devices and cosmetics
B. adopt measures to ensure pure and safe supply of foods and cosmetics
C. strengthen the BFAD
D. A & B only
E. AOTA
59. This division shall take charge of the inspection of food, drug and cosmetic establishment engaged in their
manufacture and sale.
A. Licensing Division
B. Inspection Division
C. Inspection and Licensing Division
D. Laboratory Division
E. C & D
60. Under RA 3720, The Board of Food Inspection is converted into the Board of Food and Drug Inspection which
shall consist of:
A. Representative of DOH
B. Representative of Dept. of Agriculture and Natural Resources
C. Representative of Dept. of Commerce and Industry
D. A & C only
E. AOTA
61. Under RA 3720, the Board of Food Inspection is converted into the Board of Drug Inspection which shall consist
of:
A. An authorized designate of the Commission of Custom
B. Pres. of the Phil. Medical Association
C. Pres. of the Phil. Pharmaceutical Association
D. Representative of Dept. of Commerce and Industry
E. AOTA
62. Who shall be designated by the Sec. of Health to be the Chairman of the Board of Food and Drug Inspection?
A. Representative of the DOH
B. Pres. of the Phil. Medical Association
C. Pres. of the Phil. Pharmaceutical Association
D. Representative of Dept. of Commerce and Industry
E. NOTA
63. Which Executive order abolished the Food and Drug Administration and created the BFAD?
A. EO 137
B. EO 851
C. EO 951
D. EO 147
E. EO 150
64. The term Secretary, in RA 3720, means:
A. Secretary of DOH
B. Secretary of Dept. of Commerce and Industry
C. Secretary of Education
D. Secretary of Dept. Agriculture and Natural Resources
E. AOTA
65. This means a quantity of any drug device produced during a given cycle of manufacture.
A. Batch number
B. Lot number
C. Batch
D. Control number
E. NOTA
66.’New Drugs’ means any drug, the component of which is such that said drug is not generally recognized among
experts qualified by scientific training and experience to evaluate the safety, efficacy and quality of drugs as safe,
efficacious and good quality for use. New drugs shall include drugs:
A. containing a newly discovered active ingredient
B. containing a new fixed combination of drugs
C. in an additional dosage of strength of the dosage form
D. A & B only
E. AOTA
67. Among the prohibited acts under RA 3720 are:
A. manufacture for sales, offer for sale, distribute in commerce or import into the Philippines any consumer
product which has been declared as banned consumer product
B. adulteration or misbranding of any food, drug, device or cosmetic
C. manufacture, importation, exportation, sale, offering for sale, distribution or transfer of any drug or device
which is not registered to BFAD
D. B & C only
E. AOTA
68. As stated in RA 3720, any person who commits the following shall subject to imprisonment of NLT 1 year but
NMT 5 years or a fine NLT 5000 pesos but NMT 10000 pesos or both:
A. sale or offering for sale of any drug or device beyond its expiration date
B. release for sale or distribution of a batch of a drug without batch certification when required
C. forging, counterfeiting, stimulating or falsely representing without proper authority using any mark, stamp, tag
authorized by regulations
D. A & C only
E. AOTA
69. The manufacturer, importation, exportation, sale, offering for sale, distribution or transfer of any food, drug,
device, or cosmetic that is adulterated or misbranded is a prohibited act under:
A. RA 3720
B. RA 5921
C. RA 8203
D. RA 9165
E. RA 7432
70. Under RA 3720, if a food bears or contains any poisonous or deleterious substance which may render it
injurious to health, it is deemed to be:
A. poison
B. adulterated
C. misbranded
D. counterfeit
E. hazardous
71. Under RA 3720, if a food’s container is composed, in whole or in part of any poisonous or deleterious substance
which may render the contents injurious to health, the food is deemed to be:
A. poison
B. adulterated
C. misbranded
D. counterfeit
E. hazardous
A. it has been prepared, packed or held under unsanitary conditions
B. damage or inferiority has been concealed in any manner
C. it is offered for sale under the name of other food
D. A & B only
E. AOTA
A. it is, in whole or in part, the product of a diseased animal or an animal which has died otherwise than by
slaughter
B. any substance injurious to health has been added or substituted
C. it bears or contain a coal tar color other one which is permissible
D. A & B only
E. AOTA
74. Under RA 3720, if the food is an imitation of other food, then the food is deemed to be:
A. fake
B. misbranded
C. misleading
D. adulterated
E. counterfeit
75. Under RA 3720, if the food labeling is false or misleading in any particular, then the product is deemed to be;
A. an imitation
B. misbranded
C. misleading
D. counterfeit
E. B & C
76. Who is authorized to suspend immediately upon notice any permit issued under authority if it found that any of
the conditions of the permit have been violated?
A. Secretary of health
C. Pres. of the Philippines
D. BFAD inspector
E. PRC Commissioner
77. Under RA 3720, if a drug’s strength differs from or its safety, efficacy, quality or purity falls below the standards
set forth in the compendium, then the drug is deemed to be:
A. mislabeled
B. adulterated
C. counterfeit
D. under quality
E. ineffective
78. A drug or device shall be deemed to be misbranded if it is for use by mans and contains any quantity of _______
which is/are not specified in the label.
A. barbituric acid
B. codeine
C. heroin
D. B & C only
E. AOTA
79. To whom shall any person submit an application for Licensing and Registration of any drug or device?
A. Secretary of Health
B. BFAD Director
C. PRC Commissioner
D. Licensing Officer
E. Commissioner of Customs
80. Any person who wish to file an application shall submit the following:
A. full list of articles used as components of such drug or device
B. full statement of the composition of such drug or device
C. full description of the methods used in and the facilities and control used for the manufacture of such drug or
device
D. specimen of the labeling proposed to be used for such drug or device
E. AOTA
81. Within how many days after filling of an application for Licensing registration of drugs or devices shall the
secretary approve or give the applicant notice of an opportunity for a hearing?
A. 150
B. 180
C. 200
D. 120
E. 60
82. In order to manufacture, sell, offer for sale, import or distribute any drug or device, a license to operate should
be first secured from:
A. BFAD
B. PRC
C. Dept. of Trade and Industry
D. Dept. of Commerce
E. DOJ
83. The RA provide for certification of batches of drugs composed wholly or partially of any kind of antibiotic.
A. RA 7432
B. RA 8203
C. RA 3720
D. RA 9165
E. RA 5921
85. These drug are promulgated by the Secretary to be exempted from any requirements under Section 22c Article
IX of RA 3720:
A. intended for investigational use
B. which are to be stored, processed, labeled or repacked at establishments other than where manufactured
C. Which conform to applicable standards of identity, strength, quality and purity
D. A & C only
E. AOTA
86. If a certain brand of face powder which claimed to be hypoallergenic causes itchiness and redness on the skin of
the user, the product is considered to be:
A. of high quality
B. misbranded
C. has acceptable side effects
D. adulterated
E. counterfeit
87. Drugs are considered to be adulterated if:
A. the label is misleading
B. it is an imitation of the product
C. it differs from USP standard
D. A & B
E. NOTA
88. The division in BFAD that certifies batches of antibiotics:
A. Product services
B. Laboratory services
C. Legal, Information and Compliance
D. Administrative
E. Inspection services
89. It means to bring into the Philippines by sea, land or air.
A. import
B. export
C. distribute
D. manufacture
E. NOTA
90. Who shall prescribe regulations for the efficient enforcement of the provisions of Section 30 of RA 3720, which is
about the Importation and Exportation of food, drugs, devices and cosmetics?
B. BFAD director
C. Commissioner of customs
D. A & B
E. A & C
91. According to RA 3720, these shall be published by the Bureau to serve as reference by manufacturers,
distributors, physicians, and consumers.
A. Drug reference manual
B. Drug bulletin
C. Drug information newsletter
D. A & B only
E. AOTA
92. In addition to the Administrative sanctions provided for under Letter of Instruction no. 1223, the Secretary is
authorized to impose __________ for any violation of RA 3720.
B. imprisonment of NLT 5 months but NMT 5 years
C. administrative fine NLT 1000 pesos and NMT 5000 pesos
D. fine of NLT 2000 pesos and NMT 5000 pesos
E. any of the above
93. Who shall take care and deliver to the Bureau the samples taken at random from every incoming shipment of
food, drugs, devices and cosmetics which are being imported or offered for import into the Philippines?
A. BFAD director
B. Civil service commissioner
C. Commissioner of customs
D. Secretary of health
E. NOTA
94. A food, drug, device or cosmetic intended for export shall not be deemed to be adulterated or misbranded under
RA 3720 if:
A. it conforms with the specification of the foreign purchaser
B. it is not in conflict with the laws of the country to which it is intended for export
C. it is labeled on the outside of the shipping package to show that it is intended for export
D. A & B only
E. AOTA
95. RA 3720 was amended by EO NO.________:
A. 881
B. 851
C. 175
D. 170
E. 54
96. The Comprehensive Dangerous Drugs Act of 2002 is:
A. RA 6425
B. RA 9165
C. RA 6675
D. RA 9465
E. RA 5921
97. A certified true copy of the record of dangerous drugs must be submitted to:
A. PDEA
B. BFAD
C. DDB
D. DOH
E. PRC
98. Amount of morphine subject to life imprisonment to death penalty and a fine of 500,000 pesos to 10M pesos:
A. 500g
B. 50g
C. 10g
D. 1g
E. 20g
99. Substances covered by RA 9165
A. prescription drugs
B. dangerous drugs
C. controlled precursors and essential chemicals
D. B & C only
E. AOTA
100. Prescription for dangerous drug are written in:
A. duplicate
B. triplicate
C. one copy
D. four copies
E. NOTA
101. Pharmacists are required to maintain and keep an original record of dangerous drugs.
A. sales
B. purchases
C. acquisition
D. A & B only
E. AOTA
102. The original copy of the prescription of dangerous drug is retained by the pharmacist for a period of ________
years from the date of sale or delivery of such drug.
A. 1
B. 2
C. 3
D. 4
E. 5
103. Regular member of the DDB:
B. Director of NBI
C. Secretary of Justice
D. President of the Integrated Bar of the Philippines
E. AOTA
104. Head of the PDEA:
B. Director General
C. NBI Chief
D. PNP Chief
E. BFAD Director
105. Permanent consultant of the DDB:
A. Secretary of the Health & Director of BFAD
B. NBI Director & PNP Chief
C. NBI Chief & BFAD Director
D. President of the Philippines
E. AOTA
107. This refers to any facility for the illegal manufacture of any dangerous drug/or controlled precursors and
essential chemical.
A. Clandestine laboratory
B. Laboratory equipment
C. Instrument
D. Den, Dive or Resort
E. NOTA
108. ________ is a place where any dangerous drug and/or controlled precursor and essential chemical is
administered, delivered or stored for illegal purposes, distributed or sold in any form.
A. Clandestine laboratory
B. Den, Dive or Resort
C. Centers
D. School
E. NOTA
109. This is an act of knowingly planting, growing, raising or permitting the planning, growing or raising of any plant
which is the source of the dangerous drug.
A. Cultivate
B. Culture
C. Illegal trafficking
D. Planting of evidence
E. A & B only
110. Illegal trafficking means the illegal __________ of any dangerous drug and/or controlled precursor and
essential chemical.
A. Cultivation and Culture
B. Delivery
C. Administration
D. Possession
E. AOTA
111. This refers to act of knowingly passing a dangerous drug to another, personally or otherwise and by any
means, with or without consideration.
A. dispense
B. deliver
C. administer
D. manufacture
E. NOTA
112. Chemical diversion refers to the __________ of legitimately imported, in-transit, manufactured or procured
controlled precursors and essential element in diluted, mixtures or in concentrated form to any person engaged in
the manufacture of dangerous drugs.
A. sale
B. distribution
C. supply & transport
D. A & B only
E. AOTA
113. A practitioner is any person who is a licensed:
A. Physician
B. dentist
C. chemist
D. A & B
E. AOTA
114. __________ is any act of giving away any dangerous drug and/or controlled precursor and essential chemical
Whether for money or other consideration
A. Deliver
B. Dispense
C. Sell
D. Administer
E. NOTA
115. This refers to any person who pays for, raises or supplies money for, or underwrites any of the illegal activities
prescribed under RA 9165.
A. financier
B. drug syndicate
C. pusher
D. B or C
E. NOTA
116. Methylenedioxymethampethamine ( MDMA ) is:
A. shabu
B. marijuana
C. ecstasy
D. opium poppy
E. NOTA
117. Cannabis is also known as:
A. shabu
B. marijuana
C. ecstasy
D. indian hemp
E. B & D only
118. Any person who shall import or bring into the Philippines any dangerous drug, regardless of the quantity and
purity shall have the penalty of:
A. life imprisonment to death
B. Fine of 500,000 pesos to 10M pesos
C. fine of 500, 000 pesos to 5M pesos
D. A & B
E. A & C
119. Any person who shall import ________ unless authorized by law, shall be punished by imprisonment from 12
years and one day to 20 years and a fine of 100, 000 pesos.
A. opium poppy
B. controlled precursor
C. essential chemical
D. B & C
E. AOTA
120 _________ shall be imposed on anyone who shall import into the Philippines any dangerous drug and/or
controlled precursor and essential through the use of diplomatic passport.
A. Life imprisonment
B. Maximum penalty
C. Minimum penalty
D. Fine of 500, 000 pesos
E. Death
121. Under RA 9165, the penalty of 12 years and one day to 20 years of imprisonment and a fine of 100, 000 pesos
to 500, 000 pesos shall be imposed upon any person who acts as a:
A. financier
B. protector
C. coddler
D. B & C
E. AOTA
122. Maximum penalty shall be imposed if the sale, trading, administration, delivery or distribution of dangerous
drug and/or controlled precursor and essential chemical transpires within ________ meters from school
A. 50
B. 75
C. 100
D. 125
E. 150
123. The presence of any_________ in the clandestine laboratory is a prima facie proof of manufacture of any
dangerous drug.
A. controlled precursor
B. essential chemical
C. laboratory equipment
D. A & B
E. AOTA
124. Amount of shabu subject to imprisonment to death penalty and a fine of 500, 000 pesos to 10M pesos:
A. 10g
B. 20g
C. 50g
D. 100g
E. 500g
125. Amount of marijuana subject to life imprisonment to death penalty and a fine of 500, 000 pesos to 10M pesos:
A. 10g
B. 20g
C. 50g
D. 100g
E. 500g
126. Amount of heroin subject to life imprisonment to death penalty and a fine of 500, 000 pesos to 10M pesos:
A. 10g
B. 20g
C. 50g
D. 100g
E. 500g
127. Methampethamine HCL:
A. shabu
B. marijuana
C. ecstasy
D. opium poppy
E. LSD
128. These are dangerous drugs:
A. MDMA
B. PMA
C. TMA
D. GHB
E. AOTA
129. Penalty for unlawful prescription of drugs:
A. life imprisonment to death
B. fine of 500, 000 pesos to 10M pesos
C. fine of 100, 000 pesos to 500, 000 pesos
D. A & B
E. A & C
130. Who shall take charge and have the custody of all dangerous drugs, plant sources, controlled precursor and
essential chemicals that are confiscated, seized or surrendered.
A. DDB
B. BFAD
C. PDEA
D. DOJ
E. A & C
131. The confiscated or seized dangerous drugs, plant sources, controlled precursor and essential chemicals shall
be submitted to the PDEA Forensic Laboratory for a quantitative examination within:
A. 24 hours
B. 12 hours
C. 2 days
D. 72 hours
E. 3 days
132. The following are unlawful acts under RA 9165 and any attempt to commit them shall be penalized:
A. importation of any dangerous drug and/or controlled precursor and essential chemical
B. maintenance of den, dive or resort where any dangerous drug is used in any form
C. manufacture of any dangerous drug and/or controlled precursor and essential chemical
D. A & C only
E. AOTA
133. Any person who is found guilty of planting any dangerous drug and/or controlled precursor and essential
chemical shall suffer the penalty of:
B. death
C. fine of 100,000 pesos to 500,000 pesos
D. A & C only
E. AOTA
134. If the government officials and employees are found guilty of the unlawful acts under RA 9165, they shall be
penalized by:
A. maximum penalty
B. disqualification from any public office
C. life imprisonment
D. A & B only
E. minimum penalty
135. Who shall accredit and monitor drug testing laboratories to safeguard the quality of results?
A. DOH
B. DOJ
C. BFAD
D. NBI
E. PDEA
136. Every pharmacist shall maintain and keep an original record of sales, purchases, acquisitions and deliveries of
dangerous drugs indicating the following information:
A. License number and address of pharmacist
B. Quantity and name of dangerous drug purchased
C. Date of purchase
D. Name, address and community tax certificate number of buyer
E. AOTA
137. To prescribe and promulgate rules and regulations governing the establishment of centers as described in RA
9165 is a duty of:
A. DOJ
B. DDB
C. DOH
D. BFAD
E. Pres. of Philippines
138. _________shall be the policy-making and strategy-formulating body in the planning and formulation of policies
and programs on drug prevention and control
A. BOP
B. DDB
C. PDEA
D. BFAD
E. NBI
139. The other members of DDB who shall be ex officio members are:
A. Sec. of DOJ or his representative
B. Sec. of DOH or his representative
C. Sec. of DND or his representative
D. A & B only
E. AOTA
140. The presence of ____members shall constitute a quorum whenever DDB calls a meeting.
A. 6
B. 7
C. 8
D. 9
E. 10
141. The appointed Executive Director of DDB shall act as the:
A. Secretary of the Board
B. Assistant Secretary of the Board
C. Auditor
D. Vice Chairman
E. Moderator
142. To initiate, conduct and support scientific, clinical, social, psychological, physical and biological researches on
dangerous drugs prevention and control measures is a function of:
A. BFAD
B. DDB
C. NBI
D. PDEA
E. DOH
143. PDEA stands for:
A. Philippine Drug Empowerment Agency
B. Philippine Drug Enforcement Affiliation
C. Philippine Drug Enforcement Agency
D. Philippine Drug Establishment Agency
E. NOTA
144. Responsible for the efficient and effective law enforcement of all the provisions on any dangerous drug and/or
controlled precursor and essential chemical:
A. DDB
B. PDEA
C. NBI
D. BFAD
E. DOH
145. Has the power to reclassify, add or remove, from the list of dangerous drugs:
A. DDB
B. PDEA
C. NBI
D. BFAD
E. DOH
146. To set the guidelines and overall framework to monitor and ensure the proper implementation of RA 9165 is a
function of:
A. Congressional Oversight Committee
B. PDEA
C. BFAD
D. DDB
E. NBI
147. ________ means any substance which will cause on normal living tissue, allergy or photodynamic quality of
hypersensitivity which becomes evident on reapplication of the substance.
A. strong sensitizer
B. corrosive
C. irritant
D. toxic
E. radioactive
148. Any substance or mixture of substances which is toxic, corrosive, irritant, is a strong sensitizer, is flammable or
generates pressure through decomposition heat or other means:
A. counterfeit substance
B. hazardous substance
C. poisonous substance
D. radioactive substance
E. adulterated substance
149. Revised regulations for the Licensing of Drug establishments and outlets:
A. AO 56
B. AO 52
C. AO 53
D. AO 61
E. AO 62
150. Labeling, sale and distribution of Hazardous Substances
A. PD 881
B. PD 781
C. PD 551
D. EO 175
E. AO 56
151. The Comprehensive Dangerous Drugs Act of 2002” is also known as _________
A. RA 9165
B. RA 6675
C. RA 9257
D. RA 7394
152. RA 9165was approved on __________
A. March 13, 1972
B. March 3, 1972
C. June 7, 2002
D. April 30, 1972
153. Opium is an example of a/an __________drug.
A. prohibited drug
B. regulated drug
C. exempt dangerous drug
D. none of the above
154. Which of the following is/are example of prohibited drug?
A. heroin
B. morphine
C. phenobarbital
D. AOTA
E. both A & B
155. Which of the following is/are example of regulated drug?
A. morphine
B. heroin
C. secobarbital
D. opium
156. RA 5921 is more commonly known as__________.
A. Senior Citizen’s Act
B. Pharmacy Law
C. Comprehensive Dangerous Drugs Act
D. Special Law on Counterfeit Drug
157. The pharmacy law was signed by former Pres. Ferdinand E. Marcos last________
A. June 23, 1966
B. June 29, 1969
C. June 26, 1969
D. June 23, 1969
158. This is a “place of establishment where drugs, chemical products, active principles of drugs, pharmaceuticals,
proprietary medicines or pharmaceutical specialties, devices and poisons are sold at retail and where medical,
dental, and veterinary prescriptions are compounded and dispensed.”
A. pharmacy
B. drugstore
C. pharmaceutical laboratory
D. AOTA
E. both A & B
159. This term “includes every person who acts as a merchant, broker, or agent, who sells, or distributes for resale
pharmaceuticals, proprietary medicines or pharmaceutical specialties.”
A. wholesaler
B. person
C. dealer
D. NOTA
160. The definition of drugs, as amended by EO NO.174 include/s
1. article in current official USP/NF, official Homeopathic Pharmacopeia of the US., official Drug Formulary, or
any supplement
2. articles intended for use in the prevention of diseases in man or animals; and
3. articles ( other than food ) intended to affect the structure or any function of the body of man or animals
4. refers to viruses, sera, toxins, and analogous products used for the prevention or cure of human diseases.
A. AOTA
B. 1 & 2
C. 1, 2, & 3
D. NOTA
161. This is a method of secret writing, substitutes other letters or characters for the letter intended, or transposes
the letter after arranging them in blocks or squares.
A. cipher
B. code
C. secret keys
D. Any of the above
162. This means “a system of words or other systems arbitrarily used to present words”
A. Cipher
B. Code
C. Secret keys
D. Any of the above
163. This means “characteristic styles or symbols kept from the knowledge of others or disclosed confidentially to
only one or a few”
A. Cipher
B. Code
C. Secret keys
D. Any of the above
164. This is the requirement for the opening of drugstore
A. Filipino registered pharmacist
B. 7×5 drugstore space
C. Drugstore label
D. record books
165. An ordinary prescription shall be preserved for a period of ___________
A. 5 years
B. 1 year
C. 3 years
D. 2 years
166. The records for the sale of poisons must be kept for a period of __________
A. 5 years
B. 1 year
C. 3 years
D. 2 years
167. Who can issue prescriptions for the dispensing of violent poisons?
A. physician
B. dentist
C. veterinarian
D. AOTA
168. What is the color of the label for prescriptions used externally?
A. white
B. red
C. green
D. blue
169. The age requirement in order to practice pharmacy in the Philippines
A. 18
B. 25
C. 21
D. 20
170. This a proof that a person is a licensed pharmacist
A. transcript of record
B. diploma
C. certificate of registration
D. certificate of internship
171. Which of the following is a practice of Pharmacy?
I. teaching pharmacy subjects
II. analyzing drug
III. conducting research
IV. manager of a chain drugstore
A. 3 only
B. 1 & 2 only
C. 1, 2 & 3 only
D. AOTA
172. Basis for non renewal of LTO
A. failure to comply with PRC standards and requirements
B. persistent performance that assures safety, efficacy, and quality of drugs products
C. serious repeated, rampant violation of existing laws, rules, and regulations
D. poor housekeeping
173. This is the “act of introducing any dangerous drug into the body of any person, with or without his knowledge by
injection, ingestion or other means or of commiting any act of indispensable assistance to a person in administering
a dangerous drug to himself’.
A. administer
B. cultivate
C. deliver
D. both A & B
E. both B & C
174. This is the act of knowingly planting, growing, raising of any of plant which is the source of a prohibited drug.
A. administer
B. cultivate
C. culture
D. both A & B
E. both B & C
175.”Employee” of a prohibited drug den, dive, or resort include/s____________
A. caretaker
B. lookout
C. watchman
D. AOTA
E. A & B only
176. Indian hemp is also known as
I. bhang
II. churrus
III. hashish
IV. she-bang
A. I only
B. I & II
C. I, II & III
D. I-IV
177. It refers to a state of psychic or physical dependence, or both on any dangerous drug, arising in a person
following administration or use of that drug on a periodic or continuous basis
A. druggist
B. drug dependence
C. pusher
D. coddler
178. What penalty shall be imposed upon any person who imports prohibited drugs?
A. reclusion perpetua to death
B. fine ranging from 500,000 pesos to 10M pesos
C. fine ranging from 100,000 pesos to 1M pesos
D. both A & B
E. both B & C
179. What penalty shall be imposed upon a person who, unless authorized by law, shall sell, administer, deliver,
give away to another, distribute, dispatch in transit or transport any prohibited drug, or act as a broker in such
transactions,
D. both A & B
E. both B & C
180. What penalty shall be imposed upon any person or group of persons who shall maintain a den, dive or resort
where any prohibited drug is found.
D. both A & B
E. both B & C
181.”The Expanded Senior Citizens Act” is also known as_________
A. RA 9265
B. RA 9165
C. RA 9275
D. RA 9257
182. This is the S- license for physicians, dentist, or veterinarian, who prescribes dangerous drugs
A. S-1
B. S-2
C. S-3
D. S-4
183. This is a policy and program of the National government to ensure that the safe and effective drugs are made
available to all Filipinos at any time and place and at reasonable and affordable cost.
A. National Drug Policy
B. National Formulary
C. Dangerous Drugs Board Policy
D. NOTA
184. What are the pillars of the National Drug policy?
I. Quality Assurance of Drug
II. Quality Control
III. Rational Use of Drug
IV. National Self-sufficiency in Pharmaceuticals
A. 1 & 2
B. 1, 2 & 3
C. 1, 3 & 4
D. 1, 2 & 4
185. The former president of the Philippines who enunciated the National Drug Policy
A. Fidel V. Ramos
B. Corazon C. Aquino
C. Ferdinand E. Marcos
D. Ramon Magsaysay
186. This refers to the practice of using only the necessary and effective drugs in treating an illness
A. cost- effectiveness
B. quality assurance
C. rational use of drugs
D. rational procurement
187. This is a simpler term for the scientifically recognized active ingredient of a drug.
A. generic name
B. brand name
C. chemical name
D. street name
188. This list refers to those drugs, which cure the vast majority of illnesses and should be affordable and available
to all persons. It is prepared and periodically updated by the DOH on the basis of health conditions in the
Philippines.
A. Essential Drug list
B. Core list
C. Complimentary list
189. RA 6675 is more commonly known as__________
A. Comprehensive Dangerous Drugs Act
B. Pharmacy Law
C. Food, Drug and Device and Cosmetic Act
D. Generics Act of 1988
190. This refers to the prohibited and regulated drugs
A. List A
B. List B
C. Rx
D. OTC
191. Betamethasone tablet and Methotrexate tablet belong to
A. List A
B. List B
C. Rx
D. OTC drugs
192. For drugs in list A containing the list of prohibited drugs and regulated drugs, which of the following is/are
required?
A. The S-2 license of a prescriber
B. The use of special DDB form
C. The observance of a recording system following pertinent DDB regulation
D. AOTA
E. both A & B
193. This is the act by a validly registered pharmacist of filling a prescription or doctor’s order on the patient’s chart.
A. dispensing
B. generic dispensing
C. any of the above
D. NOTA
194. This means dispensing the patient’s or buyer’s choice from among the generic equivalent.
A. dispensing
B. generic dispensing
C. AOTA
D. NOTA
195. This are pharmaceutical products of a or drug preparations that are to be dispensed only upon written order of
a validly registered physician, dentist or veterinarian for the management or treatment of a condition or disease.
A. prescription drugs
B. ethical drugs
C. OTC drugs
D. AOTA
E. both A & B
196. When the generic name is not written in a prescription, this is a case of
A. violative prescription
B. erroneous prescriptions
C. impossible prescriptions
D. NOTA
197. The generic name must be
A. enclosed by an outline circle
B. smaller font size than the trade name
C. printed in full and not abbreviated
D. written after the trade name
198. Generic prescribing is also known as
A. AO 61
B. AO 62
C. AO 63
D. AO 64
199. What is to be done with violative prescriptions?
A. shall be filled and kept
B. shall not be filled and kept for reporting to the nearest DOH office
C. shall be marked with red ink
D. shall be torn
200. Which of the following is an example of an erroneous prescription?
A. generic name is not legible and brand name is legible
B. brand name is not in parenthesis
C. only generic name is written but it is not legible
D. AOTA
201. When the generic name and brand name are not legible, this is a/an __________prescription.
A. violative
B. erroneous
C. impossible
D. NOTA
202. Sanctions for violation of the labeling requirement
A. confiscation of the LTO
B. cancellation of the certificate of registration of the pharmacist
C. recall of misbranded products
D. administrative fine of Php 6,000
203. This administrative order is about labeling requirements for pharmaceutical products
A. AO no. 67
B. AO no. 55
C. AO no. 65
D. AO no. 57
204. The generic name of the drug must be in accordance with
A. INN
B. USP/NF
C. BFAD
D. DOH
205. For products containing 3 or more ingredients, the official name for the combination shall be determined by
A. DOH
B. PRC
C. BFAD
D. DDB
206. In prescribing list B drugs, which needs strict precautions in their use, the prescriber must comply with a set of
guidelines. One guideline requires the prescriber to write the strength or dose level using units in the
________system
A. metric
B. apothecary
C. international unit
D. avoirdupois
207. According to AO NO.56,s. 1989, grounds for the revocation of LTO
A. lapses in record keeping of invoices and receipts of distribution records
B. violation of BFAD standards on quality, efficacy, purity and safety of drugs
C. sale or distribution of antibiotic products with batch certification by BFAD
D. absence of pharmacist on first inspection
208. This is all about the revised rules and regulation of registration of pharmaceutical products
A. AO no. 57
B. AO no. 55
C. AO no. 65
D. AO no. 67
209. RA 7432 is more commonly known as the__________
A. Expanded Senior Citizens Act
B. Generics Act of 1988
C. Comprehensive Dangerous Drugs Act
D. Consumer’s Act
210. The term “senior citizen” shall mean any resident citizen of the Philippines at least _____years old.
A. 50
B. 60
C. 55
D. 65
211. The senior citizens shall be entitled the grant of ________ of discount from all establishments relative to the
utilization of transportation services, restaurants and purchase of medicine anywhere in the country.
A. 20%
B. 25%
C. 10%
D. 15%
212. The government agency which issues national ID card and purchase slip booklet
A. DSWD
B. GSIS
C. OSCA
D. BFAD
213. The discount privileges of the senior citizen shall be
A. non-transferable
B. transferable but limited use only for the senior citizen
C. limited and exclusive for the benefit of the senior citizen
D. both A & C
214. Which of the following must be presented by a senior citizen when buying prescription drugs?
I. purchase slip booklet
II. prescription
III. birth certificate
IV. national identification card
A. 1 & 2
B. 2 & 3
C. 1, 2 & 4
D. 1, 2 & 4
215. __________shall mean any person whether related to the senior citizen or not who takes careof him/her as a
dependent.
A. head of the family
B. relative
C. benefactor
D. care-giver
216. Supplies or medicines to be given to senior citizens should not exceed
A. one day supply
B. one week supply
C. one month supply
D. one year supply
217. Violation of any provision of Senior Citizen’s Act is punishable by
A. a fine not exceeding 2,000 pesos
B. imprisonment not exceeding one month and a fine not exceeding 1,000 pesos
C. imprisonment not exceeding 2 months
D. both A & C
218. OSCA refers to
A. Office of the Senior Citizen’s Affiliate
B. Office of the Senior Citizen’s Affairs
C. Office of the Senior Citizen’s Academy
D. NOTA
219. It is written order and instruction of a validly registered physician, dentist, or veterinarian for the use of specific
drug product for a specific patient
A. prescription
B. medical certificate
C. medical chart
D. drug chart
220. It is the act of a validly registered pharmacist of filling a prescription or doctor’s order on the patient’s chart
A. dispenser
B. dispensing
C. selling
D. dispensary
221. When the drug product prescribed is not registered in BFAD, this is a case of
A. violative prescription
B. impossible prescription
C. erroneous prescription
D. coded prescription
222. If the brand name precedes the generic name, prescription is considered
A. violative
B. impossible
C. erroneous
D. coded
223. When a pharmacist receive a prescription wherin the generic does not correspond to the brand name, the
pharmacist
A. shall advice the prescriber
B. May dispense or fill the said prescription
C. instruct the customer the proper prescription
D. both A & B
224. Quantities less than 1 milligram shall be written in
A. gram
B. microliter
C. micrograms
D. kilogram
225. Quantities less than 1 gram shall be written in
A. milligram
B. microliter
C. micrograms
D. kilogram
226. The following are the violations of Generics act on the part of dispensers and outlets
A. failure to record and keep prescription filled
B. imposing a particular brand or product on the buyer
C. failure to report to the nearest DOH office prescription which complied to the said law
D. both A & B
227. Under the Generics Law, Which of these prescriptions shall be filled?
A. violative
B. impossible
C. erroneous
D. none of these
228. The term “drug outlet” pertain/s to
I. drugstore
II. drug trader
III. pharmacy
IV. botica
A. 1 & 2
B. 3 & 4
C. 1, 2 & 3
D. 1, 3 & 4
229. These are pharmaceutical products or drug preparations that can be dispensed even without a prescription for
the use of consumers for the prevention or symptomatic relief of minor or self-limiting ailments
A. OTC drugs
B. ethical drugs
C. non-prescription drugs
D. both A & C
230. Which of the following statement(s) is/are correct
A. Erroneous prescription should not be filled by the pharmacist, prescription kept and reported to the DOH
B. violative prescription should be filled, prescription kept and reported to the DOH
C. impossible prescription could be filled, prescription kept and reported to the DOH
D. violative prescription should not be filled, prescription kept by the pharmacist, and reported to the DOH
231. ____________has the power to reclassify, add to, or remove from the list of dangerous drugs.
A. PDEA
B. BFAD
C. DDB
D. NBI
232. Permanent consultant of the Dangerous Drugs Board
B. secretary of justice
C. President of the Integrated Bar of the Philippines
D. Director of the NBI
233. Rules and regulations to Implement Dispensing Requirements
A. AO. 63
B. AO. 62
C. AO. 67
D. AO. 64
234. Revised Rules and Regulations for the Licensing of Drug Establishment
A. AO. 55
B. AO. 56
C. AO. 42
D. AO. 62
235. Revised Rules and Regulations of Registration of Pharmaceutical Products
A. AO. 63
B. AO. 62
C. AO. 67
D. AO. 42
236. Drug registration of herbal and/or traditional drugs both local and imported
A. AO. 62
B. AO. 63
C. AO. 42
D. AO. 67
237. Re-application for LTO after revocation may be done within ________ year(s).
A. 3
B. 5
C. 2
D. 1
238. What physico-chemical assay is required for vitamin preparations?
A. pH meter
B. oven drying
C. TLC
D. Fluorophotometer
239. Prescription without specification of the generic name of the prescribed product is a violation of RA _________.
A. 5921
B. 6675
C. 6425
D. 3720
240. The ultimate objective of PNDP is/are to provide
A. low-cost high quality drugs
B. free consultation from the physician
C. high quality but expensive drug
D. both A & B
241. __________ means any substance which has a flash point at or below negative six and six-tenths degrees
centigrade as determined by the Tagliabue Open Club tester
A. extremely flammable
B. combustible
C. both A & B
D. neither A & B
242. ___________ contains the rules and regulations to implement dispensing requirements under the Generics Act
of 1988.
A. AO. No. 63
B. AO. No. 64
C. AO. No. 65
D. AO. No. 66
243. Which of the following is the Dangerous Drugs?
A. LSD
B. MDMA
C. both A & B
D. NOTA
244. This means any substance which on contact with living tissue will cause destruction of tissue by chemical
action.
A. corrosive
B. bleaching agent
C. disinfectant
D. irritant
245. This a substance which on immediate, prolonged or repeated contact with normal living tissue will induce local
inflammatory action.
A. corrosive
B. irritant
C. disinfectant
D. bleaching agent
246. RA. 7394 was signed into a law on
A. April 13, 1992
B. Feb. 7, 1992
C. Sept. 13, 1992
D. April 7, 1992
A. Sept. 23, 1998
B. Sept. 13, 1998
C. Sept. 4, 1998
D. Sept. 30, 1998
A. Feb.7, 1992
B. April 7, 1992
C. Feb. 13, 1998
D. April 13, 1992
249. Which of the following does not required a prescription?
A. finasteride
B. ibuprofen 200mg
C. zafirlukast
D. esomeprazole
250. EO. No.______ institutionalizes the Continuing Professional Education ( CPE ) Programs of the various
Professional regulatory Boards ( PRBs ) under the supervision of the Philippine Regulatory Commission.
A. 851
B. 265
C. 266
D. 267
251. Inspection Section and Licensing Section are under what organizational unit of BFAD?
A. Regulation Division I
B. Regulation Division II
C. Product Services Division
D. Laboratory Services Division
252. Cash collection and Disbursement Section, and Personnel Section are under what organizational unit of
BFAD?
A. Product Services Division
B. Laboratory Services Division
C. Legal, Information and Compliance Division
D. Administrative Division
253. This BFAD organizational unit plans, directs, organizes, and controls the activities of the Bureau with the
assistance of the Divisions and Units under it.
A. Office of the Director
B. Regulation Division I
C. Regulation Division II
D. Product Services Division
254. The Laboratory Services Division Of BFAD includes
A. food
B. toxicology
C. cosmetic
D. household hazardous substance
255. The Division in BFAD that certifies batches of antibiotics
A. Product Services
B. Laboratory services
C. Legal, Information, and Compliance
D. Administrative
256. This is the Division of the BFAD that provides assistance to person/establishment in complying with BFAD legal
requirements.
A. Laboratory Services
B. Legal, Information, and Compliance
C. Product Services
D. Regulation Division I
257. The Laboratory Division of BFAD has the duty of
A. testing, analyzing, and doing trials on submitted products
B. inspection of drug outlets
C. taking samples from different drug establishment
D. assist in the of factual evidences
258. This order prescribes the conditions and requirements for good manufacturing practice applied to premises,
equipment, personnel, product and warehouse.
A. AO. No. 202
B. AO. No. 220
C. AO. No. 221
D. AO. No. 223
259. CGMP means
A. current general manufacturing process
B. current good manufacturing procedure
C. current good manufacturing practice
D. current good manufacture practice
260. CGMP assures drug meets the requirements of the act as to
A. safety
B. identity
C. strength
D. purity
E. AOTA
261. Equipment used for manufacturing, processing, packing, labeling, testing and control of drugs must be
A. of suitable size
B. absorptive
C. non-reactive
D. both A & C
262. Test for components
A. Microbiological test
B. Test for heavy metals
C. Microscopic examination
D. all of the above
263. The amount of reserve sample of all active ingredients to be kept for all required test in the laboratory to be
performed are
A. 5×
B. 2x
C. 3x
D. 4x
264. Approved records of components which must be maintained for future reference
A. name of customer
B. lot component
C. date and amount received
D. batch uniformity
265. Production record must be kept for
A. 2 years after expiration of the product
B. 2 years after batch distribution is completed
C. 1 year after batch distribution is complied
D. 2 years before expiration date
266. Each critical step in production process must be performed and checked by _________ competent and
responsible individual
A. 1
B. 3
C. 4
D. 2
267. Laboratory controls are required for
A. finished products
B. in process drug
C. components
D. all of the above
268. This mean any ingredient intended for use in the manufacturing of drugs, including those that may not appear
in the finished product.
A. component
B. raw material
C. inactive ingredient
D. both A & B
E. both A & C
269. This means a batch or any portion of a batch of a drug produced by continuous process, an amount of drug
produced in a unit time or quantity in a manner that assures its uniformity and either case which is identified by a
distinctive lot number and has uniform character and quality within specified limits.
A. lot
B. lot number
C. control number
270. This means any distinctive combination of letters or numbers, or both by which the complete history of the
manufacture, control, packaging, and distribution of a batch or lot of a drug is determined.
A. lot
B. lot number
C. control number
D. A & B
E. B & C
271. According to AO. No. 42, the test for alcohol content in quality control requirements should not more than ___
A. 15%
B. 10%
C. 20%
D. 30%
272. This is the required test for suppositories and pessaries
A. weight variation
B. dissolution
C. melting point
D. boiling point
273. Ointments, creams, and other semi-solid preparations are tested for
A. impalpability
B. homogeneity
C. melting point
D. all of the above
274. Validity of the initial registration for herbal and traditional drugs
A. 5 years
B. 2 years
C. 1 years
D. 3 years
275. Herbal and Traditional drugs must be registered with the
A. DOH
B. DTI
C. BFAD
D. DDB
276. This means any drugs Establishment that procures raw materials, active ingredients and/or finished products
from local establishments for local distribution on wholesale basis.
A. importer
B. exporter
C. wholesaler
D. drug trader
277. This means any organization or company involved in the manufacture, importation, repacking, and/or
distribution of drugs or medicines.
A. drug establishment
B. drug outlet
C. drug manufacturer
D. drug trader
278. This a drug which has been used for at least 5 years and involving at least 5,000 patients.
A. investigational drugs
B. tried and tested drugs
C. established drugs
279. This a drug whose safety and efficacy has been demonstrated through long years of general use and can be
found in current official USP-NF, and other internationally recognized pharmacopeias.
A. investigational drugs
B. new drug
C. established drugs
280. This refers to a new chemical or structural modification of tried and tested or established drug proposed to be
used for a specific therapeutic indication.
A. investigational drug
B. new drug
C. both A & B
D. neither A or nor B
281. This refers to a new chemical or structural modification of tried and tested or established drug proposed to be
used for a specific therapeutic indication, which has undergone adequate clinical pharmacology Phase I, II, III
studies but which needs further Phase IV Clinical Pharmacology Studies before it can be given regular registration
A. investigational drug
B. new drug
C. both A & B
D. neither A nor B
282. This is also refer to as the Price Act
A. RA. 7581
B. RA. 8203
C. RA. 7432
D. RA. 6425
283. The requirements for labeling materials is under what Administrative Order?
A. AO. No. 51
B. AO. No. 52
C. AO. No. 54
D. AO. No. 55
284. __________ refers to the instructions and special care required in the use of product to avoid undesired effects
and to ensure the safe and effective use of the drug.
A. Precautions
B. Contraindications
C. Warning
285. This refers to statements regarding the occurrence of potential hazards and side effects associated with the
use of the product and limitation of its use.
A. Precautions
C. Warning
286. This refers to a statement regarding the conditions wherein the use of the product may cause harm to the
patient.
A. Precautions
C. Warning
287. __________ refers to the classification of the product based on its therapeutic action.
A. dosage form
B. mode of action
C. formulation
D. pharmacologic category
288. Pursuant to AO. No. 55, s. 1988, the alcohol content in the formulation shall be expressed in _______
A. mg%
B. %
C. ml
D. v/v
289. The net content shall indicate the total amount/quantity/number of dosage form in a given container of the
product expressed in _______
A. Arabic numeral
B. avoirdupois
C. metric system
D. roman numeral
290. What type of font was specified for printing the Generic name if the name of the product is presented using a
special typeface exclusively designed for it?
A. Arial
B. Helvetica medium
C. universe medium
D. both A & B
E. both B & C
291. Expiry date expressed in terms of
A. month and day
B. month and year
C. day and year
D. year, day and month
292. If the expiry date of the product is indicated as “January 2005”, the expiry date of the product is assumed to be
A. January 1, 2005
B. January 15, 2005
C. January 20, 2005
D. January 31, 2005
293. __________ indicates the number given by BFAD for the product code.
A. manufacture date
B. expiry date
C. registration number
D. lot number
294. Drugs with multiple components must be arranged in order of _________
A. decreasing pharmacologic activity
B. increasing pharmacologic activity
C. alphabetically
D. according to the amount of use
295. _________ contains the active ingredient and quantity of drug per dosage unit.
A. dosage form
B. mode of administration
C. formulation
D, pharmacologic category
296. Additional information for injections
A. recommended routes of administration
B. ”use only one” or “discard the remaining portion” if an anti-microbial agent is not included in the product
C. both A & B
D. Neither A nor B
297. Which of the following is exempted in the labeling requirement?
A. product for external use
B. product placed in small container
C. drugs for investigational purposes
D. large volume injections
298. The word “single use” must be included in the label for
A. biological products
B. individually wrapped products
C. large volume injections
D. small containers
299. In accordance to Administrative order No. 56, s. 1989, the initial License to Operate has a ______ years.
A. 5
B. 2
C. 1
D. 3
300. Under Administrative Order No. 56, s. 1989, the renewal of the License to Operate has a ______years
A. 5
B. 1
C. 2
D. 3
Pharmaceutical Jurisprudence and Ethics A. device
(Red PACOP) B. drugs
C. cosmetics
D. poison
1.) The following persons shall be liable for E.Biologicproducts
violation(s) of RA 8203 except:
A. the manufacturer of the counterfeit drugs 8.) It refers to the approved clinical use of the product
B. importer or agents of counterfeit drugs based on substantial and scientifically supported
C. the registered pharmacist who has actual evidence of the safety and efficacy of the drug in the
or constructive knowledge about the given dosage form:
counterfeit drugs A. pharmacologic category
D. the registered pharmacist who has no B. indication
actual or constructive knowledge about the C. dosage formulation
counterfeit drugs D. dosage form
E. none E. expiry date
2.) Which of the following statement is/are true for 9.) A drug which has been used for at least five (5)
detail man? years and involving at least 5,000 patients:
A. an initial fee of twenty pesos is needed A. investigational drugs
upon registration B. established drugs
B. he shall be, preferably a graduate of a C. new drugs
College of Pharmacy D. tried & tested drug
C. to be employed, he needs to possess the E. Innovation of the tried and tested drug and
necessary credentials issued by the PRC established drug
D. only A and B
E. All of the above 10.) In Human Studies- Clinical Pharmacology III:
A. Controlled Clinical Trials
3.) This order gives comprehensive guidelines on the B. Safety and Efficacy
registration of pharmaceutical products to be C. Tolerance and Safety
consistent with RA 6675: D. Post Marketing Surveillance
A. AO 220 E. Provisional Monitored Release
B. AO 42
C. AO 67 11.) It is a drug which contains no amount of, or a
D. AO 90 different active ingredient, or less than 80% of the
E. AO 56 active ingredient it purports to possess, as
distinguished from an adulterated drug including
4.) This order defines rules & regulations governing reduction or loss of efficacy due to expiration:
the registration and sale of herbals and/or traditional A. Counterfeit drug
drugs to ensure their quality and safety: B. New drug
A. AO 220 C. Investigational drug
B.AO 42 D. Tried & Tested drug
C. AO 56 E. Ethical drug
D. AO 67
E. AO 90 12.) Any person whether related to the senior citizen
or not who takes care of him/her as dependent:
5.) Any person who shall violate RA 6675, sec 12 (a) A. head of the family
for the first conviction shall suffer the penalty of B. benefactor
reprimand which shall be officially recorded in the C. beneficiary
appropriate books of the: D. protector
A. PRC E. dependent
B.BOP
C. DDB 13.) It is a license issued by the Director General of
D. CPE the Intellectual Property Office (IPO) to exploit a
E. PPhA patented invention without the permission of the
patent holder either by manufacture or through
6.) They ensure the provision of safe, effective and parallel importation:
quality drugs, for improved patient care and quality of A. Certificate of Product Registration
life by helping individuals protect themselves against B. Compulsory license
diseases, maintain good health and make the best C. batch certificate
use of their medication. D. PRC license
A. teachers E. NOTA
B. pharmacist
C. medical technologist 14.) It refers to pharmaceutically equivalent or
D. veterinarian pharmaceutically alternative products that may or may
E. pharmacy technician not be therapeutically equivalent:
A. multisource pharmaceutical products
7.) An article intended to be rubbed, poured, B. multi-pharmaceutical products
sprinkled, or sprayed on, introduced into, or otherwise C. source pharmaceutical products
applied to the human body or any part thereof for D. generic products
cleansing, beautifying, promoting attractiveness, or E. pharmaceutical products
altering appearance:
15.) Any person who sells, trades, administers, A. 5291
dispenses, delivers, or gives away to another, on any B. 6675
term whatsoever, or distributes dispatches in transit or C. 3720
transport dangerous drugs or who act as a broker in D. 8203
any such transactions: E. 5921
A. practitioner 24.) The Generics Act of 1988 is known as R.A:
B. coddler A. 5921
C. protector B. 6675
D. pusher C. 3720
E. drug syndicate D. 8203
E. 8293
16) If the entire batch of product is marketed under
one company, only the lot number needs to be 25.) The Intellectual Property Code of the Philippines
indicated: in known as R.A:
A. the statement is incorrect A. 7432
B. the statement is correct B. 7581
C. both the batch and the lot number should C. 8293
be indicated D. 7394
D. only the registration number is needed E. 7581
26.) The Special Law on Counterfeit Drug is known as
17.) Dangerous drug prescriptions shall be retained R.A:
by the pharmacist for a period of: A. 5921
A. 3 years B. 6675
B. 2 years C. 3720
C. 4 years D.8203
D. 5 years E. 8293
E. 1 year
27.) The Comprehensive Dangerous Drug Act of 2002
18.) Drug Registration of Herbal and/or Traditional is known as R.A:
Drugs (Local & Imported): A. 9257
A. AO 63 B. 9502
B. AO 62 C. 9165
C. AO 42 D. 9205
D. AO 55 E. 9711
E. AO 56
28.) Revised Rules and Regulations to Implement
19.) Revised Rules and Regulations to implement Prescribing Requirements under the Generic Act of
Prescribing Requirements under the Generics Act of 1988:
1988: A. AO 63
A. AO 63 B. AO 67
B. AO 62 C. AO 42
C. AO 42 D. AO 55
D. AO 55 E. AO 62
E. AO 67
29.) Revised Rules and Regulations to Implement
20.) Revised Regulations for the licensing of Drug Dispensing Requirements under the Generic Act of
Establishments and Outlets: 1988:
A. AO 42 A. AO 63
B. AO 90 B. AO 62
C. AO 64 C. AO 42
D. AO 56 D. AO 55
E. AO 55 E. AO 56
21.) The Universally Accessible Cheaper and Quality 30.) Revised Rules and Regulations on Registration
Medicines Act of 2008 is known as R.A: of Pharmaceutical Products:
A. 9257 A. AO 67
B. 9502 B. AO 90
C. 9165 C. AO 64
D. 9205 D. AO 56
E. 9527 E. AO 42
22.) The Expanded Senior Citizens Act of 2003 is 31.) The principal Display Panel comprises ____% of
known as R.A: the total surface of the container:
A. 9527 A. 10
B. 9502 B. 40
C. 9257 C. 80
D. 9165 D. 95
E. 9205 E. 85
23.) The Pharmacy Law is known as R.A:

32.) The test for alcohol content for registration of D. Director of BFAD
herbal and/of traditional drugs should not be more E. Director of FDA
than ____%:
A. 10 40.) According to A.O 55, under the formulation,
B. 40 drugs with multiple components must be arranged in
C. 80 order of:
D. 95 A. decreasing pharmacologic activity
E. 15 B. increasing pharmacologic activity
C. alphabetically
33.) Amount of marijuana subject to life imprisonment D. according to use
to death and a fine ranging from 500,000 pesos to E. according to pharmacologic category
10M pesos:
A. 500g 41.) Authorized to establish and initiate a price
B. 10g monitoring and regulation system for drugs and
C. 50g medicines:
D. 40g A. Secretary of the FDA
E. 30g B. Secretary of the DTI
C. Secretary of the DENR
34.) Amount of heroin subject to life imprisonment to D. Both B and C
death and a fine ranging from 500,000 pesos to 10M E. Secretary of the DOH
pesos:
A. 500g 42.) For products containing 3 or more active
B. 10g ingredients, the official name for the combination shall
C. 50g be designated by:
D. 40g A. DOST
E. 30g B. DTI
C. DOH
35.) If the seized drug was found to be counterfeit, the D. BFAD
business establishment must be directed for E. FDA
preventive closure for a period of:
A. 10 days 43.) The one responsible in ensuring that all drugs
B. 15 days authorized for marketing in the country conform to
C. 60 days international standards for the content, purity and
D. 30 days quality of pharmaceutical products as established in
E.25 days the International Pharmacopeia is:
A. BFAD
36.) The confiscated or seized dangerous drugs, plant B. DTI
sources, controlled precursor and essential chemicals C. DOH
shall be submitted to PDEA Forensic Laboratory for a D. DOST
quantitative examination within: E. DENR
A. 12 hours
B. 48 hours 44.) The following must be displayed conspicuously
C. 24 hours inside the drug outlet:
D. 16 hours A. certificate of product registration
E. 6 hours B. diploma of the pharmacist-in-charge
C. certificate of registration of the pharmacy
37.) The decision of the Board of Pharmacy in D. certificate of registration of the pharmacy
administrative cases involving a pharmacist becomes technician-in-charge
final and executor after the lapse of: E. certificate of registration of the pharmacist-
A. 15 days in-charge
B. 60 days
C. 30 days 45.) Grounds for suspension of LTO of Drug
D. NMT 6 months from notice to respondent Establishment:
E. 10 days A. lapses in record keeping of invoices
B. sale of antibiotics without batch certification
38.) Drug test certificates issued by accredited drug C. selling of misbranded drugs
testing centers shall be valid for _____ period from D. serious repeated or rampant violation of
the date of issued: existing laws, rules & regulations
A. 2 years E. lapses in record keeping of CPR
B. 1 month
C. 3 months 46.) Requirements for product registration, except:
D. 6 months A. prescription
E. 1 year B. brand identification
C. prescribing & dispensing regulations
39.) Responsible in granting a license to exploit a applicable
patented invention, even without the agreement of the D. available scientific evidence
patent owner, in favor of any person who has shown E. price
the capability to exploit the invention:
A. Director General of the IPO 47.) The source or circumstances of drug production
B. Director General of PDEA is/are:
C. Director of NBI A. imported as finished
B. locally manufactured from local materials B. antibiotics
C. locally manufactured from imported C. new drugs
materials D. new veterinary drugs
D. all of the above E. biologic products
E. none of the above
56.) The concentration of known active drug
48.) In a drug establishment, personnel responsible substance in formulation:
for directing the manufacture and control must: A. strength
A. be inadequate of number B. net content
B. graduate of any 4 year course C. component
C. has capabilities to commensurate with D. stability
assigned function E. expiry date
D. experience is not necessary
E. all of the above 57.) Articles (other than food) intended to affect the
structure or any function of the body of man and
49.) Heavy metals to be tested in the herbal and/or recognized in the Philippine National Formulary:
traditional drugs EXCEPT: A. medicinal plants
A. Hg B. traditional drugs
B. Pb C. herbal drugs
C. As D. Both B and C
D. Cu E. none of the above
E. Mercury
58.) It refers to the classification of the product based
50.) Requirements for registration of local herbal on its therapeutic action as specified in the product
and/or traditional drugs: registration:
A. technical specifications of the ingredients A. pharmacologic category
used as component B. indication
B. Government certificate of clearance C. dosage form
C. free sale of drug D. dosage formulation
D. certification of the importation of the drug E. formulation
E. certification of the exportation of the drug
59.) It refers to the statement regarding the
51.) It is the science of philosophy of laws: occurrence of potential hazards and side effects
A. ethics associated with the use of the product
B. jurisprudence and the limitation of its use:
C. morality A. contraindication
D. rules B. warning
E. regulation C. precautions
D. indications
52.) It refers to viruses, sera, toxins and analogous E. pharmacologic category
products used for the prevention or cure of human
diseases: 60.) It refers to the instructions and special care
A. biologic products required in the use of product to avoid undesired
B. poison effects and to ensure the safe and effective use of the
C. device drug:
D. Both A and C A. contraindications
E. Both B and C B. warning
C. pharmacologic category
53.) An instrument, apparatus or contrivances, D. indications
including their components, parts, and accessories, E. precautions
intended for use in the diagnosis, cure, mitigation,
treatment or prevention of disease in man or other 61.) _____drugs not covered by patent protection and
animals: which are labeled solely by their international non-
A. device proprietary name:
B. drug A. generic
C. cosmetics B. innovator
D. poison C. branded
E. biologic products D. essential
E. non-essential
54.) Drug intended for use for animals:
A. poison 62.) The term “Drug Outlet” does not include:
B. antibiotics A. botica
C. new drugs B. drugstore
D. new veterinary drugs C. drug laboratory
E. biologic products D. Both A and B
55.) Any drug intended for use by man containing any
quantity of any chemical substance which is produced 63.) It is an act providing protection to consumers by
by microorganism and which has the capacity to stabilizing the prices of basic necessities & prime
inhibit or destroy microorganism in dilute solution: commodities and by prescribing measures against
A. poison
undue price increases during emergency situations A. DDB
and like occasions: B. PDEA
A. RA 7394 C. FDA
B. RA 7581 D. DOH
C. RA 7432 E. PRC
D. RA 3720
E. RA 8293 71.) This refers to any facility used for the illegal
manufacture of any dangerous drug/or controlled
precursors and essential chemical:
64.) This order prescribes the conditions and A. classrooms
requirements for good manufacturing practice applied B. clandestine laboratory
to premises, equipment, personnel, product and C. licensed establishment
warehouse: D. all of the above
A. AO 220 E. none of the above
B. AO 42
C. AO56 72.) Maximum penalty shall be imposed if the sale,
D.AO 67 trading, administration, delivery or distribution of
E. AO 90 dangerous drugs and/or controlled precursor and
essential chemical transpires within ____meters from
65.) This order prescribes the activities involving drug school:
products that need to be covered by a licensed from A. 50
BFAD: B. 100
A. AO 220 C.101
B. AO 42 D.30
C. AO56 E. 10
D.AO 67
E. AO 90 73.) Penalty for unlawful prescription of dangerous
drugs:
66.) Under R.A 5921, administrative investigation A. fine of 100,000 pesos to 500,000 pesos
shall be conducted by all members of the Board of B. life imprisonment to death
Pharmacy. In case of suspension, it shall be for a C. fine of 500, 000 pesos to 10M pesos
period of NMT: D. b and c
A. 1 year E. a and c
B. 30 days
C. 6 months 74.) It refers to a licensed establishment carrying on
D. 60 days the retail business of sale of drugs and medicines to
E. 10 days customers:
A. exporter
67.) Under R.A 3720, if a drug’s strength differs from B. importer
or its safety, efficacy, quality or purity falls below the C. wholesaler
standards set forth in the compendium, then the drug D. retailer
is deemed to be: E. Both A and B
A. adulterated
B. mislabeled 75.) Penalty for illegal acts of price manipulation of
C. ineffective any drug and medicines subject to price regulation:
D. all of the above A. imprisonment of NLT 5 years nor more than
E. none of the above 15 years
B. fine of NLT 100,000 nor more than 10M
68.) Any person who shall be employed as detailman pesos
by any pharmaceutical establishment shall be C. imprisonment of NLT 10 years
required to register with the: D. imprisonment of NLT 5 YEARS
A. BFAD E. Both A and B
B. PRC
C. Board of Pharmacy 76.) _____contains the active ingredients and quantity
D. DOH of the drug per dosage unit:
E. PPhA A. dosage form
B. formulation
69.) If found guilty of neglect of duty, incompetence, C. mode of administration
malpractice, unprofessional or dishonorable conduct, D. excipient
after having been given the opportunity to defend E. preservatives
himself in administrative investigation, the Chairman
or members of the Board of Pharmacy may be 77.) Every prescription for external use filled in the
removed by: drugstore shall bear a red label showing in black ink
A. President of PACOP the components for such prescription and the word
B. President of the Philippines ______ at the bottom of the label:
C. PRC Commissioner A. “Warning: May be habit-forming”
D. Director of BFAD B. “For external use only”
E. President of PPhA C. “For internal use only”
D. “Flammable”
70.) A certified true copy of the record of dangerous E. “Inflammable”
drugs must be submitted to:
78.) The provision of this act on warranty shall not D. the number of counterfeit drug products is
applied to professional services of CPA, architects, NMT 3 brands
engineers, lawyers, veterinarians, optometrists, E. Both A and C
pharmacists, nurses, nutritionist, dieticians, physical
therapists, salesman, medical and dental practitioners 85.) Product which fails to comply with an applicable
and other professional engaged in their respective consumer product safety rule which creates a
professional endeavors: substantial risk of injury to the public is referred to:
A. RA 7581 A. misbranded
B.RA 7394 B. substandard
C. RA 7432 C. adulterated
D. RA 8293 D. expired
E. RA 8203 E. counterfeit
79.) ______for products other than biological products 86.) Basis for non-renewal of LTO:
means the date (month & year) during which the A. poor housekeeping
processing of the product, from which the goods are B. failure to comply with PRC standards and
to be filled is completed: requirements
A. expiry date C. serious, repeated or rampant violation of
B. date of distribution existing laws, rules & regulations
C. date of manufacture D. persistent performance that assures safety,
D. storage date efficacy and quality of drug products
E.stability E. All of the above
80.) Under A.O 55, the Rx symbol should be printed 87.) Only establishment with a valid LTO required
in a type size _____ of the height of the PDP: under _____ can apply to register a drug product:
A. NLT A. AO 56
B. NMT B. AO 62
C. NLT C. AO 55
D. NMT D.AO 90
E. None of the above E.AO 63
81.) The following persons shall be liable for 88.) Any person who is found guilty of “planting” any
violation(s) of RA 8203, except: dangerous drug and/or controlled precursor and
A. the manufacture of the counterfeit drugs essential chemical, regardless of the quantity and
B. importer or agents of counterfeit drugs purity shall suffer the penalty of:
C. the registered pharmacist who has actual A. Life imprisonment
or constructive knowledge about the B. death
counterfeit drugs C. Imprisonment from 6 years to 1 day to 12
D. the registered pharmacist who has no years
actual or constructive knowledge about the D. Imprisonment from 12 years to 20 years
counterfeit drugs E. Minimum penalty
E. exporter or agents of counterfeit drugs
89.) If the government officials and employees are
82.) If the unregistered imported drug product has a found guilty of the unlawful acts under RA 9165, they
registered counterpart brand in the Philippines, the shall be penalized by:
product shall be considered: A. perpetual absolute disqualification from any
A. acceptable for distribution public office
B. acceptable for importation B. imprisonment
C. Both A and B C. maximum penalty
D. counterfeit D. Both A and C
E. None of the above E. Both A and B
83.) ______shall mean, that by exercise of 90.) An establishment where pharmaceuticals,

reasonable care, one would have known the fact or proprietary medicines or pharmaceutical specialties
suspect that the drug product he or she has sold or in are prepared, compounded, standardized, and
possession of is counterfeit, such as but not limited to distributed or sold:
the knowledge, that the drug was not covered by any A. botica
sales invoice or evidence of delivery or purchase from B. Pharmaceutical Laboratory
a BFAD licensed establishment: C. Pharmaceutical Manufacturing Laboratory
A. constructive knowledge D. Both B and C
B. destructive knowledge E. Both A and B
C. limited knowledge
D. suspicious 91.) It is any drug, active principle or preparation of
E. full knowledge the same, capable of destroying life or seriously
endangering health when applied externally to the
84.) The maximum administrative penalty shall be body or introduced internally in moderate doses:
imposed when the counterfeit drug products are: A. biologic products
A. not life-saving drug products B. poison
B. life-saving regardless of the volume C. abortive products
C. the volume of the product is more than D. all of the above
100,000 pesos E. none of the above
99.) It is composed of a core list of medicines
92.) An articles intended for use in the diagnosis, considered essential and a complementary list of
cure, mitigation, treatment or prevention of disease in drugs considered useful if not essential:
man and animals: A. National Drug Policy (NDP)
A. device B. National Drug Formulary (NDF)
B. drugs C. National Drug Committee (NDC)
C. cosmetics D. none of the above
D. poison E. all of the above
E. none of the above 100.) It is a team of pharmacologist, pharmacists and
clinicians whose main task is to prepare the National
93.) The date stated in the label of a drug or device Drug Formulary and recommend to the BFAD the
after which the drug is not expected to retain its drug for delisting:
claimed safety, efficacy, and quality or potency or A. National Drug Policy (NDP)
after which it is not permissible to sell the drug or B. National Drug Formulary (NDF)
device: C. National Drug Committee (NDC)
A. manufacturing date D. none of the above
B. registration date E. all of the above
C. production date
D. stability date 101.) It is the description of the chemical structure of
E. expiration date the drug or medicine and serves as the complete
identification of a compound:
94.) It is the pharmaceutical form of the preparation A. chemical name
based on official pharmacopeia: B. generic name
A. pharmacologic category C. INN
B. indication D. Both B and C
C. dosage formulation E. Both A and C
D. dosage form
E. dosage 102.) It is the finished product form that contains the
active ingredients, generally but not necessarily in
95.) The process of approval for the manufacture, association with inactive ingredients:
importation, exportation, sale, offer for sale, A. drug product
distribution or transfer of pharmaceutical products B. generic drug
containing active ingredient/s of known chemical C. essential drug
structure and properties determined to be safe, D. drug innovator
efficacious, and of good quality according to E. Investigational drug
standards of BFAD:
A. CGMP 103.) It is the act by a validly registered pharmacist of
B. registration filling a prescription or doctor’s order on the patient
C. assay chart:
D. drug evaluation A. delivering
E. licensing B. selling
C. dispensing
96.) It is a drug, the safety and efficacy of which has D. trading
been demonstrated through long years of general use E. counseling
and can be found in the current official USP-NF, and
other internationally recognized pharmacopeias: 104.) It refers to the branch of medical science
A. investigational drugs devoted to the study of the biological and physical
B. established drugs changes and the disease of old age:
C. new drugs A. pediatrics
D. tried and tested drugs B. pharmacy
E. Innovative drugs C. geriatrics
D. orthodontics
97.) It is a policy and program of the national E. obstetrics
government to ensure that safe and effective drugs
are made available to all Filipinos at any time and 105.) These drugs may be dispensed even without a
place and at a reasonable and affordable cost: written order of a validly registered physician, dentist
A. National Drug Policy (NDP) or veterinarian in duly licensed drug outlets:
B. National Drug Formulary (NDF) A. ethical drugs
C. National Drug Committee (NDC) B. OTC drugs
D. none of the above C. prescription drugs
E. all of the above D. dangerous drugs
E. vitamins
98.) It is a special group within the DOH which
oversees the implementation of the NDP: 106.) It means a natural person who is a purchaser,
A. NDP Management Committee lessee, recipient or prospective purchaser, leaser or
B. National Drug Formulary (NDF) recipient of consumer products, services or credits:
C. National Drug Committee (NDC) A. creditor
D. none of the above B. consumer
E. all of the above C. customers
D. owner
E.lessor
commodities grossly in excess of their normal
107.) It means any substance which on contact with requirements resulting in undue shortages of such
living tissue will cause destruction of tissue by goods to the prejudice of less privileged consumers:
chemical action: A. hoarding
A. corrosive B. panic buying
B. poison C. cartel
C. antibiotics D. profiteering
D. biological E. bargain
E. antiseptic
115.) It is a contingent fund in the budget of the
108.) It means any device, written, printed, affixed or implementing agency which shall not be used in
attached to a consumer product or displayed in a normal or regular operations but only for the purposes
consumer repair or service establishment for the provided under the Price Act:
purpose of indicating the retail price per unit or A. petty cash
service: B. buffer fund
A. label C. Both A and B
B. price tag D. NOTA
C. sticker E. allocation fund
D. ID tag
E. lanyard 116.) It is the maximum price at which an basic
necessities or prime commodities may be sold to the
109.) Any person engaged in the business of selling general public:
consumer products directly to consumers: A. prevailing price
A. supplier B. price ceiling
B. exporter C. discounted price
C. telemarketing D. 50% off of the original price
D. retailer E. 25% off of the original price
E. importer
117.) The illegal cultivation, culture, delivery,
110.) It is the undue accumulation by a person or administration, dispensation, manufacture, scale,
combination of persons of any basic necessity or trading, transportation, distribution, importation,
prime commodity beyond his or their normal inventory exportation and possession of any dangerous drugs
levels: and/or controlled precursor and essential chemicals:
A. hoarding A. illegal trafficking
B. panic buying B. illegal cultivation
C. cartel C. illegal selling
D. profiteering D. illegal possession
E. hoarder E. illegal compounding
111.) An analytical test using a device, tool or 118.) Shabu:

equipment with a different chemical or physical A. Methylenedioxymethamphetamine
principle that is more specific which will validate and B. Methyldioxymethamphetamine
confirm the result of the screening test: C. MMDA
A. confirmatory test D. Methamphetamine Hydrochloride
B. screening test E. Methamphetamine
C. drug analysis
D. NOTA 119.) Ecstacy:
E. All of the above A. Methylenedioxymethamphetamine
B. Methyldioxymethamphetamine
112.) It is any combination of or agreement between C. MMDA
two or more persons engaged in the production, D. Methamphetamine Hydrochloride
manufacture, processing, storage, supply, distribution, E. Methamphetamine
marketing, sale or disposition of any basic necessity
or prime commodity designed to artificially and 120.) A rapid test performed to establish
unreasonably increased or manipulate its price: potential/presumptive positive result:
A. hoarding A. confirmatory test
B. panic buying B. screening test
C. cartel C. test analysis
D. profiteering D. laboratory test
E. bargain E. Physico-chemical test
113.) The sale or offering for sale of any basic 121).Indian hemp
necessity or prime commodity at a price grossly in A. marijuana
excess of its true worth: B. hashish
A. hoarding C. bhang
B. panic buying D. all of the above
C. cartel E. NOTA
D. profiteering
E. bargain 122. It refers to the international agreement
114.) It is the abnormal phenomenon where administered by the WTO that sets down minimum
consumers buy basic necessities and prime standards for many forms of intellectual property
regulations: Intellectual Property Rights
A. TRIPS Agreement D. both a and c
B. WTO Agreement E. both a and b
C. Agreement on Trade- Related Aspects of
123. Amendments to A.O 62: D. “shake well”

A. A.O 90, s. 2002 E. reconstitute
B. A.O 90, s. 1990
C. A.O 42 132. The potency of biological products must be
D. A.O 56 expressed in
E. A.O 64
A. metric system
124. Requirements for Labelling Materials of B. apothecary
Pharmaceutical Products C. international unit
A. A.O 55 D. avoirdupois
B. A.O 90 E. SI system
C. A.O 42
D. A.O 56 133. These are drugs found in the USP/NF and is
E. A.O 63 considered safe and efficient through long years of
general use
125. The Price Act is known as R.A A. Investigational
A. 7432 B. Established
B. 7581 C. New
C. 8293 D. Tried & Tested
D. 7394 E. Essential
E. 7349
134. Basis for non- renewal of LTO of Drug Outlet &
126. Number of years of pharmacy practice for the Drug Establishment
pharmacist to qualify as board examiner A. failure to comply with PRC standards and
A. 5 years requirements
B. 10 years B. serious repeated or rampant violation of existing
C. 15 years laws, rules & regulations
D. 20 years C. persistent performance that assures the safety,
E. 2 years efficacy & quality of drug products
D. poor housekeeping
127. R.A 9165 was signed into law on E. Minor shortcomings
A. June 7, 2002
B. February 26, 2004 135. Drug classification based on source
C. June 23, 1969 A. branded & patented
D. June 22, 1963 B. imported as finished
E. July 7, 2002 C. unbranded & off patient
D. both a and c
128. Upon finding that the drugs are counterfeit, the E. both a and b
Bureau shall file an appropriate proceeding against
the registered pharmacist with the PRC for the 136. The BFAD must be notified of such charge in the
of professional license______ establishment
A. suspension A. change of manager
B. cancellation B. change of pharmacist-in-charge
C. revocation C. change of product arrangement
D. both a and c D. change of supervisor
E. both a and b E. change of pharmacist- assistant
129. The Board of Pharmacy is composed of a 137. The BOP, upon receipt of a formal complaint
Chairman and___________members under oath against any pharmacist, shall furnish the
A. 4 latter a copy of the complaint which he shall answer
B. 3 within
C. 2 A. 30 days
D. 5 B. 10 days
E. 6 C. 60 days
D. 6 months from receipt
130. The net content of the liquid dosage form must E. 15 days
be expressed using
A. Arabic numeral & avoirdupois system 138. Any product that is not labelled in accordance
B. metric system with the requirements of A.O 55 shall be deemed
C. Arabic numeral & metric system A. misbranded
D. Roman numeral & avoirdupois system B. conforms with the USP/NF standards
E. Roman numeral C. both a and b
D. NOTA
131. It indicates that the product is a prescription drug E. Adulterated
A. Rx symbol
B. for external use 139. The sale of physician’s sample is a prohibited act
C. a vignette of skull & bones under R.A
A. 3720
B. 9275 B. PNP Chief
C. 6675 C. Secretary of Health
D. 9502 D. Director General
E. 5921 E. Director
140. Misrepresentation of any material fact in the 148. Prescription for dangerous drugs are written in
application of LTO for a drug establishment is a A. duplicate
ground for B. triplicate
C. one copy
A. cancellation of the professional license of the said D. any of the above
pharmacist E. One original and one duplicate
B. suspension of the LTO
C. revocation of the LTO 149. The following are exempted from complying with
D. temporary closure the labelling requirements, except
E. permanent closure A. if the products are used solely for investigational
use B. if the
141. Failure to properly record dangerous drugs as products are compounded by the pharmacist
determined by the DDB in a drug outlet is a ground for C. established drugs
A. cancellation of the professional license of the said D. if the products are donated by foreign agencies
pharmacist E. All of the above
C. revocation of the LTO 150. Any herbal and/ or traditional drug the
D. temporary closure registration of which is not intended to be renewed
E. permanent closure may be given an extension of NMT
A. 30 days
142. Absence of pharmacist in a drugstore on three B. 10 days
inspections by BFAD inspector is a ground for C. 60 days
A. cancellation of the professional license of the said D. 6 months after the expiry date of such registration
pharmacist E. 3 months after the expiry date of such registration
C. revocation of the LTO 151. It is the science of morality
D. temporary closure A. ethics
E. permanent closure B. jurisprudence
C. morality
143. Non- pharmacist may owned and open a D. rules
drugstore provided that there is a E. both a and c
A. supervisor
B. pharmacist assistant 152. It is identified by the willingness of individual
C. pharmacy technician practitioners to comply with ethical and professional
D. registered pharmacist standards which exceed minimum legal requirements
E. manager A. jurisprudence
B. ethics
144. Violations of any provision of Senior Citizens Act C. both a and b
is punishable by D. profess
A. a fine not exceeding 2, 000 pesos E. profession
B. imprisonment of NLT 2 months but NMT 2 years
for the first offense 153. It pertains to the ability to engage in sound moral
C. imprisonment not exceeding 2 months reasoning and consider carefully the implications of
D. a fine of 5, 000 pesos but not exceeding 10, 000 alternative actions
pesos A. ethical awareness
E. imprisonment of NLT 6 months but NMT 2 years B. laws
for the first offense C. ethical competency
D. jurisprudence
145. The discount privileges of the senior citizens E. ethics
shall be
A. transferable but limited to use only for the senior 154. It means a system of words or other systems
citizen arbitrarily used to represent words
B. non- transferable A. code
C. limited and exclusive for the benefit of the senior B. secret keys
citizen C. secret clues
D. both b and c D. cipher
E. NOTA E. coding
146. Registration of herbal and/or traditional drugs 155. An articles used for food or drink of man
must be renewed every A. device
A. year B. drug
B. 2 years C. food
C. 3 years D. poison
D. 5 years E. herbal drugs
E. 6 years
156. A quantity of any drug or device produced during
147. Head of the PDEA a given cycle of manufacture
A. NBI Chief A. batch
B. lot A. volume
C. batch number B. strength
D. lot number C. Total net
E. group D. potency
E. net content
157. Any ingredient intended for use in the
manufacture of a product, which include raw and 165. It refers to the part of the label that is most likely
packaging materials, including those that may not to be displayed, presented, shown or examined under
appear in the finished product customary conditions of display for retail use
A. component A. Principal Display Panel
B. raw material B. Primary Pack
C. both a and b C. Area of the Principal Display Panel
D. none of the above D. inserts
E. all of the above E. Package inserts
158. Any substance including food additive, used as a 166. The first pack containing the individually
component in the manufacture or preparation of a wrapped products, strips, or blister packs
food and present in the final product in its original or A. wrapper cartons
modified form B. inserts
A. raw material C. primary pack
B. minute organism D. leaflets
C. microorganism E. Area of the Principal Display Panel
D. inactive
E. ingredient 167. Any establishment which is a registered owner of
the drug product, procures the raw materials and
159. It refers to the proprietary name assigned to the packaging components, and provides the production
product by the drug establishment monographs, quality control standards and
A. trade name procedures, but sub- contracts the manufacture of
B. brand name such product to a licensed manufacturer
C. both a and b A. Drug Manufacturer
D. generic name B. Drug Trader
E. INN C. Drug Importer
D. Drug Exporter
160. It refers to the identification of drugs and E. Drug Distributor
medicine by their scientifically and internationally
recognized active ingredient as determined by the 168. A drug approved for sale to the general public
BFAD of the Department of Health under certain conditions
A. trade name A. Drug for Restricted Use
B. brand name B. Drug for General Use
C. both a and b C. Drug for Limited Use
D. generic name D. Drug for registration
E. proprietary name E. None of the above
161. Refers to the name/s and amount/s of active 169. It is a certification issued after a batch of
medicinal ingredients per dosage unit expressed in antibiotics has been found to comply with the
the metric system characteristics to identity, strength, quality and purity
A. net content A. certificate of Good Standing
B. formulation B. Batch Certification
C. strength C. Certificate of Product Registration (CPR)
D. potency D. CGMP
E. Total amount E. GMP
162. It refers to the site and manner the product is to 170. It refers to the standards and procedures
be introduced into or applied in the body whereby the laboratory achieves a defined, consistent
A. device and reliable standard in performing laboratory tests
B. directions of use and activities
C. method of determination A. GMP
D. route of administration B. GCP
E. mode of administration C. GLP
D. CPR
163. It refers to the statements regarding the E. GCP
conditions wherein the use of the product may cause
harm to the patient 171. It is a document issued by the BFAD for the
A. contraindications purpose of marketing, use of free distribution of a
B. warning product in the Philippines
C. precautions A. Certificate of Good Standing
D. indications B. Batch Certification
E. Pharmacological use C. CGMP
D. Certificate of Product Registration (CPR)
164. It refers to the total amount/quantity/number of E. GCP
the dosage form in a certain container of a product
expressed in metric system
172. It refers to the standards and procedures for A. standard
clinical trials that encompasses the design, protocol, B. services
conduct, monitoring, termination, audit, analyses, C. labor
reporting, and documentation of human studies D. all of the above
A. GMP E. none of the above
B. GCP
C. GLP 181. It includes rice, corn, bread, fish and drugs
D. CPR classified as essential by the Department of Health
E. Batch Certification A. Basic necessities
B. prime commodities
173. It means the label on or affixed to an immediate C. primary needs
container D. all of the above
A. outer label E. none of the above
B. inner label
C. immediate label 182. Any act of knowingly planting, growing, raising,
D. principal display panel or permitting the planning of any plant which is the
E. primary pack source of dangerous drugs
A. cultivate
174. It means a display of written, printed or graphic B. culture
matter upon any article or any of its containers or C. pusher
wrappers or attached to or accompanying such D. both b and c
articles E. both a and b
A. principal display panel
B. leaflets 183. Any act of knowingly passing a dangerous drug
C. label to another, personally or otherwise, and by means,
D. package material with or without consideration
E. primary pack A. cultivate
B. deliver
175. It refers to a drug products indicated for life C. culture
threatening conditions D. both a and c
A. lifesaving drugs E. both a and b
B. counterfeit drugs
C. drugs for limited use 184. Any person who is a licensed physician, dentist,
D. drugs for restricted use chemist, medical technologist, nurse, midwife,
E. Dangerous drugs veterinarian or pharmacist in the Philippines
A. practitioner
176. It is a list of drugs that meet the health care B. coddler
needs of the majority of the population C. protector
A. EDL D. pusher
B. complementary list E. professional
C. NDF
D. Generic drugs list 185. It refers to drugstores, pharmacies, and other
E. core list business establishments which sell drugs and
medicines
177. It is a written order and instruction of a validly A. Drug Outlet
registered physician, dentist or veterinarian for the B. Drug Establishment
use of a specific drug product for a specific patient C. Drug Laboratory
A. prescription D. both b and c
B. medical chart E. All of the above
C. purchase slip booklet
D. Medical order 186. Any change in the law can be done by passing
E. none of the above a/an
A. memorandum order
178. Based on RA 9527, any resident citizen of the B. amendments
Philippines at least sixty (60) years old C. bill
A. senior citizen D. administrative order
B. neonates E. Executive order
C. elderly
D. pediatrics 187. The minimum age requirement to practice
E. both a and c pharmacy in the Philippines
A. 18
179. It means any card, plate, coupon book, or other B. 19
credit device existing for the purpose of obtaining C. 20
money, property labor or services on credit D. 21
A. credit card E. 22
B. ATM card
C. ID card 188. The book kept for the purpose recording the sale
D. value card of violent poisons should be preserved for a period of
E. Discount card A. 1 year
B. 2 years
180. It means a set of conditions to be fulfilled to C. 4 years
ensure quality and safety of a product
D. 5 years 198. Amount of shabu subject to life imprisonment to
E. 3 years death and a fine ranging from 500, 000 pesos to 10M
pesos
189. Ordinary prescriptions shall be retained by the A. 500g
pharmacist for a period of B. 10g
A. 1 year C. 50g
B. 2 years D. 40 g
C. 4 years E. 20g
D. 5 years
E. 3 years 199. Amount of opium subject to life imprisonment to
death and a fine ranging from 500, 000 pesos to 10M
190. The Rx symbol is required in the label of pesos
A. ethical drugs A. 500g
B. Over-the-Counter drugs B. 10g
C. prescription drugs C. 50g
D. both a and c D. 40 g
E. both a and b E. 20g
191. Amendments of A.O 55 200. Duration of the conduct of examination in
A. A.O 67 determining the genuineness and authenticity of the
B. A.O 90 product Bureau
C. A.O 64 A. 10 working days
D. A.O 56 B. 20 working days
E. A.O 63 C. 16 working days
D. within 24 hours
192. The Foods, Drugs, Devices and Cosmetics Act is E. within 36 hours
known as R.A
A. 5921 201. The senior citizens shall be entitled the grant of
B. 6675 discount for the consumption of electricity, water and
C. 3720 telephone by the senior citizens center and residential
D. 8203 care/group homes that are non- stock, non- profit
E. 3702 domestic corporation
A. 20%
193. The Pharmacy Law is known as R.A B. 50%
A. 5921 C. 10%
B. 6675 D. 5%
C. 3720 E. 25%
D. 8203
E. 3702 202. The senior citizens shall be entitled the grant of
discount from all establishments relative to the
194. The Consumers Act of the Philippines is known utilization of transportation services, restaurants and
as R.A purchase of medicines anywhere in the country,
A. 7432 including funeral & burial services for the death of the
B. 7581 senior citizens
C. 8293 A. 20%
D. 7394 B. 50%
E. 8203 C. 10%
D. 5%
195. The Expanded Senior Citizens Act of 2003 is
E. 25%
known as R.A
A. 9257 203. For Drug Establishment, reapplication of the
B. 7581 LTO after revocation may be done within
C. 8293 year/s________
D. 7394 A. 2
E. 7432 B. 3
C. 1
196. Filling and refilling of prescription shall be done
D. 5
by
E. 4
A. intern with the supervision of the registered
pharmacist 204. R.A 5921 was signed into law on
B. RPh A. June 7 2002
C. pharmacist assistant B. February 26, 2004
D. supervisor C. June 23, 1969
E. clinicians D. June 22, 1963
E. June 23, 1963
197. A certain drug is considered counterfeit if it
contains less than how many percent of the active 205. This is the division of the BFAD that provides
ingredient it purports to possess assistance to person/establishment in complying with
A. 10 BFAD legal requirements
B. 40 A. Product Services
C. 80 B. Laboratory Services
D. 95 C. Legal, Information and Compliance
E. 20
D. Administrative 215. Under R.A 6675, which of these prescriptions
E. Regulation Division I shall be filled
A. violative Rx
206. The division of BFAD that certifies batches of B. erroneous Rx
antibiotics C. impossible Rx
A. Product Services D. both a and c
B. Laboratory Services E. none of the above
D. Administrative 216. Has the power to reclassify, add to, or remove
E. Regulation Division I any drug from the list of dangerous drugs
A. DDB
207. The division of BFAD that is involves in cash B. PDEA
collection C. BFAD
A. Product Services D. NBI
B. Laboratory Services E. DOH
D. Administrative 217. The BFAD shall be headed by a
E. Regulation Division I A. President
B. Secretary
208. The permanent consultant/s of the Dangerous C. Director
Drug Board D. Commissioner
A. PNP Chief E. Chief
B. NBI Director
C. both a and b 218. Any person desiring to operate or establish a
D. Secretary of Health drug establishments shall file with the BFAD an
E. both b and d application supported by the following documents,
except
209. Executive Order which is responsible in A. red & white labels indicating the name of the
reorganization of BFAD drugstore
A. 175 B. proof of registration
B. 851 C. list of products to be manufactured identified by its
C. 119 generic and brand names
D. 174 D. current PTR of the pharmacist-in-charge
E. 803 E. both a and b
210. Additional label to be attached to the poisons 219. Unless otherwise declared by the President,
A. warning: may be habit- forming prices of the basic necessities in an area shall
B. warning it is toxic automatically be frozen at their prevailing prices or
C. a vignette of skull & bones placed under automatic price control whenever that
D. for internal use area is
E. all of the above A. declared to be in state of rebellion
B. is placed under martial law
211. The designated person of a manufacturing C. is under state of calamity
company who will transact officially with the Bureau D. all of the above
A. branch pharmacist E. only b and c
B. liaison officer
C. detail man 220. Based on R.A 9165, sec. 15, the penalty
D. supervisor imposed upon any person apprehended or arrested
E. branch manager for the first time, who is found to be positive for use of
any dangerous drug, after a confirmatory test is
212. In the labelling requirements, the generic name A. a minimum of 6 months rehabilitation in a
must be government center
A. enclosed by an outline circle B. imprisonment ranging from 6 yrs and one day to
B. smaller font size than the brand name twelve years
C. written after the brand name C. a fine of 50, 000 pesos to 200, 000 pesos
D. printed in full and not abbreviated D. both a and b
E. Different font with the brand name E. both b and c
213. The word “single use” must be included in the 221. Based on R.A 9165, sec. 15, the penalty
label of imposed upon any person apprehended or arrested
A. biological products for the second time, who is found to be positive for
B. small containers use of any dangerous drug, after a confirmatory test is
C. individually wrapped products A. a minimum of 6 months rehabilitation in a
D. large volume injection government center
E. small volume injection B. imprisonment ranging from 6 yrs and one day to
twelve years
214. A drug product prescribed which is not registered
C. a fine of 50, 000 pesos to 200, 000 pesos
at BFAD is considered a type
D. both a and b
A. impossible Rx
E. both b and c
B. violative Rx
C. erroneous Rx 222. Serves as the implementing arm of the DDB
D. coded Rx A. BFAD
E. Rx
B. DOH B. R.A 9257
C. NBI C. R.A 9502
D. PDEA D. R.A 8485
E. PNP E. R.A 9994
223. A food shall be deemed to be misbranded if 231. An act to promote, require, and ensure the
A. it consists in whole or in part of any filthy or putrid production of an adequate supply, distribution, use,
substances and acceptance of drugs and medicines identified by
B. its labelling is false or misleading their generic names
C. it contains any poisonous or deleterious A. R.A 3720
substances B. R.A 6675
D. both a and c C. R.A 9165
E. both a and b D. R.A 9502
E. R.A 9257
224. A food shall be deemed to be adulterated if
232. An act instituting the Comprehensive Dangerous
A. it consists in whole or in part of any filthy or putrid Drugs Act of 2002, repealing R.A 6425, as amended,
substances providing funds therefore, and for other purposes
B. its labelling is false or misleading A. R.A 3720
C. it contains any poisonous or deleterious B. R.A 6675
substances C. R.A 9165
D. both a and c D. R.A 6425
E. both a and b E. R.A 9502
225. The members of the Board of Pharmacy are 233. An act to ensure the safety & purity of foods &
appointed by the cosmetics, and the purity, safety, efficacy and quality
A. PRC commissioner of drugs and devices being made available for the
B. PACOP President public, vesting the BFAD with authority to administer
C. PPhA President &enforce the laws pertaining thereto, & for other
D. President of thePhilippines purposes
E. CHED Commissioner A. R.A 3720
B. R.A 6675
226. To recognize and accredit colleges and schools C. R.A 9165
of pharmacy in the different colleges and universities D. R.A 6425
is a function of a E. R.A 9502
A. Board of Pharmacy
B. PRC 234. This Act shall be known as the “Food and Drug
C. Council of Pharmaceutical Education Administration (FDA) Act of 2009
D. PPhA A. R.A 9994
E. PACUCOA B. R.A 9165
C. R.A 9165
227. To reprimand any erring pharmacist or to D. R.A 9257
suspend or revoke his certificate of registration is a E. R.A 9711
function of
A. Board of Pharmacy 235. A candidate for Pharmacy board examination in
B. PRC the Philippines shall have the following qualification/s
C. Council of Pharmaceutical Education A. natural- born Filipino citizen
D. PPhA B. graduated with any four year course
E. FDA C. of good moral character
D. all of the above
228. The minimum mandatory requirements E. none of the above
necessary for the opening and operation of
drugstores and pharmacies shall be in a accordance 236. What type of font was specified for printing the
with the rules and regulations prescribed by the generic name if the name of the product is presented
A. BFAD using a special typeface exclusively designed for it
B. DOH A. comic sans
C. DDB B. Helvetica Medium
D. PDEA C. Universe Medium
E. PRC D. both b and c
E. both a and c
229. An act regulating the practice of pharmacy &
setting standards of pharmaceutical education in the 237. In accordance to A.O 56, s. 1989, the initial LTO
Philippines and for other purposes has a validity of_______ years
A. R.A 3720 A. 5
B. R.A 5921 B. 3
C. R.A 9165 C. 2
D. R.A 9502 D. 1
E. R.A 9994 E. 4
230. An act providing for cheaper & quality medicines 238. Under A.O 56, s. 1989, the renewal of the LTO
amending for the purpose R.A 8293, R.A 6675 and has a validity of ________years
R.A 5921, and for other purposes A. 5
A. R.A 9165
B. 3 C. products placed in small containers
C. 2 D. drugs for investigational purposes
D. 1 E. small volume injection
E. 4
248. Pharmacy Licensure Examination in the
239. Under R.A 9165, the penalty of 12 years and one Philippines is held
day to 20 years of imprisonment and a fine of 100, A. once a year
000 pesos to 500, 000 pesos shall be imposed upon B. twice a year
any person who acts as a C. every other year
A. coddler D. every December
B. financier E. thrice a year
C. protector
D. compounder 249. Refusal to allow entry of BFAD inspector is
E. either a and c penalized by
A. suspension of LTO
240. Production records must be kept for B. revocation of LTO
A. 2 years before expiration date C. temporary closure
B. 2 years after batch distribution is completed D. cancellation of LTO
C. 2 years after expiration date of the product E. permanent closure
D. 1 year after batch distribution is completed
E. 1 year after batch distribution is completed 250. It is composed of a core list of medicines
considered essential and a complimentary list of
241. This is the required test for suppositories and drugs considered useful if not essential
pessaries A. MMS
A. weight variation B. PDR
B. boiling point C. Goodman & Gillman
C. melting point D. National Drug Formulary (NDF)
D. dissolution E. EDL
E. hardness
251. Monitors the treatment and rehabilitation of drug
242. Which Executive Order abolished the Food and dependents and operation of drug rehabilitation and
Drug Administration and created the BFAD testing centers
A. EO174 A. PDEA
B. EO 851 B. BFAD
C. EO 175 C. NBI
D. EO 815 D. DOH
E. EO 119 E. PNP
243. The government agency which issues national 252. It means to bring into the Philippines by sea,
ID card and purchase slip booklet land or air
A. BFAD A. import
B. DOH B. distribute
C. OSCA C. export
D. PHILHEALTH D. manufacture
E. none of the above E. shipping
244. This means dispensing the patient’s or buyer’s 253. It means the delivery or sale of any drug or
choice from among the generic equivalent device for purposes of distribution in commerce,
A. generic dispensing except that such term does not include a
B. dispensing manufacturer or retailer of such product
C. any of the above A. import
D. NOTA B. distribute
E. all of the above C. export
D. manufacture
245. The former President of the Philippines who E. both a and c
enunciated the National Drug Policy
A. Ferdinand E. Marcos 254. Quality control requirements for herbal and/or
B. Joseph Estrada traditional drugs
C. Corazon C. Aquino A. test for the presence of heavy metals
D. Ramon Magsaysay B. test for the presence of synthetic drugs
E. DiosdadoMacapagal C. test for alcohol content
D. all of the above
246. CGMP means E. none of the above
A. current good manufacturing practice
B. current good manufacture process 255. Pursuant to A.O 55, all information required to
C. current good manufacture process appear on the label must be
D. current good manufacturing procedure A. written in English
E. none of the above B. clearly and prominently displayed
C. readable with normal vision with straining
247. Which of the following is exempted in the D. all of the above
labelling requirement E. none of the above
A. large volume injection
B. product for external use
256. INN means 264. The expiry date of the product shall be
A. International Non- proprietary name expressed I terms of the:
B. International Propriety Name A, month and year
C. Intentional Non- Proprietary Name B. month, date and year
C. year
D. International Name D. date and year
E. International Property Name E. none of the above
257. Based on the PNDF, the following are drugs 265. Requirements for registration of “Me- Too” or
acting on then CNS, except: identical products include:
A. anti-gout A. toxicology data
B. anti-schistosoma B. pharmaceutical from of the drug
C. anti-parkinsonism C. clinical investigation data
D. anti-vertigo D. mutagenicity
E. anti- lipidemic E. LD 50
258. Based on the PNDF, the following are Gastro- 266. It is the consistency system of quality assurance
Intestinal drugs, except: aimed at ensuring that products are consistently
A. anti- lipidemic manufactured to a quality appropriate for intended
B. anticholinergic use:
C. spasmolytic A. GLP
D. antacid B. GCP
E. anti-gout C. CGMP
D. CPL
259. The division in BFAD that evaluates and E. CPR
processes application for the registration of all
products under BFAD’s jurisdiction: 267. All prescriptions dispensed in the drugstore,
A. LSD botica or hospital pharmacy shall; be kept on file for:
B. PSD A. one year
C. LICD B. 2 years
D. Regulation Division II C. 3 years
E. Administrative Division D. 4 years
E. 5 years
260: The division in BFAD that conduct all test
analyses and trials of products under BFAD’s 268. Partial filling of prescription for drugs belonging
jurisdiction: to List A shall:
A. LSD A. be allowed
B. PSD B. not be allowed
C. LICD C. is allowed provided that the S-2 of the prescriber is
D. Regulation Division II indicated.
E. Administrative Division D. be allowed provided that a yellow prescription was
presented
261. The division in BFAD that conducts E. both c and d
administrative or quasi-judicial hearings and
recommends imposes appropriate legal action: 269. An acting granting additional benefits and
A. LSD privilege to senior citizens amending of the purpose
B. PSD RA 7432:
C. LICD A. R.A. 9165
D. Regulation Division II B. R.A. 9257
E. Administrative Division C. R.A. 9502
D. R.A. 8485
262. The division in BFAD that calls upon any erring E. R.A. 9711
manufacturer, distributor or advertiser to desist from
inaccurate or misleading nutritional or medical claims 270. OTC- that requires batch certification:
in their advertising: A. OTC drugs
A. LSD B. dangerous drugs
B. PSD C. prescription drugs
C. LICD D. antibiotics
D. Regulation Division II E. biological
E. Administrative Division
271. Minimum penalty shall be imposed if the
263. It refers to the prevailing specified range of counterfeit drug product is:
temperature, humidity, and other environmental A. life-saving
factors within optimal stability of the product: B. not life-saving
A. storage conditions C. both a and b
B. temperature range D. dangerous drugs
C. stability E. none of the given choice
D. expiry date
E. Humidity range 272. Government office where professional register
and where license is issued:
A. PRC
B. BFAD C. 4
C. BFAD D. 5
D. DDB E. 1
E. DOH
281. In order to manufacture, sell, offer for sale,
273. Acts as the policy formulation and sectors import or distribute any drug or device, a license to
monitoring arm of the Secretary of Health on matters operate should be first secured from:
pertaining to foods, drugs, traditional medicines, A. BFAD
cosmetics and household products containing B. DTI
hazardous substances: C. PRC
A. Director of PDEA D. PRC
B. DDB Director E. BOP
C. BFAD Director
D. President of PPhA 282. The term “elderly “shall means
E. None of the above A. senior citizen
B. any resident of the Philippines
274. Collects samples of products in outlets under C. at least 60 years old
BFAD jurisdiction for laboratory analysis: D. all of the above
A. Regulation division I E. none of the above
B. Regulation division II
C. LSD 283. The term Secretary, in RA 3720, means:
D. PSD A. Secretary of DOH
E. LICD B. Secretary of DTI
C. Secretary of Education
275. Assist in the development of the short/long range D. all of the above
plan and prepares the budget estimates of BFAD: E. none of the above
A. Office of the director
B. LICD 284. Prescription for dangerous drugs are written in:
C. PSD A. triplicate
D. Regulation Division II B. duplicate
E. Administrative Division C. five
D. Four copies
276. Coordinates the activities of the Drug Information E. One copy
Unit (DIU) for the purpose of information
dissemination 285. It refers to any establishment that imports raw
A. Office of the Director materials active ingredients and finished products for
B. Administrative Division its own use or for distribution to other drug
C. LICD establishments or outlets:
D. Regulation Division I A. exporter
E. Regulation Division II B. importer
C .wholesaler
277. Laboratory controls are required for: D. retailer
A. finished product E. none of the above
B. components
C. in process drug 286. Under RA 3720, Food means:
D. all of the above A. chewing gum
E. none of the above B. articles used for food or drink for man
C. a and b
278. Ointments, creams, and other semi-solid D. NOTA
preparations are tested for: E. nutraceuticals
A. melting point
B. homogeneity 287. Who shall take care and deliver to the Bureau
C. impalpability the samples taken at random from every incoming
D. all of the above shipment of food, drugs, devices and cosmetics which
E. none of the above are being imported or offered for import into the
Philippines?
279. As defined in RA 8203, this refers to any entity, A. Secretary of Health
whether a single proprietorship, partnership or B. BFAD Director
corporation engaged in or doing business in the C. Commissioner of Customs
Philippines: D. a and b
A. residency E. b and c
B. business establishment
C. brokering 288. Based on RA 3720, any poisonous or deleterious
D. ownership substance added to any food shall be deemed to be
E. franchising unsafe except when such substance is required or
cannot be avoided in its production of manufacture:
280. for how many years shall the chairman and A. the statement is incorrect
members of the Board of Pharmacy hold office after B. the statement is correct
appointment: C. only deleterious substance added
A. 2 D. all of the above
B. 3 E. NOTA
C. February 7, 1992
289. Minor deficiencies in GMP includes, except: D. September 13, 1988
A. inadequate storage facilities E. June 22, 1963
B. lack of minor equipment
C. lack of key technical and professional personnel 296. R.A. 7432 was signed into law on:
D. poor housekeeping A. April 13, 1992
E. inadequate storage facilities B. February 26, 1992
C. February 7, 1992
290. Drugs are considered to be adulterated if: D. September 13, 1988
A. it differs from USP standards E. June 22, 1963
B. it is an imitation of another product
C. the label is misleading 297. It is an analysis to determine the presence of a
D. both a and c substance and the amount of that substance:
E. all of the above A. assay
B. bioavailability
291. It refers to either prohibited or regulated drugs C. bioequivalence
which require a special prescriptions form: D. Physico-chemical test
A. ethical drugs E. extraction
B. OTC drugs
C. prescription drugs 298. Any device not used in health care but has been
D. dangerous drugs determined by the FDA to adversely affect the health
E. controlled precursors of the people:
A. health device
292. RA 9275 was signed into law on: B. medical device
A. June 7, 2002 C. Radiation device
B. February 26, 2004 D. contraceptive device
C. June 23, 1969 E. health- related device
D. June 22, 1963
E. February 24, 2006 299. It is the rate and extent to which the active
ingredient or therapeutic ingredient is absorbed from
293. R.A. 3720 was signed into law on: a drug and becomes available at the site of drug
A. June 7, 2002 action:
B. February 26, 2004 A. assay
C. June 23, 1969 B. bioavailability
D. June 22, 1963 C. radiation device
E. February 24, 1962 D. Physico-chemical test
A. April 13, 1992 300. It is the branch of moral science that treats of the
B. February 26, 1992 obligations which a member of a profession owes to
C. February 7, 1992 the public, to HIS profession and to his clients
D. September 13, 1988 A. professional ethics
E. June 22, 1963 B. bioethics
C. ethics
295. R.A. 6675 was signed into law on: D. Non maleficence
A. April 13, 1992 E. none of the above
B. February 26, 1992
Velasco, Noreen Faye D. BSPH 3A
PHARMACEUTICAL JURISPRUDENCE AND
ETHICS 6. Responsible in granting a license to exploit a
patented invention, even without the agreement
1. This is the proprietary name given by the of the patent owner, in favor of any person who
manufacturer to distinguish its product form has shown the capability to exploit the invention.
those of competitors. A. General Director of IPO
B. Director General PDEA
A. Chemical name C. Director General of NBI
B. Generic name D. Director General of PDA
C. Brand name E. Director General of DDB
D. Company name
E. Scientific name 7. An act regulating and modernizing the practice
of pharmacy in the Philippines, repealing R.A
2. An act ensure the safety and purity of foods and 5921.
cosmetics and purity , safety, efficacy, and
quality of drugs and devices being made A. R.A 10912
available to the public, vesting the BFAD with B. R.A 10981
authority to administer and enforce the laws C. R.A 10918
pertaining thereto, and for other purposes. D. R.A 10891
E. R.A 10189
A. R.A 3720
B. R.A 6675 8. The professional regulation commission (PRC)
C. R.A 9502 is three men commission attached to the,
D. R.A 9165
E. R.A 8203 A. Department of health
B. Office of the President
3. C instituting “Comprehensive Dangerous Act C. Food and Drug Administration
of 2002”, repealing R.A. 6425, as amended, D. Council of Pharmaceutical Education
providing funds therefore and other purposes. E. Department of the Interior and Local
Government
A. R.A 9165
B. R.A 8981 9. Indigent Senior Citizen shall be entitled to a
C. R.A 6675 monthly stipend amounting to to
D. R.A 9211 augmented the daily subsistence and other
E. R.A 10354 medical needs of Senior Citizens.
4. An act to promote, requires, and ensures A. PhP 1000.00

production of an adequate supply, distribution, B. PhP 2000.00
use, and acceptance of drugs and medicines C. Php 500.00
identified by their generic names. D. PhP 300.00
E. PhP 100.00
A. R.A 3720
B. R.A 9165 10. The head of the OSCA shall be assisted by the
C. R.A 5921 City Social Welfare and Development officer, in
D. R.A 9502 coordination with,
E. R.A 6675
A. Food and Drug Administration
5. An act providing for cheaper and quality B. Social Welfare and Development Office
medicines, amending for purposes RA 8293 or C. Department of health
the Intellectual Property code, RA 6675 or the D. PhilHealth
Generic Act of 1988 and RA 5921 or the E. City Mayor Office
Pharmacy Law, and for other purposes.
11. The Professional Regulation Commission is
A. R.A 9165 made up to members.
B. R.A 9994
C. R.A 9257 A. 2
D. R.A 7876 B. 3
E. R.A 9502 C. 4
D. 5
E. 6
12. The following are qualification of Regulatory

Board of Pharmacy Except: 17. Refer to persons who assist the pharmacists in
the different aspect of pharmacy operation
A. Be a citizen of the Philippines and resident for based on established standard operating
at least 5 years. procedure and processes, with very minimum
B. A member of the faculty of any school. degree of independence or decision making and
C. Preferably a holder of a master degree in may have supervised interaction with patient.
pharmacy.
D. Be a member in good standing of the APO for A. Pharmacy Aides
at least 5 years. B. Pharmacy Assistants
E. None of these C. Pharmacy Technicians
D. Pharmacist
13. An act modernizing the Professional Regulation E. Both A and B
Commission, repealing for the purpose P.D 223,
entitled “ Creating Regulation Commission and 18. Bureau of Food and Drugs (BFAD) is hereby
Prescribing its Powers and Functions” and for renamed the Food and Drug Administration
the other purposes. (FDA).
A. The PRC Modernization Act of 2000 A. R.A 9711

B. Accredited Professional Organization Act B. R.A 3720
C. The tobacco law C. R.A 9257
D. The health Professional law D. R.A 9502
E. Act for salt Iodization nationwide E. R.A 7581
14. Adult vaccine refer to cervical cancer, flu, 19. This act shall be known as the “Food and Drug
pneumococcal, other pre-exposure prophylactic Administration Act of 2009”.
vaccines to be administered to patients aged
Years and above. A. R.A 3720
B. R.A 6675
A. 6 C. R.A 7394
B. 10 D. R.A 8203
C. 15 E. R.A 9711
D. 18
E. 21 20. Refers to the process wherein a pharmacists
provides consultation services and conducts
15. Refer to persons who assist the pharmacists in preliminary assessment of symptoms and refers
the different aspect of pharmacy operation the patient to a physician or other health care
based on established standard operating professional.
procedure and processes, with very minimal
degree of independence or decision making and A. Referral
without direct interaction with patients. B. Referral registrar
C. Prescription filling
A. Pharmacy Aides D. Patient counseling
B. Pharmacy Assistants E. Prescription refilling
C. Pharmacy Technicians
D. Pharmacist 21. The senior citizen shall be entitled the grant of
E. Both A and B Discount for the consumption of electricity, water
and telephone by the senior citizens center and
16. Chairman and the members of the Professional residential care/group homes that are non-stock,
Regulatory Board of Pharmacy shall hold office non-profit Domestic Corporation.
for
A. 20%
A. 7 years B. 10%
B. 5 years C. 50%
C. 4 years D. 100%
D. 3 years E. 5%
E. 2 years
27. Creating an inter - Agency Committee for the
Formulation and Implementation of the National
Plan to Combat Antimicrobial Resistance (AMR)
in the Philippines.
22. Drug test certificates issued by accredited drug
testing centers shall be valid for period A. A.O 42 s.2014 DOH
from the date of issue. B. A.O 42 s.2014 FDA
C. A.O 56 s.2014
A. 2 years D. A.O 64 s.2014 DOH
B. 1 year E. A.O 56 s.2015
C. 6 months
D. 3 months 28. An act providing for the mandatory
E. 24 hours PHILHEALTH coverage for all SC amending for
the purpose R.A 7432, as amended by R.A
23. The penalty for the possession of counterfeit 9994, otherwise known “Expanded Senior
drug is: Citizens Act of 2010”
A. Imprisonment of NLT 6 months and 1 day but A. R.A 10645

NMT 6 years. B. R.A 10354
B. Imprisonment 6 years and 1 day but NMT 10 C. R.A 10640
years D. R.A 10643
C. Imprisonment of 12 years but NMT 15 years E. R.A 10642
D. Life imprisonment to death
E. Death 29. An act to further strengthen the anti-drug
campaign of the government, amending section
24. The penalty which shall be imposed for 21 of R.A 9165, otherwise known as the
counterfeiting drug intended for animals. “Comprehensive Dangerous Drug Acts of
2002”.
A. Imprisonment of NLT 6 months and 1 day but
NMT 2 years and 4 months A. R.A 10645
B. Imprisonment of 6 years and 1 day but NMT B. R.A 10354
10 years C. R.A 10640
C. Imprisonment of 12 years but NMT 15 years D. R.A 10643
D. Imprisonment of 4 months and 1 day but E. R.A 10642
NMT 6 years
E. Life imprisonment to death 30. The responsible Parenthood and Reproductive
Health Act of 2012
25. The following are health warning on cigarette
packaged EXCEPT: A. R.A 10645
B. R.A 10354
A. “GOVERNMENT WARNING: Cigarette is C. R.A 10640
Addictive” D. R.A 10643
B. “GOVERNMENT WARNING: Tobacco can E. R.A 10642
harm your children”
C. “GOVERNMENT WARNING: Smoking kills” 31. An act to effectively instill health consciousness
D. “GOVERNMENT WARNING: Cigarette through graphic health warnings on tobacco
smoking is dangerous to your health” products.
E. None of these
A. R.A 10645
26. Food and Drug Administration and PPhA Mul! B. R.A 10354
Plan to Authorize Community Pharmacist to C. R.A 10640
Administer Vaccines. D. R.A 10643
E. R.A 10642
A. FDA No. 2014-067
B. FDA No. 2014-068 32. One of the members of National Coordinating
C. FDA No. 2015-067 and Monitoring Board of R.A 9994
D. FDA No. 2015-068
E. FDA No. 2014-069 A. DOJ
B. FDA
C. DILG
D. DSWD 39. The “Price Act” is known as:
E. DOST
A. R.A 7581
33. Prescription without specification on the generic B. R.A 7432
name of the prescribed product is a violation of. C. R.A 7394
D. R.A 8981
A. R.A 9502 E. R.A 8344
B. R.A 6675
C. R.A 5921 40. A certain drug is considered counterfeit if it
D. R.A 8203 contains less than how many percent of the
E. R.A 9994 active ingredient it purports to possess?
34. It is the abnormal phenomenon where A. 10

consumers buy basic necessities and prime B. 30
commodities grossly in excess of their normal C. 50
requirement resulting in undue shortages of D. 80
such goods to the prejudice of less privileged E. 100
consumers.
41. The principal display panel comprises
A. Hoarding percent of the total surfaces of the container.
B. Panic Buying
C. Profiteering A. 10
D. Cartel B. 20
E. Buffering C. 30
D. 40
35. The penalty of cultivation of plants which are E. 50
sources of prohibited drugs is:
42. The “Consumer Act of the Philippines” is
A. 6 months rehabilitation known as:
B. Life imprisonment to death
C. 50 years imprisonment A. R.A 8344
D. 12 years and 1 day to 20 years B. R.A 7432
E. A fine of PhP 100,000.00 to PhP 200,000.00 C. R.A 7581
D. R.A 8981
36. Applicable S tax for prescribers of dangerous E. R.A 7394
drugs:
43. The “Intellectual Property Code of the
A. S-1 Philippines” is known as:
B. S-2
C. S-3 A. R.A 7581
D. S-4 B. R.A 7432
E. S-5-1 C. R.A 7394
D. R.A 8293
37. The “Special Law on Counterfeit Drugs” is E. R.A 9502
known as:
44. The “Procurement Act” is known as:
A. R.A 5921
B. R.A 6675 A. R.A 7876
C. R.A 3720 B. R.A 8172
D. R.A 7581 C. R.A 9184
E. R.A 8203 D. R.A 9211
E. R.A 8423
38. The “Generics Act” of 1988 is known as:
45. An “Act for salt Iodization Nationwide” or
A. R.A 5921 “ASIN” law is known as:
B. R.A 6675
C. R.A 3720 A. R.A 8293
D. R.A 7581 B. R.A 9711
E. R.A 8203 C. R.A 7876
D. R.A 8172
E. R.A 8344 51. Revised rules and regulations to implement
dispensing requirements under the Generic Act
46. An act penalizing the refusal of hospital and of 1988
medical clinics to administer appropriate initial
medical treatment and support in emergency or A. A.O 55
serious cases, amending for the purpose Bats B. A.O 63
Pambansa bilang 702, otherwise known as “Act C. A.O 62
Prohibiting the demand of deposit or D. A.O 64
advance payments for the confinement or E. A.O 67
treatment of patient in the hospital or
medical clinics in certain cases” is known as: 52. Amount of Methamphetamine subject to life
imprisonment to death and fine ranging from
PhP 500,000 to PhP 10M.
A. R.A 9994
B. R.A 10640 A. 500g
C. R.A 10645 B. 50g
D. R.A 8344 C. 10
E. R.A 8423 D. 1
E. Less than 1
47. Directing the mandatory use of the Philippine
National Drug Formulary (PNDF) Volume 1 as 53. Re-application of the LTO after revocation
the basis for Procurement of drug Products by maybe done within years.
the Government.
A. 2
A. A.O 42 B. 3
B. E.O 49 C. 1
C. A.O 51 D. 4
D. E.O 90 E. 5
E. A.O 163
54. Duration in the conduct of examination in
48. Amended to A.O 62 s. 1989 Re: “Rules and determining the genuineness and authenticity of
Regulation to implement Prescribing suspected counterfeit drug by the Bureau is:
requirements”
A. 10 working days
A. A.O 90 B. 20 working days
B. A.O 63 C. 30 working days
C. A.O 49 D. 16 working days
D. A.O 163 E. within 24 hours
E. A.O 50
55. If the seized drug was found to be counterfeit,
49. Amount of marijuana subject to life the business establishment must be directed for
imprisonment to death and fine ranging from preventive closure for a period of .
PhP 500,000 to PhP 10M
A. 10 days
A. 500g B. 15 days
B. 10g C. 30 days
C. 5g D. 45 days
D. 50g E. 60 days
E. 40g
56. Revised Rules and Regulations to implement
50. Drug registration of Herbal and/or Traditional prescribing requirements under the Generics act
Drugs (Local and Import) of 1988.
A. A.O 63 A. A.O 55
B. A.O 62 B. A.O 63
C. A.O 42 C. A.O 62
D. A.O 56 D. A.O 56
E. A.O 67 E. A.O 90
57. This contains the amendments of A.O 62

A. Board
A. A.O 55 B. APO
B. A.O 90 C. CPD Chairman
C. A.O 42 D. Center
D. A.O 64 E. Professional Board
E. A.O 67
64. The wholesaler of Narcotics must obtain
58. The confiscated or seized dangerous drugs,
plant sources, controlled precursor and essential A. S-1
chemical shall be submitted to the PDEA B. S-2
Forensic Laboratory for a Quantitative C. S-3
examination within . D. S-4
E. S-5-C
A. 12 hours
B. 32 hours 65. The license for the bulk storage of specific
C. 15 hours dangerous drugs and their preparations.
D. 24 hours
E. 48 hours A. S-5-I
59. The amount of Opium subject to life B. S-5-C
imprisonment to death and fine ranging from C. S-5-E
PhP 500,000 to PhP 10M D. S-5-D
E. S-5-IM
A. 500g
B. 50g 66. Unregistered imported pharmaceutical product
C. 40g not registered in FDA is considered .
D. 10g
E. Less than 5g A. Violative prescription
B. Impossible prescription
60. The amount of Morphine subject to life C. Erroneous prescription
imprisonment to death and fine ranging from D. Counterfeit Drug
PhP 500,000 to PhP 10M E. Misbranded Drug
A. 500g 67. This agency monitors the presence of

B. 50g counterfeit drugs.
C. 40g
D. 10g A. DOH
E. Less than 5g B. PDEA
C. PPhA
61. Refers to the record book maintained by D. FDA
Pharmacist, listing the patients referred to E. DDB
different health facilities for further diagnosis:
68. Requirements of labeling materials of
A. Referral Book Pharmaceutical products.
B. Referral Journal
C. Referral Registry A. A.O 64
D. Pharm. Book of Referral B. A.O 42
E. Referral Compendium C. A.O 56
D. A.O 55
62. The Professional Regulatory Board of Pharmacy E. A.O 49
is composed of a Chairman and members.
69. Revised Rules and Regulations Governing the
A. 6 Generic Labeling Requirements of Drug
B. 5 Products for Human use.
C. 4
D. 3 A. A.O 2016-0008
E. 2 B. A.O 2016-0003
C. A.O 2015-0053
63. The Professional Regulatory Board of Pharmacy D. 2015-0008
created in Section 6 of R.A 10918 is called E. 2015-0003
70. In addition to the documentary requirements B. President of the APO
submitted during the application, the following C. FDA Director General
documents shall be verified during inspection, D. DOH Secretary
EXCEPT: E. PRC Chairperson
A. Records/F-files 77. The PRBOP shall be under the administrative

B. Standard Operation Procedures control and supervision of .
C. Display information
D. Application Form A. Office of the President
E. Relevant Display Materials B. PPhA
C. PRC
71. The “Expanded Senior Citizens Act of 2010” D. FDA
is known as: E. DOH
A. R.A 9994 78. In response to the request of prescribing doctors

B. R.A 9949 to allow them to write the name of more than
C. R.A 7432 one drug product on the same page of a
D. R.A 9257 prescription form for a particular patient is A.O
E. R.A 8344
A. No. 78 s. 1988
B. No. 76 s. 1989
C. No. 79 s. 1989
72. The “PRC Modernization Act” is known as: D. No. 90 s. 1989
E. No. 99 s. 1989
A. R.A 7581 79. A license retail seller/handler of controlled
B. R.A 8981 chemical may sell acetone in a quantity not
C. R.A 8189 exceeding .
D. R.A 8423
E. R.A 7876 A. 1 liter
B. 2 liters
73. The “Traditional and Alternative Medicine C. 3 liters
Act” is known as: D. 4 liters
E. 5 liters
A. R.A 8324
B. R.A 9502 80. Refers to mode of transportation servicing the
C. R.A 8423 general population such as, but not limited to,
D. R.A 9211 elevators, airplanes, buses, taxicabs, ships,
E. R.A 9257 jeepneys, light rail transits, tricycles, and similar
vehicles.
74. The “Senior Citizen Center Act” is known as:
A. Public conveyance
A. R.A 7876 B. Public utility jeep
B. R.A 7687 C. Public places
C. R.A 7432 D. Public market
D. R.A 9257 E. Public utility bus
E. R.A 9994
81. Smoking shall be absolutely prohibited in the
75. The “Universally Accessible Cheaper and following public places, Except:
Quality Medicines Act of 2008” is known as:
A. Centers of youth activity such as playschools
A. R.A 9257 B. Elevator and stairwells
B. R.A 9502 C. Food preparation areas
C. R.A 8432 D. Designated Smoking Areas
D. R.A 8172 E. Public conveyance
E. R.A 9994
82. For radio advertisement, the warning stated after
76. The Chairperson and the members of PRBP will the advertisement shall be clearly and audibly
be appointed by: voiced over in the last seconds of the
advertisement, regardless of its duration.
A. 3 seconds C. Dosage form and strength
B. 5 seconds D. ADR Reporting
C. 10 seconds E. Storage Condition
D. 15 seconds
E. 1 minute 89. The FDA shall have the following functions,
powers, and duties, EXCEPT :
83. Those engaged in manual salt iodization shall
secure a Certificate of training from A. To analyzed and inspect health products
before they can be provided with a LTO. B. To certify batches of antibiotics and antibiotic
prescription
A. FDA C. To conduct appropriate tests on all health
B. DOH products
C. DTI D. To obtain information from any officer or
D.DOST offices of the national or local Government
E. DENR E. To administer the effective implementation of
R.A 9711
84. The term senior citizen shall mean any resident
of the Philippines of at least years old. 90. The Field Regulatory Operation Office of FDA
shall include the following, EXCEPT:
A. 50
B. 60 A. Property and Logistic Management Division
C. 55 B. All field offices of FDA
D. 65 C. Regulatory Enforcement Units
E. 70 D. Satellite Laboratories
E. Field Laboratories
85. The Rx symbol is required on the label of the

following EXCEPT:
91. The “Expanded Senior Citizen Act of 2003” is
A. Drugs under list A known as:
B. Drugs under list B
C. Ethical drugs A. R.A 9257
D. Over-the-Counter Drugs B. R.A 9502
E. Both A and B C. R.A 9165
D. R.A 8981
86. Relevant reference materials needed in E. R.A 7581
licensing at Retail Outlet for Non-Prescription
(RONPS), Except: 92. In R.A 9711, the meaning of “DEVICE” is:
A. Republic Acts A. Medical Devices

B. WHO GDP and GSP Guide B. Radiation Devices
C. PNDF C. Health Related Devices
D. Standard practice Guidelines D. In-vitro Diagnostic Devices
E. USP/NF E. A, B and C
87. The “Comprehensive Dangerous Drug Act of 93. Cosmetics means substance/preparations
2002” is known as : intended to be placed in, EXCEPT:
A. R.A 9257 A. Contact with various external parts of the

B. R.A 9502 human body
C. R.A 9165 B. With the Teeth
D. R.A 9994 C. With the various mucous membranes of the
E. R.A 9205 oral cavity
D. Articles intended for use as a component of
88. Minimum Mandatory information that shall such article
appear in the labeling materials accompanying a E. Correcting body or keeping them in good
drug product. condition
A. Product Name 94. A company with minor deficiencies in GMP is

B. Generic Name given the penalty of .
A. Closure of the Establishment A. FDA
B. Suspension of LTO B. DOH
C. Revocation of LTO C. DOST
D. Temporary closure of Establishment D. DTI
E. Suspension of the practice of Profession E. TLRC
95. Prescription for dangerous drug are written in 101. The senior citizens shall be entitled the grant of
discount in all purchases of medicines.
A. One copy only
B. Duplicate A. 20%
C. Triplicate B. 10%
D. It depends on the Physicians C. 8%
E. It depends on patient request D. 5%
E. 12%
96. The chairman of Dangerous Drug board is the :
102. It has the power to reclassify, add or remove
A. Secretary of DDB from the list of dangerous drugs.
B. Secretary of DOH
C. Secretary of DOJ A. DDB
D. Director General of FDA B. PDEA
E. Undersecretary of PDEA C. FDA
D. DOH
97. An act mandating and Strengthening the E. Forensic Laboratory
Continuing Professional Development for all
Regulated Professions, creating Continuing 103. This refers to any person who pays for, raises or
Professional Development Council, and supply money for illegal drug activities
Appropriating Funds Therefore, and for other
related purpose. Republic Act A. Financier
B. Drug Syndicate
A. 10640 C. Pusher
B. 10918 D. Coddler
C. 10990 E.Cultivator
D. 10981
E. 10912 104. It is a place where any dangerous drug and/or
controlled precursor and essential chemical is
98. PD which created the Professional Regulation administered, delivered, stored for illegal
Commission. purposes, distributed, sold or used in any form.
A. P.D 223 A. Clandestine laboratory

B. P.D 1675 B. Den, Dive or Resort
C. P.D 1363 C. Centers
D. P.D 1926 D. Private laboratory
E. P.D 881 E. Manufacturing laboratory
99. A UNIT CARTON shall contain the following 105. Permanent consultant of DDB.
minimum information EXCEPT:
A. Pack Size B. FDA Director General
B. ADR Reporting Statement C. NBI
C. Name and Address of marketing D. PNP
Authorization Letter E. C and D
D. Assay Procedure
E. Storage Condition 106. The substances covered by R.A 9165 include,
100. Shall issue a License to Operate (LTO) to A. Prescription drugs

iodized salt manufacturers and salts B. OTC drugs
importers/distributors upon their compliance with C. Dangerous drugs
prescribed documentary and technical D. Controlled precursor and Essential chemicals
requirements. E. C and D
107. The law that was repeated by R.A 9165 is: 113. Grounds for suspension or removal from office
of the chairperson and members of the board,
A. R.A 8344 EXCEPT:
B. R.A 7581
C. R.A 6425 A. Gross neglect, incompetence, or dishonesty
C. R.A 8981 in the discharge of duty
D. R.A 6675 B. Involvement in manipulation, tampering, or
rigging of the license examination
108. The license to operate is secured from: C. Receiving compensation and allowances
comparable to the compensation and
A. FDA allowances received by the member of the other
B. DOH existing professional regulatory boards under
C. DTI the PRC
D. PRC D. Conviction of an offense involving moral
E. SEC turpitude by a court of competent jurisdiction
E. All of these
109. One the qualification of chairpersons and
members of the board is to be a member in 114. In the Philippine Pharmacy Act, in order to be
good standing of the APO for at least registered and licensed as a pharmacist, a
years, but not an officer or trustee. candidate must obtain a .
A. 5 A. Weighted average of 75% with no rating lower

B. 7 than 50% in 2 subjects
C. 10 B. Weighted average of 75% with no rating
D. 12 lower than 50% in any subjects
E. 6 C. Weighted average of 75%
D. Weighted average of 65% with no rating
110. Primary label of small containers shall contain lower than 50% in 2 subjects
the following minimum information, EXCEPT: E. Weighted average of 65% with no rating lower
than 50% in any subjects
A. Product Name
B. Net content 115. An applicant who failed in licensure examination
C. Registration number for the 3rd time shall not be allowed to take the
D. Name and/or Logo of marketing Authorization next succeeding examinations and he/she will
Holder undergo refresher program, and shall be
E. Name and address of manufacturer conducted for a period of not less than ,
focusing on the subject prescribed in Section 15
111. Package insert shall contain the following of R.A 10918.
minimum information
A. 1 year review in any review centers
A. Instruction and special precautions for B. 1 year and 2 opportunities to take the
handling and disposal examination
B. Name and address of marketing Authorization C. 2 years only and 1 more chance
holder D. 2 years only and 3 more chances
C. Date of first authorization/renewal of the E. 1 year and 3 opportunities to take the exam
authorization
D. ADR Reporting 116. In addition to the minimum requirements, each
E. All of these individual dosage unit of the physician’s samples
shall include:
112. The chairperson and a member of the board
shall hold office for term of years from the A. Batch
date of appointment or until their successor shall B. Lot numbers
have been qualified and appointed. C. Date of manufacture
D. Expiration date
A. 1 E. All of these
B. 2
C. 3 117. The FDA shall have the following centers,
D. 4 EXCEPT:
E. 5
A. Food Regulation and Research B. Dosage form
B. Drug Regulation and Research C. Mode Administration
C. Device Regulation and Research D. Formulation
D. Cosmetics Regulation and Research E. Pharmacologic Category
E. Meat Regulation and Research
124. Refers to the statement regarding the conditions
118. It refers to a quantity of any drug or devices wherein the use of the product may cause harm
produced during a given cycle or manufacture. to the patient.
A. Batch A. Contraindication
B. Batch number B. Caution
C. Lot C. Warning
D. Lot number D. Precaution
E. Code number E. Indication
119. A food, drug, devices and cosmetics intended 125. Refers to the distinctive combination letters
for export shall not be deemed to be adulterated and/or numbers, assigned to a particular batch
or misbranded if . herein defined as any product produced during a
given cycle or manufacture.
A. It conforms to the specification of the local
producing company A. Lot number
B. It is not conflict with the Philippine law B. Batch number
C. It is labeled outside of the shipping package C. Production date
to show that it is intended for export D. Date manufacture
D. It is offered for sale in domestic commerce E. Expiry date
E. All of these
126. The penalty for illegal price manipulation:
120. The Generic name of the drug product must be
. A. Imprisonment for a period of NLT 5 years
NMT 15 years and fine of NLT PhP 5,000 NMT
A. Enclosed by the outline circle PhP 2M
B. Smallest font size than the Trade name B. Imprisonment for a period of NLT 1 years
C. Bigger font size in Times New Roman NMT 10 years and fine of NLT PhP 5,000 NMT
D. The active moiety based on INN PhP 1M
E. Written after the trade name C. Imprisonment for a period of NLT 4 years
NMT 10 years and fine of NLT PhP 5,000 NMT
PhP 100,000
121. The Board of Food and Drug inspection shall D. Imprisonment for a period of NLT 6 months
consist of the following, EXCEPT: NMT 5 years and fine of NLT PhP 2,000 NMT
PhP 5,000
A. Representative of DOH E. Imprisonment for a period of NLT 6 months
B. Representative of DENR NMT 12 years and fine of NLT PhP 5,000 NMT
C. President of PACOP PhP 1M
D. President of PMA
E. President of PDA 127. The potency of the biological products must be
expressed in:
122. The net content of the liquid dosage form must
be expressed using: A. Metric system
B. International units
A. Arabic numeral & Avoirdupois system C. Apothecary
B. Metric units D. Avoirdupois
C. Becquerrel system international E. A and D
D. Roman numeral and metric system
E. Roman numeral and Avoirdupois 128. The word “Single use” must be included in the
label for .
123. Refers to the classification of the product based
on its therapeutic action specified in the product A. Biological Products
registration. B. Individually Wrapped products
C. Small container
A. Dosage D. Large volume injections
E. Blister pack containers B. Temporary Closure
C. Suspension of LTO
129. Automatic price ceiling control. Unless otherwise D. Warning
declare by the President, prices of basic E. No Reprimand
necessities in an area shall automatically froze
at their prevailing prices or placed under 135. These are drugs which has undergone adequate
automatically price control whenever, EXCEPT: clinical trial of Phase I, II and III but which need
further Phase IV Clinical Pharmacology studies
A. Thant the area is proclaimed or declared a before it can be given regular registration
disaster area/under state of calamity
B. The area is declared under an emergency A. Investigational drug
C. The privilege of the writ of habeas corpus in B. New drug
that area C. Tried and Tested
D. The area is placed under martial law D. Established drug
E. The area is declared to be in sate or rebellion E. Therapeutic Innovation
130. One of the members of pricing coordination 136. These are drugs found in USP/NF and is
council: considered safe and efficient through long years
of general use and can be found in current
A. Secretary of environment and Natural official USP/NF, and other internationally
Resources recognized pharmacopeias.
B. Director General of FDA
C. Secretary of Department of Education A. Investigational drug
D. Secretary of DSWD B. New drug
E. Secretary of Tourism C. Tried and Tested
D. Established drug
131. What is the loor area requirement for drug E. Therapeutic Innovation
outlets?
137. One of the ground for suspension of LTO is:
A. NMT 15 sq. M
B. NLT 15 sq. M A. Sale of antibiotics without batch certification
C. NLT 20 sq. M B. Refusal to allow entry of FDA inspector
D. NMT 20 sq. M C. Selling misbranded drugs
E. NLT 30 sq. M D. Absence of Pharmacists on 3 inspections by
FDA inspector
E. Lack of Pharmacist
132. These shall be prima facie evidence of 138. Administrative designation assigned to persons
profiteering whenever a basic necessity or prime using narcotics in research, analysis and
commodity being sold: instruction is:
A. Has no price A. S-1

B. Is misrepresented as to its weight or B. S-2
measurement C. S-4
C. Is adulterated or diluted D. S-5-I
D. Offers for sale to general public by more than E. S-6
10%
E. All of these 139. An act granting additional benefits and privileges
to SCS further amending R.A no. 7432, as
133. The alcohol content must be expressed in . amended, otherwise known as “An act to
maximize the contribution of SCS to nation
A. Percentage Strength building, grand benefits and special
B Ration Strength privileges and for other purposes”.
C. Proof Strength
D. MI A. R.A 9994
E. Grams B. R.A 9257
C. R.A 7876
134. Lack of Pharmacists in a drugstore warrants D. R.A 10640
E. R.A 10645
A. Revocation of LTO
140. Under category B where the Professional 145. It means a set of condition to be fulfilled to
services of duly registered pharmacist and ensure quality and safety of a product.
licensed pharmacist are required, the farthest
the establishments/outlets by a single A. Standard
pharmacist must not exceed in distance. B. Services
C. Labor
A. 15KM D. Repair or service
B. 10KM E. Sale distributor
C. 40KM
D. 25KM 146. It includes rice, corn bread, fish, and drug
E. 30KM classified as essential by the Department of
Health.
141. If the seized drug was found to be counterfeited,
the business establishment must be directed for A. Basic necessities
preventive closure for a period not exceeding. B. Prime commodities
C. Primary needs
A. 10days D. Merchandise
B. 15days E. Ordinary commodities
C. 20days
D. 30days 147. It is contingent fund in the budget of the
E. 45days implementing agency which shall not be used in
normal or regular operation.
142. Composition of the commission (PRC), the
commission shall be headed by one full time A. Petty cash
chairperson and two full time commissioners, all B. Buffer fund
to be appointed by the President for a term of . C. Cash on hand
D. Operating budget
A. 3 years E. Cash refund
B. 5 years
C. 7 years 148. It is abnormal phenomenon where consumer
D. 10 years buys basic necessities and prime commodities
E. 6 years grossly in excess of their normal requirement
resulting in undue shortage of such good to the
prejudice of less privileges consumers.
A. Hoarding
B. Panic buying
C. Cartel
143. Penalty imposed when the counterfeit products D. Profiteering
are not lifesaving drugs and the volume of the E. Bilk buying
said products is not worth more than PhP 149. It is maximum price at which any basic
100,000 but NMT PhP 1M or the number of drug necessities or prime commodities may be sold to
products is more than 3 brands or Generic the general public.
products.
A. Prevailing price
A. Maximum penalty B. Price ceiling
B. Minimum penalty C. Discriminatory pricing
C. Medium penalty D. Special event pricing
D. Revocation of License E. Loss leader pricing
E. B and C
150. It is undue accumulation by a person or
144. Any person engaged in the business of selling combination of persons of any basic necessities
consumer products directly to the consumers or prime commodities beyond his or their normal
inventory levels.
A. Supplier
B. Exporter A. Hoarding
C. Importer B. Panic buying
D. Telemarketing C. Cartel
E. Retailer D. Profiteering
E. Bilk buying
C. Pusher
151. The sale or offering for sale of any basic D. Culture
necessity or prime commodity at a price grossly E. Trading
in excess of its true worth.
156. Any act of knowingly planting, growing, raising,
A. Hoarding or permitting the planting of any plant which is
B. Cartel the source of dangerous drugs:
C. Panic buying
D. Profiteering A. Cultivate
E. Wholesale buying B. Culture
C. Pusher
152. It is any combination of or agreement between D. Former
two or more persons engaged in the E. Both A and B
manufacture, processing, storage, supply,
distribution, marketing, sale or disposition of any 157. The illegal cultivation, culture, delivery,
basic necessity or prime commodity designed to administration, dispensation, manufacture, sale,
artificially and unreasonably increased or trading, transportation, distribution, importation,
manipulated its price. and possession of any dangerous drugs and/or
controlled precursor and essential chemical.
A. Hoarding
B. Panic buying A. Illegal trafficking
C. Cartel B. Illegal prescribing
D. Profiteering C. Illegal selling
E. Discriminatory selling D. Illegal possession
E. Illegal dispensing
153. An analytical test using a device, tool, or
equipment with a different chemical or physical 158. Indian hemp is .
principle that is more specific which validate and
confirm the result of the screening test. A. Marijuana
B. Hashish
A. Screening test C. Bhang
B. Drug test D. Churrus
C. Drug analysis E. All of these
D. Confirmatory Test
E. Chemical test 159. What is maximum penalty for counterfeiting
drug?
A. PhP 100,000 to PhP 500,000

B. Revocation of License
C. Permanent Closure
D. PhP 300,000 to PhP 500,000
154. Penalty imposed when the counterfeit products E. B, C and D
are not lifesaving drugs and the volume of the
said products is not worth more than PhP 160. Under category B, the maximum number of
100,000 or the number of the drug product establishment/outlet allowed to be supervised by
subject of the case is NMT 3 brands or Generic a single pharmacist is .
products.
A. 5
A. Maximum penalty B. 10
B. Medium penalty C. 15
C. Minimum penalty D. 20
D. Revocation of License E. 25
E. Permanent Closure
161. A pharmacist working Category A establishment
155. Any act of knowingly passing a dangerous drug may be allowed to simultaneously work and
to another, personally or otherwise, and by any successively render pharmacy services in
means, with or without consideration. Category B establishment/outlets with a
maximum of .
A. Cultivate
B. Deliver A. 1
B. 2 A. Net content
C. 3 B. Formulation
D. 4 C. Strength
E. 5 D. Potency
E. Dose
162. Division of FDA which shall be responsible for
evaluating health products and establishments 168. It refers to statements regarding the occurrences
for the purpose of issuance of authorization and of potential hazards and side effects associated
conditions to be observed. with the use of the products and the limitation of
its use.
A. Licensing and Registration Division
B. Product Research and Standards A. Pharmacologic category
Development Division B. Warning
C. Laboratory Support Division C. Contraindication
D. Both A and B D. Dosage formulation
E. Both B and C E. Precautions
163. An article used for food or drink for man 169. It refers to the FDA approved clinical use of the
drug product based on substantial and
A. Device scientifically supported evidence of the safety
B. Drug and efficacy of the drug in the given dosage
C. Food form.
D. Poison
E. Cosmetic A. Pharmacologic category
B. Indication
164. The data placed on the label of a drug product C. Dosage
designating the time prior to which a batch of the D. Dosage form
product is expected to remain within the E. Dosage formulation
approved shelf-life specification if stored under
defined conditions. 170. It is refers proprietary/trade name assign to the
product by the marketing authorization holder
A. Manufacturing date (MAH).
B. Registration date
C. Production date A. Product
D. Expiration date B. Brand Name
E. Both A and D C. Generic Name
D. Non Proprietary Name
165. Which of the following is an example of Medical E. Trade Name
Device?
171. It refers the instruction and special care required
A. Electrical apparatus in the use of the drug product to avoid undesired
B. Ionizing electromagnetic effects and to ensure the safe and effective use.
C. Particulate radiation
D. Sonic, infrasonic, and ultrasonic wave A. Contraindication
E. Implant or In-vitro reagents B. Warning
166. Drugs intended for use for animals including any C. Precautions
drug intended for use in animal feeds but not D. Indications
including animal feeds within the contemplation E. Cautions
of the implementing rules and regulations.
172. Penalty imposed when the counterfeit drugs are
A. Poison lifesaving regardless of the volume and/or the
B. Antibiotics volume of the counterfeit drug products is more
C. New Drugs than PhP 1M
D. Veterinary Drugs
E. New Veterinary Drugs A. Maximum penalty
B. Medium penalty
167. The name, strength and reference monograph of C. Minimum penalty
all active pharmaceutical ingredients (API’s) D. Permanent Closure
and/or excipients present in the drug product. E. A and D
173. A single pharmacist is allowed to supervise 178. It is composed of a core list of medication
multiple rounds provided the following the rules considered essential and a complementary list
are met. of drugs considered useful it not essential.
A. The pharmacist is required to dedicated a A. National Drug policy

minimum of two hours a week of physical B. National Drug formulary
presence in the RONPD. C. National Drug Committee
B. The location of each RONPD must be within D. Philippine National Drug formulary
the same provincial local government unit. E. Hospital formulary
C. The distance between the two farthest
RONPDs must not exceed 25Km in distance. 179. It refers to either prohibited or regulated drugs
D. A maximum 15 RONPDs is allowed to be which requires a special prescription form.
supervised by single pharmacist
E. All of these A. Ethical drugs
B. OTC drugs
174. What is the minimum penalty for counterfeiting C. Prescription drugs
drugs? D. Traditional drugs
E. Dangerous drugs
A. PhP 100,000 to PhP 500,000
B. PhP 100,000 to PhP 300,000 180. Any person whether related to the senior citizen
C. Revocation of LTO or not who takes care of him/her as a
D. PhP 300,000 to PhP 500,000 dependent.
E. Permanent Closure
A. Head of the family
175. It refers to drug products indicated for life B. Benefactor
threatening conditions. C. Beneficiary
D. Protector
A. Lifesaving drugs E. Nearest Surviving Relatives
B. Counterfeit drugs
C. Non-life saving drugs 181. It refers to the branch of medical science
C. Drugs for limited use devoted to the study of the biological and
E. Drugs for restricted use physical changes and the diseases of old age.
176. In opening and operation of retail A. Pediatrics

pharmaceutical outlets, the following B. Pharmacy
information/s is/are required to display in a C. Geriatrics
conspicuous space. D. Orthodontics
E. Elderly
A. Office hours and schedule of the supervising
pharmacist. 182. Refers to the provision of interventions,
B. The operating schedule of drugstore approaches, and strategies with the end goal of
C. The name of registered pharmacy technician ensuring effective reintegration of older person
D. The number of prescription being served discharged from residential facilities.
E. The number of patients being served
A. After care services
B. Medical services
C. Dental services
D. Home health care services
177. It is policy and program of the national E. Foster care services
government to ensure that safe and effective
drugs are made available to all Filipinos at any
time and at a reasonable and affordable cost 183. It is licensed issued by the Director General of
the intellectual property office to exploit a
A. National Drug policy patented invention without the permission of the
B. National Drug formulary patent holder, either by manufacturer or through
C. National Drug Committee parallel important.
D. Philippine National Drug formulary
E. Hospital formulary A. Certificate of Product registration
B. Compulsory licensed
C. Batch certificate
D. Registration certificate
E. License to operate 190. Any person who is a licensed physicians,
dentist, chemist, medical technologist, nurse,
184. It refers to pharmaceutically equivalent or midwife, veterinarian, and pharmacist in the
pharmaceutically alternative products that may Philippines.
or may not be therapeutically equivalent
A. Practitioner
A. Multisource pharmaceutical products B. Coddler
B. Multi-pharmaceutical products C. Protector
C. Source of Pharmaceutical products D. Pusher
D. Pharmaceutical products E. Financer
E. Pharmaceutically equivalent
191. Any person, who sells, trades, administers,
185. It refers to the drugstore, pharmacies and other dispenses, delivers, or gives away to another, on
business establishments which sell drugs and any terms whatsoever, or distributes, dispatches
medicines. in transit or transport dangerous drugs or who
act as a broker in any such transactions.
A. Drug outlets
B. Drug establishment A. Practitioner
C. Drug laboratory B. Coddler
D. Both B and C C. Financer
E. Both A and C D. Pusher
E. Protector
186. It means a natural person who is a purchaser,
lessee or prospective purchaser leaser or 192. The term “Secretary” in R.A 3720 means:
recipient of consumer products, service or credit.
A. Secretary of DOH
A. Creditor B. Secretary of DTI
B. Customer C. Secretary of Education
C. Consumer D. Secretary of DOJ
D. Owner E. Secretary of DSWD
E. Clients
193. R.A 3720 was amended by E.O no. .
187. “Ecstacy” is also known as:
A. E.O 851
A. Methylenedioxymethamphetamine B. E.O 174
B. Methyldioxymethamphetamine C. E.O 175
C. Methamphetamine Hydrochloride D. E.O 881
D. MMDA E E.O 119
E. Ice
194. Ordinary prescription shall be retained by the
188. “Shabu” is also known as: pharmacist for a period of .
A. Methylenedioxymethamphetamine A. 1 year
B. Methyldioxymethamphetamine B. 2 years
C. Methamphetamine Hydrochloride C. 3 years
D. MMDA D. 4 years
E. Guaza E. 5 years
189. A rapid test performed to establish

potential/presumptive positive result for 195. The “Pharmacy Law” is known as:
Dangerous Drugs.
A. R.A 5921
A. Confirmatory test B. R.A 6675
B. Screening test C. R.A 3720
C. Test analysis D. R.A 8203
D. Laboratory test E. R.A 9502
E. Physical and Chemical test
196. Which of the following guidelines is the 201. It means any substances which on contact with
regulatory and technical requirement for living tissue will cause destruction of tissue by
pharmacy-based immunization services in the chemical reaction.
Philippines Pharmaceutical outlet?
A. Corrosive
A. It should have a valid licensed to operate B. Poison
(LTO) issued by the FDA C. Antibiotics
B. It should maintain patient medication D. Biological
profile/record E. Toxins
C. As long as monitored by pharmacist who
knows how to vaccinate 202. It means any card, plate, coupons book, or other
D. A and B credit devices existing for the purpose of
E. B and C obtaining money, property, labor or services on
credit
197. The test for alcohol content for registration of
herbal and/or traditional drug should not be A. Credit Card
more than . B. ATM card
C. ID Card
A. 10 D. Value card
B. 15 E. None of these
C. 20
D. 80 203. An immunizing pharmacist should comply which
E. 95 of the following requirements?
198. The senior citizen shall be entitled the grant of A. Certificate of current Employment in the
discount from all establishment relative to the Pharmaceutical outlet
utilization of transportation services, restaurants, B. Certified NC-3 by TESDA
and purchase of medicines anywhere in the C. Valid certificate in basic life support training
country, including funeral and burial services for and valid certificate of training in vaccination
the death of the senior citizens. issued by PRC-BOP
D. A and B
A. 5% E. A and C
B. 10%
C. 20% 204. The integrated and accredited professional
D. 50% organization (APO) of pharmacists is:
E. Free
A. PAPPI
199. Dangerous drug prescription shall be retained by B. DSAP
the pharmacists for a period of . C. PACOP
D. PPhA
A. 1 year E. YPG
B. 2 years
C. 3 years 205. The COR issued by PRC shall bear the
D. 4 years following, EXCEPT:
E. 5 years
A. Registration number and the date of its
200. It refers to the international agreement issuance
administered by the WTO that sets down B. The signature of the Chairperson of the PRC
minimum standards for many forms of and the members of the board
intellectual property regulations. C. Stamp of the official seals of the PRC and of
the board
A. TRIPS agreement D. The signature of the president of the
B. WTO agreement Philippines
C. Agreement on Trade-Related Aspects of E. None of these
intellectual property rights
D. Both A and B
E. Both A and C
206. R.A 9165 was signed into law on .
A. June 7, 2002
B. June 6, 2002
C. February 26, 2004 A. Director General
D. June 23, 1969 B. Director
E. June 22, 1963 C. Undersecretary
D. Assistant Secretary
207. R.A 9994 signed into a low on . E. Deputy Director
A. February 14, 2010 213. The board under R.A 9165 shall be composed of
B. February 15, 2010 17 members, wherein 3 of which are permanent,
C. February 26, 2004 and these are.
D. June 7, 2002
E. February 10, 2010 A. Director General of DDB and two
undersecretaries
208. The OSCA shall have the following function, B. Chief of PNP and NBI
EXCEPT: C. President of integrated Bar of the Philippines
D. President of Non-Government Organization
A. To plan, implement and monitor yearly world E. Both C and D
programs in pursuance of the objectives
B. To serve as a general information and illusion 214. Upon finding that the drugs are counterfeit, the
center for senior citizens Bureau shall file an appropriate proceeding
C. To monitor compliance of provision against the pharmacist with the PRC for the
particularly the grant of special discounts and of professional license
privileges to senior citizens.
D. To conduct researches and study in geriatric A. Suspension
care, gerontology and health needs of senior B. Revocation
citizens C. Cancellation
E. To assists the senior citizens in filing D. Non-renewal
complaints. E. Both A and B
209. The division of the FDA that provides assistance 215. R.A 9257 was signed into law on .
to person/establishment in complying with FDA
legal requirements. A. February 24, 2004
B. February 26, 2004
A. Licensing and registration divisions C. February 14, 2003
B. Administration and finance office D. February 14, 2004
C. Field regulatory operation office E. February 20, 2003
D. Legal services support center
E. Laboratory support division 216. R.A 3720 was signed into a law on .
210. The division of FDA which shall be responsible A. June 22, 1969
for the conduct of research and appropriate tests B. June 13, 1963
and calibration, analysis and trials of products C. June 23, 1963
including, but not limited to assays and others. D. June 23, 1969
E. June 22, 1963
A. Licensing and registration divisions
B. Product research and Standards 217. Additional label to be attached to poisons:
development division
C. Laboratory support division A. Warning: may be habit forming
D. Administration and finance office B. Warning: It is Toxic
E. Legal services support center C. Precaution
D. For external use only
211. The FDA shall be headed by a with the E. A vignette of skull and bones
rank of .
218. The designated person of a manufacturing
A. Director General- Undersecretary company who will transact officially with the
B. Director General- Secretary FDA.
C. Deputy Director General
D. Director A. Company Pharmacist
E. Director General- Assistant Secretary B. Branch
212. Each center of FDA shall be headed by a C. Detail man
D. Liaison Officer C. Established Drug
E. Professional sales Representative D. Investigational Drug
E. Therapeutic innovation
219. Authorized to established and initiate a price 225. Documentary requirement in the application of
monitoring and regulation system for drugs and LTO
medicine
A. Proof of business registration
A. Secretary of DOH B. Self-assessment kit
B. Secretary of DTI C. Risk management plan
C. Secretary of DENR D. Credentials of pharmacist and Pharmacy
D. Director General of FDA assistant
E. Both A and B E. All of these
220. The one responsible in ensuring that all drugs 226. Under transitory Provision, Existing licensed
authorized for marketing in the country conform establishment are required to submit:
to international standards for the content, purity
and quality of pharmaceutical products as A. Risk management plan
established in the international Pharmacopoeia. B. Global positioning system (GPS Coordinates)
C. Pharmacist credentials
A. DOH D. A and C only
B. DTI E. All of these
C. DOJ
D. FDA 227. R.A 7394 was signed into a law on .
E. DOST
A. April 13, 1992
221. For products containing 3 or more active B. February 13, 1992
ingredients, the official name for the combination C. February 7, 1992
shall be designed by . D. February 13, 1992
E. September 13, 1988
A. DTI
B. FDA 228. This information will appear on the label of the
C. DOH immediate container outside of the principal
D. Manufacturer display panel.
E. Company Pharmacist
A. Name of the product
222. The FDA must be notified of such changes in B. Formulation
the establishment: C. Dosage form and strength
D. Net content
A. Change of pharmacist-in-charge E. Pharmacologic category
B. Change of Company manager
C. Change of product management 229. Heavy metals to be tested in the herbal and/or
D. Change of Liaison officer traditional drugs, EXCEPT:
E. Change of supervisor
A. Pb
223. A professional identification card issued by PRC B. As
shall bear the following, EXCEPT: C. Hg
D. Cd
A. Registration number E. Cu
B. Date of its issuance
C. Date of its expiry 230. Violation of any provision of Senior Citizen act is
D. Signature of PRC Chairperson punishable by .
E. Signature of PRBOP Chairperson
A. A fine not exceeding PhP 2,000
224. Refers to a new chemical ore structural B. Imprisonment not exceeding 2 months
modification of a tried and tested or established C. A fine of PhP 5,000 but not exceeding PhP
drug proposed to be used for a specific 10,000
therapeutic indication D. Imprisonment of NLT 2 years but NMT 6
years for the first violation
A. New Drug E. Imprisonment of NLT 4 years and 1 day but
B. Tried and Tested NMT 6 years
237. The chairperson of the commissioner of PRC
231. Under R.A 6675, what type of prescription may shall have at least years of executive or
be filled? management experience.
A. Violative A. 10 years
B. Erroneous B. 7 years
C. Impossible C. 6 years
D. Marked prescription D. 5 years
E. Special prescription E. 3 years
232. How much is the compensation of the members 238. Absence of pharmacist in a drug store on three
of the professional regulatory board? inspection by FDA inspector is a ground for:
A. Two salary grades lower than the salary A. Cancellation of the professional license of the
grade of the commissioners said pharmacist
B. Two steps higher than the members of the B. Suspension of the LTO
commission C. Revocation of the LTO
C. Equivalent to that of the department secretary D. Temporary closure
D. Equivalent to that of the undersecretary E. Both A and B
E. They are being paid based on honoraria
239. A drug shall be deemed to be adulterated if
233. R.A 6675 was signed into a law .
A. September 13, 1988 A. It is a drug and its container is composed, in

B. October 13, 1988 whole or in part, of any poisonous or deleterious
C. June 13, 2988 substances.
D. February 13, 1988 B. Its labeling is false or misleading in particular
E. December 13, 1988 C. If it is an imitation of another drug
D. If it is offered for sale under the name of
234. E.O which is responsible in reorganization of the another drug
former Bureau (BFAD). E. If it is a drug and its container is so made,
formed, or filled as to be misleading.
A. E.O 175
B. E.O 851 240. Imprisonment term of any person who was
C. E.O 174 involved in manipulation or rigging of licensure
D. E.O 223 examination results.
E. E.O 119
A. 6 months-6 years
235. The source or circumstances of drug production B. 2years-4 years
is/here: C. 4 years-10 years
D. 6 years and 1 day-12 years
A. Imported a finished E. 4 years and 1 day-6 years
B. Locally manufactured from imported materials
C. Locally manufactured from local materials 241. The presidential decree which lead to creation of
D. Both B and C PRC
E. All of these
A. P.D 221
236. The PIC shall renewed every 3 years upon B. P.D 223
presentation of the certificate of good standing C. P.D 881
(COGS) from the APO and proof of completion D. P.D 1926
of the CPD. How many units required for E. P.D 1363
renewal of PIC?
242. First time minor offender in R.A 9165 is one who
A. 15 is:
B. 30
C. 45 A. over 15 years but NMT 18 years old
D. 60 B. Not below 12 years but NMT 20 years old
E. 120 C. Not below 15 but NMT 20 years old
D. Not below 10 years but NMT 15 years old
E. Not below 15 years but NMT 21 years old
243. Failure to properly record dangerous drugs as A. Prepare, compound or manufacture,
determined by the DDB in a drug outlet is a preserve, store, distribute, procure, sell, or
ground for . dispense, or both, any pharmaceutical product
or its raw materials
A. Cancellation of professional license B. Engage in teaching scientific, technical, or
B. Suspension of LTO professional pharmacy courses in a school or
C. Revocation of LTO college of pharmacy
D. Temporary closure C. Administer adult vaccine as approved by the
E. Both A and B FDA subject to the training, certification and
244. The standard blister pack/foil strip packaging of other requirements as provided in the IRR of
a drug products shall contain the following R.A no. 10918
minimum information, EXCEPT: D. Both A and B
E. Both A and C
A. Batch number and Expiration date on each
unit for single API 249. A pharmaceutical product refilled in containers
B. Dosage form and strength of API on each unit bearing legitimate labels or marks, without
for single API authority.
C. Name of logo of the MAH
D. Product name on each unit for API A. Adulterated products
E. Rx symbol on- each unit for single API B. Counterfeit pharmaceutical products
C. Illegally imported products
245. Any foreign citizen who has gained entry in the D. Tampered products
Philippine to perform professional services E. Natural products
within the scope of the practice of pharmacy,
include: 250. These are life-threatening situations where a
patient needs immediate medical attention and
A. Engaged or employed by a Filipino employer treatment, including the occurrence of epidemic
or establishment or natural calamities.
B. Provides service in humanitarian missions
with pay A. Emergency cases
C. Consultant in local-funded or assisted B. Supernatural cases
projects of the private organizations C. Crises
D. Visiting faculty member in any field D. Urgent cases
E. All of these E. Isolated cases
246. The board shall not register any successful 251. Patient information leaflet shall be prepared and
examinee who has been: written in layman’s terms, and shall contain the
following minimum information, EXCEPT:
A. Convicted of an offense involving moral
turpitude by a court of competent jurisdiction A. Description of the product
B. Found guilty of immoral or dishonorable B. What is in the medicines?
conduct by the board C. Strength of the medicine
C. Medically proven using drug or alcohol D. Expiry date
prescribed or recommended by a physician E. ADR Reporting
D. Both A and B
E. Both A and C 252. The government agency which issue national ID
card and purchase slip booklet for SCs.
247. For products that are intended for external use,
the statement “For External use only” shall A. FDA
appear on all labeling materials in . B. DOH
C. Mayor’s Office
A. Capital letters D. DSWD
B. Capital letters against a red background E. OSCA
C. Printed Red font
D. Capital letters in black ink 253. Example of a medical device required to be
E. B and C registered.
248. Which of the following activities is exclusive to A. Cotton buds

Pharmacists? B. Toothbrushes
C. Tongue Depressors D. Morphine
D. Abdominal pads E. Both A and D
E. Surgical caps (non-sterile)
260. In applying LTO for drug store, the credentials of
254. Example of diagnostic reagents required to be identified pharmacist-in-charge must be
registered. submitted. This include:
A. Plaster bags for blood transfusion A. Valid PRC ID

B. Skin traction kit B. Certificate of attendance to appropriate FDA
C. Pregnancy test kit licensing seminar
D. Dental floss C. Resignation letter of the Pharmacist from
E. Plaster of Paris previous employer (if any)
D. A and C only
255. The former president of the Philippines who E. All of these
enunciated the National Drug Policy
261. Misrepresentation of any material fact in the
A. Ferdinand E. Marcos application of LTO for a drug establishment is a
B. Joseph E. Estrada ground for .
C. Gloria M. Arroyo
D. Corazon C. Aquino A. Cancellation of Professional license
E. Fidel V. Ramos B. Suspension of LTO
C. Revocation of LTO
256. Any person who shall violate R.A 6675, Sec 12 D. Temporary closure
(a) for the first conviction shall suffer the penalty E. Both A and C
of reprimand which shall be officially recorded in
the appropriate books of the . 262. Application requirements for renewal of LTO for
Drug manufacturer
A. PRC
B. BOP A. Location plan
C. DDB B. Risk management plan
D. DOH C. Site master plan
E. FDA D. Copy of certification issued as a result of LTO
variation
257. Existing establishments that fail to file an E. Credentials of Pharmacist
application for renewal after days
from the date of expiration shall be automatically 263. The FDA shall have the following functions,
cancelled and deleted from the list of licensed powers and duties, EXCEPT:
establishments without prejudice to their
application. A. To analyzed and inspect health products
B. To certify batches of antibiotics
A. 180 days C. To conduct appropriate test on all health
B. 120 days products
C. 60 days D. To issue ceases and desist orders
D. 30 days motupropio or upon verified complaint for health
E. 15 days products
E. To obtain information from any officer of the
258. Examples of regulated drug listed R.A no 9165 national or local government
A. LSD 264. The ultimate objective of the PNDP is to

B. Morphine
C. Heroin A. ensure safe and effective drugs are made to
D. Benzedrine available to all Filipinos
E. Both B and D B. provide high quality but expensive
C. Provide reasonable and affordable cost of
259. Examples of prohibited drug listed under R.A no. drugs
9165 D. Provide free consultation from the physician
E. Both A and C
A. Dexedrine
B. Amobarbital 265. This is the S-licensed for physicians, dentist and
C. Phenobarbital veterinarians
B. When only the generic name is written but it
A. S-1 is not legible
B. S-2 C. Where the brand name
C. S-3 D. Where the generic name is the one in
D. S-4 parenthesis
E. S-6 E. Both A and B
266. A display of written, printed, or graphic matter on 272. The following subject is classified as
the immediate container of any article Pharmaceutical sciences, EXCEPT:
A. Sticker A. Inorganic Pharm. Chemistry

B. Labeling material B. Pharmacognosy
C. Brand name C. Legal Pharmacy and ethics
D. Product information D. Microbiology
E. Label E. Physical pharmacy
267. Pharmaceutical services of a duly licensed

pharmaceutical outlet done through the use of 273. The following establishments are classified as
telephone, teleconferencing, or facsimile Category A, EXCEPT:
A. Pharmacoinformatics A. Pharmaceutical laboratories

B. Telecommunication B. 3rd class municipal health units
C. E-counseling C. St. Luke’s Medical center
D. Telepharmacy D. 2nd class municipal health units
E. Patient counseling E. Non-traditional outlets
268. Violative prescription is one: 274. The following are the applicable “minor
variations” to an approved LTO as a drug
A. When generic name is not written distributor, EXCEPT:
B. Where the brand names precedes the generic
name A. Change of ownership
C. Where the generic name is not legible and a B. Change of activity
brand name which is legible is written C. Expansion of establishment
D. Where the generic name is the one in D. Change of business name
parenthesis E. Zonal change in address
E. Both A and C
275. A retailer of narcotics must obtain S- licensed
269. The component/s of NDP based on R.A 9165
A. Quality assurance of drugs A. S-1

B. Rational use of drugs B. S-2
C. National self-sufficiency in Pharmaceuticals C. S-3
D. Rationalization of the DOH’s procurement D. S-4
program E. S-5-E
E. All of these
276. The penalty of illegal chemical diversion of
270. Erroneous prescription is: controlled precursors and essential chemicals.
A. With a phrase no substitution A. Imprisonment of 12 years and 1 day to 20

B. Where generic name is not written years
C. Where the brand name is not in parenthesis B. Life imprisonment to death
D. Where the generic name is one in C. Fine of PhP 500,000 to PhP 10M
parenthesis D. Fine of PhP 100,000 to 500,000
E. Both C and D E. Both A and D
271. Impossible prescription is: 277. Accreditation of drug testing centers and
physicians under R.A 9165 shall be done by
A. When the drug product prescribed is not
registered with FDA A. DOH
B. FDA
C. DDB 283. A consumer product which presents an
D. PDEA unreasonable risk of death, serious illness or
E. Forensic laboratory severe personal injury.
278. If there is sufficient ground for a reprimanding a A. Immediate container

pharmacist, administrative investigations shall B. Imminently Hazardous substance
be conducted by the members of the C. Irritant
D. High toxic
A. Professional regulatory board of pharmacy E. None of these
B. PRC
C. PNP 284. Mandated price ceiling may be imposed on any
D. Supreme Court basic necessities or prime commodities if any of
E. NBI the following conditions so warrants.
A. Impendency, existence, or effects of a

calamity
B. The treat, existence, or effect of an
emergency
279. Which of the following ground for reprimand,
suspension or revocation of registration
certificate of pharmacist? C. The supply available in the market
D. Impendency, existence, or effects of any
A. Conviction by a Court event that causes artificial and unreasonable
B. Violation of the Code of Ethics increase in the price of the basic necessity
C. Fraud E. The prevalence or widespread acts of illegal
D. Insanity price manipulation
E. All of these
285. Drugs and medicines subject to price regulation
280. Shall issue a LTO to iodized salt manufacturers include:
and salt importers/distributors upon their
compliance with prescribed documentary and A. Vaccines
technical requirements. B. Oral contraceptives
C. Anesthetics
A. FDA D. Intravenous fluids
B. DOH E. All of these
C. DTI
D. DENR 286. The national coordinating and monitoring board
E. DOST of R.A no.9994
281. One who produce, imports, trades, and/or A. DSWD

distributes salt ranging from more than two B. NEDA
metric tons (2 MT) to 300 metric tons (300 MT) C. DILG
per year D. DOJ
E. DOH
A. Small producers
B. Subsistence producer 287. The Vice chairperson of NCMB of R.A no.9994
C. Medium producers
D. Large producers A. DSWD
E. None of these B. DILG
C. DOJ
282. Which of the following persons is not practicing D. DOH
pharmacy? E. DTI
A. Pharmaceutical Marketing 288. The chairperson of price coordinating council of

B. Engage in teaching professional subjects of R.A 7581 is the:
pharmacy
C. Preparation or manufacture of drugs A. Secretary of Trade and Industry
D. Conduct pharmaceutical scientific research B. Secretary of Agriculture
E. None of these C. Secretary of Health
D. Secretary Justice C. Photocopying, duplicating, alternating,
E. Secretary of local government transferring, removing, approved label
D. Making selling, distribution, exporting,
289. The OSCA shall be established in all cities and importing, pharmaceutical products
municipalities headed by a SC who shall be E. Availability of such counterfeit drugs within
appointed by the Mayor for the term of the premises of any entity engaged in sale,
manufacture, and distributes drugs.
A. 3 years
B. 5 years 295. A completion of refresher course is required
C. 6 years when the examinee has failed in
D. 7 years the Pharmacist Licensure Examination.
E. 9 years
A. One time
290. R.A 9994, indigent senior citizens, refers to any B. Two times
elderly who is: C. Three times
D. Four times
A. Frail E. Five times
B. Sickly
C. With disability
D. Without pension or permanent source of
income
E. All of these
291. DOH shall have the power to implement R.A

9502. This includes: 296. Possession of counterfeit drugs by owners of
trademark, trade names or identity marks shall
A. Power to recommend the MRP of drugs and report in writing and turn over the said
medicines subject to price regulation counterfeit drugs to the FDA within
B. Power to include other drug and medicine in
the list subject to price regulation A. 20 hours
C. Power to implement cost-containment and B. 10 days
other measures C. 15 days
D. Power to impose administrative fines and D. 20 days
penalties E. 16 hours
E. All of these
297. The penalty imposed upon any person
292. Who shall take charge and have custody of apprehended or arrested for the first time, who is
dangerous drugs confiscated or seized? found to be positive for use of any dangerous
drug, after a confirmatory test is:
A. DDB
B. DOJ A. A minimum of 6 months rehabilitation in a
C. FDA government center
D. PDEA B. Imprisonment ranging from 6 years and one
E. DOH day to twelve years
C. A fine of PhP 50,000 to PhP 200,000
293. This act shall be known as the “Universally D. A fine of PhP 500,000 to Php 10M
Accessible Cheaper and Quality Medicines E. Both B and C
Act of 2008”
A. R.A 9502 298. In emergency cases where the services of a

B. R.A 9257 registered pharmacist is not available,
C. R.A 6425 prescription drugs and pharmacist only OTC
D. R.A 9165 drugs may be dispensed, provided, a report to a
E. R.A 7432 supervising pharmacist shall be made within
hours.
294. Prohibited Acts of R.A o. 8203, EXCEPT:
A. 12
A. Possession of any such counterfeit drug B. 24
B. Forging, counterfeiting, stimulating, C. 36
representing without proper authority D. 48
E. 56
299. Patients medication profiles must be kept in the

pharmacy for a period of not less than
A. 6 months
B. 12 months
C. 18 months
D. 24 months
E. 36 months
300. Referrals undertaken by the pharmaceutical

outlets shall be recorded in the referral registry
and must be kept for a period of NLT
A. 6 months
B. 12 months
C. 18 months
D. 24 months
E. 36 months
B 1. A specialized field of toxicology that designates an area of professional emphasis within the realm of medical science
a. Forensic toxicology c. Environmental
toxicology
b. Clinical toxicology d. Regulatory
toxicology
C 2. This is an area of toxicology which is concerned directly with toxicity testing, which provide necessary information for
safety evaluation and regulatory requirements.
a. mechanistic toxicology c.
descriptive toxicology
b. regulatory toxicology d. forensic
toxicology
A 3. The quantity of medicine that can kill an organism

a. fatal dose b. LD50 c. Teratology d.
Threshold Limit Value
C 4. Acute poisoning includes, except:

a. taking a strong poison c. taking several
small doses at long intervals
b. taking several small doses but frequent d. taking excessive single doses
C 5. This is obtained from an examination of the tissues and organs of the dead.
a. Experimental evidence c. Post-Mortem
evidence
b. Chemical evidence d. Circumstantial
evidence
C 6. Death may result from poisoning due to the following causes, except:
a. due to interference with the carriage of oxygen
b. due to inhibition of the respiratory movements by neuromuscular agents
c. due to interference with the enzyme system utilizing it
d. circulatory failure as a result of cardiac glucosides
D 7. Catharsis as a way of removing a poison includes, except:

a. increases intestinal injury when a corrosive is ingested
b. is avoided in a patient showing disturbed electrolyte imbalance
c. hypertonic cathartic and enemas are hazardous in the presence of impaired renal function
d. all of the above
B 8. This is recommended in phenol poisoning as a cathartic but is contraindicated in poisoning by chlorinated insecticide,
since it may increase intestinal absorption
a. magnesium sulfate b. castor oil c. mannitol d.
Fleet’s Phospho-soda
B 9. A poison which increases suddenly in its intensity of action after slow or gradual addition of it is
a. corrosive poison b. cumulative poison c. true poison d. irritant poison
B 10. The most serious potential consequence of ingestion of liquid hydrocarbon such as kerosene or gasoline is:
a. paralysis of the peristaltic motion of the GI tract
b. the aspiration of the poison into the respiratory tract
c. destruction of body enzymes by the poison
B 11. The specific antidote for the treatment of poisoning due to oral ingestion of silver nitrate would be the oral
administration of:
a. acetic acid solution b. normal saline c. sodium bicarbonate
C 12. Streptomycin can cause:

a. 4th cranial damage b. 7th cranial damage c. 8th cranial damage
th
d. 6 cranial damage
E 13. Most accidental poisoning in children is caused by:
a. detergents b. bleaches c. crayons d. insecticides
e. salicylate analgesics
B 14. Antidote for iodine poisoning:

a. silver nitrate b. starch c. potassium nitrate d. sugar
A 15. The evidences to be saved in nonfatal poisoning are the following, except:
a. lung b. urine c. food d. blood e.
body fat
D 16. When reporting cases of poisoning like eating in public restaurant, the cases should be reported to the:
a. nurse b. family doctor c. pharmacist d. public health
officer e. BFAD
A 17. The major routes by which toxic agents gain access to the body are through the ff. except:
a. blood b. GIT c. lungs d. skin e.
parenteral route
C 18. Acute exposure by inhalation refers to continuous exposure for less than 2 hours, most frequently for:
a. 2 b. 3 c. 4 d. 5
e. 6 hrs.
A 19. Dryness of the mouth is a side effect of

a. atropine b. aspirin c. acetaminophen d. cimetidine
A 20. One group of thiol-containing enzymes that may play a critical role in cell injury and death as a result of oxidative
inactivation (oxidative stress) is:
a. Ca b. Na c. K d. Mg
e. A1 transportation Alpase
A 21. The ff. are mechanisms of poison absorption, except:

a. hydrolysis b. endocytosis c. filtration d. passive diffusion
D 22. An example of a Phase 1 Reaction in the metabolism of substances is/are:

a. oxidation b. hydrolysis c. reduction d. all of the above
A 23. Pneumomediastenum is a complication of the use of:

a. gastric lavage b. hemodialysis c. hemoperfusion d.
emetics
C 24. Constipation caused by active charcoal can be relieved by concomitant administration of

a. glycerol b. water c. laxative d. none of the above
D 25. Contraindication to the use of cathartics are the ff. except:

a. GI hemorrhage b. corrosive agents c. renal failure d. none of
the above
C 26. The percentage of oxygen which is indicated for carbon dioxide poisoning to increase the conversion of
carboxyhemogloblin to hemogloblin and myoglobin and to increase oxygen saturation of the plasma is:
a. 50% b. 75% c. 100% d. 10%
C 27. Nail polish remover contain

a. aniline b. ammonium hydroxide c. acetone
d. phosphoric acid
C 28. Convulsions caused by drug poisoning are most commonly associated with:
a. Phenobarbital b. diazepam c. strychnine d. chlorpromazine
A 29. Alkalinizing the urine with sodium bicarbonate is useful in the treatment of poisoning with:
a. ASA and barbiturates b. phencyclidine c. amphetamines d.
morphine
D 30. Activated charcoal may be used in the treatment of these poisoning, except:
a. Phenobarbital b. propoxyphene c. aspirin d. methanol
D 31. These statements regarding carbon monoxide poisoning are true, except:
a. the oxygen carrying capacity of the blood is decreased
b. the oxyhemoglobin dissociation curve becomes shifted to the left, releasing less oxygen to the tissues
c. a carboxyhemoglobin level of less than 30% produces minimal symptoms
d. treatment with 100% carbon dioxide is effective
D 32. Ototoxicity may be an adverse reaction of the following, except:

a. streptomycin b. ethacrynic acid c. furosemide d. tetracyclines
D 33. Individuals who are deficient in glucose-6-dehydrogenase experience hemolysis following the treatment with these
drugs, except:
a. dapsone b. ethacrynic acid c. primaquine d.
tetracyclines
B 34. Acute intermittent porphyria is an absolute contraindication to the use of:

a. nitrous oxide b. enflurane c. ketamine d. thiopental
sodium
A 35. Direct hepatotoxicity has been observed with the following anesthetics agents:
a. halothane b. nitrous oxide c. thiopental d.
all of the above
A 36. A patient has resulted in acute hypertensive crisis after eating cheese. This interaction is possible if the patient is on:
a. MAO inhibitor b. aspirin c. tetracyclines d. all of the above
A 37. It is used in the manufacture of smoke bomb, antiseborrheic shampoos, in the treatment of bone fracture and rickets.
a. bismuth b. boron c. cadmium d. cesium
e. chromium
E 38. Its deficiency mimics diabetes mellitus, it is found in brown sugar and butter
a. bismuth b. boron c. cadmium d. cesium e.
chromium
A 39. It is used in silvering of mirror and it causes metal line gum.

a. bismuth b. boron c. cadmium d. cesium e.
chromium
C 40. It is the poison found in rust and ink eradicator.

a. nitrite b. naphthalene c. oxalate d. lead e.
mercury
A 41. It is used to preserve the color of meat in pickling.

mercury.
E 42. It is used in fingerprint photography
mercury.
D 43. It is the choice of professional poisoners.

a. nitrite b. naphthalene c. oxalate d. arsenic
e. berrylium
E 44. It is the most toxic metal.

a. nitrite b. naphthalene c. oxalate d. arsenic
e. berrylium
E 45. Ammonium salt is the antidote for

a. aniline b. cyanide c. ethyl alcohol d. iodine
e. formaldehyde
A 46. Methylene blue is the antidote for

e. formaldehyde
B 47. It is known as the prussic acid

e. formaldehyde
C 48. It is known as the Neutral spirit

e. formaldehyde
A 49. It is also known as the stink damp

a. hydrogen sulfide b. carbon monoxide c. carbon disulfide d.
nitrogen oxide
B 50. It is known as the rodent poison

a. hydrogen sulfide d. carbon tetrachloride
b. phosphorus e. carbon monoxide
c. carbon disulfide
D 51. The abuse of this drug is responsible for major medical and socio-economic problems:
a. chloral hydrate b. chloral hydrate and ethanol c. nitrous oxide
d. ethanol
B 52. Poisoning due to anticholinesterase is the best managed by the administration of:
a. theophylline b. atropine c. salbutamol
d. ethanol
B 53. Conjuctival and bronchial irritation are primary signs of exposure to:
a. ergot b. sulfur dioxide c. ethyl alcohol
d. mercury
A 54. Deferoxamine is an antidote for:

a. iron b. methanol c. calcium
d. iodine
A 55. These are simple asphyxiants which are gases, except:

a. ethyl alcohol b. methane c. nitrogen
d. none of these
A 56. Toxic substance found in “tulingan” tuna and:

a. sourine b. nenerupin c. gemblid
d. potassium bromate
C 57. Effective therapy to rattle snake bite:

a. suction and tourniquet b. antivenin c. antivenin and suction and tourniquet d. none of
these
B 58. A type of poison that causes blackening and severe corrosion in the mouth:
a. nitric acid b. sulfuric acid c. phenol
d. hydrochloric acid
D 59. It causes the Minamata disease:

a. Nickel b. manganese c. molybdenum d.
mercury
D 60. Examples of herbicides, except:

a. phenoxyacetic acid b. paraquat c. diquat
d. nicotine
C 61. Mushroom poisoning comes from:

a. belladonna b. digitalis c. Amanita phalloides
d. all of these
C 62. It is the poison in toilet bowl deodorant:

a. Nitrite b. lead c. naphthalene
d. oxalate
B 63. Lead can be effectively detoxified by:
a. barium sulfate b. BAL with EDTA c. ethanol d.
deferroxamine
A 64. An antidote to methanol poisoning:

a. ethanol b. digoxin c. atropine
d. naloxone
A 65. Induction of vomiting is accomplished by administering:

a. Syrup of ipecac b.Ginger ale c.Peppermint syrup d.None of
these
C 66. Banned toxic substance in “pandesal”, cakes and other bakery products:
a. gemblid b. venrupin c. potassium bromate
d. sourine
B 67. Fatal dose of aspirin:

a. 5 grains b. 5 grams c. 5 mg
d. all of these
B 68 Lysergic acid poisoning has this toxic syndrome/s:.

a. dilated pupil b. hallucinations and dilated pupil c. hallucinations d.
none of these
D 69. Death due to strychnine poisoning is from:

a. fatigue c. cardiac failure
b. fatigue of respiratory muscle d. exhaustion of respiratory center
B 70. Litharge is also known as:

a. magnesium oxide b. lead oxide c. arsenic trioxide d. nitrous
oxide
B 71. Manihot toxin is found in this crop root:

a. yam b. cassava c. sweet potatoes
d. none of these
C 72. Best known physiological antidote for strychnine:

a. codeine b. pilocarpine c. barbiturate
d. morphine
C 73. Phencyclidine has this toxic syndrome:

a. violent syndrome c. coma with open eyes and
violent syndrome
b. coma with open eyes d. none of these
A 74. Poisonous fishes contain unedible organs or toxins such as:

a. ciguatoxin b. saxitoxin c. aflatoxin
d. scombroid
A 75. Activated charcoal is specifically helpful in the treatment of poisoning from:

a. aromatic compound b. all of these c. alkaloid d. none of
these
B 76. Convulsions caused by drug poisoning are commonly associated with:

a. diazepam b. strychnine c. phenobarbital d.
chlorpromazine
C 77. A carcinogenic substance found in stale peanut:

a. peroxide b. glyceryl ester c. aflatoxin d.
fatty acid
B 78. Black widow spider venom is called:

a. neostigmine b. lactrotoxin c. carbachol d.
all of these
D 79. The antidote for DDT poisoning:

a. adrenaline b. atropine c. amphetamine d.
barbiturate
C 80. Causes digitalis-like toxicity and baritosis:

a. antimony b. aluminum c. barium
d. arsenic
B 81. Metal used in water purification:

a. lead b. copper c. gold
d. gallium
B 82. Bitter almond odor is symptoms of this poisoning:

a. mercury b. cyanide c. lead
d. none of these
D 83. Paraquat poisoning is characterized by:

a. bloody stool b. none of these c. hematemesis d. bloody stool and
hematemesis
C 84. The universal antidote usually contains tannic acid, activated charcoal and:
a. calcium hydroxide b. aluminum hydroxide c. magnesium hydroxide d. all of
these
C 85. A poisonous principle of Coalculus indicus used as fish poison:

a. Phenacetin b. picric acid c. picrotoxin d. colchicines
D 86. Principal active alkaloid of ipecac:

a. caffeine b. apomorphine c. ergonovine
d. emetine
C 87. Sweet odor of vomitus is/are due to this type of poison/s:

a. chloroform and acetone b. turpentine c. acetone d. chloroform
A 88. A common household substance given as antidote is milk because:

a. it is amphoteric and coats the stomach b. coats the stomach c. it is amphoteric
d. nota
A 89. It causes shellfish toxicity:

a. dinoflagellates b. snails c. jellyfish d. octopus
B 90. Treatment of bismuth poisoning involves the use of:
a. morphine b. dimercaprol c. EDTA d. none of these
C 91. Side effects frequently seen with benzodiazepines, except:

a. ataxia b. drowsiness c. seizures d.
none of these
D 92. Most commonly known animal poison:

a. scombroid b. venom c. saxitoxin d.
tetrodotoxin
B 93. A botanical insecticide:

a. malthion b. pyrethrum c. parathrion
d. none of these
A 94. An enzyme found in the snake venom is:

a. hyaluronidase b. urease c. steapsin
d. ptyalin
A 95. The effects that occurs at the site of the first contact between the biological system and the toxicant.
a. local toxicity b. economic toxicity c. systemic toxicity d.
cumulative toxicity
A 96. The effects that occur at the site of the first contact between the biological system and the toxicant.
a. local toxicity b. economic toxicity c. systemic toxicity d.
cumulative toxicity
B 97. One of the ingredients in mothballs

a. oxalic acid b. naphthalene c. activated charcoal d. arsenic e.
none of these
C 98. Poison that converts the red hemoglobin to chocolate brown color
a. aniline b. nitrobenzene c. both a and b d. ether
A 99. Dilution with water is contraindicated in the poisoning with

a. sulfuric acid b. acetic acid c. hydrochloric acid d. none of the above
A 100. The poisonous substance in Lysol:

a. cresol b. phenol c. resorcinol d.
thymol
C 101. Saxitoxin is the poison found in:

a. mushroom b. dried nuts c. marine animal d. snake
D 102. Cobra’s venom is composed of:

a. toxin b. phytotoxin c. bufotoxin d.
syntoxin
A 103. Which of the following is the toxic action of antimony?

a. inhibition of enzymes through combination with –SH group
b. combines with hemoglobin to form carboxyhemoglobin
c. both a and b
d. none of these
A 104. Yellow or disturbed vision, disturbed respiration, epileptiform convulsion can be caused by:
a. santonin b. muscarine c. atropine d. all of these
e. none of these
D 105. Oxidation of pyrocatechol and hydroquinol may tint the urine with color _______
a. black b. yellow c. blue d.
green e. none of these
B 106. Best known physiological antidote for strychnine:

a. pilocarpine b. atropine c. morphine d. codeine
C 107. A branch of toxicology which is concerned with the medical and legal consequences of poisoning:
a. environmental toxicology c. forensic toxicology
b. experimental toxicology d. economic toxicology
D 108. Mineral oil is an antidote for poisoning by kerosene.

a. adsorption c. inactivation
b. neutralization d. lessen respiratory hazard by increasing
viscosity of kerosene
C 109. A CNS stimulant, fish or bird poison, adulterant of beverage

a. muscarine d. both a and b
b. atropine e. none of these
c. picrotoxin
C 110. Brown color of smog

a. nitrogen pentoxide b. nitric oxide c. nitrogen oxide d. all of these e. none of
these
B 111. Specific antidote for silver poisoning

a. lemon juice b. saline solution c. ammonia
C 112. Which of the following metals coagulate protein:

a. lead b. mercury c. copper d.
silver
B 113. The alkaloid found in Ipecac used for amoebic dysentery were evident poisoning symptom is violent purging with
bloody stools:
a. ephedrine b. emetine c. isoquinoline d.
methylxanthine
B 114. Surface contaminated with phenol can be washed by:

a. water b. ethanol c. soap d.
all of these
A 115. Peculiar stimulation (tingling) and paresthesia (numbness) of the sensory in nerves are symptoms of poisoning due
to:
a. aconite b. muscarine c. atropine d. physostigmine
C 116. Potent cord convulsant, increases the excitability of the CNS at all level
a. morphine b. opium c. strychnine d. both a and b
B 117. Obtained from coal tar

a. kerosene b. naphthalene c. both a and b d. none of these
C 118. Intermediate acting barbiturate/s, except:

a. amobarbital b. butabarbital c. pentobarbital d.
vinbarbital
D 119. Entrance or outlet of any body cavity is termed as:

a. media b. meatus c. oral
d. orifice
A 120. Atropa belladonna belongs to the family

a. Solanaceae b. Rutaceae c. Ranunculaceae d. all of the above e.
none of the above
A 121. Poisonous substance in Paris green is:

a. arsenic b. cyanide c. antimony
d. mercury
B 122. Insecticide, fungicide, alloys in medicine, emetic drug, astringent and caustic, purification of water, escharotic
a. cadmium b. copper c. lead d. mercury
A 123. Ultra short acting barbiturates are highly lipid soluble and rapidly penetrate the brain, and is capable of
inducing:
a. anesthesia b. paralysis c. none of the above
D 124. Cocaine is commonly known as:

a. coke b. lady c. crystals d.
all of the above
A 125. Tetracyclines tend to form complexes with the following, except:

a. belladonna b. calcium ions c. magnesium ion d. iron ions
B 126. Which of the ff. symptoms is not present in digitalis intoxication?

a. vomiting b. vagal arrest of the heart c. visual disturbance
A 127. The first toxic symptoms of digitalis poisoning is:

a. gastrointestinal irritation d. cerebral excitement
b. undue depression of heart rate e. colored vision
c. flushing of skin
B 128. A type of insulin which causes exceptionally few allergic reactions is:
a. protamine zinc insulin d. lente insulin
b. NPH insulin e. salicylate analgesics
c. globulin unsulin
D 129. One of the ff. should not be listed below as a volatile poison
a. chloroform d. di-fluorocarboxyl
b. benzene e. petroleum ether
c. carbolic acid
B 130. Cases of heavy metal poisoning are concrete examples of:

a. sub-acute poisoning b. chronic poisoning c. acute poisoning d.
unknown
B 131. Calcium disodium edetate is:

a. BAL b. Ca-EDTA c. Desferal d.
Penicillamine
C 132. Example of poison which exhibits both local and remote types of effects
a. arsenic b. cantharides c. both a and b d. none of the above
C 133. Substance intended to prevent, destroy, repel or mitigate rats, mice, etc
a. herbicides b. hematocides c. rodenticides d. molluscides
B 134. fatal dose of nitrobenzene

a. 2-3 drops b. 8-15 drops c. 60-80 drop d. 0-1 drops
A 135. Characteristic odor of phosphorous intoxication
a. garlic odor b. mousey odor c. odor of bitter almonds d. odor of chico
A 136. The only poisonous variety of phosphorous

a. yellow b. red c. black d.
all of the above
A 137. Systemic emetics act by:

a. direct stimulation c. indirect stimulation
b. reflex stimulation d. none of the above
D 138. Water is avoided in poisoning by:

a. acetic acid b. nitric acid c. milk d. tea
D 139. Which of the ff preparations contains arsenic?

a. Fehling’s solution c. Nylander’s solution
b. Benedic’s solution d. Fowler’s solution
B 140. Source of phytotoxin

a. animals b. plants c. minerals d. insects
C 141. Which of the ff animals used for flocculant precipitates with human blood?
a. cat b. dog c. rabbit d. monkey
C 142. The organ of elimination for metallic poisons

a. mouth b. rectum c. liver d. skin
A 143. Strong black coffee of subcutaneous injection of caffeine citrate in the treatment of acute alcohol poisoning is
attributed to
a. antagonistic stimulant effect of caffeine
b. oxidation of alcohol
c. depressant action of caffeine
d. hypotensive effect of caffeine
A 144. The cardinal rule or the first step to be considered in the treatment of poisoning is to:
a. remove the poison from contact with the victim
b. stop the action of the poison by giving the specific antidote
c. provide symptomatic of supportive care
d. fight against the tendency of death
A 145. Activated charcoal is used in the treatment of phenol poisoning as

a. mechanical antidote b. chemical antidote c. physiological antidote
B 146. Morphine as a physiological antidote in methanol poisoning acts by:

a. reversing acidosis c. antagonizing the action of methanol
b. relieving abdominal pain d. inducing intestinal evaluation
A 147. Nalorphine acts as a specific antagonist for opium poisoning by:

a. competitive inhibition c. non-competitive inhibition
b. stimulation d. sedation
C 148. The mechanism of action involved in the use of EDTA as antidote for heavy metal poisoning is:
a. adsorption b. oxidation c. chelation d.
precipitation
C 149. The ff symptoms of poisoning from antimony are similar to those of arsenic poisoning, except:
a. diarrhea of rice-water stool c. garlic odor of breath and suppression of urine
b. severe dehydration and great thirst d. nausea and vomiting
D 150. Metallic poisons are classified as
a. corrosive poison b. irritant poison c. cerebral neurotic poison d.
all
C 151. Prussian blue is the antidote for what poisoning?

a. lithium b. nitrites c. thallium d.
cyanide
A 152. Whole Bowel Irrigation is preformed using

a. PEG b. Sodium phosphates enema c. Magnesium citrate
d. NaSO4
B 153. The ff compounds have 2 sulfhydryl (-SH) groups, except:

a. DMSA b. penicillamine c. DMPS d.
BAL
B 154. Which of the following can be used for carbamate poisoning?

a. pralidoxime b. neostigmine c. atropine d. all of the
above
B 155. Poison present in Dora rat killer

a. diphenhydramine b. coumarin c. heavy metals d.
2,4-D
A 156. The ff. are used to treat anaphylaxis

a. diphenhydramine b. dopamine c. cortisone
d. epinephrine
C 157. Calcium gluconate precipitates the ff. salts, except

a. oxalate b. fluoride c. sulfate
C 158. Causes liquefaction necrosis

a. silicones b. acids c. alkali
d. paraquat
D 159. Street names of marijuana, except:

a. grass b. mary jane c. pot
d. ice
A 160. Ecstasy is related to what drug?

a. amphetamine b. opioids c. acetylcholinesterase d.
anorectic
B 161. Antidote for cyanide poisoning, except:

a. methemoglobin producers c. hydroxycobalamine
b. EDTA d. none of the above
A 162. FPN test indicates the presence of:

a. chlorpromazine b. imipramine c. ferric chloride d.
salicylic acid
B 163. A red color in the pyridine layer after adding NaOH develops in the presence of
a. nitrobenzene b. chloroform c. ethylene d.
phenacetin
B 164. Present in tear gas:

a. cyanide b. capsaicin c. alloin
d. cysteine sulfoxide
A 165. Muscarinic antagonists, except:
a. hyoscine b. arecoline c. pilocarpine
d. NOTA
C 166. Which of the ff. conditions can cause convulsions?

a. hypoglycemia b. coma c. isopropyl alcohol toxicity
d. lactic acidosis
A 167. A warfare gas:

a. phosgene b. COCl2 c. sarin
d. all of the above
B 168. A patient passing out a yellow-green vomitus can be poisoned by:

a. iron b. chromium c. phosphorous d.
cyanide
C 169. Triad of opioid/opiate toxicity, except:

a. respiratory depression b. pin-point pupil c. convulsion d. coma
A 170. Toxic metabolite of CCl4

a. epoxides b. phosgene c. nitrite d. cyanide
D 171. Toxic metabolite of acetonitrile

a. epoxides b. phosgene c. nitrite d. cyanide
A 172. Enzyme which catalyzes conversion of paracetamol to n-acetyl-paraamino-benzoquinone imine

a. cytochrome P-450 b. superoxide dismutase c. hyaluronidase d. glucuronide
transferase
A 173. Poison from black widow spider:

a. α-latro toxin b. saxitoxin c. α-bungarotoxin d.
picrotoxin
D 174. Protamine sulfate is a/an:

a. anticoagulant b. antidote for heparin toxicity c. basic protein d.
all of the above
C 175. Capable of measuring serum concentration levels of poisons, except:

a. HPLC b. RIA c. TLC d. GLC
B 176. Digoxin FAB comes from

a. pigeons b. sheep c. fish d. cats
D 177. Thallium toxicity causes:

a. coma b. respiratory depression c. metabolic acidosis d.
hair loss
A 178. Penicillin is used to treat poisoning with:

a. Amanita mushrooms c. Botulinus toxin
b. Silibinin d. Salmonella enterotoxin
B 179. The process of detoxification wherein the drug/ substance of abuse is withdrawn gradually:
a. “cold turkey” b. “warm turkey” c. “lukewarm turkey” d.
“hot turkey”
C 180. “Angel dust”:

a. MDMA b. LSD c. PCP d.
THC
C 181. “Roofies”
a. alprazolam b. cannabis c. flunitrazepam d. heroin
A 182. A toxic insult on the developing organism may cause adverse effect during:
a. prenatal development c. prior to conception
b. postnatal development d. all of the above
A 183. Fetal alcohol syndrome is characterized by following, except:

a. long palpebral fissures c. intellectual growth retardation
b. retarded psychomotor development d. microcephaly
A 184. Pralidoxime can be used for poisoning from:

a. parathion b. aldicarb c. either a or b d.
neither a nor b
D 185. All of the ff metals have been found with substantial evidence to be carcinogenic in humans, except
a. arsenic b. beryllium c. cadmium
d. manganese
D 186. The organs adversely affected by lead, except:

a. brain b. kidneys c. blood
d. lungs
B 187. causes fetal hydantoin syndrome:

a. heroin b. phenytoin c. penicillin
d. tamoxifen
A 188. Exposures at any time during pregnancy poses a high risk of congenital structural abnormalities
a. tretinoin b. cyclophosphamide c. carbamazepine
d. tamoxifen
A 189. Enters the breast milk and can cause neonatal narcotic dependence
a. heroin b. codeine c. both a and b
d. none of these
C 190. A characteristic of arsenic poisoning

a. black gum lines b. wrist drop c. Mee’s lines d.
acrodynia
C 191. The major target organ of toxicity of benzene:

a. blood b. liver c. bone marrow d.
heart
D 192. Morphine and its derivatives can cause

a. dyspnea b. diarrhea c. constipation d. respiratory paralysis e. all of
these
A 193. An agent that neutralizes a poison or counteracts its effects is a/an:

a. antidote b. antiemetic c. counterirritant d. antibiotic
C 194. Ethanol acts by preventing the conversion of this drug to formaldehyde by competing for dehydrogenase
a. chlorine b. iodine c. methanol
d. all of these
C 195. Signs of barbiturate poisoning

a. alkalosis b. diuresis c. decrease respiratory minute volume
d. hypertension
A 196. An antidote for heparin overdosage

a. protamine sulfate b. dicumarol c. calcium salts d.
atropine
D 197. Angina pectoris is a type of pain seen in this type of poisoning

a. hydrochloric acid b. lead c. mercury
d. nicotine
D 198. Nicotinic acid produces which of the ff. effects:

a. decreases VLDL clearance c. increases VLDL clearance
b. Increases VLDL production d. none of these
B 199. An antidote for acetaminophen overdosage

a.. atropine b. n-acetylcysteine c. physostigmine d.
all of these
C 200. Aflatoxin is found in
a. nux vomica b. mushrooms c. improperly dried nuts d.
shellfish
C 201. A specific antidote for metallic poisoning like arsenic

a. sodium nitrate b. copper sulfate c. dimercaprol d. activated
charcoal
D 202. Enhancement of elimination of poisoning include:

a. manipulation of urine pH to accelerate urinary excretion
b. hemoperfusion
c. hemodialysis
d. all of these
D 203. These are chelating agents used as antidotes

a. penicillamine b. calcium edentate c. dimercaprol d.
all of these
C 204. Atropine is useful in treating poisoning by organophosphate insecticides because it

a. stimulates receptors directly
b. reactivates inhibited acetylcholinesterase
c. blocks the action of acetylcholinesterase at both central and peripheral sites
d. inhibits normal ganglionic transmission
C 205. Iron poisoning gives ____ coloration of stool and urine

a. brown b. blue c. black
A 206. Antidote for monomethylhydrazine

a. pyridoxine b. thiamine c. riboflavin d.
all of these
B 207. Caffeine can cause

a. respiratory paralysis c. drowsiness
b. restlessness d. all of these
B 208. An antidote for curare poisoning

a. atropine b. neostigmine c. homatropine d. all of
these
B 209. Rotten egg odor is a characteristic of poisoning with

a. heroin b. hydrogen sulfide c. lead d. ethylene
glycol
A 210. Drugs of high addicting property

a. amphetamines b. scopolamine c. chloral hydrate d. ketamine
B 211. the following are important air pollutants except
a. carbon monoxide b. malathion c. ozone d. sulfur
dioxide
D 212. Antipyrine has been known to cause

a. blood dyscrasia b. non-electrolyte c. fever d.
high incidence of rashes
B 213. The following antidotes could be used to treat carbamate insecticide poisoning except
a. atropine b. pralidoxime c. physostigmine d. all of
these
D 214. An antidote that acts by adsorption and is usually given when the nature of the poison is unknown
a. KMnO4 b. ipecac syrup c. tannic acid d. charcoal
D 215. The basis of understanding drug reaction is:

a. pharmacokinetics b. pharmacodynamics c. toxicodynamics d.
all of these
B 216. Non-therapeutic chemical most commonly involved in poisoning are the ff., except
a. corrosives b. insecticides c. solvents d.
analgesics
B 217. Emetics act in the ff. manner except:

a. centrally b. peripherally c. locally d. none
A 218. Ipecac syrup has the ff. adverse effect except:

a. blurred vision b. persistent GI upset c. hemorrhagic gastritis d.
all of these
B 219. the most toxic veratrine alkaloid is:

a. pseudoveratrine b. protoveratrine c. veratrine d.
pseudogerbine
B 220. This gas is used for execution in so-called gas chambers:

a. nitrous oxide b. nitrous oxide and cyanide c. cyanide
d. ozone
B 221. eating of rotten canned goods can cause:

a. salicylism b. botulism c. cinchonism
d. none of these
For questions 222-226, choose from the ff:

A. normal saline
B. dimercaprol
C. atropine
D. lead
E. neostigmine
A 222. the specific antidote for the treatment of poisoning due to he oral ingestion of silver nitrate
D 223. Ethylendiamine-tetraacetic acid is an antidote for this poison
E 224. Antidote for curare poisoning
B 225. The most effective antidote for arsenic, gold and mercury poisoning, which is a metal complexing agent
C 226. The best known physiological antidote for strychnine

A. diazoxide
B. diazepam
C. syrup of ipecac
D. charcoal
E. sodium bicarbonate
E 227. This is indicated for severe metabolic acidosis resulting fro intoxication by methanol, ethylene glycol, salicylates,
and excessive lactic acid.
B 228. This is indicated for anxiety, convulsions, muscle relaxant and chloroquine poisoning to antagonize cardiac
toxicity.
A 229. The drug is used as an oral hypoglycemic agent.
D 230. An antidote that acts by adsorption and is usually given when the nature of the poison is unknown.
C 231. This is usually given in poisoning to induce vomiting.

A. ammonia water
B. 2.5% sodium thiosulfate
C. atropine
D. BAL with EDTA
E. Pyridoxine
C 232. the best antidote for organosphoshate poisoning.

B 233. The antidote for treating poisoning with bleaching agents like Zonrox.
A 234. The best antidote for formaldehyde poisoning, since it forms a non-poisonous product which is methenamine.
E 235. The antidote for isoniazid poisoning.

A. Acetylcysteine
B. Weak acid
C. Starch
D. activated charcoal
E. Folic acid
B 236. Antidote for magnesium salts

D 237. Universal antidote contains this substance
C 238. Antidote for iodine poisoning
E 239. This B-complex vitamin, when administered to patients with methanol and ethylene glycol poisoning, may
enhance the elimination of the toxic metabolite, formic acid.
A 240. This drug is indicated for acetaminophen overdose, which acts as a sulfhydryl group donor, substituting for the
liver’s usual sulfhydryl donor glutathione.
A. acetylcysteine
B. physostigmine
C. potassium salt
D. thiamine
E. ethanol
B 241. This drug could be used to treat hydrocarbon insecticide poisoning.

E 242. The antidote for ethanol and ethylene glycol poisoning.
D 243. Glucose with this drug is given to alcoholic and malnourished patient but may aggravate hyperglycemic ischemia
and brain injury.
C 244. Used for the treatment of digitalis poisoning.
A. Vitamin K
B. Nalorphine
C. Apomorphine HCl
D. BAL
E. Citric acid
B 245. The specific antagonist for narcotic poisoning.

C 246. A local emetic.
E 247. An antidote for sodium hydroxide poisoning
A 248. An antidote for warfarin poisoning
For questions 249-253 choose from the ff:
A. CuSO4
B. Nalorphine
C. Sodium bicarbonate
D. KCl
E. Chlorpromazine
C 249. This is the antidote for chlorine gas poisoning

A 250. This is an antidote for phosphorous poisoning
E 251. A systemic antidote for amphetamine poisoning
D 252. A physiological antagonist for digitalis
B 253. Acts as a specific antagonist for opium poisoning.
For questions 254-258 choose from the ff:
A. Atropine/ pralidoxime
B. Magnesium hydroxide
C. Ethanol
D. Naloxone
E. Sodium bicarbonate
D 254. Poisoning by narcotics can be best treated by giving this drug.

C 255. Surface contamination with phenol can be washed using this substance
B 256. The universal antidote usually contains tannic acid, activated charcoal and this drug.
A 257. These drugs can treat poisoning with organphosphates like parathion and malathion.
E 258. This drug is used for effective excretion of absorbed barbiturates.
D 259. One should not e listed below as a volatile poison:

a. chloroform b. benzene c. carbolic acid d.
di-fluorocarboxyl
C 260. The botanical origin of the very toxic ergonovine:

a. Papaver somniferum b. Croton tiglium c. Claviceps purpurea d. Cantaris
vesicatoria
B 2671. The best method of isolating non-volatile poisons is by:

a. distillation with a current of steam
b. distillation without current of steam
c. extraction with water or oxalic acid
d. extraction with organic acids
B 262. Cases of heavy metal poisoning are concrete examples of:

a. sub-acute poisoning b. chronic poisoning c. acute poisoning d.
unknown
D 263. Local action of poisons are best characterized by:

a. Cantharidin b. phosphorous c. corrosive acids d. both a
and c
B 264. Digitoxin goes this kind of physiological action.

a. local b. remote c. both a and b
d. none of these
B 265. Spoiled food brings about:

a. botulism b. ptomaine c. tinnitus cureum
d. none of these
B 266. Best known physiological antidote for strychnine

a. pilocarpine b. atropine c. morphine
d. codeine
B 267. Oil of mirbane is a synonym for:

a. sulfuric acid b. nitrobenzene c. potassium hydroxide d.
potassium nitrate
B 268. Antidote for magnesium salts

a. 4% tannic acid solution c. nalorphine
b. activated charcoal d. copper sulfate
B 269. The primary toxicity of carbon tetrachloride

a. nephrotoxicity b. hepatotoxicity c. cardiotoxicity d.
pulmonary toxicity
D 270. Washing out an organ such as the stomach or bowel

a. intravenous b. irrigation c. labyrinth
d. lavage
B 271. This poison particularly affects cardiac muscles

a. strychnine b. digitoxin c. theophylline
d. pilocarpine
B 272. Exerts their effects by interfering with the oxidation of the tissues
a. narcotics b. irritants c. asphyxiants
d. convulsants
C 273. The function of the toxicologist covers:

a. diagnosis of a poisoning case
b. detection and treatment of an identified poisoning case
c. all of the above
B 274. Food poisoning is an example of:

a. organic alkaloidal poisoning c. organic animal poisoning
b. organic bacterial poisoning d. none of the above
C 275. A condition of more or less complete suspension of respiration and death may begin at the lungs:
a. syncope b. coma c. asphyxia
d. drowning
C 276. Agents which produce exhaustion and cause marked loss of vital or muscular power
a. tetanics b. neurotics c. asthenics
d. stimulants
C 277. Agents which produce stupor

a. abortives b. stimulants c. narcotics
d. convulsants
C 278. Evidence obtained by examination of body organs and tissues after death
a. experimental evidence c. post-mortem evidence
b. chemical evidence d. pre-mortem evidence
C 279. Evidence contributed by the symptoms

a. chemical evidence c. symptomatic evidence
b. post-mortem evidence d. experimental evidence
C 280. Evidence obtained by administering the suspected substance to some living animal and observing the effects
a. circumstantial evidence c. experimental evidence
b. symptomatic evidence d. chemical evidence
C 281. A type of poisoning produced by taking or absorbing for a protracted period small doses of a poison, thereby
producing gradual deterioration of function of tissues
a. acute poisoning b. sub-acute poisoning c. chronic poisoning d. none of the above
C 282. Dose which may be expected ordinarily to produce the therapeutic effects for which the preparation is employed.
a. maximum dose b. minimum dose c. average dose (median) d. above average
dose
C 283. Atmospheric substance with an oxidizing power which liberates iodine from the solution of KI
a. carbon monoxide b. oxidants c. particulates d. hydrogen
sulfide gas
C 284. This substance is produced by the incomplete combustion of carbon or carbonaceous materials
a. nitrogen materials b. sulfur oxides c. carbon monoxides d. hydrogen
sulfide
C 285. Characteristic color of the ammonium phosphor-molybdate precipitate for the presence of phosphorous
a. violet precipitate b. black precipitate c. yellow precipitate d. maroon
precipitate
C 286. Characteristic type of precipitate of magnesium ammonium phosphate for the presence of phosphorous
a. curdy, white precipitate c. crystalline, white precipitate
b. heavy, white precipitate d. white solution
C 287. Distinguishing test of carbon disulfide fro hydrogen sulfide

a. sulfocyanate test b. hypochlorite test c. xanthogenate test
B 288. Aniline + bromine water gives this characteristic precipitation

a. pinkish red precipitate c. blue green precipitate
b. flesh-colored precipitate d. yellowish globules
B 289. In order to detect with certainty nitrobenzene, one must

a. steam distill the sample
b. reduce the sample first to aniline with iron and HCL, then test it for aniline
c. smell the liquid
C 290. Nitrobenzene odor resembles that of

a. chico b. garlic c. bitter almonds d. oil of sulfates
Pharmacology & Toxicology RED PACOP B. Both the agonist and antagonist have
1. Pharmacodynamics is similar chemical structure
A. The science that examines the C. It is reversible
interrelationship of the D. The antagonist does not have the
physicochemical properties of the drug ability to activate the receptor
and the route of administration on the E. None of the above
rate and extent of systemic circulation
B. The science of the kinetics of drug 6. The relative measure f the safety and
absorption, distribution and elimination effectiveness of a drug is the ratio of TD50 to
C. The part of pharmacology, which ED50. The pharmacological term used to
deals with what a drug does to the indicate this ratio is known as
body A. Pharmacological efficacy
D. The science, which deals with the B. Pharmacological toxicity ratio
physicochemical properties of the drug C. Therapeutic index
that allow it to be designed into D. Median effective ratio
dosage forms E. Competitive antagonism
E. A and B
7. A physician may prescribed carbidopa
2. Which of the following types of drugs binds along with levodopa to increase the halflife
to a receptor and produce an effect similar to levodopa and the duration of its anti-
that of endogenous ligands? parkinsonian effect. This way of enhancing of
A. Inverse agonist drug effect is known as
B. Agonist A. Potentiation
C. Partial agonist B. Synergism
D. Competitive antagonist C. Addition
E. Noncompetitive antagonist D. Partial antagonism
E. Competitive antagonism
3. Drugs ‘x’ binds to drug ‘y’ as a result of
which an inactive complex is formed. This 8. Which of the following is the main organ of
type of antagonism is called metabolism?
A. Competitive antagonism A. Kidney
B. Non-competitive antagonism B. Liver
C. Physiologic antagonism C. Intestines
D. Neutralizing antagonism D. Pancreas
E. Partial antagonism E. Heart
4. Epinephrine and acetylcholine act on the 9. Chloramphenicol is known for which of the
sympathatetic and parasympathetic following adverse side-effects?
autonomic nervous system, respsectively, and A. Blue baby syndrome
their effects are opposite to each other. This B. Gray baby syndrome
type of antagonism is called C. Red man syndrome
A. competitive antagonism D. A and B
B. non competitive antagonism E. B and C
C. physiologic antagonism
D. neutralizing antagonism 10. Co-amoxiclav: amoxicillin/clavulanic acid :
co-trimoxazole _____
5. Which of the following is not true about A. Trimethoprim/mebendazole
competitive antagonism? B. Triamterene/mebendazole
A. It involves selective binding of the C. Triamterene/sulfamethoxazole
antagonist to a particular type of D. Trimethoprim/sulfamethoxazole
receptor in such a way as to prevent E. None of the above
the binding of the antagonist
11. Which of the following drugs does not C. Hydrolysis
belong to the group? D. Sulfonation
A. Omeprazole E. None of the above
B. Lansoprazole
C. Aripiprazole 18. Monoamine oxidase is an
D. Ranitidine A. Enzyme
E. All of the above B. Hormone
C. Inhibitor
12. Which of the following anti-TB drugs can D. Drug
cause red-green color blindness E. Cosmetic
A. Rifamcin
B. Isoniazid 19. Gon went to his farm to spray pesticide on
C. Pyrazinamide his crops. Hour later he started to experience
D. Ethambutol diarrhea, vomiting, bronchoconstriction and
E. Streptomycin tachycardia. He was immediately sent to the
hospital for treatment. Which of drugs should
13. Which of the following drugs is the least be given to Gon?
considered as prodrug? A. Serine
A. Captopril B. Edrophonium
B. Enalapril C. Atropine
C. Ramipril D. Prazosin
D. Accupril E. Methycephaline
20. Aside from the answer in #19, what other
14. (Enervon®) tablet contains the following drug can be given to Gon?
EXCEPT: A. DOM
A. Nicotinamide B. DAM
B. Calcium C. DEM
C. Ascorbic acid D. DIM
D. Magnesium E. DUM
21. Cookie was diagnosed to have HPN and
15. The sympathetic division of the ANS was prescribed beta-blockers for her
stems from_____ treatment. She has a history of asthma. Which
A. Craniosacral of the ff. beta-blockers should be given to
B. Thoracolumbar cookie?
C. Craniolumbar A. Propanolol
D. Thoracosacral B. Timolol
E. None of the above C. Levobunolol
D. Metoprolol
16. Which of the following prevents the E. None of the above
storage of the acetylcholine to terminal
vesicles? 22. Andrea is going perform in the 2011 spring
A. Vesamicol music festival. Hours before her performance
B. Reserpine she started to experience “stage fright”. Which
C. Botulinun toxin of the ff. drugs can be given to manage her
D. Hemicholinuim condition?
E. None of the above A. Lasartan
B. Enalapril
17. The following are phase II reactions C. Propanolol
EXCEPT: D. Prazosin
A. Acetylation E. Paracetamol
B. Methylation
23. The hydraulic equation is C. Headache
A. CO=PVR x BP D. All of the above
B. PVR=CO x CO E. None of the above
C. BP=CO x PVR
D. All of the above 30. Montelukast is a/an
E. None of the above A. Leukotriene pathway inhibitor
B. Mast cell stabilizer
24. Which of the ff. are substrates of kininase C. Anti – IgE monoclonal antibodies
II/peptidyl dipeptidase? D. All of the above
A. Angiotensin I E. None of the above
B. Bradikinin
C. Angiotensin II 31. DOC for typical absence seizure
D. A and B A. Lamotrigin
E. A and C B. Phenytoin
C. Ethosuximide
25. Lanoxin acts on which of the following. D. Carbamazepine
A. Na/K ATPase pump E. All of the above
B. Na/H ATPase pump
C. H/K ATPase pump 32. Flumazenil is
D. Na/Ca ATPase pump A. Barbiturate antagonist
E. None of the above B. Benzodiazepine antagonist
C. Barbiturates antagonist
26. Anti-arrhythmic drugs under class 4 acts D. Benzodiazepine agonist
on E. None of the above
A. Na channels
B. Ca channels 33. Arrange the correct order of the stages of
C. K channels anesthesia
D. B blockers I. Stage of excitement
E. None of the above II. Stage of medullary depression
III. Stage of surgical anesthesia
27. Which of the following are loop diuretics? IV. Stage of analgesia
I. Ethacrynic acid A. I,IV,II,III
II. Furosemide B. IV,I,II,III
III. Bumetimide C. IV,I,III,II
IV. Indapamide D. I,IV,III,II
A. I and II E. None of the above
B. II and III
C. I and IV 34. Dissociative anesthetic state characterized
D. I, II and III by catatonia, amnesia, and analgesia can be
E. II, III and IV produced by which drug?
A. Etomidate
28. Andrei works as a pilot in an airline B. Ketamine
company. Which of the following C. Propofol
antihistamines can he take? D. Thiopental
A. Fexofenadine E. Seconal
B. Bromoheniramine
C. Promethazine 35. Neuroleptanesthesia is produce by which
D. Chlorpheniramine drug combination?
E. All of the above A. Fentanyl, droperidol and NO
B. Propofol, fentanyl and halothane
29. 5HT3 antgonist are used for: C. Fentanyl, etomidate and halothane
A. Nausea and vomiting D. All of the above
B. Diarrhea E. None of the above
42. Which of the ff. vitamin can be used to
36. Which of the following does not belong to lower cholesterol levels?
the group? A. Retinol
A. Lidocaine B. Thiamine
B. Mepivacaine C. Riboflavin
C. Prilocaine D. Niacin
D. Benzocaine E. Panthothenic acid
E. Arecholine
43. Which of the given is considered the
37. What is the treatment for malignant DMAD”s of 1st choice to treat rheumatoid
hyperthermia? arthritis?
A. Succinylcholine A. Cyclophosphamide
B. Gabapentin B. Methotrexate
C. Rocuronium C. Azathioprine
D. Dantrolene D. Mycophenolate mofetil
E. Arecholine E. Cyclodextrins
38. Which of the following antiviral drug can 44. Isoniazid can cause the following
be used for Parkinsonism? laboratory data except?
A. Abacavir A. Lactic acidosis
B. Dinanosine B. Anemia
C. Efavirenz C. Hypoglycaemia
D. Amantadine D. Leukocytes
E. NOTA E. NOTA
39. Jet a five year old boy is having a problem 45. DOC for chronic gout
with bed wetting. What drug can be prescribed A. Colchicines
for his condition? B. Probenecid
A. Citalopram C. Febuxostat
B. Furosemine D. Serine
C. Sertraline E. Allopurinol
D. Amitriptyline
E. Amilorine 46. A peptide hormone secreted by the
posterior pituitary that participates in labor and
40. It is the dextrorotatory stereoisomer of delivery and elicits milk injection in lactating
methylated derivative of levorphanol which is women.
used as antitussive? A. Prolactin
A. Codeine B. Oxcytocin
B. Dextromethorphan C. Insulin
C. Dolophine D. Somatostatin
D. Revex E. Simvastatin
E. Morphine
47. Which of the following betablockers is
41. HMG-CoA reductase inhibitors are most widely used in the therapy of
advised to be given during night time with the thyrotoxicosis?
EXEPTION of _______ which can be given A. Betaxolol
anytime of the day. B. Bisoprolol
A. Simvastatin C. Metoprolol
B. Lovastatin D. Propranolol
C. Atorvastatin E. Linalool
D. Flivastatin
E. NOTA
48. Marie is pregnant and was diagnosed with E. I and III only
thyrotoxicosis. Which of the following
thionamodes shoul be given to her? 54. Calcitonon
A. PTU A. Lower serum calcuim and phosphate
B. Methimazole B. Increase serum calcium and
C. Carbimazide phosphate
D. Mebendazole C. Increase serum phosphate only
E. All of the above D. Both A and B
E. Neither A nor B
49. Soluble “peakles”, ultra long acting analog
A. Glargine 55. What is the oral form of penicillin?
B. NPH A. Pen G
C. Insulin lispro B. Pen V
D. All of the above C. Pen C
50. Safest sulfonylurea for the elderly E. All of the above
diabetics
A. Tolbutamide 56. What is the 1st generation PARENTERAL
B. Chlorpropamide cephalosporin still in general use?
C. Tolazamide A. Cefalexin
D. Nateglinide B. Cephadrine
E. None of the above C. Cefadoxole
D. Cefazolin
51. Synthetic analog of amylin that modulate E. All of the above
postprandial glucose levels and is approved
for preprandial use in individuals with type I 57. Vancomycin is from
and type II DM A. Streptococcus orientalis
A. Sitagliptin B. Streptomyces orientalis
B. Pramlintide C. Streptococcus orchidaceus
C. Exenatide D. Streptomyces orchidaceus
D. All of the above E. None of the above
58. Which of the following is derived from
52. Useful for reversing the cardiac effects of erythromycin by addition of methyl group and
an overdose of B-blocking agents because has an improved acid stability and oral
ability to increase cAMP production in the absorption
heart A. Azithromycin
A. Amylin B. Clarithromycin
B. Exenatide C. Clindamycin
C. Sitagliptin D. Streptomycin
D. Glucagon E. None of the above
E. All of the above
59. Concurrent use of aminoglycoside with
53. Vitamin D is loop diuretics may result to:
I. Has vitamin D2 as a natural A. Ototoxicity
form B. Neprhrotoxicity
II. A secosteroid C. Hypertension
III. Produced in the skin from 7- D. Both A and B
dehydrocholoesterol E. None of the above
A. I only
B. III only 60. The most ototoxic aminoglycosides are:
C. II and III only A. Neomycin and kanamycin
D. A and II only B. Streptomycin and gentamicin
C. Neomycin and gentamicin
D. All of the above 68. Methylated morphine
E. None of the above A. Codeine
B. Heroin
61. Trimethoprim acts on C. Methadone
A. Dihydropteroate synthase D. Naloxone
B. Dihydrofolate reductase E. all of the above
C. DNA gyrase
D. A and B 69. Which of the following H2- antagonist has
E. A and C the highest bioavailability?
A. Cimetidine
62. This anti-fungal drugs absorption is B. Ranitidine
improved when taken with fatty foods: C. Famotidine
A. Ketoconazole D. Nizatidine
B. 5-flucytosine E. None of the above
C. Nystatin
D. Griseofulvin 70. Which is the most potent H2- antagonist?
E. All of the above A. Cimetidine
B. Ranitidine
63. This drug is the treatment of choice for C. Famotidine
giardiasis, trichomoniasis and amoebiasis. D. Nizatidine
A. Iodoquinol E. All of the above
B. Diloxanide furoate
C. Metronidazole 71. Plasil® is
D. paramomycin A. Metoclopramide
E. none of the above B. Chlopropamide
C. Enalapril
64. Prussian blue is used to chelate D. Furosemide
A. Thallium E. All of the above
B. Cesium
C. Cyanide 72. Silymarin is for the
D. A and B A. Liver
E. B and C B. Kidney
C. Brain
65. Treatment for iron poisoning D. All of the above
A. Deferoxamine E. None of the above
B. Methylene blue
C. Ferroin 73. Ginkgo should not be given with
D. Penicillamine A. Aspirin
E. None of the above B. Vancomycin
C. Caffeine
66. Antidote for acetaminophen overdose D. Juice
A. NAC E. All of the above
B. Atropine
C. Bicarbonate 74. Royal jelly is used as
D. Fomepizole A. Diet aid
E. All of the above B. Analgesic
C. Tonic
67. Acetylated morphine D. Digestive aid
A. Codeine E. All of the above
B. Heroin
C. Methadone 75. What is the mechanism of action of a
D. Naloxone chloramphenicol?
A. Cell wall synthesis inhibitor A. Reversible inhibition of
B. Protein synthesis inhibitor acetylcholinesterase
C. DNA gyrase inhibitor B. Spasm of accomodation
D. Antimetabolite C. Constipation
E. None of the above D. Bronchoconstriction
76. Mr. Jones is admitted to General Hospital E. Weakness of skeletal muscle
with pneumonia due to gram-negative
bacteria. The antibiotic tobramycin is ordered. 81. Typical symptoms of cholinesterase
The CL and Vd of tobramycin in Mr. Joses are inhibitor toxicity include all of the following
80 ml/min and 40 L. respectively. What EXCEPT
maintenance dosage must be administered A. Nausea, vomiting, diarrhea
intravenously every 6 hours to eventually B. Salivation
obtain average steady-state plasma C. Miosis
concentrations of 4 mg/L? D. Paralysis of skeletal muscle
A. 0.32 mg E. Paralysis of accommodation
B. 115 mg
C. 160 mg 82. Atropine overdosage may cause all of the
D. 230 mg following EXCEPT
E. None of the above A. Mental aberrations
B. Relaxation of gastrointestinal smooth
77. If you wish to give Mr. Jones (of question muscle
101) a loading dose to achieve the therapeutic C. Decrease in gastric secretion
plasma concentration of 4 mg/L immediately, D. Papillary constriction
how much should you give? E. Increase in cardiac rate
A. 0.1 mg
B. 10 mg 83. A college friend consults you regarding the
C. 115.2 mg suitability of the theraphy his doctor has
D. 160 mg prescribed for hypertension. He complains of
E. None of the above postural and exercise hypotension
(“dizziness”), some diarrhea, and problems
78. Biotransformation (metabolism) usually with ejaculation during sex. Which of the
results in a product that is following is most likely to produce these
A. More likely to distribute intracellularly effects?
B. Less lipid-soluble than the the original A. Propranol
drug B. Guanethedine
C. More likely to be reabsorbed by kidney C. Prazosin
tubules D. Hydralizine
D. More lipid-soluble than the original E. Captopril
drug
E. All of the above 84. Captopril and Enalapril do all of the
following EXCEPT
79. Physostigimine and bethanechol in small A. Increase renin concentration in the
doses have similar effects on all of the blood
following EXCEPT B. Inhibit an enzyme
A. Neuromuscular junction (skeletal C. Competitively inhibit angiotensin at its
muscle) receptor
B. Salivary glands D. Decrease the angiotensin II
C. Ureteral tone concentration in the blood
D. Sweat glands E. Increase sodium and decrease
E. Gastric secretion potassium levels in the urine
80. Pyridostigmine and neostigmine may 85. The primary mechanism of action of
cause all of the following EXCEPT digitalis involves
A. An increase of the action potential D. It inhibits aromatic L-amino acid
amplitude decarboxylase
B. An increase in ATP synthesis E. It inhibits monoamine oxidase type B
C. A modification of the actin molecule 91. This drug is a hydrazide derivative that
D. An increase in systolic intracellular binds irreversibly to monoamine oxidase types
calcium levels A and B, resulting in prolonged inhibition of
E. A block of sodium-calcium exchange amine metabolism.
A. Amoxapine
86. Which of the following is (are) frequently B. Amitriptyline
associated with increased gastrointestinal C. Isocarboxazid
motility and diarrhea D. Maprotiline
A. Timolol E. Fluoxetine
B. Prostaglandins E1 and E2
C. Corticosteroids 92. This drug has analgesic efficacy
D. Leukotriene B4 equivalent to morphine. It is an antagonist at
E. None of the above mu receptors.
A. Dextromethorphan
87. The major action of cromolyn B. Nalbuphine
A. Smooth muscle relaxation release in C. Methadone
the bronchi D. Codeine
B. Stimulation of cortisol release by the E. Naltrexone
adrenals
C. Block of calcium channels in 93. This antagonist drug has been proposed
lymphocytes as a maintenance drug for addicts in
D. Block of mediator release from mast treatment programs. A single oral dose will
cells block the effects of injected heroin for up to 48
E. Block of cAMP synthesis in basophils hours.
A. Dextromethorphan
88. Each of the following is recognized as a B. Nalbuphine
central neurotransmitter EXCEPT C. Methadone
A. Serotonin (5-hydroxytryptamine, 5-HT) D. Codeine
B. Norepinephrine E. Naltrexone
C. Dopamine
D. cAMP 94. This drug is free of analgesic and
E. Acetylcholine addictive properties and only rarely causes
constipation. It is an effective antitussive.
89. Which ONE of the following best describes A. Dextromethorphan
the mechanism of action of benzodiazepines? B. Nalbuphine
A. Blockade of the excitatory actions of C. Methadone
glutamic acid D. Codeine
B. inhibition of GABA transaminase E. Naltrexone
leading to increased levels of GABA
C. Activation of glycine receptors in the 95. This drug is a full antagonist at opioid
spinal cord receptors. It has analgesic activity equivalent
D. Facilitation of GABA-mediated to that of morphine, but its actions are more
increases in chloride conductance prolonged. Withdrawal signs on abrupt
discontinuance are milder than those with
90. Which of the following statements about morphine.
carbidopa is accurate? A. Dextromethorphan
A. It crosses the blood brain barrier B. Nalbuphine
B. It inhibits monoamine oxidase type A C. Methadone
C. It is converted to the false transmitter, D. Codeine
carbidopamine E. Naltrexone
102. Important drugs used in the treatment of
96. Activation of plasminogen to plasmin thyrotoxicosis include all of the following
A. Is brought about by heparin EXCEPT
B. Is brought about by warfarin A. PTU
C. Is brought about by anistreplase B. KI
D. Is used preoperatively and during C. Thyroglobulin
surgery in patients at risk of deep vein D. Radioactive iodine
thromboses E. Methimazole
E. Can be reversed by administration of
Vitamin K1 oxide 103. All of the following act by a similar
mechanism EXCEPT
97. Aspirin should be used cautiously in a A. Tolbutamide
patient receiving heparin because aspirin B. Tolazamide
A. Inhibits Vitamin K absorption C. Chlorpropamide
B. Has antithrombin activity D. Glipizide
C. Inhibits heparin metabolism E. Metformin
D. Inhibits platelet aggregation
E. All of the above 104. All of the following antimicrobial agents
are inhibitors of protein synthesis EXCEPT
98. Increased levels of which of the following A. Clindamycin
may be associated with a decreased risk of B. Tetracycline
atherosclerosis? C. Vancomycin
A. VLDL D. Stretomycin
B. LDL E. Chloramphenicol
C. IDL
D. HDL 105. The mechanism of antibacterial action of
E. Cholesterol cephalosporins involves
A. Inhibition of peptide synthesis
99. Which of the following causes a reduction B. Interference with the synthesis of
in absorption of bile acids from the GIT ergosterol
A. HMG-CoA reductase inhibitors C. Inhibition of transpeptidase enzymes
B. Colestipol D. Inhibition of beta-lactamases
C. Niacin E. Inhibiton of DNA gyrase
D. Probucol
E. All of the above 106. The mechanism of antibacterial action of
tetracycline involves
100. Drugs used in the treatment of gout A. Inhibition of the conversion of
include the following EXCEPT lanosterol to ergosterol
A. Indomethacin B. Inhibition of DNA-dependent RNA
B. Allopurinol polymerase
C. Colchicines C. Blockade of binding of aminoacyl-
D. Probenecid tRNA to bacterial ribosomes
E. Aspirin D. Selective inhibition of ribosomal
peptidyltransferases
101. All of the following are hormones E. None of the above
EXCEPT
A. Bromocriptine 107. All of the following statements about
B. Somatotropin aminoglycosides are accurate EXCEPT
C. Thyrotropin A. They exert synergistic effects with
D. Vasopressin beta-lactam antibiotics against
E. Somatomedin selected organisms
B. They are bactericidal
C. Their antibacterial action involves A. Dactinomycin
binding to the 50s ribosomal subunit B. Daunorubucin
and subsequent inhibition of C. Vincristine
peptidyltransferase D. Cisplastin
D. Clinical resistance occurs through E. Mechlorethamine
plasmid-mediated formation of group
transferase-inactivating enzymes 113. Which of the following is (are) important
E. Staphylococci resistant to methicillin adjuvants in cancer chemotheraphy involving
are usually resistant to cyclophosphamide and ifosfamide to prevent
aminoglycosides urotoxicity?
A. MESNA
108. The primary reason for the use of drug B. Acrolein
combinations in the treatment of TB is to C. Sodium 2-sulfanylthanesulfate
A. Prolong the plasma half-life of each D. A and B
drug E. A and C
B. Lower the incidence of adverse effects
C. Enhance the activity against 114. Which of the following is true about the
metabolically inactive mycobacteria drug Pritor®?
D. Delay the emergence of resistance A. It is of the same therapeutic class and
E. All of the above indication as Hypace® and Diovan ®
B. It is used to treat essential
109. Which ONE of the following anticancer hypertension
drugs is cell cycle nonspecific? C. It is associated with tachycardia,
A. Vinblastine bradycardia, hypotension, and edema
B. Etoposide D. A and B
C. Cytarabine E. B and C
D. Daunorubucin
E. All of the above 115. Which of the following is not present in
Cluviscol® tablets?
110. Which of the following is not a proton- A. Vitamin D2 400 IU
pump inhibitor? B. Calcium 120mg
A. Omeprazole C. Ferrous fumarate 15mg
B. Metronidazole D. Vitamin C 150mg
C. Pantoprazole E. Cobalt 3mg
D. Lansoprazole
E. None of the above 116. Which of the following is true regarding
N-acetylcysteine?
111. Filariasis, an infection which can lead to A. Intravenously, it is indicated for the
lymphatic obstructive disease, is caused by treatment of paracetamol poisoning
Wuchereria bancrofti and Brugia malay. B. It is used as a mucolytic agent
Eradication of the microfilaria can be C. It is marketed as Acetadote®,
accomplished by the use of which of the Fluimucil® and Hidonac®
following agents? D. A and B only
A. Praziquantel E. A, B and C
B. Diethylcarbamazine
C. Niclosamide 117. Which of the following is true regarding
D. Albendazole Cellcept®?
E. Metronidazole A. It contains a prodrug that is converted
to the active drug in the liver.
112. Which of the following antineosplastic B. It inhibits inosine monophosphate
agents is considered as cell cycle phase- dehydrogenase
specific agent in terms of its action on cancer C. It decreases B cell proliferation
cells? D. A and B only
E. A, B and C B. Danazol
C. Omeprazole
118. Xalatan® can best be described as a(n) D. Pramipexole
A. Cholinesterase inhibitor E. Methimazole
B. Osmotic diuretic 125. Which of the following is an indication of
C. Beta-adrenergic blocking agent Ergotamine?
D. Prodrug A. Partial seizures
E. Prostaglandin agonist B. Arthritic pain
C. Tachycardia
119. As an antiarrythmic drug, Tonocard® is D. Psoriasis
most similar in mechanism of action to which E. Migraine headaches
one of the following agents?
A. Amiodarone 126. At clinical doses, anti-Parkinson’s
B. Propranolol Disease Eldepryl® is a (n):
C. Flecainide A. MAO-A inhibitor
D. Verapamil B. MAO-B inhibitor
E. Mexiletine C. COMT
D. Anticholinergic
120. Which of the following antiarrythmic E. All of the above
drugs is (are) associated with an adverse
effect of cinchonism? 127. Which hypoglycemic agent is most
A. Acebutolol similar in pharmacological action in miglitol?
B. Moricizine A. Glipizide
C. Quinidine B. Lispro insulin
D. Lidocaine C. Proglitazone
E. Disopyramide D. Replaganide
E. Acarbose
121. Colestipol can be classified as a(n)
A. HMG-CoA reductase inhibitor 128. Statement 1: Simeco® contains 25mg of
B. Vasopressor simethicone. Statement 2: It is used for the
C. Potassium-sparing diuretic sympotomatic relief of hyperacidity and
D. ACE inhibitor flatulence.
E. Bile acid sequestrant A. If Statement 1 is correct, Statement 2
is incorrect
122. Valium® appear to act as anxiolytic by B. If Statement 2 is correct, Statement 1
A. Altering the Na ion influx into the CNS is incorrect
B. Potentiating the effects of GABA C. If both Statements 1 and 2 are correct
C. Altering the Ca ion influx into the CNS D. If Both Statements 1 and 2 are
D. Interfering with amine pump incorrect
E. Inhibiting the action of MAO E. All of the above
123. Clavunalic acid in Timentin® 129. Statement 1: Ceporex®is a trade name

A. Inhibits beta-lactamases for cefalexin. Statement 2: cefaclor belong to
B. Prevents the urinary excretion of the same generation of cephalosporins as
ticarcillin cephalexin.
C. Prevents first pass metabolism of A. If Statement 1 is correct, Statement 2
ticarcillin is incorrect
D. Is a buffer B. If Statement 2 is correct, Statement 1
E. Is an antiprotozoal agent is incorrect
C. If both Statements 1 and 2 are correct
124. Propylthiouracil is used for the same D. If Both Statements 1 and 2 are
indication as incorrect
A. Fluororacil E. None of the above
134. Statement 1: Lescol® and Lipitor® inhibit
130. Statement 1: Somatotropin is secreted by the formation of mevalonate by the HMG-CoA
the posterior pituitary. Statement 2: Alpha- reductase. Statement 2: Lescol® is
hypophamine is secreted by the posterior contraindicated for use in patients who are
pituitary. pregnant
A. If Statement 1 is correct, Statement 2 A. If Statement 1 is correct, Statement 2
is incorrect is incorrect
B. If Statement 2 is correct, Statement 1 B. If Statement 2 is correct, Statement 1
C. If both Statements 1 and 2 are correct C. If both Statements 1 and 2 are correct
D. If Both Statements 1 and 2 are D. If Both Statements 1 and 2 are
incorrect incorrect
E. None of the above E. None of the above
131. Statement 1: Inhalation of cannabis may 135. Statement 1: Scopolamine is available in

cause the decreased pulse rate, perceptual a transdermal form for the prevention of
changes and vascular congestion of the eye. motion sickness. Statement 2: It acts by
Statement 2: The active component in blocking muscarinic acetylcholine receptors.
cannabis is 9-tetrahydocannabinol. A. If Statement 1 is correct, Statement 2
A. If Statement 1 is correct, Statement 2 is incorrect
is incorrect B. If Statement 2 is correct, Statement 1
B. If Statement 2 is correct, Statement 1 is incorrect
is incorrect C. If both Statements 1 and 2 are correct
C. If both Statements 1 and 2 are correct D. If Both Statements 1 and 2 are
D. If Both Statements 1 and 2 are incorrect
incorrect E. None of the above
136. Statement 1: Haloperidol is not an
132. Statement 1: Warfarin therapy is antipsychotic while chlorpromazine is an
monitored by INR. Statement 2: It is important antipsychotic used clinically. Statement 2:
to maintain the INR between 2 to 3. Haloperidol does not produced extrapyramidal
A. If Statement 1 is correct, Statement 2 effects in contrast to chlorpromazine.
is incorrect A. If Statement 1 is correct, Statement 2
B. If Statement 2 is correct, Statement 1 is incorrect
is incorrect B. If Statement 2 is correct, Statement 1
C. If both Statements 1 and 2 are correct is incorrect
D. If Both Statements 1 and 2 are C. If both Statements 1 and 2 are correct
incorrect D. If Both Statements 1 and 2 are
E. None of the above incorrect
133. Statement 1: Ridaura® is a gold-
cointaining DMARD. Statement 2: It is 137. Statement 1: The “first-dose” effect is
indicated in the treatment of rheumatoid characterized by marked hypotension on
arthritis and multiple sclerosis. taking the first few doses of medication.
A. If Statement 1 is correct, Statement 2 Statement 2: This effect is seen with the use
is incorrect of doxazosin.
B. If Statement 2 is correct, Statement 1 A. If Statement 1 is correct, Statement 2
C. If both Statements 1 and 2 are correct B. If Statement 2 is correct, Statement 1
D. If Both Statements 1 and 2 are is incorrect
incorrect C. If both Statements 1 and 2 are correct
E. None of the above D. If Both Statements 1 and 2 are
incorrect
E. None of the above I. Bacampicillin
II. Amoxicillin
138. Statement 1: Dilantin® blocks voltage- III. Ampicillin
gated Ca ion channel in the neuron. A. I only
Statement 2: Its use is associated with B. III only
adverse effects such as gingival hyperplasia, C. I and II only
hirsutism and ataxia. D. II and III only
A. If Statement 1 is correct, Statement 2 E. I, II and III only
is incorrect
B. If Statement 2 is correct, Statement 1 143. Which of the following is (are) used as an
is incorrect anti-fungal agent?
C. If both Statements 1 and 2 are correct I. Cycloserine
D. If Both Statements 1 and 2 are II. Mafenide
incorrect III. Terbinafine
E. None of the above A. I only
B. III only
139. Statement 1: Accutane® is a vitamin A C. I and II only
derivative that is under pregnancy category X. D. II and III only
Statement 2: It is used for the treatment of E. I, II and III only
patients Psoriasis and alopecia.
A. If Statement 1 is correct, Statement 2 144. Which of the following is (are) blockers of
is incorrect H1 receptors?
B. If Statement 2 is correct, Statement 1 I. Diphenhydramine
is incorrect II. Hydroxyzine
C. If both Statements 1 and 2 are correct III. Ranitidine
D. If Both Statements 1 and 2 are A. I only
incorrect B. III only
E. None of the above C. I and II only
D. II and III only
140. Which of the following is(are) E. I, II and III only
dopaminergic anti-parkinson’s agents
I. Ropinerole 145. Which of the following is (are) false about
II. Pergolide milrinone lactate?
III. Procyclidine A. It may be administered Orally or
A. I only parenterally
B. III only B. It produces positive inotropic action
C. I and II only C. Altering the Ca ion influx into the CNS
D. I,II and III D. It inhibits phosphodiesterase 3,
E. NOTA thereby increasing cAMP levels
E. Both A and D
141. Which of the following is protease
inhibitors 146. The following statements about alteplase
I. Cidofovir are true except:
II. Acyclovir A. It is produce by recombinant DNA
III. Nelfinavir technology
A. I only B. It is a tissue plasminogen activator
B. III only C. It is administered parenterally
C. I and II only D. It stimulate RBC production
D. II and III only E. NOTA
E. I, II and III only
147. The following statements about Zocor®
142. Which of the following are are true except:
aminopenicillins A. Inhibit the HMG-CoA reductase.
B. It is an antiviral drug D. dispositional antagonism
C. It is contraindicated to pregnant E. none of the above
patient
D. It requires to be taken at right 153. When a chemical A and B administered
E. NOTA simultaneously, their combine effects are far
greater than the sum of their effects when
148. Which of the following is (are) true about given alone. The chemical interaction between
dobutamine? chemicals A and B can be described as which
A. It is clinically use as an antidepressant of the following?
and antihypertensive agent. A. Potentiative
B. It is only given parentally B. Additive
C. It is stumulate beta-1 receptor C. Antagonistic
D. A and B D. functionally antagonistic
E. B and C E. synergistic
149. Which of the following is true about 154. A type of antagonism that occurs when
fentanyl? the absorption, biotransformation, distribution,
A. It is available as a transdermal system or excretion of chemical is altered so that the
B. It may be use as a cough suppressant concentration and duration at the target of
C. It is use as local anesthetic diminished.
D. Both A and C A. receptor antagonism
E. Both A and B B. functional antagonism
C. chemical antagonism
150. reserpine, an alkaloid from rauwolfia can D. dispositional antagonism
lower the blood pressure and depress the E. none of the above
CNS. What enzyme or part of the biosynthetic
pathway is inhibited by reserpine to bring 155. A type of dose response relationship
about these effect? which describe the response of an individual
A. DOPA decarboxylase or organism to varying doses of chemical.
B. Storage of catecholamines in the A. individual dose-response relationship
presynaptic vesicle B. quantal dose-response relationship
C. Release of norepinephrine from C. graded dose-response relationship
presynaptic terminals D. both A and B
D. MAO enzyme E. both A and C
E. Uptake- 1 mechanism
156. A type of dose response relationship
151. Which of the following areas of which characterized the distribution of
toxicology focuses on the primarily on the response to different doses in a population of
medico legal aspects of the harmful effects of individual organism.
chemical in the human and animals A. individual dose-response relationship
A. Environmental toxicology B. quantal dose-response relationship
B. Clinical toxicology C. graded dose-response relationship
C. Forensic toxicology D. both A and B
D. Developmental toxicology E. both A and C
E. Reproductive toxicology
157. A dose U- shaped dose response
152. A type of antagonism that occurs when curved which result with some xenobiotics that
two chemicals counterbalance each other by imparts beneficial or stimulatory effects at low
producing opposite effect on the same doses but adverse effects at higher doses.
physiological function. A. hormesis
A. receptor antagonism B. threshold
B. functional antagonism C. individual dose response curve
C. chemical antagonism D. graded response curve
E. none of the above D. chloroform
158. It is defined as the ratio of the dose E. carbon tetrachloride
required to produce a toxic effect and the
dose need to illicit desire therapeutic 164. It is use primarily in the production of the
response. refrigerant chlorodifluoromethane.
A. ED50 A. toluene
B. threshold B. carbon tetrachloride
C. therapeutic index C. ethanol
D. LD50 D. benzene
E. none of the above E. chloroform
159. Areas of toxicology that focuses on the 165. Metabolite of phosgene which damage
impact of chemical pollutants in the membranes and other intracellular structures
environment on biological organism, specilly leading to necrosis and tumor formation.
studying the impacts of chemicals on A. tetrachloroethylene
nonhuman organism B. phosgene
A. forensic toxicology C. methylene chloride
B. clinical toxicology D. ethylbenzene
C. developmental toxicology E. none of the above
D. reproductive toxicology
E. environmental toxicology 166. Enzyme catalyses oxidation of ethanol to
acetaldehyde
160. The dose required to result in a response A. aldehyde dehydrogenase
in 50 percent of population. B. catalase
A. median dose C. alcohol dehydrogenase
B. ceiling dose D. both A and C
C. potency E. none of the above
D. LD50
E. ED50 167. Ingestion of these substance may cause
visual disturbance ranging from mild
161. Place the following mechanism of toxin photophobia and blurred vision to markedly
delivery in order from most effective to least reduced acuity and complete blindness
effective. 1: intravenous 2:subcutaneous 3: A. Ethanol
oral 4: inhalation 5: dermal B. Chloroform
A. 1,5,2,4,3 C. Ethylene glycol
B. 4,1,2,3,5 D. Methanol
C. 1,4,2,3,5 E. Carbon tetrachloride
D. 4,2,1,5,3
E. 1,4,3,2,5 168. Which of the following is NOT an
important enzyme in ethanol metabolism?
162. It is the primary rout of exposure of A. Alcohol dehydrogenase
benzene in industrial setting. B. Formaldehyde decarboxylase
A. inhalation C. CYP2E1
B. subcutaneous D. Catalase
C. oral E. Acetaldehyde dehydrogenase
D. dermal
E. intravenous 169. Which of the following statements
regarding benzene is false?
163. Toxic substance present in paints, A. High level exposure to benzene could
lacquer, thinners, cleaning agent and glues. result in acute myelogenous leukemia
A. benzene (AML)
B. ethanol
C. toluene
B. Gasoline vapour emissions and auto- A. Iron
exhauted are the two main B. Copper
contributors to benzene inhalation. C. Zinc
C. Benzene is used as an ingredient in D. Both A & B only
unleaded poisoning. E. All of the above
D. Benzene metabolites covalently bind
DNA, RNA and protein and interfere 176. Metals related to medicinal therapy
with their normal functioning A. Aluminium
E. Reactive oxygen species can be B. Lithium
delivered from benzene C. Platinum
D. Both A & B only
170. Which of the following is NOT associated E. All of the above
with glycol ether toxicity?
A. Hematotoxicity 177. The following pesticides are correctly
B. Craniofacial malformation matched EXCEPT:
C. Seminiferous tubule atrophy A. Rodenticides –rats
D. Irreversible spermatotoxicity B. Molluscides –snails
E. Cleft lip C. Pediculocides – lice
D. Fungicides –molds
171. A major constituent of antifreeze, E. Ascaricies –insects
hydraulic fluids and drying agents.
A. Methanol 178. Insecticidesm first developed from the
B. Glycol ethers extracts from the flower heads of
C. Propylene glycol chrysanthemum cinerariaefolium
D. Ethylene glycol A. DDT
E. Ethanol B. Rotenoids
C. Pyrethrins
172. It is also known as quick silver. D. Aldrin
A. Ag E. Endrin
B. Hg
C. Mg 179. Which of the following drugs may induce
D. Sb visual system abnormalities such as
E. As decreased vision, flickering scotomas and
altered color vision.
173. Contact dermatitis is the most common A. Digoxin
adverse effect of which of the following B. Metoprolol
metals? C. Colchicine
A. Nickel D. Rifampicin
B. Copper E. Lidocaine
C. Arsenic
D. Lead 180. A drug that is used to ameliorate nausea
E. Cadmium and vomiting in pregnancy but results to
malformations of Amelia and various degree
174. Wilson’s disease is an autosomal genetic of phocomelia.
disorder caused by which of the following A. Diethylstilbestrol
metals? B. Thalidomine
A. Aluminium C. Ethanol
B. Copper D. Nicotine
C. Arsenic E. Retinoids
D. Cadmium
E. Lead 181. The main target for lead toxicity
especially in developing fetus and young
175. Essential chemicals EXCEPT? children.
A. Bone marrow
B. Kidneys 188. It is the antidote for warfarin toxicity.
C. Gastrointestinal tract A. Vitamin K
D. Reproductive organs B. Vitamin C
E. Central nervous system C. Vitamin E
D. Pyridoxime
182. Minamata Disease is caused by E. Thiamine
A. Lead
B. Cadmium 189. Toxins found in peanuts
C. Mercury A. Saxitoxin
D. Silver B. Cigutoxin
E. arsenic C. Scrombroid
D. Aflatoxin
183. In japan, Itai-itai disease is caused by E. Tetrodotoxin
consumption of rice contaminated by
A. Lead 190. Toxins found in several species of
B. Cadmium Alexandrium dinoflagellates
C. Mercury A. Saxitoxin
D. Silver B. Cigutoxin
E. Arsenic C. Scrombroid
D. Aflatoxin
184. Chronic exposure to this metal result to E. Tetrodotoxin
hyperpigmentation and hyperkeratosis of the
palm and soles. 191. Toxin produced by puffer fish.
A. Lead A. Saxitoxin
B. Cadmium B. Tetrodotoxin
C. Mercury C. Scromboid
D. Silver D. Aflatoxin
E. Arsenic E. ciguatoxin
185. It is also known as dimercaprol 192. The most prevalent polycyclic aromatic
A. Succimer hydrocarbon found in cigarette smoke.
B. Unithol A. scromboid
C. Deferoxamine B. Benzopyrene
D. BAL C. Ciguatoxin
E. Penicillamine D. Anthracene
E. Nicotine
186. It is mixture of copper and arsenic salt
that is used to control insects in 1800’s 193. This naturally occurring furan is produced
A. Bordeaux by the mold Fusarium solani that infects sweet
B. Rotenone potatoes.
C. DDT A. Ciguatoxin
D. Paris green B. Monocratolin
E. Pyrethrin C. Ipomeanol
D. Anthracene
187. A natural compound derived from E. Benzopyrene
Urginea maritime and is effective in controlling
rodents. 194. Exposure to this vitamin can cause
A. Pyretrin malformation of the face, limbs, heart, CNS
B. Red squill and skeleton of the developing fetus.
C. Paris Green A. Vitamin A
D. Bordeaux mixture B. Vitamin D
E. Rotenone C. Vitamin C
D. Vitamin K E. Accumulation of iron within
E. Vitamin B complex erythroblast
195. The following drugs and chemicals are 201. the normal erythrocyte has metabolic
associated with the development of aplastic mechanism for reducing heme iron to ferrous
anemia EXCEPT state. Failure of these control mechanism may
A. Tetracycline lead to which of the following?
B. Chloramphenicol A. Aplastic anemia
C. Carbamazepine B. Megaloblastic anemia
D. Indomethacin C. Methemoglobinemia
E. Nitric oxide D. Iron deficiency anemia
E. Sideroblastic anemia
196. Laboratory test used to monitor therapy
with unfractionated heparin. 202. This type of anemia is characterized by
A. aPTT peripheral blood pancytopenia,
B. Creatine kinase reticulocytopenia, and bone marrow
C. AST hypoplasia.
D. PT A. Aplastic anemia
E. ALT B. Megaloblastic anemia
C. Iron deficiency anemia
197. Laboratory test used to monitor therapy D. Sideroblastic anemia
with warfarin. E. Methemoglobinemia
A. Aptt
B. Creatine kinase 203. It is used to treat APAP toxicity; its
C. AST primary action is to enhance hepatocyte
D. PT synthesis of glutathione.
E. ALT A. Vitamin K
B. Fomepizole
198. The following are clotting factors inhibited C. Disulfiram
by warfarin and its analogs EXCEPT D. N-acetylcysteine
A. III E. None of the above
B. X
C. IX 204. Which of the following metals is NOT
D. VII nephrotoxic?
E. II A. Cadmium
B. Lead
199. Which of the following type of anemia is C. Mercury
properly paired with its cause? D. Platinum
A. Megaloblastic anemia- lead poisoning E. None of the above
B. Aplastic anemia-ethanol
C. Sideroblastic anemia-vitamin B12 205. Shaver’s disease is caused by
deficiency A. Ammonia
D. Megaloblastic anemia-folate B. Cadmium oxide
supplementation C. Hydrogen fluoride
E. Iron deficiency anemia-blood loss D. Bauxite fumes
E. Kaolin
200. The inability to synthesize the porphyrin
ring of haemoglobin will most likely to result in 206. Chemotherapeutic agent that causes
which of the following? pulmonary fibrosis.
A. Iron deficiency anemia A. Vincristine
B. Inability to synthesize thymidine, B. Doxorubicin
C. Improper RBC mitosis C. Bleomycin
D. Bone marroe hyperplasia D. Vinblastine
E. Azathioprine
213. Metabolite of bromobenzene that is
207. Mycotoxin found in claviceps purpurea. approximately thousand fold more potent than
A. Aflatoxin bromobenzene in producing nephrotoxicity.
B. Saxitoxin A. Cystein
C. Ciquatoxin B. Phosgene
D. Ergot C. Cysteine-S-conjufate
E. Tetrodotoxin D. Glutathione
E. Diglutathione conjugate of
208. The most toxic type of aflatoxin. hydroquinone
A. B1
B. B2 214. It is the toxic metabolite of methanol that
C. G1 mediates the metabolic acidosis as well as
D. G2 retinal toxicity.
E. None of the above A. Formic acid
B. Acetaldehyde
209. Neurotoxin found in improperly canned C. Acetic acid
foods. D. Phosgene
A. Aflatoxin E. Chloroquine
B. Ciguatoxin
C. Saxitoxin 215. Anti-tubercular agent that may cause
D. Tetrodotoxin optic neuropathy
E. Botulinum toxin A. Rifampicin
B. Isoniazid
210. A growth promoter in animals that is no C. Pyrazinamide
longer use because of the discovery that D. Ethambutol
tumor of genital organ have developed in the E. Streptomycin
offspring of mothers who had taken this during
pregnancy in large dose for medical purposes. 216. A deficiency of which of the following
A. Diethylstilbestrol vitamins can result in degeneration of optic
B. Testosterone nerve fibers?
C. Progesterone A. Vitamin A
D. Estradiol. B. Vitamin B3
E. Somatotropin C. Vitamin C
D. Vitamin B 12
211. The following side effects may be E. Vitamin E
experience upon exposure to an
organophosphate and carbamate insecticides 217. High exposure to this metal cause “black
EXCEPT foot disease” which is circulatory disorder
A. Diarrhea reflecting endothelial cell damage.
B. Bronchoconstriction A. Lead
C. Involuntary urination B. Cadmium
D. Mydriasis C. Arsenic
E. Salivation D. Mercury
E. Silver
212. Metabolite of tetrafluoroethylene that is
the penultimate nephrotoxicant. 218. Which of the following drugs/chemical
A. Cysteine may cause hyperpigmentation of the skin?
B. Phosgene A. Phenolic germicides
C. Cysteine-S-conjugate B. BHT
D. Glutathione C. Hydroquinone
E. Diglutathione conjugate of D. Mercaptoamines
hydroquinone E. Amiodarone
219. Which of the following drugs/chemical B. Ehrlichiosis
may cause hypopigmentation of the skin? C. Lyme disease
A. Chloroquine D. Rocky mountain spotted fever
B. Amiodarone E. Q-fever
C. Bleomycin
D. Hydroquinone 226. Neurotoxin found in black widow spiders.
E. Minocycline A. Serotoxin
B. Loxosceles
220. An organic compounds that is C. Latrotoxin
approximately 49% elemental mercury by D. Rotenone
weight and has been widely used as E. Saxitoxine
preservative since 1930’s in contact lens
solution, biologics, and vaccine particularly 227. A species of which of the following
those in multi-dose container. animals produces a venom that contains 60%
A. Thimerosal formic acid?
B. Merthiolate A. Snakes
C. Mercurothiolate B. Lizards
D. Sodium ethylmercuriethiosalisylate C. Ants
E. all of the above D. Scorpions
E. spiders
221. Which of the following drugs is/are often
associated with phototoxic reaction? 228. Which of the following is NOT
A. Tetracycline characteristic of Lepidoptera envenomation?
B. Sulphonamides A. Decreased plasminogen levels
C. Sulfonylureas B. Increased risk of haemorrhaging
D. Phenothiazine C. Decreased partial thromboplastin time
E. All of the above D. Increased in prothrombin time
E. Decreased fibrinogen levels
222. Dicumarol is fungal metabolite that
causes which of the following? 229. Food Poisoning with which of the
A. Prothrombin deficiency following bacteria occurs when meat has been
B. Epileptiform seizure contaminated with intestinal contents of
C. Acute renal failure slaughters and then roasted and inadequately
D. Photosensitivity stored.
E. Parasympathetic overactivation A. C. perfringerns
B. R. Ricketsii
223. The compound found in red pepper is C. S. Aureus
A. Anthracenones D. C. botulinum
B. Capsaicin E. E. coli
C. Hyoscyamine
D. Atropine 230. This includes the chemical, biochemical,
E. Scopolamine and molecular events that lead to deleterious
effects on development.
224. Alkaloid found in Datura stramonium A. Mutagenesis
A. Capsaisin B. Teratogenesis
B. Antracenones C. Carcinogenesis
C. Red squill D. Behavioral toxicology
D. Scopolamine E. None of the above
E. All of the above
231. it is highly irritating and oxidizing gas that
225. Which of the following is NOT commonly is formed by photochemical action of UV light
caused by tick envenomation? on nitrogen dioxide smog.
A. Cat scratch disease A. Nitrogen oxide
B. Carbon monoxide C. Aconite
C. Ozone D. A and B
D. Volatile organic compounds E. B and C only
238. Notorious plant that can be found
232. It is known as the “bad ozone” that Conium maculatum
occurs from 0 to 10 miles above the earth’s A. Poison hemlock
surface. B. Henbane
A. Tropospheric ozone C. mandrake
B. stratospheric ozone D. Aconite
C. Volatile organic hydrocarbons E. opium
D. Either A and B
E. None of the above 239.Notorious plant poison that can be found
in Veratrum Album
233. Follic acid supplementation should be A. Poison hemlock
provided to patient chronically using B. Henbane
A. Phenytoin C. mandrake
B. Propranolol D. Aconite
C. Levodopa + carbidopa E. Hellebore
D. Sulindac
E. Tetracycline 240. Commercial preparations of universal
antidote is composed of
234. Dermopathy, an erythematous A. 1 part tannic acid, 2 parts magnesium
desquamation of the palms and soles also oxide. 1 part activated charcoal
called as hand-foot syndrome is seen after B. 2 parts tannic acid, 1 part magnesium
extended infusion of which of the oxide, 2 parts activated charcoal
chemotherapeutic agents? C. 1 part tannic acid, 1 part magnesium
A. Doxorubicin oxide, 1 part activated charcoal
B. Cytarabin D. 1 part tannic acid, 1 part magnesium
C. 5-FU oxide, 2 parts activated charcoal
D. Methotrexate E. None of the above
241. Tartar emetic had a long history of use of
235. The drug used to antagonize the effects an emetic, as well as sedative, expectorant,
of opioid toxicity. cathartic and diaphoretic. The chemical name
A. Nubain for tartar emetic is
B. Narcan A. Potassium bipthalate
C. Revex B. Potassium antimony tartrate
D. Depade C. Potassium antimony bitartrate
E. Either A and B D. Potassium antimony bipthalate
236. which of the following is the effects of
digoxin to atrial muscles at toxic dose? 242. Metabolic acidosis with an anion gap is a
A. Extrasystoles hallmark of toxic alcohol poisoning. Which of
B. Fibrillation the following is the primary cause of metabolic
C. Arrhythmia acidosis in ethylene glycol poisoning?
D. Tachycardia A. Formic acid
E. All of the above B. Glycolic acid
C. Acetone
237. Notorious plant poison found in Aconitum D. Acetic acid
species E. all of the above
A. Mandrake
B. Monkshood
243. Metabolic acidosis with an anion gap is a 249.This drug is used together with atropine in
hallmark of toxic alcohol poisoning. Which of the management of patient poisoned by
the following is the primary cause of metabolic organic phosphorous and carbamate
acidosis in methanol poisoning? pesticides. Its primary mechanism is to
A. Formic acid reactivate the enzyme cholinesterase
B. Glycolic acid A. 2-PAM
C. Acetone B. Disulfiram
D. Acetic acid C. Pralidoxime
E. all of the above D. Both A and B
E. Both A and C
244. The most prominent end organ effect of
ethylene glycol is 250.Glycine acts as a post synaptic inhibitory
A. Nephrotoxicity neurotransmitter in the spinal cord and lower
B. Hepatotoxicity brainstem. Which of the following substance is
C. Hemorrhagic gastritis classified as glycine antagonist?
D. Visual impairment to total blindness A. Ethanol
E. None of the above B. Picrotoxin
C. Clozapine
245. In the pathway of ethylene glycol D. Propofol
metabolism which of the following substance/s E. D-serine
enhances the formation non-toxic metabolites.
A. Fomepizole 251. Which of the following is classified as
B. Thiamine glycine re-uptake inhibitor?
C. Pyridoxine A. Ethanol
D. A and B B. Picrotoxin
E. B and C only C. Clozapine
D. Propofol
246. Disulfiram therapy is indicated in the E. D-serine
following alcohol toxicity EXCEPT
A. Methanol 252. Which of the following causes metabolic
B. Ethylalcohol alkalosis?
C. Isopropanol A. Administration of diuretics
D. Both A and B B. Administration of sodium bicarbonate
E. Both B and C C. Vomiting
D. Magnesium deficiency
247. The following are advantages of using E. All of the above
fomepizole over ethanol in the treatment of
ethylene glycol toxicity EXCEPT 253. Which of the following substance causes
A. Fomepizole does not cause CNS hypercalcemia?
depression A. Aminoglycosides
B. Fomepizole does not require serum B. Furosemide
concentration monitoring C. Ethanol
C. Fomepizole is readily available D. Bisphosphonates
D. Fomepizole is low-cost E. Lithuim
E. Both C and D
254. Which of the following substance causes
248. An alkaloid found in Strychnos nux hypocalcemia?
vomica A. Vitamin A
A. Strychnine B. Tamoxifen
B. Aconite C. Androgens
C. Nicotine D. Calcitonin
D. Muscarine E. Glucocorticoids
E. Carnitine
255. Toxic epidermal necrolysis is a rare life- 261. The following management/s is done to
threatening dermatologic emergency and patient suspected of overdose of proguanil or
medications are causally implicated in 80%- pyrimethamine EXCEPT:
90% of cases. Which of the following drugs A. Folate supplementation
causes toxic epidermal necrolysis? B. administration of methylene blue for
A. Allopurinol methemoglobinemia
B. Acetaminophen C. administration of cimetidine to prevent
C. Picrotoxin the conversion to a toxic metabolite
D. Nickel D. administration of multiple dose of
E. None of the above charcoal to enhance it elimination
E. All of the above
256. CNS toxin found in Artemisia absinthuim
A. Ephedra 262. Whole bowel irrigation is the most
B. Nicotine effective process for evacuating the intestinal
C. atropine tract in poisoned patients. Which of the
D. absinthe following conditions wherein whole bowel
E. Scopolamine irrigation is contraindicated?
A. GI perforation
257. CNS toxin found in Areca catechu B. Volume depletion
A. Ephedra C. GI haemorrhage
B. atropine D. Compromised airway
C. absinthe E. All of the above
D. Scopolamine
E. Arecholine 263. Which of the following is true with dosage
of syrup of ipecac?
258. It is extracted from the fruit of the A. For children 1-12 years old the dose is
evergreen Myristica fragrans and it is the main 15ml
active ingredient in myristicin. B. For older children and adult the dose
A. Nutmeg is 30ml
B. Pine oil C. For children 6-12 mos of age dose
C. Wintergreen should be limited to a maximum single
D. Clove dose of 10ml
E. Camphor D. If vomiting does not ensure after the
first dose, the same dose may be
259. Toxic ingredient found in Bufo repeated once in 20-30min.
gangarizan E. All of the above
A. Anthraquinones
B. Coumarin 264. Antibotic that causes aplastic anemia
C. Bufadienolides A. Tetracycline
D. Arecholine B. Erythromycin
E. Amygdalin C. Vancomycin
D. Chloramphenicol
260. Classic description of chronic intake of E. Amikacin
this antibiotic is the “gray baby syndrome”
which is characterized by vomiting, anorexia, 265. It is hygroscopic polysaccharide derived
respiratory distress, abdominal distention, from the bean of the cyamopsis psorabides. It
green stools and cyanosis. This is syndrome expands 10-20 fold in the stomach, forming a
is caused by gelatinous mass that produces the senasation
A. Tetracycline of satiety.
B. Chloramphenicol A. Guar gum
C. Erythromycin B. Chitosan
D. Sulfonamides C. Dinitrophenol
E. Vancomycin D. Xenical
E. none of the above unfractionated heparin and for some of the
effects of LMWH.
266. Antidote for APAP toxicity A. Vitamin K
A. Activated charcoal B. Protamine
B. NAC C. Hirudin
C. PAM D. Tissue plasminogen activator
D. Oxime E. None of the above
E. Ipecac
273. It is polypeptide produced by the salivary
267.Which of the following causes a brown- glands of the medicinal leech, hirudo
black urine? medicinalis that reversibly blocks thrombin
A. Cascara without the need for antithrombin III.
B. Iron A. Hirudin
C. Metyldopa B. Heparin
D. Senna C. Protamine
E. All of the above D. Warfarin
268. Which of the following drugs causes
cataracts? 274. Thimerosal is an organic compound that
A. Acetazolamide approximately contains 49% by weight of:
B. Amiodarone A. Hg
C. Chlorpromazine B. Ag
D. Corticosteroids C. S
E. Cisplatin D. Al
269. Which of the following antibiotics causes
disulfiram like effects? 275. This drug is known as “soda loading”. It
A. Cefotetan buffers the lactic acidosis caused by exercise,
B. Metronidazole thereby delaying fatigue and enhancing
C. Co-trimoxazole performance.
D. Moxalactam A. Caffeine
E. all of the above B. Calcuim hydroxide
C. Diuretics
270. Methamphetamine is also known as D. Amphetamines
A. Crack E. Sodium bicarbonate
B. Speed
C. Yaba 276. This is used in sports in which the athlete
D. Go must achieve a certain weight to complete in
E. All of the above discrete weight classes. It is used by body
builders to give their skin a greater definition
271. Food interaction occur when as this causes the skin to draw tightly around
pharmacologically active dietary monoamines the muscles.
such as tyramine is ingested by patients A. Amphetamine
taking MAOIs. Which of the following foods B. Sodium carbonate
has the highest tyramine effect? C. Diuretics
A. Yogurt D. Caffeine
B. Avocados E. None of the above
C. Redwines
D. Aged, mature cheese 277. This vitamin reduces iron from ferric to
E. Smoked meats or fish the ferrous state, thereby increasing intestinal
absorption of iron.
272. It is rapidly acting antidote used for A. Vitamin A
reversing the anticoagulant effects of B. Vitamin B
C. Vitamin C A. Methemoglobinemia occurs when the
D. Vitamin D iron atom in haemomoglobin loses 2
E. Vitamin E electron to an oxidant
B. Methemoglobinemia when ferrous
278. it is cololess, oily liquid with a faint state of iron is transformed into the
aromatic odor that Is commonly added to ferric state.
pharmaceutical products as a bacteriostatic C. Methemoglobinemia is normally
agent. It causes “gasping syndrome” in infants present in the body at high
which is the characteristized by hypotension concentration
bradycardia, gasping respiration seizures, D. Both A and B
cardiovascular collapsed and death. E. Both B and C
A. Chlorobutanol
B. PEG 284. It is used in the treatment of aniline
C. Propylene glycol induced Methemoglobinemia
D. Ethylene glycol A. Methylene blue
E. Benzyl alcohol B. Glucagon
C. Oximes
279. Patient taking rifampicin in combination D. PAM
with isoniazid develops what type of toxicity? E. EDTA
A. Nephrotoxicity
B. Ototoxicity 285. The following are example of chemical
C. Neurotoxicity asphyxiants EXCEPT
D. Hepatotoxicity A. Carbon monoxide
E. None of the above B. Carbon dioxide
C. Hydrogen sulphide
280. Which of the following drugs causes “red D. Oxides of nitrogen
man red neck syndrome”? E. Hydrogen cyanide
A. Sulfonamides
B. amphotericin B 286. Toxic combustion product that exert a
C. Vancomycin space-occupying effect simply displacing
D. Erythromycin oxygen.
E. None of the above A. Chemical asphyxiants
B. Simple asphyxiants
281. An antimycobacterial agent that is C. irritant
classified as congener of INH and have the D. A and B
same mechanism of action with INH. E. All of the above
A. Capreomycin
B. Ethionamide 287. Q fever occurs naturally as a self limited
C. Para-aminosalicylic acid febrile, zoonotic disease contracted from
D. Isoniazid domestic livestock. Q fever I classified as
E. Pyrazinamide biological warfare agent and is now known to
caused by
282. Pyridoxine is a water soluble vitamin that A. Coxiella burnetti
is used as antidote for which of the following B. Brucalla melitensis
poisoning? C. Baciilus anthracis
A. INH D. Yersinia pestis
B. Ethylene glycol E. None of the above
C. PZA
D. A and B 288. It is anti-muscarinic compound that was
E. A and C developed as an incapacitating chemical
warfare agent. It is 25-fold more potent
283. Which of the following statements is centrally than atropine.
CORRECT about methemoglobinemia? A. BZ
B. QNB 294. It is one of the extrapyrimadal syndromes
C. 3-quinuclidinyl benzilate characterized by restlessness and inability to
D. A and B only sit still
E. All of the above A. Acute dystonia
B. Akathisia
289. Vesicants are agents that cause C. Parkinsonism
blistering of skin and mucous membrane. D. Neuroleptic malignant syndrome
Which of the following is classified as E. Tardive dyskinesia
vesicants but does not cause vesiculation of
the skin? 295. It is one of the extrapyramidal syndromes
A. Sulphur mustard characterized by sustained, involuntary
B. Lewisite muscle contraction, torticollis, including
C. Phosgene oxime blephaospasm and oculogyric crisis.
D. Cyanide A. Acute dystonia
E. None of the above B. Akathisia
C. Parkinsonism
290. BAL should be administered through D. Neuroleptic malignant syndrome
A. IV E. Tardive dyskinesia
B. IM
C. SQ 296. It is hydantoin derivative and structurally
D. Oral similar to local anesthetics that is used for the
E. A and B only treatment of malignant hyperthermia.
A. Phenytoin
291. What specific element is present in B. Diazepam
dimercaprol? C. Dantrolene
A. Magnesium D. Phenobarbital
B. Sulfur E. Tensilon
C. Iron
D. manganese 297. It is the drug of choice for beta
E. None of the above adrenergic antagonist poisoning
A. Propranolol
292. It is active substance in the Chinese B. Atropine
plant Ma-huang has been used for the C. Glucagon
treatment of asthma. D. Ethanol
A. Khat E. Valium
B. Cathionone
C. Methcathinone 298. Ipecac is derived from rhizome and roots
D. Ephedrine of plants found in Brazil belonging to the
E. None of the above family Rubiaceae. Which of the following
substance is/are responsible for the
293. An extrapyrimidal syndrome that occurs production of nausea and vomiting of ipecac
3 months to years after taking an anti- syrup?
psychotic drug it is characterized by A. Cephaelin
involuntary choreiform movements like B. Emetine
buccolinguomasticatory movements C. Scopolamine
A. Acute dystonia D. A and B only
B. Akathisia E. B and C only
C. Parkinsonism
D. Neuroleptic malignant syndrome 299. Contraindicated of syrup of ipecac
E. Tardive dyskinesia A. The patient is younger than 6 month of
age
B. Ingestion of caustic poison
C. Ingestion of a foreign body such as a
drug packet or sharp item
D. The patient does not meet the criteria
for gastric emptying
E. All of the above
300. Gastric emptying may be indicated if

A. Significant spontaneous emesis has
occured
B. The ingested poison has a high
efficient antidote
C. the patient presents many hours post
ingestion
D. The ingested poison is well adsorbed
activated charcoal
TOXICOLOGY
-----------------------------------------------------------------
I. INTRODUCTION III. POISONS

 Toxicology – study of poison, its mechanism of action, and its I. EFFECTS OF POISIONS
management; study of adverse effects/events of  According To Extent/Location
physical/chemical agents in humans, other organism and o Local – ex. Phenol
environment o Remote – ex. Paraquat  pulmonary fibrosis
 Poisons: (1) Mechanism of Toxicity; (2) Functional Effects; (3) o Systemic – ex. Metabolic Acidosis
Probability of Occurrence  According To Duration
 Risk Assessment – estimate potential effect on human health o Acute – ↑dose in short period of time
and environmental significance of various types of chemical o Chronic – ↓dose in longer period of time
exposure
 Areas of Toxicology II. FACTORS THAT INFLUENCE EFFECTS OF POISON
o Mechanistic – mechanism of toxicity  Route
o Descriptive – direct toxicity testing o Oral – most common/important; ↑A = lipid; ↓GER = delay
o Regulatory – decision making process using information absorption (ex. anticholinergic)
from: mechanistic and descriptive (asses safety) o Dermal – lipid soluble = ↑damage; ↑absorption – (ex.
 Specialized Areas of Toxicology phenol)
o Clinical Toxicology – study of adverse effects in humans o Inhalation – gases/particle < 0.5µm; systemic or local effects
caused by incidental/accidental overdose o Intravenous
o Environmental Toxicology – impact of pollutants to non- o Intramuscular
human organism o Rectal
o Forensic Toxicology – medicolegal  Concentration – ↑concentration = ↑toxicity
 Patient Related Factor
II. TOXICOKINETICS o Age
 Pediatric
I. ABSORPTION
 Child Inutero
 Parameters: Bioavailability (F) – rate and extent of absorption;
o 1-2 weeks – conception/implantation; abortion
extent/fraction of drug that enters systemic circulation
o 3-8 weeks – embryogenesis period; morphologic
 Affected by:
change (ex. ACE I)
o Physical Properties – lipid soluble = ↑extent; water soluble
o > 8 weeks – minor physiologic changes
= ↑rate
 Examples:
o Gastric Emptying Rate - ↓GER = ↓absorption
o Tetracycline – teeth discoloration and bone
o Health of GI Tract
problems
o First Pass Effect – hepatic metabolic
o ACE Inhibitors – renal dysgenesis
o Diethylstibestrol – uterine/cervical cancer to
II. DISTRIBUTION
daughter
 Parameters: Volume of Distribution (Vd)
𝑑𝑜𝑠𝑒 o Thalidomide – phocomelia  limb deformities
𝑉𝑑 =
𝑝𝑙𝑎𝑠𝑚𝑎 𝑐𝑜𝑛𝑐𝑒𝑛𝑡𝑟𝑎𝑡𝑖𝑜𝑛
 Affected by: Protein Binding – ↓BP = ↓VD
III. METABOLISM AND EXCRETION

 Parameter: Clearance – rate by which a known volume of
plasma is cleared by drug
 Affected by: Liver and Kidney Function
PAGE 1 OF 6 © MANOR REVIEW CENTER NOTES (K.L)

 Geriatric - ↓liver/kidney function; ↓muscle mass; ↑fat  Counterindicated – absence of bowel sounds;
deposition evidence of intestinal obstruction; pre-existing
 Tolerance/Tachyphylaxis – increase dose to get same electrolytes imbalance; renal dysfunction; GI bleeding
effect; (ex. Nitrates; Morphine)  Whole Bowel Irrigation – administer with PEG with
 Idiosyncracy & Pharmacogenetics electrolytes until completely cleansed
o G6PD Deficiency – triggers: antimalarial, sulfadrugs,  Endgoal – effluent is same color of infusate
analgesics (ASA), acetanilide, antibiotics (Nalidixic  Indication – substances are poorly absorbed (ex. Li, Fe,
Acid), INH, nitrofurantoin Pb); slow release of preparations; late presentation
RBC = HEMOLYTIC ANEMIA (takes 2-4 hours)
 Forced Diuresis/pH Manipulation – kidneys  filtration,
GLUTATHIONE
OA
GLUTATHIONE
reabsorption, secretion;
(reduced form) (oxidized form)  Examples: salicyliates + NaHCO3 (alkalizer);
G6PD
amphetamine + Vit. C or NH4Cl (acidifier)
o Pseudocholinesterase Deficiency – ex. o Inhalation – remove from hazardous environment; (+) 100%
succinylcholine  malignant hyperthermia humidified O2; assisted ventilation; bronchodilators
o NAT2 Polymorphism – ex. Isoniazid  fast o Dermal Exposures – remove exposed clothes; rinse with
acetylators: Asians; slow acetylators: Caucasians copious H2O in 30 minutes
o Ocular Exposures – irrigate with saline solution for 15
III. MANAGEMENT OF POISONED PATIENT minutes with eyelids retracted
 Primary Survey – (ABCDE) o Extracorporeal Methods
o Airway  Hemodialysis – passing of blood through a semi-
o Breathing permeable membrane with counter current dialysate
o Circulation flow, allowing passage of solute
o Disability  Dialyzable Toxins:
o Exposure – remove clothing for better evaluation o Low Vd – (< 1L/kg)
 Secondary Survey – history (SATS – substance, amount, time, o Protein Binding < 50%
symptoms)and physical examination o Low MW – < 600 daltons
 Management – diagnostics and therapeutics  Supportive Measure – (A,E,I,O,U)
 Decontamination o Acid-Base disturbances that are unresponsive
o Ingestion o Electrolyte disturbances that are unresponsive
 Lavage – passage of tube via mouth or nose down to o Intensive Care disturbances that are unresponsive
stomach followed by sequential administration of warm o Overhydration
saline solution and removal of small volume of liquids o Uremia
 Dilution/Neutralization – counterindicated in alkali and  Hemoperfusion – blood passes through an adsorbent
acids (charcoal)
 Emesis – Syrup of Ipecac – toxin does not cause rapid  Indications – highly protein bound; high Vd; lipid
onset coma/convulsion  aspiration soluble
 Counterindicated:  Peritoneal Dialysis – least invasive; 10-15% as effective
o Children < 6 years old – underdeveloped airway than hemodialysis
protection mechanism
o Agents which may cause comatose – alcohol; short IV. COMMON MAJOR PATHOPYSIOLOGIC
acting barbiturates; non-barbiturates hypnotics; TCA
o Agents causes rapid onset convulsions – beta MECHANISM
blockers; calcium channel blockers; chloroquine; I. INTERFERE WITH O2 UTILIZATION
camphor; codein; TCA; mefenamic acid; Respiration  O2 transport  cellular respiration
organophosphate; strychnine; phencyclidine Energy Production: Glycolysis  Kreb’s Cycle  Electron
(angel’s dust) Transport Chain (ETC)  O2, ATP, CO2
 Activated Charcoal – adsorbs toxin  Carbon Monoxide – product of incomplete combustion;
 Gastrointestinal Dialysis – repeated dose of charcoal; presentation: pallor; headache; vertigo; cherry red skin (post
creates concentration gradient between intestinal mortem)
lumen and plasma CO + Hgb  methemoglobin (↑affinity to O2) = hypoxia
 Cathartics – saline cathartics

 Hydrogen Sulfide – rotten egg odor; hot springs; highly toxic, weakness + fasciculations, adrenal medulla = increase
colorless gass; irritation of mucous membrane, respiratory epinephrine activity, tachycardia, cramping, hypertension
depression; treated by: amyl nitrite (inhalation) and NaNO 2 o Treatment
(IV), methemoglobin + sulfide ion  sulfmethoglobin,  Atropine – anticholinergic
hypertonic O2  Pralidoxime – early poisoning (24-36 hours); reverse bond
blocks cytochrome  blocks O2 utilization between acetylcholinesterase and organophosphate by
 Cyanide – found in prunus spp. (wild blackberry; bitteralmond; forming an oxime phosphate bond to release ACh E; done
apricot), cassava, lima beans, silver jewelry cleaner before aging into a covalent bond
Inhibits cytochrome oxidase = ↓O2 utilization
o Clinical Effects: CNS disturbances; death from seizure and IV. AFFECT VASCULATURE AND HEART
central respiratory depression  hypotension or cardiac arrhythmia; (ex. nitroglycerin)
o Treatment: ↑cGMP  relax smooth muscle  vasodilation
 12
V. AFFECTS LUNGS EITHER SYSTEMICALLY OR LOCALLY
 Paraquat – systemically
 Aspiration – locally
VI. LOCAL DAMAGE

 Phenol – aka carbolic acid; denatures protein; presentation:
burning sensation, tingling, numbness, leaves a burn mark;
treatment: castor oil or PEG
VII. DELAYED EFFECTS ON LIVER AND KIDNEY – (ex.

acetaminophen; heavy metals)
 Hydroxycobalamin (B12) – binds with CN 
cyanocobalamin
 Methylene Blue – high dose to produce methemoglobin V. SPECIFIC TOXICANTS
 Nitrites/Nitrates I. INDUSTRIAL + HOUSHOLD TOXICANTS
o Inorganic Nitrates – preservatives: KNO3  Salt Peter;  Solvents – ex. alcohol, glycol, aldehydes, hydrocarbons;
NaNO3  Chile Salt ↑lipophilic = ↑chances CNS disturbances; aldehydes –
o Organic Nitrates – ISDN, glyceryl trinitrate generally irritating; amides – sensitizers  allergic reaction;
o Inorganic Nitrites – NaNO3 halogenated HC – cytotoxic; mutagenicity
o Mechanism of Toxicity o Ethylene Glycol – anti-freeze preparation
 Methemoglobin Formation
 ↑ cGMP  desphosphorylate myosin light chain 
smooth muscle relaxation  vasodilation
o Clinical Effects: cyanosis; dizziness; headaches;
lightheadedness; nausea; diarrhea; vomiting
o Treatment: methylene blue ↓ doses 1-2mg/kg
II. DEPRESSION OR STIMULATE CNS CAUSING COMA OR

CONVULSION
 Depression – coma; (ex. alcohol; sedative; hypnotics)
 Stimulate – convulsions; (ex. cocaine; sympathomimetics)
III. AFFECT THE AUTONOMIC NERVOUS SYSTEM,

PARASYMPATHETIC (ACh), SYMPATHETIC (NE/E), ENTERIC  Clinical Presentation
NERVOUS SYSTEM  1st Stage – (30 minutes to 12 hours); CNS depression
 Organophosphate + Carbamates – insecticides;  coma  ethanol intoxication
organophosphate  malathion, parathion; carbamates   2nd Stage – (12 hours to 98 hours); cardiopulmonary
edrophonium, physostigmine symptoms; tachypnea; tachycardia
o Mechanism of Toxicity – inhibit acetyl cholinesterase;
irreversibly (OP); reversibly (carbamates); muscarinic –
increase cholinergic activity (DUMBBELS); nicotinic – muscle
 Treatment: II. ACIDS + ALKALIS – household bleach; drain cleaners;
 Ethanol – competes with alcohol dehydrogenase disinfectant
 Thiamine/Pyridoxine – facilitate conversion to α-  Mechanism of Toxicity
hydroketoadipate glycine o Acids – coagulation necrosis – eschor (protective)  deeper
 Leucovorin – facilitate conversion of formate  CO2 layer (protects)
 Fomepizole – aka 4-methylpyrazole; alcohol o Bases – liquefactive necrosis  deeper penetration
dehydrogenase inhibitor  Treatment – supportive; surgery  perforation; avoid
 Methanol – colorless liquid volatile at room neutralization and dilution
temperature
methanol (non-toxic)  metabolites (formic acid) III. HEAVY METALS
toxic  Common MOT – binds sulfhydryl groups of enzymes causing
methanol –[o]-> formaldehyde –[o]-> formic acid inactivation; treated with chelators
o Formic Acid – inhibits cytochrome oxidase in optic
nerve blindness VI. CHELATOR PHARMACOLOGY
o Clinical Presentation  substances that has lone pair of e- (-NH, -SH, -OH)
 Metabolic Acidosis
 Deferoxamine – complexes with ferric ion  hexadentate
hyperventilation – compensation; pale +
complex ferrioaxime  urine; does not bind with Hgb,
clammy skin
cytochrome
confusion/lethargy – decrease; intracerebral
 Dimercaprol – British Anti-Lewisite (BAL); Lewisite – arsenic
pH
gas; first commercially available chelator; As, Au, Hg; adjunct
hypotension – H+ (negative inotrope);
with severe Pb poisoning (CaEDTA); forms stable dimercaptide
myocardial depression
(dimercaprol [2:1] metal); most toxic among all chelator;
arrhythmia – H+  K+ shifts outside cells
median lethal dose is 1 mmcl/kg; ↑systolic + diastolic BP by 50
 Blindness – treatment: ethanol – competes with
mmHg; pain in injection site
alcohol dehydrogenase
o Counter Indication – Cd, Se, Tc, Fe and organomercurial 
o Formaldehyde – colorless liquid with pungent odor;
increases tissue uptake
embalming liquid
 Dimercaptosuccinic Acid/Succimer/DMSA – water soluble
 Clinical Effects:
form of BAL; orally
 Local Effects – mucosal irritation; (oral, oropharyngeal,
 D-penicillamine – cuprimine; oral chelator, monothiol; DOC
conjunctiva)
for Cu toxicity (Wilson’s Disease); bind Fe, Hg, Pb, Zn, As
 Metabolic Acidosis
possibly other heavy metals
o Hydrocarbons and Petroleum Distillates
o Counter Indication – penicillin allergy
 Hydrocarbons – organic compounds H and C
 CaEDTA – binds both divalent and trivalent metals; forms H2O
 Distillates – mixture of aromatic and aliphatic HC
soluble complex  kidneys; used for Cd, Co, Cu, U, Zn
 Physical Properties
poisoning
 High Volatility, Minimal Viscosity – simple gases such
as methane and butane
 Intermediate Volatility, Low Viscosity – gasoline and VII. HEAVY METALS
turpentine  Arsenic – lewisite metal; Salvarsan, Arsphenamine
 Low Volatility, Low Viscosity – petroleum spirits, o Clinical Presentation – Mee’s Line – white lines in nails;
kerosene milky + rosy complexion; abnormal weight gain
 Minimal Volatility, High Viscosity – lubricating oil, o Treatment – BAL; BAL + penicillamine (severe)
mineral oil  Lead – leaded gasoline; paint; newspapers; earthenwave;
 Mode of Transmission – aspiration associated with automobile exhaust
increasing volatility but decreasing viscosity - ↑irritation o Kinetics – t½ (bones) = 32 years; t½ (kidneys) = 7 years
to the lungs o MOT: interferes with heme synthesis  cytochrome
 Clinical Presentation – burning sensation; choking; production  anemia
coughing; gagging; atelectasis and bronchopneumonia; o Clinical Presentation – peripheral neuropathy – wrist drop,
CNS manifestation foot drop; anemia; encephalopathy – ataxia, delirium, coma,
 Treatment – respiratory support; selective β2 agonist  ↓IQ
bronchospasm; mineral oil  ↑viscosity ↓aspiration o Treatment – CaEDTA; BAL; succimer; DMSA; DMPs
 Cadmium – causes Itai-Itai disease
o MOT – displaces Ca2+ in bones
o Clinical Presentation X. HERBICIDES
 Osteomalacia, Fracture, Renal Abnormalities – fanconi-
 bipyridyl herbicides; MOT: inhibition of superoxide mutase
like syndromes
 Paraquat – pulmonary fibrosis; hemorrhage; edema
 Fanconi Syndrome – proteinuria; aminoaciuria; glucosuria
 Diquat – burning pain in mouth; throat chest; upper
and ↓phosphate reabsorption
abdomens; pulmonary edema; pancreatitis; renal damage;
 Gait Disturbances
CNS effects
o Treatment – EDTA
 Mercury – quicksilver; Minamata Disease
o Types: XI. MEDICAL TOXICOLOGY
 Elemental Hg – thermometers; amalgam I. ANALGESICS
 Inorganic Hg – HgCl2 (corrosive sublimate); Hg2Cl2  Aspirin
(calomel) o Reye’s Syndrome – fatty liver + hepatic encephalopathy due
 Organic Hg – thimerosal (merthiolate) to ASA in children after viral infection
o Clinical Presentation – acrodynia/pink disease – pink palm o MOT – direct effect on CNS  respiratory alkalosis +
and soles; irritability; photophobia bicarbonaturia; severe cases: CNS respi center 
o Treatment – BAL – inorganic; penicillamine – low level Hg; respiratory acidosis; uncoupling of oxidative
Na formaldehyde sulfoxinate – most useful antidote phosphorylation  hyperthermia; inhibition of
 Iron – caused by ingestion of Fe tablets among children aminotransferase in Kreb’s cycle  metabolic acidosis;
o Clinical Presentation – GI hemorrhage salicylic acids  metabolic acidosis
o Treatment – Deferoxamine o Clinical Presentation
 Copper – probably binds to hepatic enzymes  free radicals  Mild – salicylism – tinnitus; hyperthermia;
 hepatic injury and renal tubular injuries hyperventilation
o Clinical Presentation  Severe – hallucinations; acid base balance disturbances
 Acute kidney/liver injury  kidney/liver failure  Fatal – respiratory depression
 Kaiser-Fleischer rings  copper deposits of limbs of o Treatment – activated charcoal; forced alkaline diuresis;
cornea gastric lavage; emesis; ice blanket (hyperthermia); NaHCO3
o Treatment – penicillamine solution (acidosis)
 Acetaminophen – paracetamol
VIII. INSECTICIDES – include OP + carbamates
 Chlorinated HC – lidocaine; chlordane; DDT; neurotoxin
o MOT – after Na+/K+ flux (myocardial irritation)  CNS
hyperexcitability
o Clinical Presentations – CNS excitations – tremors,
headaches, agitation, seizures, disorientation, coma;
respiratory depression; nausea + vomiting
 Pyrethoids – more commonly used in insecticides; 1000x more o MOT – hepatic injury
toxic to insect than man o Clinical Manifestation – non-specific; nausea, vomiting,
o MOT – ↑Na conductance +; ↓Cl conductance – abdominal pain; jaundice
o Clinical Effects – dizziness; headache; fatigue; o Treatment – N-acetylcysteine (Fluimucil®)
seizure/coma
II. ISONIAZID – inhibits pyridoxal phosphokinase; presentation –
IX. RODENTICIDES signs of liver failure, irritability, seizure; isoniazid metabolites 
 Coumarin Derivatives – MOT: inhibits vitamin K dependent toxic (hepatic)
clotting factors; Treatment: vitamin K (phytonadione)
 Phosphrous III. DRUGS OF ABUSE
o Yellow – waxy; fat-soluble; highly poisonous  Opioids and Opiates
o Red – granular; non-absorbed; non-poisonous o MOT – stimulation of opioid receptors
o Clinical Presentations – luminous vomitus or stool with o Clinical Presentation – pinpoint pupils; coma; respiratory
garlic odor; hypocalcemia; cardiac arrhythmia; coma; depression
cardiac arrest o Treatment – antidote: Naloxone – competitive opioid
o Treatment – CuSO4 lavage; BZD – for seizures antagonist

 Sedative Hypnotics – BZDs/Barbiturates
o Clinical Presentation – drowsiness; ataxia; somnolence;
confusion
o Treatment – BZD (Flumenzenil)
 Hallucinogen – no specific antidotes
o Lysergic Acid Diethylamide (LSD) – ergot derivative
 MOT – targets 5HT2a receptors  hallucination
 Clinical Presentation – HTN; tremors; vomiting; profound
mydriasis
o Amphetamine + Related Compounds
 Ecstasy – MDMA; cocaine
 MOT – stimulate adrenergic receptors  releases NE
 Clinical Presentation – bruxism (teeth grinding);
hyperthermia (most toxic); hypertension
 Treatment – Labetalol; Na Nitroprusside
o Phencylidine – angel dust; ketamine-like  dissociative
anesthesia
 Clinical Presentation – disorganized thought process;
nystagmus; hypertension
o Marijuana – hashish; hashoids; active: THC  delta-9-
tetrahydrocannabinoids; most commonly used illegal drugs
 MOT – stimulates cannabinoid receptors  CNS
 Clinical Presentation – tachycardia; rhinitis; increase
appetite; impaired short-term memory; impaired reaction
time; acute psychosis; bizarre behavior; motor
disturbances
o Alcohol
 MOT – CNS depressant – rostral to caudal progression;
GABA ergic; acid-base disturbances; respiratory acidosis =
decrease CNS respiratory center; metabolic alkalosis =
increase vomitus; metabolic lactic acidosis  lactic acid
 Clinical Presentation – metabolic acidosis; coma;

hyperthermia; hypoglycemia
 Treatment
o Vit B1 + glucose – Wernicke-Korsakoff Syndrome
o Severe – hemodialysis
o Dehydration – IV fluid; supportive
IV. AIR POLLUTANTS

 CO, NO, SO2 + O3; airway irritation; pulmonary edema
 Chronic – gradual
 Lung Damage – chronic cardiopulmonary disease

TOXICOLOGY
-----------------------------------------------------------------
I. INTRODUCTION III. POISONS

 Toxicology – study of poison, its mechanism of action, and its I. EFFECTS OF POISIONS
management; study of adverse effects/events of  According To Extent/Location
physical/chemical agents in humans, other organism and o Local – ex. Phenol
environment o Remote – ex. Paraquat  pulmonary fibrosis
 Poisons: (1) Mechanism of Toxicity; (2) Functional Effects; (3) o Systemic – ex. Metabolic Acidosis
Probability of Occurrence  According To Duration
 Risk Assessment – estimate potential effect on human health o Acute – ↑dose in short period of time
and environmental significance of various types of chemical o Chronic – ↓dose in longer period of time
exposure
 Areas of Toxicology II. FACTORS THAT INFLUENCE EFFECTS OF POISON
o Mechanistic – mechanism of toxicity  Route
o Descriptive – direct toxicity testing o Oral – most common/important; ↑A = lipid; ↓GER = delay
o Regulatory – decision making process using information absorption (ex. anticholinergic)
from: mechanistic and descriptive (asses safety) o Dermal – lipid soluble = ↑damage; ↑absorption – (ex.
 Specialized Areas of Toxicology phenol)
o Clinical Toxicology – study of adverse effects in humans o Inhalation – gases/particle < 0.5µm; systemic or local effects
caused by incidental/accidental overdose o Intravenous
o Environmental Toxicology – impact of pollutants to non- o Intramuscular
human organism o Rectal
o Forensic Toxicology – medicolegal  Concentration – ↑concentration = ↑toxicity
 Patient Related Factor
II. TOXICOKINETICS o Age
 Pediatric
I. ABSORPTION
 Child Inutero
 Parameters: Bioavailability (F) – rate and extent of absorption;
o 1-2 weeks – conception/implantation; abortion
extent/fraction of drug that enters systemic circulation
o 3-8 weeks – embryogenesis period; morphologic
 Affected by:
change (ex. ACE I)
o Physical Properties – lipid soluble = ↑extent; water soluble
o > 8 weeks – minor physiologic changes
= ↑rate
 Examples:
o Gastric Emptying Rate - ↓GER = ↓absorption
o Tetracycline – teeth discoloration and bone
o Health of GI Tract
problems
o First Pass Effect – hepatic metabolic
o ACE Inhibitors – renal dysgenesis
o Diethylstibestrol – uterine/cervical cancer to
II. DISTRIBUTION
daughter
 Parameters: Volume of Distribution (Vd)
𝑑𝑜𝑠𝑒 o Thalidomide – phocomelia  limb deformities
𝑉𝑑 =
𝑝𝑙𝑎𝑠𝑚𝑎 𝑐𝑜𝑛𝑐𝑒𝑛𝑡𝑟𝑎𝑡𝑖𝑜𝑛
 Affected by: Protein Binding – ↓BP = ↓VD
III. METABOLISM AND EXCRETION

 Parameter: Clearance – rate by which a known volume of
plasma is cleared by drug
 Affected by: Liver and Kidney Function

 Geriatric - ↓liver/kidney function; ↓muscle mass; ↑fat  Counterindicated – absence of bowel sounds;
deposition evidence of intestinal obstruction; pre-existing
 Tolerance/Tachyphylaxis – increase dose to get same electrolytes imbalance; renal dysfunction; GI bleeding
effect; (ex. Nitrates; Morphine)  Whole Bowel Irrigation – administer with PEG with
 Idiosyncracy & Pharmacogenetics electrolytes until completely cleansed
o G6PD Deficiency – triggers: antimalarial, sulfadrugs,  Endgoal – effluent is same color of infusate
analgesics (ASA), acetanilide, antibiotics (Nalidixic  Indication – substances are poorly absorbed (ex. Li, Fe,
Acid), INH, nitrofurantoin Pb); slow release of preparations; late presentation
RBC = HEMOLYTIC ANEMIA (takes 2-4 hours)
 Forced Diuresis/pH Manipulation – kidneys  filtration,
GLUTATHIONE
OA
GLUTATHIONE
reabsorption, secretion;
(reduced form) (oxidized form)  Examples: salicyliates + NaHCO3 (alkalizer);
G6PD
amphetamine + Vit. C or NH4Cl (acidifier)
o Pseudocholinesterase Deficiency – ex. o Inhalation – remove from hazardous environment; (+) 100%
succinylcholine  malignant hyperthermia humidified O2; assisted ventilation; bronchodilators
o NAT2 Polymorphism – ex. Isoniazid  fast o Dermal Exposures – remove exposed clothes; rinse with
acetylators: Asians; slow acetylators: Caucasians copious H2O in 30 minutes
o Ocular Exposures – irrigate with saline solution for 15
III. MANAGEMENT OF POISONED PATIENT minutes with eyelids retracted
 Primary Survey – (ABCDE) o Extracorporeal Methods
o Airway  Hemodialysis – passing of blood through a semi-
o Breathing permeable membrane with counter current dialysate
o Circulation flow, allowing passage of solute
o Disability  Dialyzable Toxins:
o Exposure – remove clothing for better evaluation o Low Vd – (< 1L/kg)
 Secondary Survey – history (SATS – substance, amount, time, o Protein Binding < 50%
symptoms)and physical examination o Low MW – < 600 daltons
 Management – diagnostics and therapeutics  Supportive Measure – (A,E,I,O,U)
 Decontamination o Acid-Base disturbances that are unresponsive
o Ingestion o Electrolyte disturbances that are unresponsive
 Lavage – passage of tube via mouth or nose down to o Intensive Care disturbances that are unresponsive
stomach followed by sequential administration of warm o Overhydration
saline solution and removal of small volume of liquids o Uremia
 Dilution/Neutralization – counterindicated in alkali and  Hemoperfusion – blood passes through an adsorbent
acids (charcoal)
 Emesis – Syrup of Ipecac – toxin does not cause rapid  Indications – highly protein bound; high Vd; lipid
onset coma/convulsion  aspiration soluble
 Counterindicated:  Peritoneal Dialysis – least invasive; 10-15% as effective
o Children < 6 years old – underdeveloped airway than hemodialysis
protection mechanism
o Agents which may cause comatose – alcohol; short IV. COMMON MAJOR PATHOPYSIOLOGIC
acting barbiturates; non-barbiturates hypnotics; TCA
o Agents causes rapid onset convulsions – beta MECHANISM
blockers; calcium channel blockers; chloroquine; I. INTERFERE WITH O2 UTILIZATION
camphor; codein; TCA; mefenamic acid; Respiration  O2 transport  cellular respiration
organophosphate; strychnine; phencyclidine Energy Production: Glycolysis  Kreb’s Cycle  Electron
(angel’s dust) Transport Chain (ETC)  O2, ATP, CO2
 Activated Charcoal – adsorbs toxin  Carbon Monoxide – product of incomplete combustion;
 Gastrointestinal Dialysis – repeated dose of charcoal; presentation: pallor; headache; vertigo; cherry red skin (post
creates concentration gradient between intestinal mortem)
lumen and plasma CO + Hgb  methemoglobin (↑affinity to O2) = hypoxia
 Cathartics – saline cathartics

 Hydrogen Sulfide – rotten egg odor; hot springs; highly toxic, weakness + fasciculations, adrenal medulla = increase
colorless gass; irritation of mucous membrane, respiratory epinephrine activity, tachycardia, cramping, hypertension
depression; treated by: amyl nitrite (inhalation) and NaNO 2 o Treatment
(IV), methemoglobin + sulfide ion  sulfmethoglobin,  Atropine – anticholinergic
hypertonic O2  Pralidoxime – early poisoning (24-36 hours); reverse bond
blocks cytochrome  blocks O2 utilization between acetylcholinesterase and organophosphate by
 Cyanide – found in prunus spp. (wild blackberry; bitteralmond; forming an oxime phosphate bond to release ACh E; done
apricot), cassava, lima beans, silver jewelry cleaner before aging into a covalent bond
Inhibits cytochrome oxidase = ↓O2 utilization
o Clinical Effects: CNS disturbances; death from seizure and IV. AFFECT VASCULATURE AND HEART
central respiratory depression  hypotension or cardiac arrhythmia; (ex. nitroglycerin)
o Treatment: ↑cGMP  relax smooth muscle  vasodilation
 12
V. AFFECTS LUNGS EITHER SYSTEMICALLY OR LOCALLY
 Paraquat – systemically
 Aspiration – locally
VI. LOCAL DAMAGE

 Phenol – aka carbolic acid; denatures protein; presentation:
burning sensation, tingling, numbness, leaves a burn mark;
treatment: castor oil or PEG
VII. DELAYED EFFECTS ON LIVER AND KIDNEY – (ex.

acetaminophen; heavy metals)
 Hydroxycobalamin (B12) – binds with CN 
cyanocobalamin
 Methylene Blue – high dose to produce methemoglobin V. SPECIFIC TOXICANTS
 Nitrites/Nitrates I. INDUSTRIAL + HOUSHOLD TOXICANTS
o Inorganic Nitrates – preservatives: KNO3  Salt Peter;  Solvents – ex. alcohol, glycol, aldehydes, hydrocarbons;
NaNO3  Chile Salt ↑lipophilic = ↑chances CNS disturbances; aldehydes –
o Organic Nitrates – ISDN, glyceryl trinitrate generally irritating; amides – sensitizers  allergic reaction;
o Inorganic Nitrites – NaNO3 halogenated HC – cytotoxic; mutagenicity
o Mechanism of Toxicity o Ethylene Glycol – anti-freeze preparation
 Methemoglobin Formation
 ↑ cGMP  desphosphorylate myosin light chain 
smooth muscle relaxation  vasodilation
o Clinical Effects: cyanosis; dizziness; headaches;
lightheadedness; nausea; diarrhea; vomiting
o Treatment: methylene blue ↓ doses 1-2mg/kg
II. DEPRESSION OR STIMULATE CNS CAUSING COMA OR

CONVULSION
 Depression – coma; (ex. alcohol; sedative; hypnotics)
 Stimulate – convulsions; (ex. cocaine; sympathomimetics)
III. AFFECT THE AUTONOMIC NERVOUS SYSTEM,

PARASYMPATHETIC (ACh), SYMPATHETIC (NE/E), ENTERIC  Clinical Presentation
NERVOUS SYSTEM  1st Stage – (30 minutes to 12 hours); CNS depression
 Organophosphate + Carbamates – insecticides;  coma  ethanol intoxication
organophosphate  malathion, parathion; carbamates   2nd Stage – (12 hours to 98 hours); cardiopulmonary
edrophonium, physostigmine symptoms; tachypnea; tachycardia
o Mechanism of Toxicity – inhibit acetyl cholinesterase;
irreversibly (OP); reversibly (carbamates); muscarinic –
increase cholinergic activity (DUMBBELS); nicotinic – muscle
 Treatment: II. ACIDS + ALKALIS – household bleach; drain cleaners;
 Ethanol – competes with alcohol dehydrogenase disinfectant
 Thiamine/Pyridoxine – facilitate conversion to α-  Mechanism of Toxicity
hydroketoadipate glycine o Acids – coagulation necrosis – eschor (protective)  deeper
 Leucovorin – facilitate conversion of formate  CO2 layer (protects)
 Fomepizole – aka 4-methylpyrazole; alcohol o Bases – liquefactive necrosis  deeper penetration
dehydrogenase inhibitor  Treatment – supportive; surgery  perforation; avoid
 Methanol – colorless liquid volatile at room neutralization and dilution
temperature
methanol (non-toxic)  metabolites (formic acid) III. HEAVY METALS
toxic  Common MOT – binds sulfhydryl groups of enzymes causing
methanol –[o]-> formaldehyde –[o]-> formic acid inactivation; treated with chelators
o Formic Acid – inhibits cytochrome oxidase in optic
nerve blindness VI. CHELATOR PHARMACOLOGY
o Clinical Presentation  substances that has lone pair of e- (-NH, -SH, -OH)
 Metabolic Acidosis
 Deferoxamine – complexes with ferric ion  hexadentate
hyperventilation – compensation; pale +
complex ferrioaxime  urine; does not bind with Hgb,
clammy skin
cytochrome
confusion/lethargy – decrease; intracerebral
 Dimercaprol – British Anti-Lewisite (BAL); Lewisite – arsenic
pH
gas; first commercially available chelator; As, Au, Hg; adjunct
hypotension – H+ (negative inotrope);
with severe Pb poisoning (CaEDTA); forms stable dimercaptide
myocardial depression
(dimercaprol [2:1] metal); most toxic among all chelator;
arrhythmia – H+  K+ shifts outside cells
median lethal dose is 1 mmcl/kg; ↑systolic + diastolic BP by 50
 Blindness – treatment: ethanol – competes with
mmHg; pain in injection site
alcohol dehydrogenase
o Counter Indication – Cd, Se, Tc, Fe and organomercurial 
o Formaldehyde – colorless liquid with pungent odor;
increases tissue uptake
embalming liquid
 Dimercaptosuccinic Acid/Succimer/DMSA – water soluble
 Clinical Effects:
form of BAL; orally
 Local Effects – mucosal irritation; (oral, oropharyngeal,
 D-penicillamine – cuprimine; oral chelator, monothiol; DOC
conjunctiva)
for Cu toxicity (Wilson’s Disease); bind Fe, Hg, Pb, Zn, As
 Metabolic Acidosis
possibly other heavy metals
o Hydrocarbons and Petroleum Distillates
o Counter Indication – penicillin allergy
 Hydrocarbons – organic compounds H and C
 CaEDTA – binds both divalent and trivalent metals; forms H2O
 Distillates – mixture of aromatic and aliphatic HC
soluble complex  kidneys; used for Cd, Co, Cu, U, Zn
 Physical Properties
poisoning
 High Volatility, Minimal Viscosity – simple gases such
as methane and butane
 Intermediate Volatility, Low Viscosity – gasoline and VII. HEAVY METALS
turpentine  Arsenic – lewisite metal; Salvarsan, Arsphenamine
 Low Volatility, Low Viscosity – petroleum spirits, o Clinical Presentation – Mee’s Line – white lines in nails;
kerosene milky + rosy complexion; abnormal weight gain
 Minimal Volatility, High Viscosity – lubricating oil, o Treatment – BAL; BAL + penicillamine (severe)
mineral oil  Lead – leaded gasoline; paint; newspapers; earthenwave;
 Mode of Transmission – aspiration associated with automobile exhaust
increasing volatility but decreasing viscosity - ↑irritation o Kinetics – t½ (bones) = 32 years; t½ (kidneys) = 7 years
to the lungs o MOT: interferes with heme synthesis  cytochrome
 Clinical Presentation – burning sensation; choking; production  anemia
coughing; gagging; atelectasis and bronchopneumonia; o Clinical Presentation – peripheral neuropathy – wrist drop,
CNS manifestation foot drop; anemia; encephalopathy – ataxia, delirium, coma,
 Treatment – respiratory support; selective β2 agonist  ↓IQ
bronchospasm; mineral oil  ↑viscosity ↓aspiration o Treatment – CaEDTA; BAL; succimer; DMSA; DMPs
 Cadmium – causes Itai-Itai disease
o MOT – displaces Ca2+ in bones
o Clinical Presentation X. HERBICIDES
 Osteomalacia, Fracture, Renal Abnormalities – fanconi-
 bipyridyl herbicides; MOT: inhibition of superoxide mutase
like syndromes
 Paraquat – pulmonary fibrosis; hemorrhage; edema
 Fanconi Syndrome – proteinuria; aminoaciuria; glucosuria
 Diquat – burning pain in mouth; throat chest; upper
and ↓phosphate reabsorption
abdomens; pulmonary edema; pancreatitis; renal damage;
 Gait Disturbances
CNS effects
o Treatment – EDTA
 Mercury – quicksilver; Minamata Disease
o Types: XI. MEDICAL TOXICOLOGY
 Elemental Hg – thermometers; amalgam I. ANALGESICS
 Inorganic Hg – HgCl2 (corrosive sublimate); Hg2Cl2  Aspirin
(calomel) o Reye’s Syndrome – fatty liver + hepatic encephalopathy due
 Organic Hg – thimerosal (merthiolate) to ASA in children after viral infection
o Clinical Presentation – acrodynia/pink disease – pink palm o MOT – direct effect on CNS  respiratory alkalosis +
and soles; irritability; photophobia bicarbonaturia; severe cases: CNS respi center 
o Treatment – BAL – inorganic; penicillamine – low level Hg; respiratory acidosis; uncoupling of oxidative
Na formaldehyde sulfoxinate – most useful antidote phosphorylation  hyperthermia; inhibition of
 Iron – caused by ingestion of Fe tablets among children aminotransferase in Kreb’s cycle  metabolic acidosis;
o Clinical Presentation – GI hemorrhage salicylic acids  metabolic acidosis
o Treatment – Deferoxamine o Clinical Presentation
 Copper – probably binds to hepatic enzymes  free radicals  Mild – salicylism – tinnitus; hyperthermia;
 hepatic injury and renal tubular injuries hyperventilation
o Clinical Presentation  Severe – hallucinations; acid base balance disturbances
 Acute kidney/liver injury  kidney/liver failure  Fatal – respiratory depression
 Kaiser-Fleischer rings  copper deposits of limbs of o Treatment – activated charcoal; forced alkaline diuresis;
cornea gastric lavage; emesis; ice blanket (hyperthermia); NaHCO3
o Treatment – penicillamine solution (acidosis)
 Acetaminophen – paracetamol
VIII. INSECTICIDES – include OP + carbamates
 Chlorinated HC – lidocaine; chlordane; DDT; neurotoxin
o MOT – after Na+/K+ flux (myocardial irritation)  CNS
hyperexcitability
o Clinical Presentations – CNS excitations – tremors,
headaches, agitation, seizures, disorientation, coma;
respiratory depression; nausea + vomiting
 Pyrethoids – more commonly used in insecticides; 1000x more o MOT – hepatic injury
toxic to insect than man o Clinical Manifestation – non-specific; nausea, vomiting,
o MOT – ↑Na conductance +; ↓Cl conductance – abdominal pain; jaundice
o Clinical Effects – dizziness; headache; fatigue; o Treatment – N-acetylcysteine (Fluimucil®)
seizure/coma
II. ISONIAZID – inhibits pyridoxal phosphokinase; presentation –
IX. RODENTICIDES signs of liver failure, irritability, seizure; isoniazid metabolites 
 Coumarin Derivatives – MOT: inhibits vitamin K dependent toxic (hepatic)
clotting factors; Treatment: vitamin K (phytonadione)
 Phosphrous III. DRUGS OF ABUSE
o Yellow – waxy; fat-soluble; highly poisonous  Opioids and Opiates
o Red – granular; non-absorbed; non-poisonous o MOT – stimulation of opioid receptors
o Clinical Presentations – luminous vomitus or stool with o Clinical Presentation – pinpoint pupils; coma; respiratory
garlic odor; hypocalcemia; cardiac arrhythmia; coma; depression
cardiac arrest o Treatment – antidote: Naloxone – competitive opioid
o Treatment – CuSO4 lavage; BZD – for seizures antagonist

 Sedative Hypnotics – BZDs/Barbiturates
o Clinical Presentation – drowsiness; ataxia; somnolence;
confusion
o Treatment – BZD (Flumenzenil)
 Hallucinogen – no specific antidotes
o Lysergic Acid Diethylamide (LSD) – ergot derivative
 MOT – targets 5HT2a receptors  hallucination
 Clinical Presentation – HTN; tremors; vomiting; profound
mydriasis
o Amphetamine + Related Compounds
 Ecstasy – MDMA; cocaine
 MOT – stimulate adrenergic receptors  releases NE
 Clinical Presentation – bruxism (teeth grinding);
hyperthermia (most toxic); hypertension
 Treatment – Labetalol; Na Nitroprusside
o Phencylidine – angel dust; ketamine-like  dissociative
anesthesia
 Clinical Presentation – disorganized thought process;
nystagmus; hypertension
o Marijuana – hashish; hashoids; active: THC  delta-9-
tetrahydrocannabinoids; most commonly used illegal drugs
 MOT – stimulates cannabinoid receptors  CNS
 Clinical Presentation – tachycardia; rhinitis; increase
appetite; impaired short-term memory; impaired reaction
time; acute psychosis; bizarre behavior; motor
disturbances
o Alcohol
 MOT – CNS depressant – rostral to caudal progression;
GABA ergic; acid-base disturbances; respiratory acidosis =
decrease CNS respiratory center; metabolic alkalosis =
increase vomitus; metabolic lactic acidosis  lactic acid
 Clinical Presentation – metabolic acidosis; coma;

hyperthermia; hypoglycemia
 Treatment
o Vit B1 + glucose – Wernicke-Korsakoff Syndrome
o Severe – hemodialysis
o Dehydration – IV fluid; supportive
IV. AIR POLLUTANTS

 CO, NO, SO2 + O3; airway irritation; pulmonary edema
 Chronic – gradual
 Lung Damage – chronic cardiopulmonary disease

MODULE 5
 PHARMACEUTICS
 MANUFACTURING PHARMACY
 PHARMACEUTICAL DOSAGE FORMS
 PHYSICAL PHARMACY
 JURISPRUDENCE & ETHICS
Manufacturing Pharmacy
Drugs DRUG ESTABLISHMENTS
Drug Products 1. Drug Manufacturer means any establishment engaged in operations
Drug Establishments involved in the production of a drug, including
Drug Manufacturer
Drug Trader
propagation, processing, compounding, finishing,
Drug Importer filling, packing, repacking, altering, ornamenting and
Drug Exporter labeling with the end in view of storage, distribution
Drug Departments or sale of the product: provided that for the purpose
Dosage Form of this regulation the compounding and filling of
Liquid Dosage Forms
prescriptions in drugstores and hospital pharmacies
Solution
Suspension shall not be considered as production operations.
Emulsion a. Ethical Manufacturers
Sterile Products b. Proprietary/ Generic Manufacturers
Other Areas c. Biologicals Manufacturers
Packaging, Labeling & Storage of Drugs
d. Veterinary Products manufacturer
Quality Control
Drug Cosmetics
e. Medicinal Chemical Manufacturers
f. Toll/Contract Manufacturers
MANUFACTURING  the manufacture, propagation, preparation & 2. Drug Trader means any establishment which is a registered owner of the
processing of a drug product in a large scale drug product, procures the materials and packaging
components, and provides the production monographs,
the making by physical, chemical, biological, or any
quality control standards and procedures, but sub-contracts,
other procedure of any article that meets the
the manufacture of such product to a licensed manufacturer.
definition of drugs
In addition, a trader may also engage in distribution, and/or
the manipulation, sampling, testing, or control
marketing of its products.
procedures applied to the final product or any other
3. Drug Distributor/Importer means any establishment that imports raw
part of the process
materials, active ingredients and/or finished
the packaging, repacking, or changing the container,
products for its own use or for wholesale
wrapper or label of any drug package in preparation
distribution to other drug establishments or
for its distribution from the manufacturer to the final
outlets.
user
4. Drug Distributor/Exporter means any drug establishment that exports
mass production of drug products
raw materials, active ingredients and/or
Extemporaneous Compounding  small scale preparation of drug products finished products to another country.
prescription order 5. Drug Distributor/Wholesaler means any drug establishment that exports
specific for a particular patient raw materials, active ingredients and/or
finished products from local establishments
Drugs for diagnosis, prevention, cure, treatment & mitigation of disease in for local distribution on wholesale basis.
man or animals
 recognized in USP or official compendia DEPARTMENTS IN A DRUG ESTABLISHMENT
affect structure & function 1. Research Department  “patent”; “evergreening”
 used as component of the above articles 2. Production Department  involves in actual manufacturing drugs
3. Quality Control Department
Drug Product  finished dosage form w/ or without active ingredients or a 4. Marketing Department responsible for the sale & distribution of drugs
“Placebo” 5. Engineering Department  for installation
Dosage Form  drug & additives 6. Purchasing Department  responsible for procuring raw materials &
 means the pharmaceutical form of the preparation based on packaging materials
official pharmacopoeia. 7. Medical Department  perform clinical studies
Batch  produced from a single order within same cycle of  for physical & health examination
manufacturing
 means a quantity of any drug or device produced during a
given cycle of manufacture. Current Good Manufacturing Practices (cGMP)
Lot  specified portion of batch chapter 21 of the Code of Federal Reguralations Part 211
Batch/ Lo Number  for identification were first promulgated by the US Food & Drug Administration
-Batch number  means a designation printed on the label of a (FDA) in 1963; & finalized in 1979.
drug or device that identifies the batch, and permits were established to ensure that minimum standards are met for
the productions history of the batch including all drug product quality
stages of manufacture and control, to be traced and other cGMPs: UK, European Economic Council, WHO, ASEAN
reviewed.
-Lot number refers to any distinctive combinations of letters
and/or numbers assigned to a particular lot, herein
defined as a portion of a batch.
Liquid Dosage Forms 5.Filling & Packaging
Solution *Gravimetric Filling  for mobile & frothy solutions
*Vacuum Filling  for viscous solutions
General Formulation:
*Pressure Filling  for viscous solutions
1. Active Ingredients  consider solubility & stability
2.Solvent  consider clarity, toxicity, viscosity, comparability, palatability
 water (best solvent) Suspension
3. Co-solvent  used in combination with the solvent to increase General Formulation:
solubility of the solute 1. Active Ingredients  should be insoluble
 Ethanol, Sorbitol, Glycerin, Propylene Glycol,  must be uniformly dispersed
Polyethylene Glycol 2.Dispersion medium  Aqueous /Non-aqueous
4. Solubilizer  surfactant (Tweens) 3. Wetting Agent  displaces the air from crevices of drug particles
5. Viscosity Enhancer/ Controller  improves pourability  Glycerin, Sorbitol Solution, Syrup
& to some extent, palatability 4. Solubilizer  surfactant (Tweens)
 Sugar, PVP, 5. Suspending Agent (Viscosity Enhancer)
Cellulose Derivatives Hydrocolloids  Acacia, Tragacanth, Veegum, Cellulose der.
Classification of Viscosity Enhancing Agent: Clays  Bentonite, kaolin
~Ionic Polymer: Na CMC Others: Agar, Gelatin, Pectin, Gelatinized Starch
~Nonionic Polymer: Cellulose Derivative 6. Buffer
(MC, CMC) 7. Sweetening Agent
6. Buffer  controlling pH to maintain solubility & stability 8. Flavor
 most common; pH 4-7 9. Coloring Agent
 Citric Acid, lactic Acid, Glutaric Acid 10. Preservative
7. Sweetening Agent
8. Flavor General Scheme for Suspension Formulation:
9. Coloring Agent Problems:
10. Preservative  prevent microbial growth 1. Caking
Classification: 2. Partial Solubility of the active ingredient
~Acidic: Phenol(Carbolic Acid) oldest preserv. 3. Polymorphism of the active ingredient
Parabens  synergistic to each other
*Methyl  for molds
*Propyl  for yeasts
(Methyl:Propyl is 9:1)
Benzoic Acid
Sorbic Acid
~Mercurial: Thimerosal Emulsion
~Neutral: Chlorbutanol General Formulation:
~Quaternary Ammonium Salts (NH4): 1. Active Ingredient
Benzalkomium Chloride 2. Aqueous Phase
Cetylpuridium Chloride 3. Oleaginous Phase
General Steps in the Manufacture of Pharmaceutical Solutions: 4. Emulsifier
1. Preparation of formulation material & equipment 5. Antioxidants  protects the emulsified lipids which are
2. Compounding susceptible to oxidation
charge the solute to the solvent  Example: BHA, BHT, Tocopherol,
agitate w/ the use of mixers until solution is homogenous Ascorbic Acid, EDTA
heat may be employed to increase solubility 6. Preservative  should be effective for both phases
ensure complete solution before further processing 7. Sweetener
solutes in small concentrations (such as dyes & intensively 8. Flavoring Agent
colored materials) must be predissolved prior to mixing w/ the 9. Colorant
whole batch 10. Humectant  reduces the evaporation of moisture from the
3. Storage & Aging product
to allow complete blending of all the components  Example: Glycerin, Sorbitol, Propylene Glycol
4. Filtration & Clarification
aim for 3-5 micros or less Manufacturing Process
filter media: Cellulose Nitrate, 1. Oil Phase containing oil-soluble ingredients is heated at about
Polyamide 5-10C above the melting point of the ingredient w/ the
Polyvinylidene Chloride highest melting point.
Nylon 2. Aqueous Phase is heated to the same Temperature
*Types of Filtration: 3. The two phases are mixed.
Gravity Filtration  slow 4. Volatile ingredients are added at the lowest temperature as
Vacuum filtration  large scale possible (usually 45-55C)
Pressure Filtration  fast, to achieve highly polished prod. 5. Adjust the final weight when emulsion reaches 35C
*Classification:
Parallel Filtration  one type of filter Equipments
Series Filtration  more than one filter Mechanical Stirrers
*Types of Filter Paper: Colloid Mills
Fluted Filter Paper  if you need the “filtrate” Homogenizers
Ordinary Filter Paper  if you need the “residue”
Sterile Products
Sterile Preparations:
Categories:
solutions ready for injection
dry soluble products ready to be combined with a solvent prior
to use
suspensions ready for injection
dry soluble products ready to be combined w/ a vehicle prior to 2. Components (Formulation)
use a. Active Drug
emulsions ready for injection b. Solvent/ Vehicle  highest portion
liquid concentrates ready for dilution prior to use  usually Water for Injection, USP
Main Concerns in Parenteral Manufacture WFI  purified by distillation or
1. Production Facilities purification process
easy to clean, safe, sterile equivalent or superior to
5 Sections distillation in removing
a. Materials Support Area  surfaces should be continuous, chemicals & microorganisms
class 10,000 environment Aqueous
 constructed of impervious Water Miscible
materials Vegetable Oils
b. Compounding Area  most stringent control Non-Vegetable Oils
 stainless steel cabinets & counters, c. Other Excipients (Additives):
continuous surfaces Buffer
 Class 10,000 environment Preservative
(Class 100 Chelating Agent
max of 100 particles per feet Isotonicity Adjusting Agent
0.5m or larger) Example: NaCl, Mannitol
c. Aseptic Filling Area  heart of production area Goal: To diminish pain upon
 Laminar Air Flow (LAF) administration
w/ HEPA Filter (High Efficiency d. Container
Particulate Air) e. Closure/ Stoppers
 class 100 f. Production Procedure
sealed ceiling, wall floor g. HEPA Filter (High Efficiency Particulate Air Flow)
 stainless required for incoming air to achieve a class 100
condition
demountable parts for those
equipment in touch w/ product effluent air sweeping downstream at uniform velocity
 sterile cover-all for personnel normally 90ft/min  20% along parallel line
Laminar Air Flow  minimum eddy
 (+) air space
Turbulent  opposite of Laminar Air Flow
 air locks
99.97% efficient in removing from air 0.3 m particles
d. Quarantine Area  storage while waiting for QC results
generated by vaporized DOP (Dioctylphthalate) test
*Quarantine  Yellow
*Reject  Red
Parts (HEPA Filter)
*Accept  Green
B  Blower
e. Finishing Area
E  Electrostatic
P  Prefilter
MOA
-interception
-diffusion
-impaction
Test for Efficiency: DOP Test (air velocity

determination)
Design
Compunding Aseptic Quarantine
Stock Area Filling
Area Storage
Material
Finishing
Support Sterilization
Other Areas
A. Medicinal Plants
site selection
plant material is from one source during same harvest season
=authenticate
processing: Weigh/ Assign a Batch #

Washing

Drying

Garbing
(removal of extraneous materials)

Milling/ Sieving
(particle size reduction)

Storage
Phytochemical Screening
QC Test
Bioassay (Physicochemical & Microbilogical Test)
B. Modified Release Dosage Form

Advantage: Decrease in fluctuation of plasma drug level
Disadvantage: “Dose Dumping”
Requirements for Drug Candidate:
 uniform absorption
administered in small doses
good margin of safety
for chronic disease
Transdermal Drug Delivery System
passage drug from skin surface to systemic circulation
Device Design: Monolith/ Matrix
Rate-Limiting Membrane Type
Liposomes
 lipid bilayer
contains Phospholipids
 use for the delivery of anticancer drugs & dietary
supplements
C. Biopharmaceutical Drugs
produced by Biotechnology
Production:
Active Ingredient

Freeze Drying/ Lyophilization
(Food for the Incas)

Weighing

Fermentation

Filling/ Packaging
•Packaging, Labeling & Storage of Drugs Material Used for Packaging
1. Glass
Constitution of Official Glass Types
Packaging  an economical means of providing presentation,
Type General Description Uses Test
protection, preservation, identification, information,
containment, convenience, & compliance for a drug I Highly Resistant For parenteral Powdered
product Borosilicate Glass Glass Test
II Treated Soda Lime For parenteral Water
Glass Attack Test
Container  device that holds a drug & is or may be in direct contact w/
III Soda Lime Glass For Parenteral Powdered
the drug
Glass Test
Types:
IV General Purpose Soda Other Products Powdered
a. Primary Container  in contact w/ the product
Lime Glass except Parenterals Glass Test
 immediate container
 protect the preparation from the Powdered Glass Test  performed on ground/powdered glass
environment hazard to expose internal surface
b. Secondary Container  for presentation tests the leaching potential of the glass
 encloses the primary containers alkali titrated w/ 0.2N sulfuric acid
Water Attack Test  exposure of the glass
Classification of Containers: w/ sulfuric dioxide at 121C
1. Immediate Container  is that which is in direct contact w/ the Defect in Glass container:
article at all times Minor Defect: Seeds (appears as small bubbles in the glass)
Major Defect: Stone (a small inclusion of any non-glass
2. Well-closed Container  minimally acceptable container
material)
protects the contents from extraneous
Critical Defect: Pin Hole (any opening causing leakage)
solids & from loss of the article under
Limit Test (in mL of 0.020 N acid consumed)
ordinary conditions of handling,
shipment, storage, & distribution Type Test Size/ mL Limit/ mL
3. Tight Container  protects the contents from contamination by I Powdered Glass Test All 1.0
extraneous liquids. Solids, or vapors, from loss of II Water Attack Test 100 or less/ 0.7/0.2
the article, & from efflorence, deliquescence or over 100
evaporation under the ordinary or customary III Powdered Glass Test All 8.5
conditions of handling shipment, storage, & IV Powdered Glass Test All 150 mL
distribution & is capable of tight reclosure. 2. Plastic  does not apply to a single material but rather to a vast
4. Light Resistant Container  protects the contents from number of materials each developed to have desired
photochemical deterioration features
 amber, opaque, blue Advantage: Lightweight, Flexibility, resistance to impact.
5. Hermetic Container  is impervious to air or any other gas under Disadvantage: Permeability, Leaching, Sorption,
the ordinary or customary conditions of Transmission of light,
handling, shipment, storage, & distribution Alteration of container upon storage
 generally sterile Two Types: Thermoplastic: squeeze
Sterile Hermetic Containers  hold preparation intended for Thermoset: firm & light
injection or parenteral Plastic Materials:
administration 1. Polyvinyl Chloride (PVC)  produced when a chlorine atom is
Single-Dose Container  is one that holds a quantity of added to every other carbon in the
drug intended as a single dose polyethylene polymer.
& when opened, cannot be  is rigid & has good clarity
resealed w/ assurance that  useful in blister packaging
sterility has been maintained  has a significant drawback for packaging
 include: Fusion-sealed ampuls medical devices
Prefilled Syringes  it is unsuitable for gamma sterilization, a
Cartridges method that is being used increasingly.
Multiple-Dose Container  is a hermetic container that 2. Polyethylene (PE)  cannot be autoclave
permits withdrawal of  low-density (dropper & sprays)
successive portions of the  high-density (solid oral preparations)
contents w/out changing the 3. Polypropylene (PP)  autoclavable
strength or endangering the 4. Polyethylene Terephthalate (PET):
quality or purity of the -APET (Amorphous Polyethylene Terephthalate Glycol)
remaining portions -PETG (Polyethylene Terephthalate Glycol)
commonly called “Vials”  for beverages
 have excellent transparency & luster
 can be sterilized w/ gamma radiation
Problems Encountered in the use of Plastic Containers:
a. Permeability of the containers to atmospheric oxygen & to moisture
vapor
b. Leaching of the Constituents of the container to the internal contents
c. Absorption of drugs from the contents to the containers
d. Transmission of Lights through the container
e. Alteration to the container upon storage
3. Metal
4. Rubber
5. Paper & Board
Safety Packaging
1. Child-Resistant Container  one that is difficult for most children
under 5 years of age to open or gain
access to the contents or obtain a Other Container Materials
harmful amount of the contents Liner
 based on the principle that a young Inner Seal
child is unlikely to coordinate two or Rubber Stooper
more actions to achieve a successful Coil
opening Dessicant
2. Tamper-Resistant Container  uses an indication or barrier to entry Package Insert
that is distinctive by design, or must
employ an identifying characteristic
which if breached or missing can Permeability  is considered a process of solution & diffusion w/ the
reasonably be expected to provide penetrant dissolving in the plastic on one side &
visible evidence to consumers that diffusing through the other side.
tampering has occurred. Leaching  is a term used to describe the movement of component of
a container into the contents
EXAMPLES OF TAMPER-EVIDENT PACKAGING  may be influenced by:
PACKAGE TYPE TAMPER PROTECTION -temperature
Film wrapper Sealed around product and/or product -excessive agitation of the filled container
container; film must be cut or torn to -solubilizing effect of liquid contents on one or
remove product more of the polymer additives
Blister/strip pack Individually sealed dose units; removal Sorption  is a term used to indicate the binding of molecules to
requires tearing or breaking individual polymer materials, includes both adsorption & absorption.
compartment  occurs through chemical & physical means
Bubble pack Product and container sealed in plastic,
usually mounted on display card; Physical Inspection for Containers (Criteria)
plastic must be cut or broken open to 1. Shape
remove product 2. Volume
Shrink seal, band Band or wrapper shrunk by heat or 3. Finish
drying to conform to cap; must be torn 5. Diameter
to open package 6. Height
Foil, paper, Sealed individual packet; must be torn 7. Weight
plastic pouch to reach product 8. Thickness
Bottle seal Paper or foil sealed to mouth of 9. Color
container under cap; must be torn or 10. Clarity
broken to reach product 11. Leak
Tape seal Paper or foil sealed over carton fl ap or 12. Torque
bottle cap; must be torn or broken to 13. Print
reach product 14. Peeling of Paint
Breakable cap Plastic or metal tear away cap over 15. Cleanliness
container; must be broken to remove 16. Light Transmission
Sealed tube Seal over mouth of tube; must be 17. Stress Crack Resistance
punctured to reach product
Sealed carton Carton flaps sealed; carton cannot be Physico-Chemical Test for Containers
opened without damage 1. Identification
Aerosol Tamper-resistant by design 2. 2. Infra-red Properties
container 3. Thermal Analysis
4. Extractable Substance
5. Non-volatile Residue
Storage Temperature of Pharmaceutical Products 6. Water vapor Permeation/ Transmission
Term Condition 7. Moisture
Cold Place Not exceeding 8C 8. Resistance to water attack
Freezer 24C to 10C
Refrigerator 2  8C Containers:
Cool Between 8C  15C Prescription bottles  are used to dispense liquids of low viscosity
Room Temperature 15C  30C Wide Mouth bottles  are used to dispense viscous liquids
Controlled Room 20C  25C Application Bottles  used for applying liquid medication to a wound
Temperature or skin surface
Warm 30C  40C Round Vials  are used primarily for solid dosage forms as capsule &
tablets
Excessive Heat Above 40C
Aerosol Containers  used for powders to applied by sprinkling
Slide boxes  are used for dispensing suppositories & powders
prepared in packets
Ointment jars & Collapsible tubes  used to dispense semi-solid
dosage forms, such as creams &
ointments
Dropper Bottles  are used for dispensing ophthalmic, nasal, otic, or
oral liquids to be administered
•Quality Control
Standards & Specifications

Product must cover the ff. points:
1. Formula  concise & precise statement of the ingredient
Sources of Variation:
2. Raw Materials Specification  should enumerate the
Materials
characteristics of all materials
Examples:
3. Standard Operating Procedure  step-by-step method
ⓐ Variation between suppliers of same substance
4. Finished Product Specifications  cover all characteristics that
affect the proper ⓑ Variation between batches from same suppliers
performance, purity, safety, ⓒ Variation within a batch
& stability of the product Machines
5. Packaging Material Standards  should be set for everything Examples:
that goes around the ⓐ Variation equipment for the same process
product ⓑ Difference in adjustment of equipment
6. Testing Methods  indispensible in assuming conformity to ⓒ Aging & improper care
standards  Methods
Examples:
ⓐ Inexact procedure
Defects  is an undesirable characteristics of a product ⓑ Inadequate procedures
Defectives  when a unit of a product contains one or more defects ⓒ Negligence
Classifications:  Men
1. According to Measurability Examples:
a. Variable Defect  can be measured directly by instruments ⓐ Improper working conditions
b. Attribute Defect  cannot be measured directly by ⓑ Inadequate training, & understanding
instruments ⓒ Dishonesty, fatigue & carelessness
2. According to Seriousness or Gravity
a. Critical Defect  may endanger life or property & may
render the product non-functional
Ex: Absence of Warning
b. Major Defect  may affect the function of the object, & Statistical Quality Control
therefore, may render the product useless. is the monitoring quality by the application of statistical methods in
Ex: Crack in a Bottle all stages of production.
c. Minor Defect  doest not endanger life or property but
remains a defect. Two basic Quality Control Charts:
Ex: Slight deviation of the color of the label ①Attribute Chart
from the color standards is a chart when makes use of discrete data classifying the number of
3. According to Nature item conforming & the number of items failing to conform to any
a. Ocular Defect  visible specified requirements
Ex: Foreign particulate contamination Example: the control chart for fraction defective known as “P chart”
b. Internal Defect  not seen although present ②Variable Chart
Ex: Subpotent Drug Product is a chart using actual records of numerical measurement on a full
c. Performance Defect  defect in function continuous scale such as meter, grams, liter.
Ex: Suppository that does not melt at body Example: X and R charts
temperature
Accelerated Stability Testing  is used to predict product stability

Factors that accelerate Instability are:
1. Temperature
2. Light
3. Moisture
4. Gravity
5. Agitation
6. Inversion
7. Method of Manufacture
Control Test: Signs of Degradation of Specific Dosage Forms
Solid Preparations: Semi-Solid Preparations: 1. Tablets 6. Topical Nonmetered 10. Small-Volume
1. Assay for the Active Ingredient/s 1. Assay for the Active Ingredient Appearance Aerosols Parenterals
2. Assay for the degradation products 2. Assay for degradation products
3. Disintegration 3. Identification test for active
(cracking, chipping, Appearance Appearance
4. Dissolution ingredients & possible contaminants mottling) Odor Color
5. Content Uniformity 4. Visual Appearance Friability Pressure Particulate Matter
6. Weight Variation 5. Color hardness Weight Loss DIspersability
7. Identification Test for the Active 6. Odor
Ingredient/s & possible 7. Viscosity
color Net Weight (Suspensions)
contaminants 8. Softening Range moisture content Dispensed pH
8. Visual Appearance 9. Loss of Water clumping Delivery Rate Sterility
9. Odor 10. Consistency disintegration Spray Pattern 11. Large-Volume
10. Taste 11. Homogeneity
11. Texture 12. Particle size distribution dissolution 7. Topical Creams, Parenterals
12. Hardness 13. PH 2. Capsules Ointments, Lotions, Appearance
13. Friability 14. Release rate of Active Ingredients
Moisture Tackiness Solutions, & Gels Color
14. Powder Fineness from dosage form
Color Appearance Clarity
15. Moisture Content 15. Sterility Testing
16. Humidity Effect 16. Storage Condition Appearance Color Particulate Matter
17. Color Stability Shape Homogeneity pH
18. Storage Condition
Brittleness Odor Volume &
19. Microbiological Burden Extractbales (when
20. Thickness Dissolution pH
Resuspendability plastic container is
3. Oral Solutions &
(Lotion) used)
Lyophilization Preparations & Products Suspension
for Reconstitution Before Use: Appearance Consistency Sterility
Particle Size Pyrogenecity
1. Assay for the Active Ingredient Precipitation
(original & reconstituted) Closure Integrity
2. Assay for degradation products
 pH Distribution
Liquid Preparations: Color Strength 12. Suppositories
3. Identification test for active
1. Assay for the Active Ingredient ingredients & possible contaminants Odor Weight Loss  Softening Range
2. Assay for degradation products 4. Visual Appearance Redispersability Appearance
3. Identification test for active 8. Ophthalmic & Nasal &
(original & reconstituted)
(suspension) Melting
ingredients & possible 5. Color of Cake Oral Inhalation
contaminants Clarity (solutions) 13. Controlled-Release
6. Odor of Cake Preparations
4. Visual Appearance Membrane Drug
5. Color
7. Odor of Solution 4. Oral Powders Appearance
8. Color of Solution Delivery Systems:
6. Odor Appearance Color
9. pH (original & reconstituted) Seal Strength of the
7. Taste 10. Moisture content of cake Color Consistency
Drug Reservoir
8. Redispersability 11. Clarity of Solution Odor Clarity (Solutions)
9. Suspendability Decomposition
12. Rate of Solution (Lyophilized) Moisture  Particle Size
10. Pourability 13. Container Pressure Products
5. Metered-Dose Resuspendability
11. Viscosity 14. Storage Conditon Membrane Integrity
12. Isotonicity Inhalation Aerosols (Suspension,
13. Particle Size Agglomeration & Drug Strength
Deliver Dose per Ointments)
Drug Release Rate
Particle Distribution
14. Clarity Actuation Strengths
15. Crystallization Number of Metered Sterility
16. Gas evolution Dose 9. Emulsions
17. Specific Gravity Color Appearance
18. pH
19. Refractive Index Loss of Propellant (such as Phase
20. Surface Tension Pressure Separation)
21. Pyrogen Testing Valve Corrosion Color
22. Sterility Testing
Spray Pattern Odor
23. Toxicity Testing
24. Storage Condition Absence of pH
25. Fill Volume Pathogenic Viscosity
26. Leak Test Microorganisms
Aerosols:
1. Assay for the Active Ingredient
2. Assay for degradation products
3. Identification test for active
ingredients & possible
contaminants
4. Net Content
5. Spray Test
6. Leak Test
7. Pressure Measurement
8. Moisture Determination
9. Propellant
10. Valve Delivery Accuracy
11. Particle size distribution
12. Storage Condition
•Drug Cosmetics
Cosmetics  are intended for external application to the human body
for cleansing, beautifying, promoting attractiveness, or
altering the appearance of the user
Classes of Cosmetic Preparations:

1. Cleansing Creams & Lotions  for removing the facial make-up,
surface grime, & oil from the face &
throat through its solvent action.
2. Emollient Creams & Lotions  to prevent or relieve dryness a swell
as protect the skin
3. Hand Creams & Lotions  to make water available to the Stratum
Corneum & to regulate the rate & Eye Makeup  is one of the oldest & most extensively used cosmetics
quantity of water take-up by the Types of Eye Makeup:
Stratum Corneum 1. Eye Shadow  am be manufactured in the form of cream, stick,
4. Suntan Creams & lotions  to prevent melanogenesis liquid, powder, or pressed cake, (used w/ puffer
Ex: The oxidation of Melanin Pigment through brush)
exposure to ultraviolet radiation which 2. Mascara can be made as a cake, cream, or liquid
results in the darkening of the skin.  applied w/ a “wand”
5. Skin Lightener  to ameliorate skin complexion where the skin is 3. Eyebrow makeup  may take the form of crayon, extruded pencil,
dark or has become mottled due to stick, cream, or pressed cake
age or drug therapy 4. Eyeliner  are liquids, cream, or pressed cake
6. Shaving Creams  preparations which make the process of cutting  applied w/ a brush or pencil
hair on or about the face more pleasant, 5. False Eyelashes  made of either natural hair or synthetic fibers.
convenient, & necessary ritual. 6. Cover-up Makeup  used under & around the eyes, takes the
form of cream, powder, cake, or sticks
Basic Material for Cream Preparations: 7. Makeup Remover  for removal of eye makeup that either
1. Beeswax  contributes to cream consistency creams or liquid
 melting point 62-65C 8. Eye Cream or Eyesticks  *Eye Cream  usually a water in oil
2. Mineral oil  a stable hydrocarbon, inexpensive, & not subject emulsion,
to rancidity & odorless *Eyestick  is a wax base containing
3. Borax (Sodium Borate)  the amount of borax used is a critical lubricants & emollients
factor in producing a satisfactory cream
4. Emollients Basic Ingredients of Eye Makeup:
5. Ozokerite & Ceresin  stiffen the cream & prevent the bleeding Petrolatum
of oils when oil content is high. Lanolin
6. Perfume Oil  usually added in the concentration of 0.6% Ceresin
7. Agents used for Skin Lightening & Skin Bleaching Carnauba Wax
Covering Agents used are the pigments Beeswax
 the most efficient pigment is Titanium Dioxide  Stearic Acid
8. Pilomotor agents  Isopropyl Myristate
 Propylene Glycol
Face Powders  is basically a cosmetic product which ha its prime  Gum Tragacanth
function is the ability to complement skin color by  Methyl Cellulose
imparting velvet like finish. Preservatives
Essential Characteristics of Face Powders: Pearlessence
1. Covering Power  the ability to mask skin defects such as skin
shine, enlarged pores, & minor blemishes.
2. Slip  the faculty of spreading over the skin without dragging, &
giving the characteristics smooth feeling
3. Adhesiveness  the ability to cling to the face
4. Absorbancy  the capability of absorbing skin secretions
(perspirations & oiliness) without evidence of
such absorption.
5. Bloom  the ability to impart a velvety, peach like finish, to the
face.
Five Basic Types of Binders used in Compact Face Powder are:

1. Dry Binders: Metallic Stearates
2. Oil Binders: Mineral Oil, Isopropyl Myristate, & Lanolin
Derivatives
3. Water-Soluble Binders: Gums (Tragacanth, Karaya, & Arabic) &
PVP
4. Water-Repellent Binders: Mineral Oil, Fatty Esters of all types of
Lanolin Derivatives.
5. Emulsion Binders: Soap Such as Triethanolamine Stearate, Non-
ionic Emulsifiers & Glyceryl Monostearate
Shampoo Additives: Perfume  is a concentrated alcoholic blend of fragrant materials, sold
1. Foam Binder (Foam Stabilizer)  increase quality, volume & or ready for sale as a finished product for the consumer
stability of lather Categories of Raw Materials for Perfume: (Natural or Synthetics)
2. Conditioning Agents  coat the hair 1. Plant Materials
3. Opacifying Agents  include higher alcohols: Stearyl Alcohol a. Essential Oils (obtained by distillation or expression)
Ceryl Alcohol Clove Oil
4. Clarifying Agents  maintain shampoo clarity: Terpineol Cinnamon Oil
5. Sequestering Agents  prevention of lime soap formation b. Flower Oils
6. Antidandruff Agent  containing Selenium Sulfide/Zinc Pyrithione Jasmine Absolute
7. Thickening Agent  increase viscosity Rose Absolute
8. Preservatives Formaldehyde, Ethanol, Parabens c. Resins, Gums, & Exudations
9. Stabilizers  Antioxidants, Sunscreen, Suspending Agents Gum Styrax
& pH Control Agent  Balsam Peru
10. Other Cosmetic Additives: Perfume & Dye  Benzoin
Labolanum
Shampoo Evaluations:  Myrrh
1. Performance Properties 2. Animal Secretions:
a. Foam & Foam Stability Castoreum
b. Detergency & Cleaning Action  Civet
1. Effect of water harness Musk
2. Surface Tension & Wetting Ambergis
3. Surfactant Content & Analysis 3. Chemical Substances
c. Rising a. Isolate from plant materials
d. Conditioning Action b. Derivatives of plant materials
1. Softness c. Synthetic organic Substances
2. Luster
3. Lubricity Types of Fragrance:
4. Body, Texture, Set Retention 1. Oriental  intense heavy full-bodies fragrance
e. Irritation 2. Cologne Blend  harmonious combination while fragrance
f. Dandruff Control derived from citrus oils
2. Product Characteristics 3. Bouquet  harmonious combination of two or more floral notes
a. Fragrance 4. Floral  flower type
b. Color 5. Chypre  mossy-wood complex w/ sweet citrus top note
c. Consistency 6. Fougere  dominant sweet note w/ mossy, lavender, citrus
d. Package 7. Spice Blend  fragrance combination w/ floral spice
Nail Lacquers or Enamel consist of: 8. Wood Blend  woody notes
1. Primary Film Former: Nitrocellulose is an Outstanding Film Form 9. Aldehyde Blend  blending their specific unique characteristics
2. Secondary Resin  used in conjuction w/out nitrocellulose through superimposition of certain chemical
compositions to improve the degree of film 10. Amber  heavy full bodied powdery, warm scent tone
buil & also to promote better depth, gloss, &
adhesion
3. Plasticizer  control flexibility & elongation of the film
4. Colorants  give an acceptable shade & opacity to the film
5. Specialty Filler  impart certain characteristics iridescence.
Quality Control Checks for Nail Lacquers:

Nonvolatile Content
Drying Time
Smoothness of Flow
 Gloss
 Hardness
Color
Application  Water Resistance
Abrasion
Resistance
Adhesion
Flexibility
Viscosity
ISO (International Organization for Standardization)
has a number of management system standards, each focusing on
different issues affecting global business
Management System Standards:
Quality Management ISO 9000 family
Environmental Management ISO 14,000 family
Food Safety Management ISO 22,000 family
Energy Management ISO 50,001 family
 PAT (Process Analytical Technology)

At-line  sample is removed, isolated from & analyzed in close
proximity to the process stream
On-line  sample is diverted from the manufacturing process &
may be returned.
In-line  sample is not removed from the process steam.
beatifying, promote, attractiveness & alter physical
I. Solid Dosage Forms appearance
A. Powders
Dosage Form  formulation containing a specific quantity of active
B. Granules ingredient(s) in combination with one or more excipients
C. Capsules  tablets, capsules, syrups, suppositories, etc
D. Tablets
E. Solid Oral Modified-release Dosage The Need for Dosage Forms:
Forms • To protect the drug substance from the destructive influences of
atmospheric oxygen or humidity (coated tablets, sealed ampoules)
F. Inserts • To protect the drug substance from the destructive influence of
1. Suppositories gastric acid after oral administration (enteric-coated tablets)
2. Vaginal Inserts • To conceal the bitter, salty, or offensive taste or odor of a drug
II. Semisolid Dosage Forms substance (capsules, coated tablets, flavored syrups)
• To provide liquid preparations of substances that are either
A. Ointments insoluble or unstable in the desired vehicle (suspensions)
B. Creams • To provide clear liquid dosage forms of substances (syrups,
C. Gels solutions)
D. Miscellaneous Semisolids • To provide rate-controlled drug action (various controlled-release
tablets, capsules, and suspensions)
1. Pastes • To provide optimal drug action from topical administration sites
2. Plaster (ointments, creams, transdermal patches, and ophthalmic, ear,
3. Glycerogelatins and nasal preparations)
III. Transdermal Drug Delivery System • To provide for insertion of a drug into one of the body’s orifices
(rectal or vaginal suppositories)
IV. Liquid Dosage Forms: Single Phase • To provide for placement of drugs directly in the bloodstream or
V. Liquid Dosage Forms: Two-phase/ body tissues (injections)
Dispersed Phase • To provide for optimal drug action through inhalation therapy
VI. Sterile Dosage Forms (inhalants and inhalation aerosols)
VII. Special Dosage Forms Preformulation Considerations:
1. Pharmaceutical Aerosols 1. Physical Description
2. Radiopharmaceuticals 2. Microscopic Examination
3. Biotechnology 3. Heat of Vaporization
4. Melting Point Depression
Introduction 5. The Phase Rule
Drug Delivery  process whereby drugs are delivered to their site of action 6. Particle Size
using a minimum amount of drug necessary to provide & 7. Polymorphism
maintain therapy. Effect over a certain period of time with 8. Solubility
minimum toxicity. 9. Solubility & Particle Size
10. Solubility & pH
Drug Delivery System  means administering drugs as formulated
11. Dissolution
preparations
12. Membrane Permeability
formulations which provide a therapeutic amount of
13. Partition Coefficient
drug to the proper site in the body promptly &
14. pKa/ Dissociation Constants
maintain the desired drug concentration
 products that allow for the uniform release or Five types of stability concern pharmacists:
targeting of drugs into the body 1. Chemical: Each active ingredient retains its chemical integrity and
labeled potency within the specifi ed limits.
 encompass the drug formulation, interaction
2. Physical: The original physical properties, including appearance,
among drugs, formulation matrix, the container &
palatability, uniformity,dissolution, and suspendability
the patient
areretained.
Drug Product  the finished dosage form that contains the active
3. Microbiologic: Sterility or resistance to microbial growth is retained
ingredient, generally, but not necessarily, in association with
according to the specified requirements. Antimicrobial
one or more other ingredients
agents retain effectiveness within specifi ed limits.
Additive/ Excipients/ Pharmaceutic Necessities/ Adjuncts
4. Therapeutic: The therapeutic effect remains unchanged.
agents that are used to the following purposes:
5. Toxicologic: No signifi cant increase in toxicityoccurs.
to solubilize, suspend, thicken, dilute preserve, emulsify,
colorant & flavorant, & medicinal agent Factors of Patients considered in determining a drug dose in clinical
to efficacious dosage forms investigations:
must be “inert” 1. Age
Active Ingredients 2. Pharmacogenetics
3. Body Weight
a. Drugs  agent intended to be use in diagnosis, mitigation, treatment,
4. Body Surface Area
cure, or prevention of disease in MAN & other animals
5. Sex
 agents intended to affect the structure & function of the
6. Pathologic State
body of man & other animals
7. Tolerance (the ability to endure the influence of drug)
b. Cosmetic  agents intended to rubbed, sprinkled, sprayed, introduce,
8. Concominant Drug Therapy
or applied, into the body to be use in cleansing,
9. Time & Condition of Administration
10. Dosage Form & Route of Adminstration
I. Solid Dosage Forms Types of Powders
A. Powders 1. Bulk Powders  dispensing in large quantities
 small individualized drug particles (1) Oral Powders
 intimate mixtures of finely divided drugs or chemicals intended (2)Dentrifices  mild abrasive;
anticariogenic (prevents cavity formation)
to be used internally or externally
(3)Insufflation  finely divided powders intended to body cavity by
Advantages:
a device known as “Insufflator”
flexibility in compounding
relatively dry & devoid of moisture (4)Triturations  are dilutions of potent powdered drugs, prepared
relatively stable by intimately mixing them w/ a suitable diluents
Disadvantages: in a definite proportion of weight.
not easily wetted (5) Dusting Powder  intended to be dusted on the skin by
inaccuracy of the dose sprinkling or by means of sifter-top
not suitable for dispensing containers.
some powders are hygroscopic & deliquescent (6)Aerosols  administered w/ the aid of inhalers, w/c delivers
Particle Size Analysis  to obtain quantitative data regarding the micronized drugs in metered quantities
size, shape, & distribution of drug particles & (7)Douche Powder  preparation of vaginal douche
particles & other components to be used in  used for the hygienic effect, some contain
the formulation anti0infective agents
Simple Diffusion  reduce in particle size Components of Douche Powders:
a. Boric Acid or Sodium Borate
 lipophlic
b. Astringents, for example, potassium, alum, ammonium
 unionized/ free from alum, zinc sulfate
 Comminution  reduction in particle size c. Antimicrobials, for example, oxyquinoline sulfae,
 process of reducing larger solid unit masses povidone iodine
d. Quaternary Ammonium Compounds,
to smaller sizes by mechanical means/
for example, Benxethonium Chloride
milling e. Detergents, for example, Sodium Lauryl Sulfate
 to aid processing f. Oxydizing Agents, for example, Sodium Perborate
 to improve solubility up to certain extent g. Salts, for example, Sodium Citrate, Sodium Chloride
h. Aromatics, for example, Methol, Thymol, Eucalyptol,
 to reduce bulk volume
Methyl Salicylate, Phenol
Small Scale: 2. Divided Powder  “chartulae”; known as individualize powders
1. Trituration  the use of mortar & pestle
 paper tablets; “papelitos”
 1:10 dilution/ method *Types of Paper in Paper Tablets:
*Three Types of Mortar & Pestle: (1)Simple Bond paper  has n moisture resistance
(1)Porcelain  soft aggregates/ crystals (2)Vegetable Parchment  a thin semiopaque w/ limited
(2)Wedgewood  crystal moisture resistance
(3)Glass  smooth surface/ non porous (3)Glassine  a glazed, transparent paper,
 solution, suspension, & ointment also w/ limited moisture resistance
 used for staining subsatnce (4)Waxed paper  a transparent waterproof paper
2. Levigation  commonly used in small scale preparation  use for hygroscopic or deliquescent
of ointments & suspensions to reduce powder
particle size & grittiness of the added May be used only a limited
products
 formation of paste by addition of non-
Glassine
Vegetable Parchment  barrier against moisture is
necessary
solvent (levigating agent) Waxed Paper

If powder containing volatile
-mineral oil Glassine components
-glycerin
-propylene glycol
Terms:
3. Pulverization by Intervention  addition of volatile Hygroscopic  absorb moisture from the air
substance Deliquescent  absorb moisture from the air to the extent that they
Ex: Camphor + Alcohol liquidify by partially or wholly forming a solution
I2 Crystals . e.g. Potassium citrate, sodium nitrate
Efflorescent  release water; boom
Large Scale (Mills & Pulverization)
Example of Efflorescent Substance:
1. Tumbling  drug particles are enclosed in a rotating -Citric Acid
chamber -Ferrous Sulphate
 use motorized blades by shaking or -Atropine Sulphate
rotating Effervescent  producing gas in the form of tiny bubbles
 thorough but time-consuming Standards for Vegetable & animal Drugs
2. Spatulation  the use of spatula (movement of spatula) Descriptive Term Seive Size Limit
 for non potent powders Very Coarse No. 8 NMT 20% pass through No. 60
3. Sifting  by passing them through sifters Coarse No. 20 NMT 40% pass through No. 60
 is not acceptable for the incorporation of Moderately Coarse No. 40 NMT 40% pass through No. 60
potent drugs into a diluents powder Fine No. 60 NMT 40% pass through No. 100
 for non potent powders Very Fine No. 80 No limit Greater fineness
 “Sifters” / Sieves Standard Chemical Drugs
4. Geometric dilution  to ensure the uniform distribution Descriptive Term Seive Size Limit
of potent drug, which is placed w/ Coarse No. 20 NMT 60% pass through No. 40
an approximately equal volume of Moderately Coarse No. 40 NMT 60% pass through No. 40
the diluents in a mortar & is Fine No. 60
mixed thoroughly by trituration. No limit Greater fineness
Very Fine No. 120
Micronization  a method of producing finer drug particles
under 10m size.
B. Granules Ways to improve Flowability:
 prepared agglomerates of powders 1. Alteration of particle size & size distribution
 aggregates of powders that adhere or bond to each other to  use larger particles
form larger unit particles  reduces the amount of fines
 Sieve Size: No. 4 – No. 12 (coarse to very coarse) 2. Alter particle shape & texture
 Granules in Tablet Formulation: No.12 – No. 20  the rounder (more spherical),
Advantages: the smoother the particles ,
1. Flows well compared to powders the better (more flowable)
facilitates the transport of the drug material 3. Use of Flow Activators:
from the hopper to the tablet press G  Glidant  to increase friction
2. Less surface area A  Anti-adherent
more stable from atmosphere humidity L  Lubricant  to prevent wear & tear
 less tendency to cake or harden  to facilitate ejection
3. Easily Wetted *If No Lubricant  there is screening sound
 suitable for material that needs striation
reconstitution prior to use stretch mark
Granulation  process to prevent segregation of powders *Lubricant must be fine
to improve flow properties *Example: Metallic Stearate  prolongs
to improve compressibility disintegration time
Methods of Granulation:  decrease
1. Wet Granulation  most widely used bioavailability
 uses binder 4. Alter process condition
5. Alteration of surface Forces
 Advantages: -Increased Compressibility
-Improved Dissolution reduce/ increase electrostatic charges
Disadvantage: -Its not applicable to water/ reduce moisture content
moisture & heat sensitive Problems in Fluidity/ Flowability of Granules
(ex: Aspirin) a. rat-holling/ piping/ funneling
*moisten the mass  screen b. bridging/ arching
*granulating fluids  H2O c. flooding (solution: Regranulation)
*fluid bed processing  alcohol isopropanol Characterization of Granules:
fluid bed granulation (liquid is sprayed on 1. Angle of Repose
suspended powders) 2. Carr’s Compressibility Index
2. Dry Granulation  for heat & moisture sensitive materials 3. Hausner’s Ration
 particles are aggregated using high pressure 4. Bulk Density
 Disadvantage: Messy 5. Critical Orifice Diameter
 Processes: 6. Hopper Flow Rate
a. Roll Compaction  uses thin sheets
powders are rolled into Scott Volumeter  used in the determination of Bulk Density
dense sheets Bulk & Tapped Density data – can help us identify the volume
sheets are granulated of the container for the storage of
using a mechanical raw materials
granulator Effervescent Granules
 sieve granules to obtain release CO2 gas in water
desired size to increase palatability of vehicle
b. Slugging  tablet pressed  mixture of citric acid, tartaric acid, & sodium bicarbonate
 slugging of powders (formation Ratio: 1 : 2 : 3.4
of large tablets called a “slugs”)  when Tartaric acid is used as the sole acid in
slugs are granulated using an effervescent granules, the resulting granules will
appropriate equipment -Lose their firmness & crumble.
 sieve the granules to obtain  when Citric Acid is used as the sole acid in
desired size effervescent granules, the resulting granules will
 poorly formed tablets -Be sticky & difficult to granulate.
method: 1. Fusion (to release water of crystallization of
Types of Granules:
ingredients)
a. Good Granules  particles that pass through sieve 20 & are
2. Addition of moistening binding agent
retain at sieve 40
 *Quality of a Good Granulation:
-as spherical as possible
-uniform in content Method exist for the Determination of Particle size
-normal or bell-shaped distribution of 1. Seiving  passed by mechanical shaking
particle sizes 2. Microscopy  through the use of a calibrated grid
b. Fines  particles that pass sieve 40 3. Sedimentation  by measuring the terminal settling velocity of
 act as bridges by filling interparticulate spaces particles through a liquid medium
*Excess Fines  there is interparticulate friction 4. Light Energy Diffraction or Light-scattering  by the reduction in
*Excess Granules  there is void spaces light reaching the sensor as the particle
5. Laser Holography  in which a pulsed laser is fired through an
Properties of Granules for Tablet Production aerosol particle spray
Fluidity/ Flowability 6. Cascade Impaction  by an airstream
Compressibility
C. Capsules Characteristics of Added substances to Capsule Formulations:
1. Are harmless in the quantities used
solid dosage form in which one or more medicinal &/or inert
2. Do not exceed the minimum amounts required to provide their
substances are enclosed within a small edible shell usually made intended effect
of gelatin 3. Do not impair the products bioavailability, therapeutic efficacy,
Types of Capsules: or safety
1. Hard Gelatin Capsule (HGC) 4. Do not interfere w/ requisite compendia assays & tests
 aka Dry-filled Capsule Goals in Developing a capsule formulation:
Two-piece Capsule to prepare a capsule w/ the following characteristics:
a. Accurate Dosage
 has 12-15% or 13-16% moisture b. Good Bioavailability
 investigational drug & extemporaneous. c. Ease of Filling & Production
gelatin shells are manufactured in a separate process d. Stability
(dipping PEGs made of manganese bronze in a melted e. Elegance
gelatin mixture) Materials for Capsule Shell Making
shell composed of: 1. Gelatin  result of the partial hydrolysis of collagen obtain form
Gelatin Colorants the skin, white connective tissues & bones of animals
Water 0.15% Sulfur Dioxide  contains important amino acids,
Sugar Titanium Oxide only tryptophan is absent
has two(2) parts: Body & Cap/Head  Two Types of Gelatin: Type A  Acid Hydrolysis
 has 8 sizes (5 to 000) Type B  Basic Hydrolysis
Capsule sizes available for Human use: 2. Plasticizer  for elastcicity & flexibility
Capsule Size Volume Capacity Powder Capacity  Ex: Glycerin
(mL) (mg) Sorbitol
000 1.40 650-200 mg 3. Colorants : FD & C
00 0.95 4. Preservatives: 0.15% Sulfur Dioxide
0 0.68
5. Opacifying Agent: Titanium Dioxide
1 0.50
2 0.37 For large scale, glidants, lubricants & surfactants may also be
3 0.30 employed
4 0.21 Order of Capsule Shell Manufacturing:
5 0.13 60-130 Dipping, Spinning, Drying, Stripping, Trimming, Joining
Large Capsules are available for Veterinary use.  Encapsulation Procedure of Capsules from start to finish:
 0  is the largest capsule size for human use.
Rectification  Separation  Filling  Joining
2. Soft Gelatin Capsules (SGC) 
has 6-10% moisture Printing Banding Ducting & polishing
rendered plastic-like with the addition of plasticizers Capsule Excipients:
(glycerin or sorbitol) 1. Diluent or Filler  to produce the proper capsule fill volume
oblong, oval, spherical, tube, pearl, suppository type Ex: Lactose
filled with pumpable solutions, suspensions, pasty Microcrystalline Cellulose
material or powders Starch
formed, filled, & sealed in a single manufacture 2. Disintegrants  to assist the breakup & distribution of the
process (Plate Process or Rotary Process) capsule’s contents in the stomach
Liquids that may be encapsulated into SGC Ex: Pregelatinized Starch
(1) Water-immiscible volatile & non-volatile liquids: Eroscarmellose
vegetables & aromatic oils Sodium starch Glycolate
aromatic & aliphatic hydrocarbons 3. Lubricants or Glidants  to enhance flow properties
chlorinated hydrocarbons Ex: Fumed Silicon Dioxide
ethers Magnesium Stearate
esters Calcium Stearate
alcohols Stearic Acid
organic acid Talc
(2) Water-miscible non-volatile liquids: 4. Surfactant or Surface-Active Ingredients  to facilitate wetting by
Polyethylene Glycols the gastrointestinal fluids to overcome problems
Polysorbate 80 (non-ionic surface active Ex: Sodium Lauryl Sulfate
agent) Edible Gelatin (Specifications)
(3)Water-miscible & relatively non-volatile Type A Type B
compounds: pH 3.85.5 57.5
Propylene Glycol & Isopropyl Alcohol Isoelectric Point 79 4.75.4
Bloom Strength  measure of gelatin capsule’s rigidity Gel Strength (Bloom) 50300 50300
Encapsulation Process Viscosity (mps) 1575 2075
1. Preparation of Formulation Ash 0.32 0.52
2. Filling Capsule Storage: If too moist  Tacky
3. Sealing If too dry  Brittle
4. Cleaning & Polishing Spansule  a capsule composed of hard gelatin shell containing hundreds
Packaging: of tiny coated beads/ pellets of drugs for sustained release
Cachet  a flat containing drug that has an unpleasant taste
Protection Information is swallowed intact by the patient
Preservative Compliance Parvules  bullet-shaped
Presentation Convenience Troche  a medicinal lozenge, taken by mouth, used to treat conditions of
Identification Container the mouth or throat & also of the alimentary canal
Capsulating Machine (Parts): Peg-ring Pellets or Implants  are sterile, small, usually cylindrical solid object
intended to be implanted subcutaneously to provide
Hopper continuous release of medication over time
Closing palate
D. Tablets
most widely used dosage form
solid dosage form that contain active ingredients & excipients
prepared by either molding or compression
(8) Effervescent Tablets  releases gas in contact w/ water
Two Types of Tablets:
*Bubble action  can assist the
1. Molded Tablets  soft tablets
breakup of the Tablet
 are intended to dissolve slowly in the mouth.
(9) Buccal Tablets flat, oval tablets,
 do not contain disintegrants, lubricants, or
that erode slowly on the cheeks
coatings to slow their rate of dissolution
(10) Sublingual Tablets  flat, oval tablets,
Ex: Tablet Triturates  are small, usually
that placed under the tongue
cylindrical, containing
(11)Instantly-release Tablets
small amounts of potent
(Rapidly dissolving tablets or RDTs)  are
drugs
characterized by disintegrating or
2. Compressed Tablets  hard tablets
dissolving in the mouth within 1
Ex: (1) Compressed Tablets
minute, some within 10 seconds
(2) Multicompressed Tablets
Dissolution in the mouth within
 appear as layered
approximately 15-30 sec. anything slower
 are prepared by subjecting the fill material to
would not be categorized as rapidly
more than a single compression
dissolving.
(3) Layered Tablets
(12) Extended Release Tablets (Controlled-release Tablets)
 are prepared by initial compaction of a position
are designed to release their medication in a
of ill material in a die followed by additional fill
predetermined manner over an extended
material & compression to form two-layered or
period.
three layered tablets, dispensing on the number
(13) Vaginal Tablets/ Vaginal Inserts
of separate fills
 are uncoated, bullet-shaped, or ovoid (egg-
 layer may contain a different medicinal agent,
formed) inserter into the vagina for local
separated for reasons:
effects
physical or chemical incompatibility
 prepared by compression & shaped to fit
staged drug release
smugly on plastic inserter devices that
simply for the unique appearance of the accompany the product
layered tablet
(14) Hypodermic Tablets  were originally used by
(4) Sugar Coated Tablets
physicians in extemporaneous
 (a) Mask the offensive taste of the drug preparations of parenterals
(b) Offers protection
(15) Immediate-Release Tablets  are designed to
*Disadvantage:
disintegrate & release
(a) Adds bulk/weight to th eformulation
their medication with no
(adds 50% to the tablets weigh)
special coatings & other
*Tablet thickness: Microcalliper=
techniques
+15% tolerance
 75% of labeled amount
every 30 minutes
dissolves in 45 minutes.
(b) time-consuming
(16) Dispensing Tablets  better have termed as
(c) needs expertise
“Compounding Tablets”
(4) Film Coated Tablets
(17) Orally Disintegrating Tablet  placed in the oral cavity
 are compressed tablets coated w/ a thin layer of
& can be taken without
a polymer / plastic-like matrials capable of
water.
forming a skinlike film to make the tablet more
durable
 not time-consuming
 does not add weight/ bulk to the formulation
(5) Enteric Coated Tablets
 have delayed-release features
 meant to disintegrate in small intestine
 to prevent gastric mucosa irritation
(6) Gelatin Coated Tablets
 a recent innovation, gelcap, is a capsule-shaped
compressed tablet that allows the coated
product to be about one-third smaller than a
capsule filled w/ an equivalent amount of
powder
(7) Chewable Tablets
 have smooth, rapid disintegration when chewed
or allowed to dissolve in the mouth,
 have a creamy base, usually of special flavored &
colored mannitol
Excipient: Mannitol
Xylitol (Sugar-Free)
 for individuals w/ difficulty in swallowing
Gaviscon®  Sodium Alginate + Calcium
Carbonate + Sodium Bicarbonate
Three Basic Methods in preparing Compressed Tablets: Components of Excipients/ Adjuncts used in Tablet Formulation:
1. Wet Granulation  widely employed method A. Essential Components  imparts satisfactory characteristics to the
 required some steps: formulation
a. Weighing & blending the ingredients 1. Diluents/ Fillers  to prepare tablets of the desired size/ bulk
b. Preparing a dampened powder or a damp Ex: Starch, Lactose, Mannitol, Kaolin
mass -Lactose  most common diluents
c. Screening the dampened powder or damp  water-soluble
mass into pellets or granules readily releases drug
d. Drying the granulation -Mannitol  for water-sensitive
e. Sizing the Granulation by dry screening -Sorbitol  highly hygroscopic
f. Adding lubricant & blending 2. Binders/ Adhesives  promote adhesion
g. Forming tablets by compression
 promote granular process & cohesive
2. Dry Granulation  the powder mixture is compacted in large compacts
pieces & subsequently broken down or sized
Ex: Constarch (Starch, 5-10%), Glucose
into granules
Method of Addition:
 for moisture sensitive material
-added along w/ diluents
 thermolabile n the during process -added as a slurry
Slugging  the powder is slugged, a compressed, into large excess binding  difficulty in compression if colored
flat tablets or pellets about 1 inch in diameter 3. Disintegrants/ Disintegrating Agents
Roller Compaction  is a method often preferred to slugging  promote break up of the tablets after
 powder compactors may be used to administration to smaller particles for ready
increase the density of a powder by drug availability
pressing it between rollers at 1-6 tons  attract water into the tablet causing the
of pressure. The compacted material is tablet burst
broken up, sized, & lubricated, &
 break tablet in an aqueous environment
tablets are prepared by compression in
 opposes binder action
the usual manner
 if not effective: no drug release
 Method of Dry Granulation for Tablet Manufature:
Ex: Cellulose Derivatives, Clays, Starch (5-20%)
Milling  Mixing  Slugging  Screening
Two Types of Disintegrants

Compression  Mixing w/ disintegrant & lubricant -External: tablet  granules
3. Direct Compression Tabletting  some granular chemicals, like -Internal: granules  powder
Methods of Addition:
potassium chloride, possess
-before compression
free-flowing & cohesive -before wet granulation
properties that enable them to -half before granulation
be compressed directly in a -half before compression
tablet machine without any B. Compression Aids  impart satisfactory compression
need of granulation characteristics
Antiadherents,Glidants, Lubricants
 enhance the flow
increase the flowability of the drug material
 prevent the wear & tear of the tableting
machine
 prevent the sticking of the material in the
tableting machine
1. Glidants  enable the granules to flow from a hopper on the
tablet press to the die & for consistent & uniform fill
2. Lubricants  aid in releasing the compressed tablet from the die
3. Antiadherents  prevent the formation of residue films of tablet
granulations on the punches
C. Supplementary Components  give additional desirable physical
characteristics to the finished
products
Miscellaneous adjunts  Colorants, Flavorants,
Sweeteners, Asorbents
 improves the aesthetic appearance
improves the palatability of the preparation
Adsorbents  capable of holding quantities of fluids in an
apparently dry state
Colorants for identity; can use dyes & lakes pigments
-Dyes  water soluble
-Lakes Pigments  dye&salt; water-insoluble
Sweeteners  Naturals: Sucrose, Stevia,
Honey (Apis mellifera)
Synthetic: Aspartame
180X sweeter than sucrose
CI: Phenylketonuria)
Saccharin
 500X sweeter than sucrose
Coloring Pharmaceuticals Advantages of Tablet over some oral Medication:
Coloring Agents  are used in pharmaceutical preparations for a. Precision of Dosage
aesthetics b. Durability of physical characteristics foe extended period
Agents that have inherent color & employed as colorants: of storage
-Sulfur  Yellow c. Stability of chemical & physiologic activity of drugs
-Riboflavin  Yellow d. Convenience of administration
-Cupric Sulfate  Blue
-Cyanocobalamin  Bluish Green Tablet Press: -Single
-Ferrous Sulfate  Red -Rotatory/ Multiple
-Red Mercuric Iodide  Vivid Red Basic Elements/Parts of Tablet Press:
 have inherent color & are not thought of 1. Hopper  for storing the material for compressing
as pharmaceutical colorants in the usual 2.Feed Frame  for distributing the materials into the dies
terms 3. Dies  for controlling the size & shape of the tablet
Certified Color Additives are classified: 4. Punches  for compacting the materials within the dies
1. FD & C color Additives : used in food, drugs, & cosmetics  they also shape the tablet
-FD & C Red no.2  also known as Amaranth, 5. Cams tracks  guides the movement of the punches
caused cancer in rats
-FD & C Red no. 4  terminated as mashinocherries & Types of Tablet Printing
ingested drugs because of unresolved a. Debossed  means imprinted w/ a mark below the surface
safety questions b. Embossed  means imprinted w/ a mark above the surface
2. D & C color additives  some used in drugs, cosmetics & c. Engraved  means imprinted w/ a code that is cut into the
medical devices surface during production
3. External D & C color Additive  the use of which is restricted
to external parts of the body, Tablet Coating: Sugar Coating
not including the lips or any Film Coating
other body surface covered Enteric Coating
by mucous membrane Reasons for Coating Solid Dosage Forms:
(1) To mask unpleasant taste
COLORS FLAVORS (2) To protect components form atmospheric degradation
Pink to Red  cherry, strawberry, apple, raspberry (3) To prevent contact with a drug which is irritating or
Brown  choco, maple, caramel, nut molasses, potentially allergic
(4) To separate reactive ingredients
Yellow to orange  lemon, lime, orange, banana, cherry
(5) To control the site of drug release (enteric coating)
Green  lime, mint, menthol, pistachio, spearmint
(6) To delay or prolong absorption of the drug component
Off White/ White  vanilla, banana, caramel, mint, custard
by retarding release of drug from the dosage form
Violet o Purple  grape, plum, licorice
(sustained-action)
Blue  mint, blueberry, plum, licorice, mixed DFR (7) To improve appearance
Speckled  color of speckling or background (8) To change the physical surface of ingredients
corresponding to flavor chosen
Basic Processes used in the application of coating are:
Sweetening Pharmaceuticals: (a) Compression Coating  make possible to some special
1. Aspartame  breaks down in the body into three components: dosage forms
-amino acid phenylalanine (b) Pan Coating  is used in both sugar & film-coating
-aspartic acid makes use of coating pans provided w/ a
-methanol hot & cold air input system & am
discourages by persons w/ Phenylketonuria exhaust system to remove moisture &
 200 times sweeter than sucrose fine powder generated during the
2. Cyclamate  has carcinogenic potential coating operation.
 possible causation of genetic damage & testicular (c) Air Suspension Coating  one of most dependable
atrophy methods for applying film-
3. Saccharin  130X as sweet as sucrose & is excreted unchanged in coats. The coating material
urine; bitter after taste is atomized & applied to
 sources: Sugar cane, Sugar beet, Sugar maple tablets
4. Stevia Powder  the extract from the leaves of the plant (d) Dip Coating  the materials to be coated are usually
Stevia rebaudiana bertoni placed in baskets & dipped into
 natural, nontoxic, & about 30X as sweet as cane containers of coating solutions
sugars (sucrose)  has not been widely accepted because
 can used in both hot & cold of the difficulties encountered during
the coating procedure & lack of coat
uniformity
BASELINE TASTE RECOMMENDED FLAVORS
Sweet  honey, mixed fruits, berries, vanilla, maple Equipments: (1) Coating Pan (Ex: Accela Cota, Fellegrini)
Bitter  chocolate, anise, cherry mint, nut, fennel (2) Steam Jacketed Tanks
Salty  butterscotch, melon, maple, peach, (3) Drying Oven
raspberry, mixed citrus/fruit, nut (4)Polishing Drum
Sour  citurs, rootbeer, anise, cherry, strawberry, Uncoated Tablets should be: sufficiently hard
licorice optimum convexity
Metallic  grape, burgundy, lemon-lime minimal friability
Alkaline  chocolate, cream, vanilla, mint combination rapid disintegration
Sugar Coating  sucrose-base solutions
*Disadvantage: -Significance increase tablet weight
-Requires highly skilled personnel
*Sugar Coating Processes:
(1) Sealing  aka “water proofing”
 separate the core from the water
 uses alcoholic solution of resin
 optional step
 Ex: Shellac
(2) Subcoating  round off the tablet contour rapidly
 improve bond between seal coat & sugar coat
 standardize tablet size
(3) Syruping  particularly demanding & involves three basic
phases
a. Grossing  base color
 application of a syrup solution w/
subcoating powder
b. Heavy Sugar Coating  to build up a
solid color
c. Regular Syrup Coating  desired color
 dilute syrup solution
 finishing w/out permitting
the tablet to become as
dusty as previous two
syrupiing stages
(4) Finishing  initiated when the desired color is attained
(5) Polishing  done in a canvas polishing pan
Film-Coating  thin, skin-tight coating of plastic like material

*Advantage: No significant increase in tablet weight, size, shape
Retain contour of original core
About 2-5% increase in thickness only
*Enteric Coating  form of functional coating
*Film-Coating Solutions may be non-aqueous/ aqueous:
1. Non-aqueous Solutions contain the following types of materials
a. Film-former  capable of producing smooth, thin films
reproducible under conventional coating
conditions & applicable to a variety of tablets
shapes.
 Example: Shellac;
CAP (Cellulose Acetate Phthalate
b. Alloying Substance imparts water-solubility/ permeability
 Example: PEG (Polyethylene Glycol)
c. Plasticizer  imparts flexibility & elasticity
 Example: Castor Oil; Sorbitol;
d. Surfactant  imparts spreadability
 Example: Spans; Tweens;
Polyoxythylene sorbitan derivatives
e. Opaquants  Example: Titanium Dioxide
f. Glossant  provide luster to the tablets w/out a separate
polishing operation
 Example: Beeswax
h. Volatile Solvent  allow the spread of the other components
over the tablets while allowing rapid
evaporation to permit an effective yet
speedy operation
 Example: Alcohol mixed with acetone
2. Aqueous Film-Coating Formulation contains:
a. Film-forming Polymer (7% to 18%): Cellulose ether polymers
b. Plasticizer (0.5 to 2.0%): Glycerin
c. Colorant & Opacifier (2.5% to 8%)
d. Vehicle (water, to make 100%)
Enteric Coating  designed to resist dissolution in the stomach but dissolve
in the less acidic environment of the small intestines (pH
4.8 or greater)
Ex: Shellac, HPMC
*Problems attendant on aqueous Film-Coating:

1. Picking  small amount of film fragments flaking from the tablet Sugar Coated Film Coater
surface (punch) rounded retain original core
 removal of material from the surface of the tablet & 30-50% increase in tablet weight 2-3% increase in tablet weight
adheres to the punch face multi-stage process usually single-stage process
2. Peeling  large amounts of film fragments flaking from the tablet
surface
3. Orange peel effect  roughness of the tablet surface due to Quality Standards & Compendial Requirements:
failure of spray droplets to coalesce 1. Tablet weight & USP weight Variation: 10% of the standard wt
4. Mottling  uneven color distribution  Tablet Weight can be adjusted
5. Bridging  filling-in of the score line or indented logo on the by Lowering the lower punch adjustment knob.
tablet by the film; masking of monogram 2. Content Uniformity: 15% of standard content of A.I.
6. Tablet Erosion  disfiguration of the core tablet when subjected 3. Tablet Thickness: 5% of the standard thickness
for too long the coating solution 4. Tablet Hardness & Friability
7. Wrinkling  caused by improper drying or film former defect 5. Tablet Disintegration
8. Sweating  oil droplets 6. Tablet Dissolution
9. Blistering  reduced adhesion between film & surface of tablet
due to rapid drying The Thickness of the Tablet is determined by the following:
diameter of the die
*Other Problems in Tabletting: amount of fill permitted to enter the die
1. Chipping  removal of edges/ small portion of tablet the compaction characteristics of he fill material
 the separation of small piece of tablet surface after the force of pressure applied during compression
ejection
 breaking of tablet edges while the tablet leaves the
press
2. Capping  the partial or complete separation of the top or
bottom of a tablet from the main body
3. Lamination  multilayered; the separation of tablet into two or
more distinct layers
4. Bloom  dull film due to humid conditions or migration of
plasticizer to surface of coat
5. Spotting  due to migration of plasticizers, dyes or other
additives in the coating formulation
6. Flaking  removal of tablet surface
7. Sticking  adhesion of granulation to the die walls
8. Cracking
9. Weight Variation  causes: -Poor mixing
-Punches (unequal length of lower
punches)
-Poor Flow
-Size & distribution of the Granules
being compressed
10. Hardness Variation  have the same causes as weight
variation
 depends on the weight of material
11. Double Impression  involves only lower punches
 tablet receives the imprint of the punch
E. Solid Oral Modified-release Dosage Forms
dosage forms in which drug release features are based on
time, coarse & location that are designed to accomplish
therapeutic or convenience objectives not offered by
conventional or immediate-release forms 3. Microencapsulation Drug
Reasons: a. For drugs, that are not inherently long lasting in is a process by which solid, liquids, or even gasses may be
effects. enclosed in microscopic particles by formation of thin
b. For drugs, that requires multiple dosing coatings of wall material around the substances
materials used:
-Gelatin  is a common wall-forming material
1. Extended Release Dosage Forms (ER) -Synthetic polymers  polyvinyl alcohol,
Controlled, Sustained ethylcellulose, polyvinyl
provides immediate release of the large amount of drug chloride
that produce the desire effect & followed by gradual advantages: The administered dose of the drug is
release of remaining amounts subdivided into small unit that are spread over a
allows the reduction in dosing frequency from that large area of the gastrointestinal tract, which may
necessitated by a conventional dosage form enhance absorption by diminishing local drug
 Problem: Dose Dumping (lead to toxic effects) concentration
Example: Potassium Chloride (Micro-K Extencaps,
2. Delayed Release Dosage Forms (DR) A.H. Robins)
 designed to release the drug at a time other than 4. Embedding Drug in Slowly Eroding or
promptly after administration Hyrdrophilic Matrix System
Example: Enteric Coating (PET) the drug substance is combined & made into granules w/
a. ph dependent an excipient materials that slowly erodes in body fluids,
b. enzyme dependent progressively releasing the drug for absorption.
c. time dependent Hydrophilic Cellulose Polymers
 are commonly used as the excipient base in
3. Repeat Action  contain two single doses of medication, tablet matrix systems.
one for Immediate Release & the Hydrocypropyl Methylcellulose (HPMC)
other for Delayed-release (DR)  a free-flowing powder, is commonly used to
provide the hydrophilic matrix
4. Targeted Release Dosage Forms  describes drug released Example: Oramorph SR Tablets (AllPharma)
directed toward isolating or  contains Morphine Sulfate
concentrating a drug in a body 5. Embedding Drug in Inert Plastic Matrix
region, tissue, or site for  the drug is granulated w/ an inert plastic material such as
absorption of for drug action. polyethylene, polyvinyl acetate, or polymethacrylate, &
the granulation is compressed into tablets
 GITS  type of modified release formutlation consists of a drug  the drug is slowly release from the inert plastic matrix by
reservoir surrounded by a semi-permeable membrane, diffusion.
which has a single precision-laser-drilled pore on the drug- inert tablet matrix  expended of drug, is excreted w/
reservoir side. the feces
 Example: Gradumet (Abbott)
Characteristics of drugs commonly incorporated into an 6. Complex Formation
Extended-release product: provides the extended release of the drug because of the
a. They neither very slow nor very fast rates of absorption & excretion slow dissolution rate
b. They are uniformly absorbed form the gastrointestinal tract Example: Salts of Tannic Acid (Rynatan) -Wallace
c. They are administered in relatively small doses
d. They possess a good margin safety
7. Ion exchange Resins
e. They are used in the treatment of chronic rather than acute form a complex by the replacement of hydrogen atoms.
conditions Resin-drug Complex  is washed & amy be tableted,
encapsulated or suspended in
Extended-Release Technology for Oral Dosage Forms an aqueous vehicle.
1. Coated Beads, Granules & Microspheres System Example:
the drug is distributed onto beads, pellets, granules, or -Hydrocodone Polistirex & Chlorampheniramne
other particulate systems Polistirex Supension (Tussionex Pennkinetic
Example: Spansule (SmithKline Beecham) Capsule Extended Release Suspension [Celltech])
a capsule containing beads of different -Phentermine Resin Capsules (Ionamin Capsules
coating thickness [Celltech])
2. Multitablets System incorporates a polymer barrier coating & bead technology
small spheroids compressed tablets 3.4 mm in diameter in addition to the ion exchange mechanism
may be prepared to have varying drug release 8. Osmotic Pump
characteristics  the pioneer oral osmotic pump drug delivery system is the,
may be placed in gelatin capsule shells to provide the Oros System Developed by Alza
desired pattern of drug releas is composed of a core tablet surrounded by a
each capsule may contain 8-10 (tablets) minitablets semipermeable membrane coating having a 0.4
-uncoated  for immediate release diameter hole produced by laser beam
-coated  for extended drug release Example: Glucotro XL, Procardia XL, Covera HS
F. Inserts Rectal Suppository  is not usually compressed as
1. Suppositories tablets unlike vaginal
2. Vaginal Inserts suppositories
Suppository Bases:
1. Suppositories 1. Oleaginous Base (Fatty Base)
 solid dosage forms intended to be inserted in body the most frequently employed suppository
orifices where they would melt & dissolve to exert their a. Cocoa Butter, NF  roasted seeds of Theobroma
local or systemic effects Cocoa (fam. Sterculiaceae)
Types of Suppositories: also known as Theobroma Oil
Rectal Suppositories melts at 30-36C (86-97F)
Vaginal Suppositories/ Pessaries ideal suppository base
Urethral Suppositories/ Bougies exhibits marked polymorphism
Features Rectal Vaginal Urethral because of its triglyceride content
Weight 5 grams 3-5 grams Males: 4 g Triglycerides: (a) Oleopalmistostearin
(Infants: 1g) Females: 2 g (b) Oleostearin
Size 1.5 inc long/ varies Males: 3-6 mm Polymorphs: (a) Alpha
32mm diameter (b) Beta more stable
100-150 mm long/ solid until 32C
usually, 140 mm melt between 34-35C
Females: 60-75 mm Phenol & Chloral Hydrate can decrease its
long/ usually 70 melting point when incorporated w/ it.
mm b. Wecobee  source from coconut
Shape Cylindrical & Globular, Slender, c. Witepsol  saturated fatty acis C12-C100
have tapered at Oviform, pencil-shaped, &  main saturated FA is lauric acid
one end or conical pointed at one d. Other examples:
both, resembles (cone- extremity/ hydrogenated fatty acids of vegetable oils
torpedo, bullet shaped) Palm Kernel Oil
or little finger thinner & tapered Cottonseed Oil
containing compounds of glycerin
(for children:
Palmitic Acid
Pencil-like)
Stearic Acid
Age (Children: ½ of For adults For Adult
Glyceryl Monostearte & Glyceryl Monopalmitate
Difference the adult size)
Gender Both Female only Both 2. Water-Soluble or Water-miscible Base
Precaution: Moisten the Tip of the Suppository to
Preparation of Suppositories: prevent mucosal irritation & to
1. Hand Molding (No heat application) facilitate the smooth passage of
 Hand rolling & shaping suppository in the body-orifices.
simplest & oldest method for preparing a. Glycerinated Gelatin  most frequently used in
suppositories preparation of vaginal
 is a historic part of the art of the pharmacist suppositories
2. Cold Compression (No heat application) slower to soften & mix w/ the
cold-grated mass is formed into a mold under physiologic fluids
pressure, using a wheel-operated press b. Polethylene Glycols  polymers of ethylene oxide &
by forcing the mized mass of the base & water
medicaments into special molds using do not melt at body temperature
suppository-making machines but rather dissolve slowly in
the base & other formulative ingredients are the body’s fluid
combined by through mixing, the friction of the  for vaginal administration
process softening the base into a pastelike
consistency 3. Miscellaneous Bases
3. Fusion or Melt Molding (Pour Molding)  generally combination of lipophilic & hydrophilic
most commonly used for producing suppositories substances
on both small or large scale operation  mixtures of oleaginous & water-soluble or water-
common molds used today: Stainless Steel miscible materials
Aluminum  Example: Polyoxyl 40 stearate  a surface-active
Brass agent that is employed
Plastic in a number of
Steps in Molding: commercial suppository
(1) Melting the base base
(2) Incorporating any required medicaments
(3)Pouring the melt into molds General Specifications of an Ideal Suppository Base:
(4) Allowing the melt to cool & congeal into 1. Nontoxic & Non-irritating to mucous membranes
suppositories 2. Compatible with a variety of drugs
(5) Removing the formed suppositories from 3. Melts or dissolves in rectal fluids
the mold 4. Stable on storage: Should not bind or otherwise
4. Compression in a tablet press interfere with release & absorption of drug
a. Carbon Dioxide  releasing tablet substances
b. Vaginal Compressed Tablet
2. Vaginal Inserts/ Vaginal Tablets
 are uncoated, bullet-shaped, or ovoid (egg-formed)
inserter into the vagina for local effects
 prepared by compression & shaped to fit smugly on
“Plastic Inserter “devices that accompany the
product
Methods: Direct Compression
 contains: Antimicrobial Agent
II. Semisolid Dosage Forms
1. Ointments
2. Creams
3. Gels
4. Miscellaneous Semisolids: Pastes
Plaster
Glycerogelatins
1. Ointments
are semisolid preparations intended for external
application to the skin or mucous membranes
may be medicated or not
Uses: Emollients  make the skin more pliable
Protective Barriers
Vehicles  in which to incorporate medication
Ointment Bases:
1. Oleaginous Bases (Hydrocarbon Bases) 3. Water Removable Bases (Water-washable Base)
characteristics: resembles o/w emulsion & creams
 greasy may dilutes with water or aqueous
 non-water washable solutions
 offer the best emollient & occlusive have the ability to absorb serous
effects discharges
a. Petrolatum, USP Example: Hydrophilic Ointment, USP
purified mixture of semisolid hydrocarbon 4. Water Soluble Base (Greaseless Base)
obtained from petrolatum do not add large amount of H2O into the
aka Yellow Petrolatum (Vaseline®), base because they soften easily
Petrolatum Jelly complete water washable
b. White Petrolatum, USP (White Vaseline®) do not contain oleaginous components
purified mixture of semisolid hydrocarbon, used for the incorporation of solid
obtained from petroleum that has been substances
nearly or wholly decolorized. Example: PEG Ointment, NF
c. Yellow Wax  wax obtained from the honeycomb
of Apis Mellifera (European
Methods in the Preparation of Ointments:
Honeybee)
a. Incorporation  mixing of all components, until a
d. Yellow Ointment (Simple Ointment)
uniform mixture is achieved
yellow wax + Petrolatum USP
using mortar & pestle, or a spatula
e. White Ointment, USP
Incorporation of Solid  preparing an ointment by
white wax (yellow wax that has been
Spatulation
bleached) + White petrolatum, USP b. Fusion  mixing all of the component by melting w/
2. Absorption Bases emollient & occlusive effect constant stirring then allowed to cool until
greasy; non-water washable congealed.
 may permit the incorporation of
aqueous solutions in small amount Bleeding  liberation oil or water from ointment
a. Hydrophilic Petrolatum, USP (Aquaphor®)
bases
stearyl alcohol + white wax + cholesterol +
white petrolatum
b. Lanolin (Wool Fat)
wax-like substance from the wool of the 2. Creams  are semisolid preparations containing one or more
sheep (Ovis arie) medicinal agents dissolve or dispersed in either a
Anhydrous Lanolin (Woolfat) w/o or o/o emulsion or in another type of water-
 NMT 0.25% moisture washable base
Hydrous Lanolin (Woolfat)  more preferred than ointments
 NMT 25% moisture  because of the ease in spreadability
Modified Lanolin  lanolin that has been  less viscid (sticky) & lighter than ointments
processed to remove free lanolin  are considered to have grater aesthetic appeal fo
alcohols + excess detergents their non-greasy character, ability to vanish into the
skin upon rubbing, & ability to absorb serous
discharges from skin lesions
 Example: Vanishing Cream  o/w emulsion
 stearic acid
Cold Cream (w/o emulsion)
3. Gels  are semisolid consisting of dispersions of small or large 4. Miscellaneous Semisolids
molecules in an aqueous liquid vehicle rendered jellylike Pastes  are semisolid preparations intended fro
by the addition of a gelling agent application to the skin
 among the gelling agent used:  are generally contain a larger proportion of solid
synthetic macromolecules: Carbomer 934 material than ointments (25% more of solid
cellulose derivatives: Carboxymethylcellulose/ particles)
Hydroxypropyl Methylcellulose  stiffer/harder than ointments, so they remain in
natural gums: Tragacanth place after application & are effectively employed
 aka “Jellies” to absorb serous secretions
Two Types of Gels:  easier to spread & remove than oitment
(a) Single-Phase Gels  gels in which macromolecules are  can be prepared in the same manner as ointments
distinguished somewhat uniformly CI: Not applied on hairy part of the body
in a liquid vehicle & no apparent Use: to absorb serous secretions
boundary can be seen (for protective action)
(b) Two-Phase Gels  gels made up of flocculated small Example: Zinc Oxide Paste
distinct particles Lassar’s Plain Zinc Paste
 Ex:Milk of Magnesia(7-8.5%MgO) 25% each of Zinc Oxide Paste
Classifications of Gels: Starch w/ white
 First Classification Scheme: petrolatum
1. Inorganic Hydrogels  usually two-phase system Plasters  solid or semisolid adhesive masses spread on a
Ex: Aluminum Hydroxide Gel backing of paper, fabric, moleskin, or plastic.
Bentonite Magma (also an ointment base)  are applied to the skin to provide prolonged
2. Organic Gels  usually single-phase system contact at the site
Ex: Carbopol Use: To prolong the contract of the active
Tragacanth ingredient to the site of absorption
 Second Classification Scheme: Examples: Salicylic Acid Plaster (10-40%)
1. Hydrogels  disepersible as colloidal or soluble in use to remove corns & warts
water; they include organic hydrogels,
natural & synthetic gums, & inorganic
hydrogels. Glycrogelatins  are plastic masses containing:
2. Organogels  include the hydrocarbons, animal& Glycerin (40%)
vegetable fats, soap base, greases, & the Water (35%)
hydrophilic organogels. Gelatin (15%)
Example: Petrolatum (semisolid gel) Medicinal Substance (10%)
Plastibase (hydrocarbon type, are applied to the skin for the long term.
combination of mineral oils Example: Zinc Gelatin (treatment of
& heavy hydrocarbon varicose ulcers)
waxes)
Epicutaneous Route  drugs are administered topically, or applied to the

skin, for their action at the site of application or
for systemic drug effects
Semisolid: Ointments, Creams, Pastes
Solid: Medicinal Powders  are intimate mixture of medicinal substances
usually in an inert base such as Talcum
powder or Starch
Liquid: Lotion  are emulsions or suspensions generally in an aqueous
vehicle
may be preferred over semisolid preparations because of
their nongreasy character & their increased spreadability
over large areas of skin.
III. Transdermal Drug Delivery System Layers of TDDSs:
often called as “Transdermal patches” a. Occlusive Backing Layer  to protect the system form environment
facilitate the passage of the drug from stratum corneum to entry & from loss of drug from the
the systemic circulation system or moisture from the skin
b. Drug Reservoir/ Matrix System  to store & release the drug at the
Two Types of TDDSs: skin site.
1. Monolithic Transdermal System c. Release Liner  removed before application & enables drug
 incorporate a drug matrix layer between the backing & release
frontal layers d. Adhesive layer  to maintain contact w/ the skin after application
2. Membrane-controlled Transdermal System e. Protective Peel Strip
 are designaed to contain a drug reservoir or pouch,
usually in liquid or gel form, a rate-controlling Four Layers for Membrane-controlled & Continuous Transdermal
membrane, & backing, adhesive & protecting layer System:
1. Backing Layer
Advantages & Disadvantages of TDDSS 2. Drug Reservoir
Advantages: 3. Microporous rate-limiting membrane
1. They can avoid gastrointestinal drug absorption difficulties. 4. Adhesive foormulation
2. They can substitute for oral administration of medication when
that route is unsuitable, as with vomiting and diarrhea.
3. They avoid the first-pass effect.
4. They are noninvasive, avoiding the inconvenience of parenteral
therapy.
5. They provide extended therapy with a single application.
6. The activity of drugs having a short half-life is extended through
the reservoir of drug
7. Drug therapy may be terminated rapidly.
8. They are easily and rapidly identified in emergencies.
Disadvantages:
1. Only relatively potent drugs are suitable candidates for Layers of the Transderm-Nitro Transdermal Therapeutic System
transdermal delivery because of the natural limits of drug entry (Summit):
imposed by the skin’s impermeability. 1. Backing
2. Some patients develop contact dermatitis at the site of 2. Drug Reservoir
application from one or more of the system components, 3. Control Membrane
necessitating discontinuation. 4. Adhesive Layer
5. Protective Peel Strip
General Clinical Considerations in the Use of TDDSs
1. Percutaneous absorption may vary with the site of application.
2. TDDSs should be applied to clean, dry skin that is relatively free of
hair and not oily, irritated, infl amed, broken, or callused.
3. Use of skin lotion should be avoided at the application site
because lotions affect skin hydration and can alter the partition
coefficient between the drug and the skin.
4. TDDSs should not be physically altered by cutting (as in an attempt
to reduce the dose) since this destroys the integrity of the Nitro-Dur Transdermal Infusion System:
system. 1. Foil Coverstrip 5. Microporous Tape
5. A TDDS should be removed from its protective package, with care 2. Drug Matrix 6. Absorbent Pad
not to tear or cut into the unit. 3. Release Liner 7. Occlusive Overlay
6. A TDDS should be placed at a site that will not subject it to being 4. Foil Baseplate
rubbed off by clothing or movement (as the belt line).
7. A TDDS should be worn for the full period stated in the product’s
instructions.
8. The patient or caregiver should be instructed to cleanse the hands
thoroughly before and after applying a TDDS.
9. If the patient exhibits sensitivity or intolerance to a TDDS or if
undue skin irritation results, the patient should seek
reevaluation.
10. Upon removal, a used TDDS should be folded in half with the
adhesive layer together so that it cannot be reused. The used
patch, which contains residual drug, should be placed in the
replacement patch’s pouch and discarded in a manner safe to
children and pets Layers of Two-Layer Transdermal Drug Delivery System:
Factors Affecting Percutaneous Absorption: 1. Film Backing
1. Drug Concentration 2. Drug/ Adhesive Layer
2. Large Area of Application
3. Physicochemical attraction to the skin
4. Drugs with molecular weights of 100-800
5. Hydration of the skin
6. Percutaneous absorption
7. The longer the medicated application remain on the skin, the
greater is the total absorption.
Examples of TDDSs: Novel Topical Systems:
1. Transdermal Scopolamine 1. Iontophoresis (IP)
for motion sickness, nausea & vomiting  is an electrochemical method that enhances the transport of
anticholinergic/ antimuscarinic (M1) some solute molecules by creating a potential gradients through
Transdermal Scop  first TDDS the skin w/ an applied electrical current or voltage
1979 (Baxter®)  induces increase migration of ionic drugs into the skin by
 Ciba®  Novartis® electrostatic repulsion.
2. Transdermal Clonidine  Advantages of IP:
first TDDS for Hypertension a. Control of the delivery rates by variation of current density,
pulsed voltage, drug concentration, & ionic strength
3. Transdermal Nitroglycerin b. Eliminating gastrointestinal incompatibility, erratic absorption, &
for the relief of pain associated w/ angina pectoris first-pass metabolism
4. Transdermal Nicotine c. Reducing side-effects & variation among patients
for smoking cessation to prevent withdrawal symptoms & d. Avoiding the risks of infection, inflammation, & fibrosis associated
w/ continuous injection or infusion.
physical dependence e. Enhancing compliance w/ a convenient & non-invasive
5. Transdermal Estradiol therapeutic regimen.
hormone replacement therapy: Disavantage of IP: Skin irritation at high current densities
-primary ovarian failure (this can be eliminated or minimized by reducing
-female hypogonadism the current)
-vasomotor symptoms associated w/ menopause Drugs deliver through IP:
-atrophic vaginitis Pilocarpine-induce sweating in the diagnosis of cystic fibrosis
-Kraurosis Vulvae  aka Briesky Disease Topical:
6. Transdermal Testosterone -Fluoride  to the teeth
Testoderm®  only applied at scrotal skin -Dexamethasone  anti-inflammatory into joints
Androderm®  both the scrotal & at the back of patient -Lidocaine  as a topical anesthetic
 Variation affecting IP:
1. Current  can be direct, alternate, or pulsed & can have
various waveforms, including square, sinusoidal,
triangular & trapezoidal
2. Physicochemical Variables  include the charge, size,
structure & lipophilicity of the
drug.
3. Formulation Factors  include drug concentration, pH, ionic
strength & viscosity
4. Biologic Factors  pertain to the skin, to which the electrodes
are applied, its thickness, permeability,
presence of pores, & so on.
5. Electroendosmotic Flow  results when a voltage difference is
applied across a charges porous membrane,
resulting in a bulk fluid flow in the same
direction as the flow of counter ions.
2. Phonophoresis  synonyms:
-ultrasound
-sonophoresis
-ultrasonophoresis
-ultraphophoresis
 is the transport of drugs through the skin using
ultrasound
 is combination of ultrasound therapy w/ topical drug
therapy to achieve therapeutic drug concentrations
at slected sites in the skin.
 used by physiotherapist
Three Effects of Ultrasound:
1. Cavitation  is formation & collapse of very small
air bubbles in a liquid in contact w/
ultrasound & waves
2. Microstreaming  closely associated w/
cavitations, result in efficient mixing by
inducing eddies in small-volume elements
of a liquid; this may enhance dissolution of
suspended drug particles, resulting in a
higher concentration of drug near the skin,
for absorption
3. Heat Generation  results from the conversion of
ultrasound energy to heat energy & can
occur at the surface of the skin as well as in
deeper layer of the skin.
most often drug administered through
Phonophoresis:
Hydrocortisone
IV. Liquid Dosage Forms: Single Phase
Solutions  are liquid preparations, that contain one or more
chemical substances dissolved in a suitable solvent or
mixture of mutually miscible solvents
 homogenous one-phase system consisting of 2 or more
components
 most commonly used liquid dosage form
Advantages:
(1) Complete homogenous doses
(2) Immediate availability for absorption & distribution
(3) Provides a flexible dosage form
-easy to swallow
-can be used by any route of administration
-easy to adjust dose
General Rules in Preparing Solution:
1. Know the solubility characteristics of the drug or
chemical
b. Choose the proper solvent
3. The salt form of the drug is used
4. When adding salt to syrup, dissolve in a few mL of Topical Solutions:
water then add syrup to volume if an alcoholic 1. Aluminum Acetate Topical Solution (Burrows Solution)
solution of a purely water-soluble drug is used, add  used in dermatologic loton, creams, & pastes
the aqueous solution to the alcoholic solution  astringent wash
Physicochemical: Product of any combination of the three  after dilution of 10-40 part of water, used as wet dressing
states of matter: Solid, Liquid, Gas 2. Aluminum Subacetate Topical Solution
(S-L, L-L, S-G, L-G) starting solution for Aluminum Acetate Solution
Pharmaceutical: Liquid Dosage Forms containing active astringent wash & wet dressing
ingredients dissolve in a suitable solvent  Ration of Aluminum Oxide  HAc:
or a mixture of mutually miscible solvent. Al.Sub  1:2:35
 Solubility: State when the total amount of solute in the Al. Ac  1:13:52
solution & excess particles reaches Equilibrium. 3. Calcium Hydroxide Topical Solution (Limewater; Liquor Calcis)
Descriptive Terms Parts of Solvent needed to  composed of not less than 140 mg of Ca(OH)3 in every
dissolve 1 part of solvent 100mL of solution
Very Soluble <1 used as astringent
Freely Soluble 110  Preparation: Ca(OH)3 more soluble in cold water
Soluble 1030  Dispensing: Dispense the supernatant liquid using a
Sparingly Soluble 30100 “SIPHON”
Slightly Soluble 1001000 4. Coal Tar Topical Solution
Very Slightly Soluble 100010,000 composed of 20% coal tar + 5% Polysorbate 80 (solubilizer)
Insoluble >10,000 nearly black viscous liquid w/ a sharp burning taste & has
Topical Oral (Dental) Solutions: naphthalene-like odor.
local antieczema (contact dermatitis)
 Benzocaine  Topical anesthetic
5. Hydrogen Peroxide Topical Solution (Agua Oxygenada)
 Camphorated  Dental antiinfective.
Bubbling Effect: release of O2
Parachlorophenol
 Carbamide Peroxide Topical  Dental H2O2 catalase O2
Solution  anti-infective 3%  10 volumes
6%  20 volumes
 Cetylpyridinium Chloride  Local antiinfective
Solution & local anti-infective for use topically on the skin & mucous
Cetylpyridinium Chloride membrane
Lozenges 6. Povidone-Iodine Topical Solution
 Erythrosine Sodium Topical  Diagnostic aid (dental complex of I2 + Polyvinylpyrolidone (PVI)
Solution & disclosing agent) Iodine in Povidone Iodine  10%
Erythrosine Sodium Soluble surgical scrub & non-irritating antiseptic solution
Tablets  1:5000  concentration of Iodine which is effective to
 Eugenol:  Dental analgesic combat many common bacteria in distilled water
7. Thimerosal Topical Solution
 Lidocaine Oral Spray:  Topical dental anesthetic
water-soluble organic antibacterial use for its bacteriostatic
 Nystatin Oral Suspension  Antifungal
or fungistatic effect
 Saliva Substitutes  Electrolytes in a
Thimerosal in solution  o.1%
carboxymethylcellulose base
Dispense= 1:5000 concentration
 Sodium Fluoride Oral Solution  Dental caries prophylactic
disinfect skin prior to surgery & as a first aid application to
& Sodium Fluoride Tablets
wounds & abrasions.
 Sodium Fluoride And  Dental caries prophylactic
Phosphoric Acid Gel &
Sodium Fluoride And
Phosphoric Acid Topical
Solution
 Zinc Oxide–Eugenol Mixture  Temporary filling mix.
Types of Solutions:
Aqueous Solutions:
1. Aromatic Water (Medicated Waters)
 clear, saturated aqueous solutions of volatile oils or
other aromatic or volatile substances.
uses: Perfuming
Vehicle
storage: Tight, Light-resistant Bottles
2. Aqueous Acids: Sweet or Other Viscid (Sticky) Aqueous Solutions:

a. Hydracids  do not contain oxygen 1. Syrups  are concentrated solution of sugar such as sucrose in
b. Oxygen-containing acid water.
c. Diluted Acids  aqueous solutions of concentrated acid dissolve  Two Types: (a) Medicated  AI
in purified water of suitable strength 10% w/v (b) Non-medicated  vehicle
(except Acetic Acid, 6%)  Methods in Syrup Making:
 Example: Diluted HCl (treatment for Achlorydia/ 1. Solution w/ the aid of Heat
Hypochlorydia)  if we want to produce syrup quickly
 Primary Considerations  Must be sipped using a 2. Solution w/ Agitation w/out the aid of Heat
straw to protect dental  if we want to prevent sucrose inversion or
enamel caramelization
 Percentage strength of official undiluted acid is expressed 3. Addition of Sucrose to a flavored or medicated Liquid
in % (w/w) 4. Percolation
 Percentage strength of official diluted acids is expressed in a. Syrup, NF (Simple Syrup)  nearly saturated aqueous solution
% (w/v) of sucrose (85% w/v)
 low solvent capacity for water
soluble drugs
3. Douches  used as cleansing or antiseptic agent directed against a  inherently stable & resistant to
part or into cavity of the body the growth of microorganisms
 most frequently dispensed in the form of a powder w/ when properly prepared &
the directions for dissolving in a specified quantity of maintained
warm water b. Cherry Syrup  if the drug material requires an acid medium
Vaginal Douche  cleanse the vagina c. Cocoa Syrup  if the drug is Bitter tasting
 mostly has antibiotic (Chlorhexidate d. Orange Syrup  if the drug is stable in acid medium
Glucorate) e. Raspberry Syrup  disguise the sour or salty taste of saline
***vagina must be Acidic medicaments
f. Ora-sweet or Ora-sweet SF (Sugar Free)  for extemporaneous
4. Enemas  rectal injection employed to evaluate the bowel compounding of syrups
Rectal Enema  used to cleanse the bowel in large intestines
before & after surgery 2. Honeys  are thick liquid preparations somewhat allied to the
 contain in plastic squeeze bottle syrups
 components:-Na phosphate/Biphosphate Oxymel  mixture of Honey & Acetic Acid
-Docusate Na (Stool Softener)
- Glycerin 3. Mucilages  are thick, viscid, adhesive liquids by dispensing gum in
- Light Mineral Oil water.
Examples: Sodium Phosphate Enema
Hydrocortisone Enema 4. Jellies  are class of gels in which the structural coherent matrix
Aminophylline Enema contains a high portion of liquid, usually water
5. Gargles  for treating the pharynx & nasopharynx
6. Washes  most often used for its deodorant, refreshing or

antiseptic effects
7. Juices  are prepared from fresh ripe fruits
8. Sprays  are applied to the mucous membranes of the nose &

throat by means of “Atomizer” or “Nebulizer”
 aqueous or oleaginous solutions in the form of coarse
droplets or finely divided solid usually introduce into
body cavities especially in Nasopharyngeal Tract.
Nonaqueous Solutions:
1. Alcoholic or Hydroalcoholc Solutions: 4. Oleaginous Solutions
a. Tinctures  from vegetable materials or form chemical a. Liniments (Embrocations)  applied w/ friction or by rubbing
substances  alcoholic or Oleaginous solutions
 alcohol content: 15-80% containing mpre than one
Preparations: Maceration medicinal agent intended to be
Percolation rubbed on the skin
 Examples:  CI: Broken Skin or Bruise Skin
- Iodine Ticture  Label “For external use Only”
- Paregoric, USP  camphorated opium tincture  Two types:
- Opium Tincture, USP  (Laudanum) Alcoholic Liniment  if you want
counterirritant Effect
b. Elixirs  are clear, pleasantly flavored, sweetened hydroalcoholic Rubefacient Effect
liquids intended oral use. Penetrating Action
 alcohol content:5-40%,but most of the time,varies widely Oleaginous Liniment  if you want Massage
Methods: Solution w/ Agitation  less irritating
Admixtures of Solution b. Oleovitamins  are fish liver oils diluted w/ edible vegetable oil
 Two types of Elixirs: of solutions of the indicated vitamins
-Non-medicated  vehicle c. Toothache Drops  for temporary relief of toothache
-Medicated  Antihistamine
Digoxin 5. Medicated Solutions for Vaporization
Barbiturates a. Inhalations  are drugs or solution of drugs administered by the
 Examples: nasal or respirator route for local or systemic
- Aromatic Elixir, NF  22% alcohol effect
Preparation: Always add aqueous solution to alcoholic b. Inhalations (Insufflations)  consist of finely powdered or liquid
solution. drugs that are carried into the
respiratory passage by the use of
c. Spirits (Essences)  are alcoholic solution of volatile substances special delivery system.
prepared usually by simple solution or by c. Inhalants  drugs or combination of drugs which by virtue of
admixture of the ingredients their high vapor pressure, can be carried by an air
 may be taken orally, applied externally, or current into the nasal passage where they exert
used by inhalation effect.
 alcohol Content: >60% alcohol  Examples:
 Methods: Simple Solution - Aromatic Elixir, NF  22% alcohol
Solution w/ maceration
Distillation
2. Ethereal Solutions
a. Collodions  a liquid preparations containing pyroxylin in a
mixture of ethyl ether & ethanol
 is prepared by dissolving pyroxillin (4%) in a 3:1
mixture of ether & alcohol.
 Salicylic Acid Collodions  keratolytic in the
treatment of corns & Other Solutions:
warts a. Nasal Solutions  aqueous solutions designed to be administered to
10% SA the nasal passages in the form of drops or sprays
 Collodion, USP / Flexible Collodions Ephedrine  nasal decongestant (vasoconstrictor)
 water-repellant protective for minor Lypressin  for diabetes
cuts & scratches. b. Otic or Aural Solutions  aqueous solutions designed to be
Flexible Collodions  10% of Salicylic Acid + administered t.o the ear
3% Castor Oil (for flexibility) c. Irrigation Solution  aqueous solutions used to wash or bathe
2% Camphor (for water- surgical incisions, wounds, or other body
proofing) tissues
Pyroxylin  aka Soluble Guncotton
Nitocellulose
Collodion Cotton
 product of reaction of nitric acid & sulfuric
acid on cotton (Gossipiun hirsutum)
 is composed chiefly of cellulose tetranitrate
 harsh to touch& extremely flammable
moisten by 30% alcohol
 4% of Pyroxylin (in collodion), dissolve in 3:1
ratio of ether & alcohol
3. Glycrin Solution  valuable pharmaceutical solvent forming

permanent & concentrate solutions
a. Glycerites  are solutions or mixture of medicinal substances in
Not Less Than 50% Glycerin
 are hygroscopic & should be stored in tightly closed
containers
Extraction  involves the separation of medicinally active portions of plant Solutions Prepared by Extraction Process: (Galenicals)
or animal tissue from inactive or inert components by use of 1. Fluid Extracts (Liquid Extracts)  are alcoholic or hydroalcoholic liquid
selective solvents in standard extraction procedures. preparations of vegetables containing
alcohol as a solvent or as a
Methods of Extraction: preservative, or both, so made that
1. Maceration  Latin word “macerare”, meaning to soak each mL contains the therapeutic
 15-20C constituents of 1g of the standard
 2-14 days drug that is represents
 is process in which the properly comminuted drug  are made by Percolation
is permitted to soak in the menstruum until the Fluid Extracts are made by Percolation w/ the ff. variations:
cellular structure is softened & penetrated by 1. Process A: Percolation method than can be modified for
menstruum & the soluble constituents are fluid extracts that must be assayed
dissolved. 2. Process: An Alternative for process A in which percolation
2. Percolation  Latin word “per”= through; “colare”= to strain is conducted on a column of drug much
 allow the solvent to pass through the column of greater in length than in diameter
drugs. 3. Process D: Boiling Water is used as the menstruum,
Rate of Flow: alcohol being added as a preservative to
Percolate Slowly NMT 1 mL/min concentrated percolate
Percolate at a Moderate Rate 1-3 mL/min 2. Extracts are concentrated preparation of vegetable or animal drugs
Percolate Rapidly 3-5 mL/min obtanined by:
-Removal of the active constituents of the respective
drugs w/ suitable menstrual
-Evaporation of all or nearly of the solvent
-Adjustment of the residual masses or powders to the
prescribed standard
 mostly prepared by Percolation
Three Forms of Extracts:
1. Semiliquid Extracts (Liquids)
consistency: Syrup
no intention to remove all of the solvent
2. Pillular (Solid Extracts)
consistency: Plastic
there is an intention to remove nearly or almost
of the solvent
3. Powdered Extracts (Dry Powders)
 there is an intention of removing all of the
solvent
3. Decoctions  are preparations containing water-soluble & heat-stable
constituents extracted from crude drugs by boiling the
latter in water (for 15 minutes)
4. Infusions  are dilute solutions of readily soluble constituents of crude
drugs prepared by short maceration of the drugs w/ either
cold or boiling water.
5. Tincture  are alcoholic or hydroalcoholic solutions prepared form
vegetable materials or from chemical substances.
Process P  Percolation
Process M  Maceration
 A tincture of non-potent drugs contains 10g of the
crude drugs per 100mL of the tincture.
6. Digestion  maceration w/ gentle heat
General Formulation: General Steps in the Manufacture of Pharmaceutical Solutions:
1. Active Ingredients  consider solubility & stability 1. Preparation of formulation material & equipment
2.Solvent  consider clarity, toxicity, viscosity, comparability, 2. Compounding
palatability charge the solute to the solvent
 water (best solvent) agitate w/ the use of mixers until solution is homogenous
3. Co-solvent  used in combination with the solvent to increase heat may be employed to increase solubility
solubility of the solute ensure complete solution before further processing
 Ethanol, Sorbitol, Glycerin, Propylene Glycol, solutes in small concentrations (such as dyes & intensively
Polyethylene Glycol colored materials) must be predissolved prior to mixing w/ the
 Cosolvency/ Blending  the increase in mutual solubility whole batch
of 2 or more partially miscible 3. Storage & Aging
solvents by another agent to allow complete blending of all the components
4. Solubilizer  surfactant (Tweens) 4. Filtration & Clarification
5. Viscosity Enhancer/ Controller  improves pourability aim for 3-5 micros or less
& to some extent, palatability filter media: Cellulose Nitrate,
 Sugar, PVP, Polyamide
Cellulose Derivatives Polyvinylidene Chloride
Nylon
Classification of Viscosity Enhancing Agent:
*Types of Filtration:
~Ionic Polymer: Na CMC
~Nonionic Polymer: Cellulose Derivative Gravity Filtration  slow
(MC, CMC) Vacuum filtration  large scale
6. Buffer  controlling pH to maintain solubility & stability Pressure Filtration  fast, to achieve highly polished product
 most common; pH 4-7 *Classification:
 Citric Acid, lactic Acid, Glutaric Acid Parallel Filtration  one type of filter
7. Sweetening Agent Series Filtration  more than one filter
8. Flavor *Types of Filter Paper:
9. Coloring Agent Fluted Filter Paper  if you need the “filtrate”
10. Preservative  prevent microbial growth Ordinary Filter Paper  if you need the “residue”
Classification: 5.Filling & Packaging
~Acidic: Phenol(Carbolic Acid) oldest preserv. *Gravimetric Filling  for mobile & frothy solutions
Parabens  synergistic to each other *Vacuum Filling  for viscous solutions
*Methyl  for molds *Pressure Filling  for viscous solutions
*Propyl  for yeasts
(Methyl:Propyl is 9:1)
Benzoic Acid
Types of Instability:
Sorbic Acid
1. Chemical Instability
~Mercurial: Thimerosal
a. Incompatibility w/ Ingredients
~Neutral: Chlorbutanol
b. Incompatibility w/ container
~Quaternary Ammonium Salts (NH4): *Leaching  release of compounds within the plastic
Benzalkomium Chloride *Sorption  permeation of compounds outside the plastic
Cetylpuridium Chloride c. Hydrolysis
*Penicillin G & Benzyl Penicillin  -lactam ring is destroyed via
hydrolysis
*Acetylsalicylic Acid  hydrolyzed to acetic acid
& Salicylic Acid
d. Oxidation  by air, trace metals, light or heat
*Remedy: Add Antioxidants or chelating gents (for trace metals)
2. Microbial Contamination
a. Raw Materials
b. Equipment
c. Personnel
d. Packaging Material
*Remedy: Add Preservatives depending on the spectrum of activity
V. Liquid Dosage Forms: Two-phase/ Dispersed Phase Types of Suspension Formation:
A. Suspension  preparations made up of finely divided solids ~Precipitation  organic solvent precipitation
(suspension) distributed uniformly in a liquid vehicle  pH of the medium
where it exhibits minimum solubility. ~Dispersion  ensure uniform wetting of solid
 purposes for formulating a suspension:
-Sustaining Effect Wet Point vs. Flow Point
-Stability ~Wet Point  amount of vehicle to wet all of the powder
-Taste ~Flow Point  amount of vehicle to produce pourability
Reasons: Mask the disagreeable taste of the drug
Easy to swallow General Formulation:
Flexibility in dose adjustment 1. Active Ingredients  should be insoluble
 Properties of a Good Suspension:  must be uniformly dispersed
a. Particle size of the suspension should remain fairly 2.Dispersion medium  Aqueous /Non-aqueous
constant throughout long periods of undisturbed 3. Wetting Agent  displaces the air from crevices of drug particles
standing  Glycerin, Sorbitol Solution, Syrup
b. Dispersed particles of the suspension should settle 4. Solubilizer  surfactant (Tweens)
slowly & should be readily redispersed upon gentle 5. Suspending Agent (Viscosity Enhancer)
shaking of the container Hydrocolloids  Acacia, Tragacanth, Veegum, Cellulose der.
c. The suspension should pour readily & evenly from
Clays  Bentonite, kaolin
its container
Others: Agar, Gelatin, Pectin, Gelatinized Starch
Ideal Characteristics: 6. Buffer
does not settle rapidly 7. Sweetening Agent
no hard cake 8. Flavor
redispersable 9. Coloring Agent
10. Preservative
not to viscous
pharmaceutical elegant General Scheme for Suspension Formulation:
Problems:
standard mesh size where suspended particles 1. Caking
should pass through 2. Partial Solubility of the active ingredient
Ex: Hammer Mill: 4-325 mesh 3. Polymorphism of the active ingredient
20-200 mesh Problems:
particle size range: 10-20 m(ansel) Creaming  upward movement
particles have diameters for the most part Sedimentation  downward movement
greater than 0.1 mcm. Aggregation  reversible
 Preparation: Coalescence  irreversible
1. Comminution of the drug
2. Wetting of Powder  accomplished by levigation to B. Gel/ Magmas
displace air in the crevices of Terminologies:
the particles to make the drug 1. Thixotrophy  is a reversible sol-gel/gel-sol formation w/ no charge
more penetrable by the in volume or temperature, a type of non-newtonian
dispersion medium flow.
Common Levigating Agents: Glycerin 2. Imbibition  gel takes up the liquid but there is no increase in
Propylene Glycol volume
Alcohol 3. Swelling  gel takes up the liquid but there is increase in volume
3. The suspending agent dispersed in the vehicle is
4. Syneresis  occurs when the interaction between particles of the
added to the wetted powder by geometric dilution
dispersed phase becomes so great that on standing
4. The product is brought to final volume using the
 liquid medium is squeezed out from the gel & the gel
vehicle
strikes
 Suspending Agents
 is a form of instability in aqueous & non-aqueous gels
increase viscosity
 instability of preparations resulting to expulsion of the
inhibit agglomerates
liquid from the gel.
decrease the rate at which particles settle
5. Xerogel  when the liquid come out of the gel & only the
 Precaution:
framework remains
Pour suspension in a tight container Example: Gelatin Sheets
Suspensions are not filtered. Tragacanth Ribbons
Label: “Shake well before use” Acacia Tears
Types of Suspension: Official Gels/ Magmas:
Flocculated  loose aggregate a. Bentonite Magma, NF
 higher sedimentation rate  use: Suspending Agent
easily redispersable 5%
 pharmaceutically elegant >4% Thixotropic
 rapid clearance of supernatant b. Aluminum Hydroxide Gel
Deflocculated  separate entities insoluble Al(OH)3 + Hydrated Aluminum Oxide
 lower sedimentation rate CI: Tetracycline
 non-dispersable cake Quinolones
 close packing of the sediment AE: Constipation
 pleasing appearance on standing c. Milk of Magnesia
~Other Examples of Suspension: Ge  Gel 7.85% MgOH
Lo  Lotion MgSO4 +NAOH
Ma  Magma AE: Diarrhea
Mi  Mixtures Magma  a gel mass consisting of floccules of small distinct particles
C. Emulsion  are dispersed systems in which the dispersed phase is
composed of small globules of a liquid distributed throughout
a vehicle in which it is immiscible.
Purposes of Emulsions: Methods of Preparation:
Increased drug stability 1,Continental (Dry Gum) Method
Prolonged Drug action  for W/O (4:2:1)
Improved Taste
 the emulsifying agent (usually acacia) is mixed w/ the oil
Improved Appearance
rapidly before the addition of water
Parts:
2. English (Wet Gum) Method
Dispersed Phase/ Internal Phase/ Discontinous Phase  for O/W
Dispersion Medium/External Phase/ Continuous Phase  the emulsifying agent is added to the water (in which it is
Emulsifying Agent  acts as the bridge between the 2 solution) to form a mucilage & then the oil is slowly
immiscible phases incorporated to form the emulsion
 stabilizer of the internal phase  *water + emulsifier + oil is added drop by drop
 retards coalescence of the globules 3. Forbes Bottle (Bottle) Method
 Third Phase  is reserved for volatile oils or less viscous oils & is a
(to prepare a stable emulsion) variation of the dry gum method
O/W (oil-in-water) Emulsions: External  Oleaginous 4. Nascent Soap (In Situ Soap) Method
Internal  Aqueous  alkali + oil
W/O (water-in-oil) Emulsions: External  Aqueous  developed two types of soaps which are calcium soaps &
Internal  Oleaginous soft soaps
Types of Emulsions: 5. Auxillary Method
1. Oil-in-Water (O/W) an emulsion prepared by either the wet gum or the dry
Oil is dispersed as droplets in an aqueous medium gum method can generally be increased in quality by
passing it through a hand homogenizer
Oral products & external, washable products
 easily diluted & remains stable w/ aqueous solvent
Microencapsulation  are thermodynamically stable, optically
 dissolves amaranth green
transparent isotropic mixtures of a biphasic
 lamp glows on conductivity test
O/W system stabilized w/ surfactant
 gives a spotty fluorescence when placed under UV light.
2. Water-in-Oil (W/O)
Water is dispersed as droplets in an oil or oleaginous
Problems in Emulsion Stability:
medium a. Creaming  the upward or downward movement of the
internal phase of the emulsion
Used for external preparations when emollient,
b. Cracking  total separation of the two phase
lubricating, or protective properties are desired
c. Phase Inversion
 gives a continuous fluorescence when placed under UV
light.
3. Multiple Emulsions ( O/W/O or W/O/W) Hydrophilic-Lipophilic Balance (HLB) - AWWODS
4. Microemulsions  appear translucent or transparent & have Surfactant Application (Activity) HLB Value Range
droplet diameter in the nanometer size Antifoaming Agents 13 0 3
range W/O Emulsifying Agents 36 4 6
Wetting Agents 79 7 9
Factors that determine Emulsion Type: O/W Emulsifying Agents 818 818
(1) Emulsifier Detergents 1316 1315
 Some emulsifiers form either w/o or w/o emulsion, Solubilizing Agents 1520 1018
others form only one type
(2) Phase Ratio (relative amounts of oil & water)
Theories of Emulsification: SOP
 Phase present in greater concentration tens to be the
1. Surface Tension Theory  the use of surface active (surfactant or
external phase.
wetting agents as emulsifiers & stabilizers lowers the
(3)Order of Mixing
interfacial tension of the two immiscible liquids,
 The phase that is being added by portions tends to be reducing the repellent force between the liquids &
internal phase diminishing each liquids attraction for its own molecules
2. Oriented-wedge Theory  assumes monomolecular layers of
emulsifying agent curved around a droplet of the
internal phase of the emulsion
3. Plastic or Interfacial Film Theory  places the emulsifying agent
at the interface between the oil & water, surrounding
the droplets of the international phase as a thin layer
film adsorbed on the surface of the drops.
Types of Emulsifying Agents
General Formulation: (& Stabilizers for Pharmaceutical Systems) are:
1. Active Ingredient 1. Natural
2. Aqueous Phase Carbohydrate Materials
3. Oleaginous Phase Acacia
4. Emulsifier Tragacanth
5. Antioxidants  protects the emulsified lipids which are Agar Produce O/W Emulsions
susceptible to oxidation Chondrus
 have the capability of functioning chemically Pectin
as reducing agnet.
Protein Substances
 Example: BHA, BHT, Tocopherol,
Gelatin
Ascorbic Acid, EDTA
Egg yolk Produce O/W Emulsions
BHT  is the true Antioxidant
Casein
6. Preservative  should be effective for both phases
7. Sweetener 2. Finely Divided Solids
8. Flavoring Agent Colloidal Clays:
9. Colorant Bentonite
10. Humectant  reduces the evaporation of moisture from the Magnesium Hydroxide
product Aluminum Hydroxide
 Example: Glycerin, Sorbitol, Propylene Glycol Magnesium Trisilicate
3. Synthetics
Manufacturing Process Anionic
1. Oil Phase containing oil-soluble ingredients is heated at Monovalent, Polyvalent, & Organic Soaps
about 5-10C above the melting point of the ingredient w/ Triethanolamine Oleate
the highest melting point. Sulfonates  Sodium Lauryl Sulfate
2. Aqueous Phase is heated to the same Temperature Cationic
3. The two phases are mixed. Benzalkonium Cl  Has bactericidal property
4. Volatile ingredients are added at the lowest temperature as
Ionic
possible (usually 45-55C)
Sorbitan Esters
5. Adjust the final weight when emulsion reaches 35C
Polyoxythylene Derivatives
Equipments Nonionic
Mechanical Stirrers Spans
Colloid Mills Tweens
Homogenizers
Span & Tweens  are Polyalkene derivatives.
4. High-Molecular-Weight Alcohols:
Stearyl Alcohol
Cetyl Alcohol Produce O/W Emulsion
Glyceryl Monostearate
Cholesterol
Employed in external used W/O Emulsion
Cholesterol der.
 Cetyl Alcohol  is used to minimize the foam in the

production of emulsion
Examples of Oral Emulsions:

1. Mineral Oil Emulsion (Liquid Petrolatum Emulsion)
 is an O/W Emulsion prepared by the ff. formula:
Mineral Oil  500 mL
Acacia (Finely Powdered)  125 g
Syrup  100 mL
Vanillin  40 g
Alcohol  60 g
Purified Water, to make  1000 mL
2. Castor Oil Emulsion  is used as a laxative for isolated bouts of
constipation & in preparation of the colon
for radiography & endoscopic examination
3. Simethicone Emulsion  is a water-dispersible form of
Simethicone used as a defoaming agent
for the relief of painful symptoms of
excessive gas in the gastrointestinal
tract
Liquid Dosage Forms
Advantage over solids:
Can be easily administered
Better Biovailability
Water  the most commonly used solvent for drug solutions

 the USP recognizes six(6) types of water for the
preparation of dosage forms
Types of Water:
1. Purified Water, USP
 obtained by FRIED
-Filtration
-Reverse Osmosis
-Ion-Exchange
-Distillation
pH 5-7
 used in prescription & manufactured finished
products except parenterals & other sterile
solutions
2. Water for Injection
 purified water that is free of Pyrogens
 obtained by distillation or reverse osmosis
 used for the preparation of parenteral
solutions
 contains Benzyl Alcohol
as bacteriostatic agent
3. Sterile Water for Injection
 water for injection that is sterilized &
packaged in single-dose containers <1L
clear, colorless, odorless liquid sterilized &
suitably packaged & contains no
bacteriostatic agent
4. Bacteriostatic Water for Injection
 sterile water for injection that contains 1 or
more antimicrobial agents
packaged in single or multiple-dose containers
<30mL
5. Sterile Water for Inhalation
 water purified by distillation or reverse
osmosis & rendered sterile
not used for the preparation of parenteral
solutions or other sterile dosage forms
6. Sterile Water for Irrigation  water for injection that
is sterilized & suitably
packaged
Solvents for Liquid Preparations:

1. Alcohol, USP (Ethanol/ Ethyl Alcohol)
 next to water, alcohol is the most useful solvent in
pharmacy
primary solvent for many organic compounds
2. Diluted Alcohol, NF
prepared by mixing equal volumes of alcohol, USP &
Purified Water
3. Rubbing Alcohol
about 70% ethyl alcohol by volume
4. Glycerin, USP (Glycerol)
comparable w/ alcohol
miscible w/ both water & alcohol
5. Isopropyl Alcohol
70% alcohol
7. Propylene Glycol, USP
substitute for Glycerin
8. Purified Water, USP
contain dissolved inorganic salts
VI. Sterile Dosage Forms
Parenterals  intended for use by injection
Two Requirements:
1. Sterile  absence of microorganisms including its Spores Official Types of Injections (USP)
2. Pyrogen-Free  source: Endotoxin (Gram-Negative) 1. Injection: Liquid preparations that are drug substances or
Parenteral Routes solutions thereof
Intra-arterial Joint space Example: Insulin Injection, USP
Intrasynovial Joint fluid are 2. For injection: Dry solids that, upon addition of suitable vehicles,
yield solutions conforming in all respects to the
Intrathecal Spinal column
requirements for Injections
Intra-arterial Arteries
Example: Cefuroxime for injection,USP
Intracardiac Heart
3. Injectable emulsion: Liquid preparation of drug substance
Intravenous, IV Into the vein
dissolved or dispersed in a suitable
Intamuscular, IM Into the muscles emulsion medium
Intradermal, IB/ Intracutaneous Into the skin Example: Propofol, USP
Subcutaneous, SC/ Sub-Q, SQ/ Under the Skin 4. Injectable suspension: Liquid preparation of solid suspended in a
hypodermic suitable liquid medium
IV  100% Bioavailability Example: Methylprednisolone Acetate
Suspension, USP
Labels on containers of Parenteral Products must state the ff: 5. For injectable suspension: Dry solid that, upon addition of suitable
• Name of the preparation vehicle, yields preparation conforming
• Percentage content of drug (For a liquid preparation) in all respects to the requirements for
• Amount of Active Ingredient (For a dry preparation) injectable suspensions
• Route of Administration Example: Imipenem and Cilastatin
• Storage Conditions for injectable suspension, USP
 Expiration Date
• Name of the manufacturer and distributor Single-dose container: A hermetic container holding a quantity of sterile
• Lot Number drug intended for parenteral administration as a
single dose; when opened, it cannot be resealed
Official Solvents & Vehicles for Injections with assurance that sterility has been maintained.
1. Water for Injection, USP  most frequently used solvent in the Multiple-dose container: A hermetic container that permits withdrawal of
largescale successive portions of the contents without
 is purified by distillation or by reverse changing the strength, quality, or purity of the
osmosis remaining portion.
2. Purifi ed Water, USP  that is, not more than 1 mg/100 mL water
for injection, USP Methods of Sterilization
is not required to be sterile, it must be  Sterilization  means destruction of all living organisms and their
pyrogen free. spores or their complete removal from the
3. Sterile water for injection, USP  is packaged in single-dose preparation.
containers not larger than 1 L. (1) Steam (Moist Heat Sterilization)
4. Bacteriostatic water for injection, USP  sterile water for injection is conducted in an Autoclave/employs Steam under pressure
containing one or more  happens at 121C & 15 psi for 15-20 minutes
suitable antimicrobial method of Choice
agents.  MOA: Protein coagulation
 “Not for use in neonates” (2) Dry heat Sterilization
5. Sodium chloride injection, USP  sterile isotonic solution of sodium  carried out in ovens designed for this purpose.
chloride (0.9%) in water for less effective in killing microorganisms than in moist heat
injection.  happens at 150-170C for not less than 2 hours.
6. Bacteriostatic sodium chloride injection, USP MOA: Oxidation
 sterile isotonic solution of sodium chloride in water (3) Sterilization by Filtration
for injection. physical removal of microorganism by adsorption on the
 contains one or more suitable antimicrobial agents, filter medium or by a sieving mechanism
which must be specified on the labeling.  for heat-sensitive solutions
 “Not for use in neonates” (4) Gas Sterilization
7. Ringer’s injection, USP  a sterile solution of sodium chloride, for heat-labile enzyme preparation
potassium chloride, and calcium chloride in  MOA: Alkylation
water for injection.  Ethylene Oxide
8. Lactated Ringer’s Injection, USP  has different quantities of the (5) Ionizing radiation Sterilization
three salts in Ringer’s injection,  by gamma rays & cathode rays
and it contains sodium lactate.
Miscellaneous Solvent:
(1) Fixed Vegetable Oils (2) Glycerin
 IM (3) Alcohol
 SeCoCoPen (4)PEG
Sesame (5) Propylene Glycol
Cottonseed
Corn
Peanut
Validation: 2. Components (Formulation)
1. Biological Indicators a. Active Drug
Bacillus sterothermophilus b. Solvent/ Vehicle  highest portion
moist-heat  usually Water for Injection, USP
 vapor pressure hydrogen peroxide (VPHP)  WFI  purified by distillation or
Bacillus subtilis purification process
dry heat equivalent or superior to
gas sterilization distillation in removing
Bacillus pumilus chemicals & microorganisms
ionizing radiation  Isopropyl myristate  non-aqueous
2. Pyrogen Test vehicle for IM administration
3. Bacterial, Endotoxin Aqueous
 Test: LAL Test Water Miscible
Vegetable Oils
Non-Vegetable Oils
Sterile Preparations: c. Other Excipients (Additives):
Categories: Buffer
solutions ready for injection Preservative
dry soluble products ready to be combined with a solvent Chelating Agent
Isotonicity Adjusting Agent
prior to use
Example: NaCl, Mannitol
suspensions ready for injection
dry soluble products ready to be combined w/ a vehicle prior Goal: To diminish pain upon
to use administration
d. Container
emulsions ready for injection
e. Closure/ Stoppers
liquid concentrates ready for dilution prior to use
f. Production Procedure
Main Concerns in Parenteral Manufacture
g. HEPA Filter (High Efficiency Particulate Air Flow)
1. Production Facilities
required for incoming air to achieve a class 100
easy to clean, safe, sterile
condition
5 Sections
effluent air sweeping downstream at uniform velocity
a. Materials Support Area  surfaces should be continuous,
normally 90ft/min  20% along parallel line
class 10,000 environment
Laminar Air Flow  minimum eddy
 constructed of impervious
Turbulent  opposite of Laminar Air Flow
materials
99.97% efficient in removing from air 0.3 m particles
b. Compounding Area  most stringent control
generated by vaporized DOP (Dioctylphthalate)
 stainless steel cabinets & counters,
continuous surfaces
Parts (HEPA Filter)
 Class 10,000 environment
B  Blower
(Class 100
E  Electrostatic
max of 100 particles per feet
P  Prefilter
0.5m or larger)
c. Aseptic Filling Area  heart of production area
MOA
 Laminar Air Flow (LAF) -interception
w/ HEPA Filter (High Efficiency -diffusion
Particulate Air) -impaction
 class 100
sealed ceiling, wall floor Test for Efficiency: DOP Test (air velocity
 stainless determination)
demountable parts for those
equipment in touch w/ product
 sterile cover-all for personnel Class 100 Environment  defined as total particles do not exceed
100 per cubic foot of air of 0.5 m at
 (+) air space
normal condition
 air locks
d. Quarantine Area  storage while waiting for QC results
*Quarantine  Yellow
*Reject  Red
*Accept  Green
e. Finishing Area
Design
Compunding Aseptic Quarantine
Stock Area Filling
Area Storage
Material
Finishing
Support Sterilization
Special Consideration in the Preparation of
Solutions & Suspensions for Ophthalmic Use:
Sterility
Preservation (Benzalkonium Chloride)
Isotonicity (Boric Acid)
Buffering
Viscosity
Ocular Bioavailability
Packaging
Three Basic Types of Contact Lenses:

1. Hard Contact Lenses
2. Soft Contact Lenses
3. RGP Rigid Gas Permeable
 more comfortable than hard contact lense (for daily use)
Examples of Drugs that do enter breast milk

and may be passed on to nursing infants:
Theophylline
Penicillin
Reserpine
Codeine
Meperidine
Barbiturates
Diltiazem,
Thiazide Diuretics
Sulfonamides
Salicylates
Potent Agents like:
Quinine
Meperidine
Morphine
Meperidinde & Morphine
narcotic analgesics with great
potential for addiction.
Preservatives & their Concentrations Commonly Employed in
Pharmaceutical Preparations:
Benzalkonium Chloride
0.002%  0.01%
Phenylmercuric Nitrate & Acetate
Benzoic Acid
Sodium Bezoate 0.1%  0.2%
Combination of Methylparabens & Propylparaben
Phenol
0.1%  0.5%
Cresol
Chlorobutanol 0.5%
Alcohol 15%  20%
INSULIN  the active principle of the pancreas gland,
 is primarily concerned with the metabolism of carbohydrates
but also influences protein and fat metabolism
 facilitates the cellular uptake of glucose and its metabolism in
liver, muscle, and adipose tissue
 increases the uptake of amino acids and inhibits the
breakdown of fats and the production of ketones.
 is administered by needle, pen device,and pump Isophane Insulin Suspension & Regular Insulin
 is used in the treatment of diabetes mellitus that cannot be Humulin 50/50  consists of 50% isophane insulin suspension
controlled satisfactorily by dietary regulation alone or by oral and 50% regular insulin.
antidiabetic drugs  achieves a higher insulin concentration (Cmax)
 improve the appetite and increase the weight in selected cases and maximum glucose infusion rates with
of nondiabetic malnutrition and is frequently added to IV more rapid elimination than Humulin 70/30.
infusions.  is useful when a greater initial response is
required and for patients who have been using
Regular insulin  is a sterile aqueous solution of insulin extemporaneously compounded insulin
 was prepared from beef or pork pancreas or both mixtures in a 50/50 ratio.
 is prepared exclusively through biosynthetic means
(human insulin) Humulin 70/30  consists of 70% isophane insulin suspension
and 30% regular insulin
Human Insulin  was the first recombinant DNA drug product to  provides an initial response tempered with a
receive approval from FDA more prolonged release of insulin.
Humulin (Lilly) became available in 1983.
is produced by using a special non–disease-forming Humalog Mix  is a manufactured premixed insulin consisting of
laboratory strain of Escherichia coli and insulin lispro and neutral protamine lispro (NPL) in a
recombinant DNA technology. fixed ratio.
Humalog Mix 50/50  consists of 50% insulin NPLsuspension and
Insulin Lispro  consists of zinc–insulin lispro crystals dissolved in a 50% insulin lispro injection.
clear aqueous fluid.  Humalog Mix 75/25  contains 75% insulin NPL suspension and
is rapidly absorbed after SC administration, and 25% insulin lispro injection.
demonstrates no ~These fixed combinations were developed to give better
significant differences in absorption from abdominal, control for diabetes patients who use a
deltoid, and femoral sites of injection. combination of short- and long-acting insulins.
~In comparison to Humulin 70/30, Humalog Mix 75/25
Insulin Aspart  is a recombinant, ultra–shortacting insulin using demonstrated lower postprandial blood glucose
Saccharomyces cerevisiae (baker’s yeast) as the levels and no difference between the afternoon
production organism and overnight glucose values
is homologous with regular human insulin except for a ~Insulin NPL suspension  was developed as an alternative to
single substitution of the amino acid proline by combinations employing NPH
aspartic acid in position B28. insulin.
~NPH insulin  was unstable over weeks to months when
Insulin Glulisine (Apidra)  is a recombinant rapid-acting insulin analog mixed with lispro insulin.
that differs from human insulin by the
replacement of two amino acids on the Insulin Glargine  is a long-acting (up to 24 hours) basal insulin
beta-chain at positions B3 (i.e., aspargine preparation intended for once daily SC
replaced by lysine) and B29 (i.e., lysine administration at bedtime in the treatment of type
replaced by glutamic acid). 1 diabetes mellitus in adults and children.
is produced by recombinant DNA can also be used by adults with type 2 diabetes who
technology using a nonpathogenic strain require long-acting insulin.
of E. coli (K12)  is a recombinant, human insulin analog.
equipotent to regular human insulin
whenadministered intravenously. Insulin Detemir  is an intermediate to long acting basal insulin, which
is dosed subcutaneously either once or twice daily.
Isophane Insulin Suspension (NPH Insulin)  maintains its long-acting property through slow
 is a sterile suspension in an aqueous vehicle buffered systemic absorption.
with dibasic sodium phosphate to pH 7.1 to 7.4.
 is prepared from zinc–insulin crystals modified by the Insulin Pens  use disposable or single-use cartridges fi lled with either
addition of protamine so that the solid phase of the 150 or 300 U of insulinand packaged fi ve per box (21).
suspension consists of crystals of insulin, zinc, and are available for a number of insulin types, for example,
protamine. regular insulin, insulin isophane, insulin glulisine, and
Protamine  is prepared from the sperm or the mature testes insulin glargine.
of fish belonging to the genus Oncorhynchus advantage of the pen devices is that they improve the
and others. accuracy of insulin administration when compared to
NPH  used in some product names stands for neutral the traditional vial and syringe administration.
protamine Hagedorn, because the preparation is
neutral (pH about 7.2), contains protamine, and was Insulin Infusion Pumps  allow an estimated 300,000 patients to
developed by Hagedorn. achieve and maintain blood glucose at nearly
normal levels on a constant basis through
continuous SC insulin infusion (i.e., CSII) (24).
CSII  is achieved through the use of small and lightweight
pumps and eliminates the need for the patient to adhere
rigidly to a regimen of multiple daily injections of insulin.
 is generally recommended for patients more than 10 years
of age.
VII. Special Dosage Forms
1. Pharmaceutical Aerosols Pressurized Package  is commonly used when referring to the
2. Radiopharmaceuticals aerosol container or completed product
3. Biotechnology
Space Sprays  are aerosols used to provide an airborne mist
1. Pharmaceutical Aerosols  include: Room Disinfectants
those products which depend upon the power of a liquefied Room Deodorizers
or compressed gas to dispense active ingredient/s in a finely Space Insecticides
dispensed mist, foam, or semisolid Surface Sprays (Surface Coatings)
are pressured dosage forms that upon actuation emit a fine  are aerosols intended to carry the active ingredient
dispersion of liquid &/or solid materials containing one or to a surface
more active ingredients in a gaseous medium  include: Dermatologic Aerosols
Advantages: Dessert Toppings & Food Spreads
rapid onset of action Cosmetic & Household Aerosols:
prevent first-pass effect, avoidance of GIT degradation
minimize ADRs due to lower dose Types of Pharmaceutical Aerosols:
allows dose titration & ideal for prn medication (1) Solution Aerosols  consists of solutions of active ingrediens in
alternate route to prevent chemical & physical interactions w/ pure propellant & solvents
other drugs given concurrently (2) Dispersions or Suspensions (powder aerosols)
useful when oral & parenteral administration is not suitable  similar to solution aerosols excepts that the active
ingredients are suspended or dispersed
Metered Dose Inhalers (MDIs) throughout the propellant/s or propellant/s or
 pharmaceutical aerosols intended for administration as propellant & sovents phase
fine, solid particles, or as liquid mists via, the respiratory  used for difficult to dissolve compounds
system or nasal passages (e.g. Antibiotics, & Steroids)
particle size: <10micrometer, usually 3-6 micrometers for (3) Emulsions  can be dispersed as a spray, stable foam, or quick-
maximum therapeutic response braking foam
can be O/W or W/O type
(4) Semisolid Preparations  depend on nitrogen to push content
form package
Aerosol Systems:
Two-phase Systems
Liquid Phase (liquefied propellant & product concentrate) Valve Assembly  is to permit expulsion of the contents of the can
Vapor Phase in the desired form at the desired rate, & in the
Three-phase Systems case of metered valves, in the proper amount of
Liquid Propellant dose.
Product Concentrate Parts of Aerosol (Aerosol Valve Assembly):
Vapor Phase 1. Actuator  being pressed for emission of the product
 allows the product to be dispensed in the desired
form, & in a rapid & convenient way
 permits easy opening & closing the valve
Components of Aerosols:
2. Stem  supports the actuator & delivers the formulation in
1. Aerosol propellant  Agent responsible for developing the
the proper form to the chamber of the actuator
pressure within an aerosol container
and expelling the product when the 3. Gasket  placed snugly w/ the stem, prevents leakage of the
valve is opened formulation when the valve is closed
 supplies the necessary force to expel the 4. Spring  holds the gasket in place & is the mechanism by
product & also acts to serve as the which the actuator retracts when pressure is release,
solvent & diluents returning the valve to the dose position
a. Liquefied Gases: 5. Mounting Cup  attached to the aerosol can or container,
-Saturated HC (N-Butane, Propane) hold the valve in place
-Chlorofluorocarbons (CFCs) – phased out 6. Housing  directly below the mounting cup, the housing links
Dichlorodifluoromethane the dip tube & the stem & actuator.
Dichlorotetrafluoroethane 7. Dip tube  extends from the housing down into the product;
Trichloromonofluoromethane brings the formulation form the container to the
-Dimethy Ether valve
-Hydorflurocarbons (more accepted compared
to CFCs) Method of Filling Aerosols (Filling Operations)
b. Compressed Gases: a. Cold Filling  both the product concentrate & propellant must
-Carbon Dioxide be cooled to -34.5C to -40C (-30F to -40C)
-Nitrogen Gas b. Pressure Filling  the products is quantitatively placed in the
-Nitrous Oxide aerosol container, the valve assembly is
2. Product Concentrate  is the active ingredient of the aerosol inserted & crimped into place, & the
combined w/ the required adjuncts, liquefied gas, under pressure, is metered
such as antioxidants, surface active into the valve stem form a pressure
agents, & solvents, to prepare a stable burette.
& efficacious product is used for most pharmaceutical aerosols
3. Container: (a) Tin  plated steel; light & relatively inexpensive  Two advantages over Cold Filling:
(b) Aluminum  preferred for use w/ most MDIs, 1. Less danger of moisture
strong & less reactive than the contamination of the product
other metals 2. Less propellant is lost in the process
(c) Glass  high aesthetic value & minimal
incompatibilities; use is limited to
products w/ low pressure & propellant
percentage
4. Valve  most basic part through which the contents of the
package are emitted;
 regulates the flow of product from the container;
 either spray valve or foam valve.
2. Radiopharmaceuticals
 is a radioactive pharmaceutical agent that is used for
diagnostic or therapeutic procedures
 a chemical containing a radioactive isotope for use in humans
for the purposes of diagnosis, mitigation, or treatment of a
disease
fundamental unit: Curie (Ci)
international unit of activity:
Becquerel (Bq) = one disintegration/ second
Note: mCi = 37Mbq
Radiopharmaceuticals & their uses:

Nonradioactive Pharmaceutical Use in Nuclear Medicine:
Radiopharmaceutical Uses
1. Acetazolamide (Diamox)  an agent used to treat glaucoma by
Technetium 99mPhytate  Liver imaging & potency studies diuretic action, has been shown to
Technetium 99mHeptagluconate  Kidney imaging, increase cerebral blood flow following
 determining renal function intravenous administration.
Technetium 99mIDA  Hepatobiliary studies 2. Captopril (Capoten)  is used to help diagnose renovascular
Techetium 99mElidronate  Bone imaging hypertension in hypertensive patients with
Technetium 99mInjection  Brain Scanning abdominal bruits, declining renal function,
I-131-Human Serum Albumin  Blood plasma volume/ and poorly controlled hypertension with
 cardiac output determination drug therapy.
Iodohippurate I 131 Injection  Cardiac infarct imaging 3. Cimetidine  reduces the volume and concentration of stomach
acid
NaI- 1125  Localization of ocular tumors
4. Dipyridamole (Persantine)  is used as an alternative to a
Sodium Phosphate Serum Albumin  Thyroid Function
treadmill stress test prior to cardiac
imaging.
Cyanocobalamin 57 capsules  Pernicious anemia 5. Furosemide (Lasix)  a loop diuretic, is administered to help
I 125 Serum albumin injection  Blood Volume Determination confirm or rule out mechanical renal
Iodohippurate I 131 injection  Renal Function obstruction during renal scintigraphy when
Sodium Chromate 51 injection  Blood Volume Determination signifi cant retention of radioactivity is
Sodium Iodide 131 capsules/solution  Thyroid function, Thyroid noted in the renal pelvis
inhibitor  inhibits the reabsorption of electrolytes,
Sodium Pertechnetate 99m injection  Brain & Thyroid scanning most notably sodium, in the ascending limb
Sodium Phosphate 32 solution  Ocular Tumor localization, of the loop of Henle and in the proximal and
Antipolycythemic distal tubules.
Tc 99m Albumin Aggregated Injection  Lung scanning 6. Vitamin B12
Schilling test determines a patient’s capability to absorb
Tc 99m Sulfur Colloid Injection  Liver scanning
radioactive vitamin B12 from the intestine.
Tc 99m labeled RBC  Cardiac pool pumping
Typical urinary excretion of B12 ranges from 15% to 40%.
Tc 99m Methylene Diphosphonate  Bone imaging
Tc 99m Pyrophosphate  Cardiac infarct imaging
Tc 99mSulfur Colloid cooked in  Gastric Emptying Imaging
scrambled eggs
Tl-201 Thalous Chloride  Myocardial Perfusion Scan
3. Biotechnology
 encompasses any technique which uses living organisms 4. Daclizumab (Zenapax®)
is an immunosuppressive humanized IgG1 MAb produced by
(microorganisms) in the production or modification of
rDNA technology that binds specifically to the alpha unit (Tac
products. subunit) of the human high-affinity IL-2 receptor that is
 is the use of microorganism in industry & medicine expressed on the surface of activated lymphocytes.
Protein  classic example of biotechnology drugs. is a composite of human (90%) and murine (10%) antibody
sequences.
 is the first of the novel biotechnologic pharmaceuticals
5. Gentuzumab Ozogamicin (Mylotarg®)
Techniques used to produce Biotechnologic Products: was the fi rst drug specifi cally approved for treating relapsed
1. rDNA Technology AML (acute myeloid leukemia).
a technique for joining two different DNA molecules 6. Ibritumomab Tiuxetan (Zevalin®)
uses other techniques (replication, separation, identification) is the first commercially available radiolabeled antibody for
that permit production of large quantities of purified cancer therapy.
combined techniques, that allow the removal of a specific 7. Infliximab (Remicade®)
piece of DNA out of a larger, more complex molecule DNA
is the only approved drug therapy specifically indicated for the
fragments
treatment of fistulizing Crohn disease, an inflammation of the
DNA  Deoxyribonucleic acid, intestine.
 has been called the “substance of life” 8. Muromonab-CD3 (Orthoclone OKT3®)
 constitutes genes, that allow cells to reproduce & is a murine MAb that reacts with a T3 (CD3) molecule linked
maintain life. to an antigen receptor on the surface membrane of human T
2. MAb Technology  Monoclonal Antibodies lymphocytes.
 blocks both generation and function of the T cells in response
 are produced as a result of perpetuating the
to antigenic challenge and is indicated for treatment of organ
expression of a single beta lymphocyte.
transplant rejection.
 a highly specific immunoglobulin produced by
 is combined with azathioprine, cyclosporine, and/or
cell culture cloning.
corticosteroids to prevent acute rejection of renal transplants.
3. Polymerase Chain Reaction  is a biotechnologic process whereby
9. Omalizumab (Xolair®)
there is substantial amplification
(more than 100,000-fold) of a target is the first humanized therapeutic antibody for the treatment of
nucleic acid sequence (a gene). asthma
first approved therapy designed to target immunoglobulin E
4. Gene Therapy  is a process in which exogenous genetic material is
(IgE) in the management of asthma.
transferred into somatic cells to correct an
inherited or acquired gene defect.
10. Palivizumab (Synagis®)
5. Nucleotide Blockade/ Antisense Nucleic Acids is a humanized MAb (IgG1K) produced by rDNA
 focuses on the study of function of specific proteins and technology, directed to the epitope in the A antigenic site
intracellular expression. of the F protein of respiratory syncytial virus (RSV).
Sense sequence  sequence of a nucleotide chain that is a composite of human (95%) and murine (5%) antibody
contains the information for protein sequences.
synthesis is called the is for intramuscular use only
6. Peptide Technology  entails screening for polypeptide 11. Rituximab (Rituxan®)
molecules that can mimic larger proteins. was the first MAb approved to treat cancer
Tissue Plasminogen Activators is used to treat patients with relapsed or refractory low-
are substances produced in small quantity by the inner lining of grade or follicular CD20 positive beta-cell NHL.
blood vessels and by the muscular wall of the uterus 12. Satumomab Pendetide (OncoScint CR/OV Kit®)
 prevent abnormal blood clotting by converting plasminogen, a
is a diagnostic imaging agent that is indicated for
component of blood, to the enzyme plasmin, which breaks
down fibrin, the main constituent of a blood clot. determining the extent and location of extrahepatic
Monoclonal Antibodies malignant disease in patients with known ovarian
1. Adalimumab (Humira®) carcinoma
for reducing signs and symptoms in rheumatoid arthritis 13. Tocilizumab (Actemra®)
patients who have not responded to previous treatments with is the first IL-6 receptor inhibiting MAb for the treatment of
methotrexate and other DMARDs rheumatoid arthritis.
Offers an attractive alternative for patients who require TNF-α is a fusion of murine and human components.
blocker therapy inhibits the binding of IL-6 to its receptor
also indicated for psoriatic arthritis, ankylosing spondylitis, and IL-6  a proinflammatory cytokine, plays a primary role in
Crohn disease. causing local and systemic manifestations of
TNF-α  is responsible for much of the pain and rheumatoid arthritis.
inflammation associated with rheumatoid arthritis. 14. Trastuzumab (Herceptin®)
2. Basiliximab (Simulect®)  September 1998, became the second MAb approved to treat
is an IL-2 receptor antagonist cancer
an example of a chimeric (murine–human) MAb (IgG1K) is indicated for the treatment of metastatic breast cancer or
produced by rDNA technology cancer that has spread beyond the breast and lymph nodes
as an immunosuppressive agent under the arm.
 is indicated for the prophylaxis of acute organ rejection in
patients receiving renal transplants.
3. Bevacizumab (Avastin®)
used in combination with IV 5-fluorouracilbased chemotherapy
for first- or second-line treatment of patients with metastatic
carcinoma of the colon or rectum.
is also being investigated for the treatment of advanced
macular degeneration (AMD), a leading cause of blindness in
older patients.
Prodrug  describe a compound that requires metabolic
biotransformation after administration to produce the desired
pharmacologically active compound Ebers Papyrus  the most famous of these surviving memorials of early
Goal Drug  would produce the specifically desired effect, be administered drugs
by the most desired route (generally orally) at minimal dosage  is dominated by drug formulas, w/ more than 800 formulas
& dosing frequency, have optimal onset & duration of activity, or prescriptions being described & more than 700 drugs
exhibit no side effect, & following its desired effect would be mentioned
eliminated from the body efficiently, completely, & w/out is now preserved at the university of Leipzig
residual effect is named for the noted German Egyptologist Georg Ebers,
Lead Compound  is a prototype chemical compound that has who discovered it in the tomb of a mummy & partly
fundamental desired biologic or pharmacologic translated it during the last half of 19 Century
activity. Contributors to the advancement of the Health Sciences
Notable among those whose genius & creativeness has a revolutionary
influence on the development of Pharmacy & Medicine
Pharmaceutical Same therapeutic moiety/API 1. Hippocrates  Greek Physician
alternatives Different salts, esters, or complexes  is credited w/ introduction of scientific pharmacy &
Different dosage forms medicine
Different strength  rationalized medicine, systematized medical
Ex: tetracycline phosphate 250mg  tetracycline knowledge, & put the practice of medicine on a high
HCl 250mg ethical plane
Pharmaceutical Same active ing. is honored by being called the “Father of Medicine”
Equivalence Same dosage form Pharmakon  purifying remedy for good only
Same salts or esters 2. Pedanios Dioscorides  Greek Physician & Botanist, or Pharmaco-
Same route of administration botanist
Same strength/concentration  was the first to deal w/ botany as an applied
Ex: Chlordiazepine HCl 5mg cap science of Pharamcy
(branded)(generic)  wrote “De Materia Medica libri cinque”
Pharmaceutical Process of dispensing pharmaceutical alternatives meaning “Concerning Medical
Substitution Example: ampicillin suspension & ampicillin Matter in Five Volumes”
capsules is considered a milestone in the
Nifedipine 5mg cap & nifedipine 20mg development of pharmaceutical
GITS tab botany & in the study of naturally
Therapeutic Different active ing. occurring medicinal materials
Alternatives Same therapeutic effect or pharmacologic class is an area of study known today as
Example: Ibuprofen aspirin natural product chemistry &/or
Therapeutic Are pharmaceutical equivalents contain identical “Pharmacognosy”
Equivalence amounts of the same active drug ingredient in the Greek Word
same dosage form & route of administration. -Pharmakon  drug
Therapeutic Process of dispensing a therapeutic alternative -gnosis  knowledge
Substitution 3. Claudius Galen  Greek Pharmacist Physician who attained Roman
Citizenship
USP Guideline on Stability of  aimed to create a perfect system of physiology,
Extemporaneous Compounded Formulations: pathology, & treatment.
1. nonaqueous liquids and solid formulations in which the was one of the most prolific authors of his or any
manufactured drug is the source of the active ingredient, other era, having been credited w/ 500 treatises on
not later than 25% of the time remaining until the product’s medicine & some 250 other on philosophy law &
expiration date or 6 months, whichever is earlier; grammar.
2. nonaqueous liquids and solid formulations in which a USP or  originated so many preparations of vegetable drugs
National Formulary (NF) substance is the source of active ingredient, by mixing or melting the individual ingredient that
 a beyond-use date of 6 months; the field of pharmaceutical preparations was once
3. for water-containing formulations prepared from ingredients in solid commonly referred to as “Galenic Pharmacy”
form, ’Galen’s Cerate”  the most famous of the Galen’s
 a beyond-use date not later than 14 days in storage at cold Formula for a cold cream.
temperatures; 4. Paracelsus  Aureolus Theophrastus Bombastus von Hohenheim
4. for all other formulations,  influenced the transformation of Pharmacy from a
 a beyond-use date of the intended duration of therapy or 30 profession based primarily on botanical science to one
days, whichever is earlier based on chemical science
 believed it was possible to prepare a specific medicinal
agent to combat each specific disease & introduced a
host of chemical substances to internal therapy.
Pharmacopeia  from the Greek word

-Pharmakon  drug
-Poiein  make
 the combination indicates any recipe or formula or
other standards required to make or prepare drug
Pharmaceutical Ingredient
1. Acidifying agent  Used in liquid preparations to provide acidic medium 10. Chelating agent  Substance that forms stable water-soluble complexes
for product stability (chelates) with metals; used in some liquid
o Citric acid pharmaceuticals as stabilizers to complex heavy
o Acetic acid metals that might promote instability. In such use,
o Fumaric acid they are also called sequestering agents
o Hydrochloric acid o Edetic acid
o Nitric acid o Edetate disodium
2. Alkalinizing agent  Used in liquid preparations to provide alkaline 11. Colorant  Used to impart color to liquid and solid (e.g., tablets and
medium for product stability capsules) preparations
o Ammonia solution o FD&C Red No. 3
o Ammonium carbonate o FD&C Red No. 20
o Diethanolamine o FD&C Yellow No. 6
o Monoethanolamine o FD&C Blue No. 2
o Potassium hydroxide o D&C Green No. 5
o Sodium bicarbonate o D&C Orange No. 5
o Sodium borate o D&C Red No. 8
o Sodium carbonate o Caramel
o Sodium hydroxide o Ferric oxide, red
o Trolamine 12. Clarifying agent  Used as a filtering aid for its adsorbent qualities
3. Adsorbent  An agent capable of holding other molecules onto its surface Bentonite
by physical or chemical (chemisorption) means 13. Emulsifying agent  Used to promote and maintain dispersion of finely
o Powdered cellulose subdivided particles of liquid in a vehicle in which it
o Activated charcoal is immiscible. End product may be a liquid
4. Aerosol propellant  Agent responsible for developing the pressure emulsion or semisolid emulsion (e.g., a cream)
within an aerosol container and expelling the o Acacia
product when the valve is opened o Cetomacrogol
o Carbon dioxide o Cetyl alcohol
o Dichlorodifl uoromethane o Glyceryl monostearate
o Dichlorotetrafl uoroethane o Sorbitan monooleate
o Trichloromonofl uoromethane o Polyoxyethylene 50 stearate
5. Air displacement  Agent employed to displace air in a hermetically 14. Encapsulating agent  Used to form thin shells to enclose a drug for ease
sealed container to enhance product stability of administration
o Nitrogen o Gelatin
o Carbon dioxide 15. Flavorant  Used to impart a pleasant flavor and often odor to a
6. Antifungal preservative  Used in liquid and semisolid preparations to preparation. In addition to the natural flavorants listed,
prevent growth of fungi. Effectiveness of many synthetic ones are used
parabens is usually enhanced by use in o Anise oil
combination o Cinnamon oil
o Butylparaben o Cocoa
o Ethylparaben o Menthol
o Methylparaben o Orange oil
o Benzoic acid o Peppermint oil
o Propylparaben o Vanillin
o Sodium benzoate 16. Humectant  Used to prevent drying of preparations, particularly
o Sodium propionate ointments and creams
7. Antimicrobial preservative  Used in liquid and semisolid preparations to o Glycerin
prevent growth of microorganisms o Propylene glycol
o Benzalkonium chloride o Sorbitol
8. Antioxidant  Used to prevent deterioration of preparations by oxidation 17. Levigating agent  Liquid used as an intervening agent to reduce the
o Ascorbic acid particle size of a powder by grinding, usually in a
o Ascorbyl palmitate mortar
o Butylated hydroxyanisole o Mineral oil
o Butylated hydroxytoluene o Glycerin
o Hypophosphorous acid o Propylene glycol
o Monothioglycerol 18. Ointment base  Semisolid vehicle for medicated ointments
o Propyl gallate o Lanolin
o Sodium ascorbate o Hydrophilic ointment
o Sodium bisulfi te o Polyethylene glycol ointment
o Sodium formaldehyde o Petrolatum
o Sulfoxylate o Hydrophilic Petrolatum
o Sodium metabisulfite o White ointment
9. Buffering agent  Used to resist change in pH upon dilution or addition of o Yellow ointment
acid or alkali o Rose water ointment
o Potassium metaphosphate 19. Plasticizer  Component of film-coating solutions to make film more
o Potassium phosphate, pliable, enhance spread of coat over tablets, beads, and
o monobasic granules
o Sodium acetate o Diethyl phthalate
o Sodium citrate, anhydrous and dihydrate o Glycerin
20. Solvent  Used to dissolve another substance in preparation of a 27. Tablet binders  Substances used to cause adhesion of powder particles
solution; may be aqueous or not (e.g., oleaginous). in tablet granulations
Cosolvents, such as water and alcohol (hydroalcoholic) and o Acacia
water and glycerin, may be used when needed. Sterile o Alginic acid
solvents are used in certain preparations (e.g., injections) o Carboxymethylcellulose sodium
o Alcohol o Compressible sugar (e.g.,
o Corn oil o Nu-Tab)
o Cottonseed oil o Ethylcellulose
o Glycerin o Gelatin
o Isopropyl alcohol o Liquid glucose
o Mineral oil o Methylcellulose
o Oleic acid o Povidone
o Peanut oil o Pregelatinized starch
o Purifi ed water 27. Tablet and capsule diluents  Inert filler to create desired bulk, flow
o Water for injection properties, and compression
o Sterile water for injection characteristics of tablets and capsules
o Sterile water for irrigation o Dibasic calcium phosphate
21. Stiffening agent  Used to increase thickness or hardness of a o Kaolin
preparation, usually an ointment o Lactose
o Cetyl alcohol o Mannitol
o Cetyl esters wax o Microcrystalline cellulose
o Microcrystalline wax o Powdered cellulose
o Paraffi n o Precipitated calcium carbonate
o Stearyl alcohol o Sorbitol
o White wax o Starch
o Yellow wax 28. Tablet coating agent  Used to coat a tablet to protect against
22. Suppository base  Vehicle for suppositories decomposition by atmospheric oxygen or
o Cocoa butter humidity, to provide a desired release pattern, to
o Polyethylene glycols (mixtures) mask taste or odor, or for aesthetic purposes.
o PEG 3350 Coating may be sugar, film, or thick covering around a tablet.
23. Surfactant (surface active agent)  Substances that absorb to surfaces or Sugar-coated tablets generally start to break up in the stomach.
interfaces to reduce surface or o Liquid glucose
interfacial tension. May be used as o Sucrose
wetting agents, detergents, or
emulsifying agents Film forms a thin cover around a formed tablet or bead. Unless it is
o Benzalkonium chloride enteric, film dissolves in the stomach.
o Nonoxynol 10 o Hydroxyethyl cellulose
o Octoxynol 9 o Hydroxypropyl cellulose
o Polysorbate 80 o Hydroxypropyl methylcellulose
o Sodium lauryl sulfate o Methylcellulose (e.g., Methocel)
o Sorbitan monopalmitate o Ethylcellulose (e.g., Ethocel)
24. Suspending agent  Viscosity-increasing agent used to reduce
sedimentation rate of particles in a vehicle in which Enteric coating passes through the stomach to break up in the
they are not soluble; suspension may be intestines.
formulated for oral, parenteral, ophthalmic, o Cellulose acetate phthalate
topical, or other route o Shellac (35% in alcohol, pharmaceutical glaze)
o Agar Some water-insoluble coatings (e.g., ethylcellulose) are used to
o Bentonite not suitable for oral route administration slow the release of drug in the gastrointestinal tract
o Carbomer (e.g., Carbopol) 29. Tablet direct compression excipient  Used in direct compression tablet
o Carboxymethylcellulose sodium formulations
o Hydroxyethyl cellulose o Dibasic calcium phosphate (e.g., Ditab)
o Hydroxypropyl cellulose 30. Tablet disintegrant  Used in solid forms to promote disruption of the
o Hydroxypropyl methylcellulose mass into smaller particles more readily dispersed
o Kaolin or dissolved
o Methylcellulose o Alginic acid
o Tragacanth o Polacrilin potassium
o Veegum o (e.g., Amberlite)
25. Sweetening agent  Used to impart sweetness to a preparation o Sodium alginate
o Aspartame o Sodium starch glycolate
o Dextrose o Starch
o Glycerin 31. Tablet glidant  Used in tablet and capsule formulations to improve flow
o Mannitol properties of the powder mixture
o Saccharin sodium o Colloidal silica
o Sorbitol o Cornstarch
o Sucrose o Talc
26. Tablet antiadherents  Prevent tablet ingredients from sticking to
punches and dies during production
o Magnesium stearate
32. Tablet lubricant  Used in tablet formulations to reduce friction during
tablet compression
o Calcium stearate
o Magnesium stearate
o Mineral oil
o Stearic acid
o Zinc stearate
33. Tablet or capsule opaquant  Used to render a coating opaque. May be
used alone or with a colorant
o Titanium dioxide
34. Tablet polishing agent  Used to impart an attractive sheen to coated
tablets Carnauba wax
o White wax
35. Tonicity agent  Used to render solution similar in osmotic-dextrose
characteristics to physiologic fluids, e.g., in ophthalmic,
parenteral, and irrigation fluids
o Sodium chloride
36. Vehicle  Carrying agent used in formulating a variety of liquids for oral
and parenteral administration
Generally, oral liquids are aqueous (e.g., syrups) or
hydroalcoholic (e.g., elixirs). Solutions for intravenous use are
aqueous, whereas intramuscular injections may be aqueous or
oleaginous
Flavored, sweetened
o Acacia syrup
o Aromatic syrup
o Aromatic elixir
o Cherry syrup
o Cocoa syrup
o Orange syrup
o Syrup
Oleaginous
o Corn oil
o Mineral oil
o Peanut oil
o Sesame oil
Sterile
o Bacteriostatic sodium
o chloride injection
37. Viscosity-increasing agent  Used to render preparations more resistant
to flow. Used in suspensions to deter
sedimentation, in ophthalmic solutions to
enhance contact time (e.g.,
methylcellulose), to thicken topical
creams, etc.
o Alginic acid
o Bentonite
o Carbomer
o Carboxymethylcellulose
o Sodium
o Methylcellulose
o Povidone
o Sodium alginate
o Tragacanth
PHYSICAL PHARMACY
1. Forces of Attraction 6. pH & Buffer  Physical Properties of Systems:

(a) Additive Property  depends on the sum of the individual properties
2. Gas Laws 7. Rheology of the components present in a system
3. Solubility 8. Micromeritics  total contribution of the atom
4. Colligative Property 9. Phase Equilibria  Example: Molecular Weight
5. Isotonicity 10. Chemical Kinetics (b) Constitute Property  depends on the type & arrangement of the
components present in a system
 kinds of atoms in the molecules
Physical Pharmacy  application of physical & chemical principles  Examples: Refraction of Light
& laws in pharmaceutical sciences Optical Activity
physical chemistry in pharmacy Surface
to understand & develop dosage forms & drug Interfacial Characteristics
delivery systems. (c) Colligative Property  depends on the number of components
 study of physic-chemical properties of present in a system
substances used in drug formulation  number of particles
 Examples: Osmotic Pressure
Freezing Point Depression
Vapor Pressure Lowering
I. FORCES OF ATTRACTION Boiling Point Elevation
INTRAmolecular  forces within a molecule  Types of Properties:
a. Covalent Bond  made by sharing electrons (1) Extensive/ Extrinsic  depends on the size of the amount of material
-Nonpolar [Cl2, CO2, CCl2] –no significant diff. of EN in the system
-Polar [HCl, HCHO] –has significant dif. of EN  mass dependent
b. Ionic bond  affinity between oppositely charged particles Examples: *Volume
 present in salts/ ionic compounds *Weight
 forces that hold ions together in the crystal *Pressure
lattice of a salt *Heat content
INTERmolecular forces hold molecules together (2) Intensive/ Intrinsic  does not depend on the size of the amount of
1. VAN DER WAALS material in the system
1. London Dispersion Forces (LDF)  mass independent
 aka Induced Dipole-Induced Dipole Examples: *Density *Melting point
 result from the tendency of molecules to align *pH *Freezing point
themselves w/ the oppositely charged ends of their *Color *Sublimation temperature
neighbor *Concentration *Optical activity
 bond between nonpolar molecules (no charges) *Boiling point
 weakest bond
2. Dipole-dipole or Permanent Dipole Density, Specific Gravity, & Specific Volume
 aka Keesom Orientation Force 𝑚
Density  mass per unit volume of a substance (g/mL) 𝐷 =
 operate on polar or dipole molecules (polar+polar) 𝑣
 stronger than LDF Specific Gravity  a ratio, expressed decimally, of a weight of a
3. Dipole- Induced Dipole substance to the weight of an equal volume of a
 aka Debye Induction Force standard determined at the same temperature
 bond between a charged (dipole) and an uncharged (if not stated 25C/25C, except when specified in the
particles (induced dipole) monograph & for alcohol which is at 15.56C/
2. Hydrogen Bonding 15.56C)
 bond of Hydrogen with a highly electronegative atom of another 𝑚
𝑆𝑝𝑒𝑐𝑖𝑓𝑖𝑐 𝑔𝑟𝑎𝑣𝑖𝑡𝑦 = 𝐷𝑒𝑛𝑠𝑖𝑡𝑦 =
molecules 𝑣
 special type of dipole-dipole interaction.  Density: g/mL
H  attached to highly electronegative atoms (N, O, F)  Specific Gravity: No unit
H-bond  D-D  LDF Note: Density & Specific Gravity is numerically equal in the metric
system, but they are different when the density is expressed in the
  common system.
relative strength Specific Volume  reciprocal of Specific gravity
3. Ion-ion, Ion-dipole, & ion induced dipole  no unit
 (+) & () interaction in the solid sate 1
𝑆𝑝𝑒𝑐𝑖𝑓𝑖𝑐 𝑉𝑜𝑙𝑢𝑚𝑒 =
 strongest bond 𝑆𝑝𝑒𝑐𝑖𝑓𝑖𝑐 𝐺𝑟𝑎𝑣𝑖𝑡𝑦
 responsible for the solubility of Iodine in Solution by the 𝑉𝑜𝑙𝑢𝑚𝑒
𝑆𝑝𝑒𝑐𝑖𝑓𝑖𝑐 𝑉𝑜𝑙𝑢𝑚𝑒 =
addition of salts. 𝑀𝑎𝑠𝑠
Debye-Huckel Theory:
Strong Electrolytes completely ionize in dilute solutions & the
deviations from ideal behavior are due to electrostatic effects
of oppositely charged ions.
States of Matter: Solid, Liquid, Gas, Plasma
Plasma  aka “Mesophase”, “Liquid Crystals”
 has solid like properties (part solid & part liquid)
 resemble those of a crystal in the formation of loosely
ordered molecular arrays similar to a regular crystalline lattice
& anisotropic refraction of light
The more imperfect the lattice, the harder the solid.
 Tends to flow like liquid under extreme conditions
Two main types of Liquid Crystals:
-Smectic (soap- or grease-like)  mobile in 3 direction
 is most pharmaceutically
important because it forms
a ternary complex mixture
w/ additives
-Nematic (thread-like)  mobile in 2 direction
-Cholesteric  combination of nematic & smectic
Six Distict Crystal System:
1. Cubic (sodium chloride) 4. Rhombic (iodine)
2. Tetragonal (urea) 5. Monoclinic (sucrose)
3. Hexagonal (iodofrom) 6. Triclinic (boric Acid)
Phases of Matter:
Mesophase
 middle: Liquid Crystal
LCD, LED
LCD LED
Thickness thicker thinner
Price Expensive More Expensive
Electric e- e-
Consumption Consumption Consumption
Life span 10 years >10 years
21” 32”
 Cholesteryl Benzoate  the first recorded type of liquid crystal that was
obtained by the application of heat
Starch-Iodine  is an example of Channel-Lattice
II. GAS LAWS
Gases
 have kinetic energy that produces rapid motion
held together by weak intermolecular forces
capable of filling all available space
are compressible
for many, are invisible
 Kinetic Molecular Theory of Gases:
(a) Total volume of gas molecules is negligible as compared to
the volume of space in which they are confined
(b) Gas particles do not attract one another but rather move
independently from each other
(c) Particles exhibit continuous random movement due to their
kinetic energy
(d) Gas molecules exhibit perfect elasticity
1. Boyle’s Law
6. Gay-Lussac’s law or Amonton’s Law
 Volume is inversely 𝑃1 𝑉1 = 𝑃2 𝑉2  Pressure is directly proportional to temperature, if V is constant
proportional to pressure Constant: n, R, T
 nonlinear relation for Variable: P, V
volume & pressure Relationship: Inverse 7. Clausius-Clapeyron
𝑃2 ∆𝐻𝑣 (𝑇2 − 𝑇1 )
2. Charles’ Law  Latent heat  heat required 𝑙𝑜𝑔 =
 Volume is directly 𝑉1 𝑉2 𝑃1 2.303 𝑅𝑇2 𝑇1
= for phase transition to Where:
proportional to 𝑇1 𝑇2 happen. P= Pressure
temperature (Kelvin), Constant: P, n, R -Hf  heat of fusion (S⇌L) T= Temperature
273Kstandard Variable: V, T
Relationship: Direct -Hv  heat of vaporization (L⇌G) Hv = heat of vaporization
-Hs  heat of sublimation (S⇌G) R= gas constant + 8.314 J/molK
3. Avogadro’s Law
 Volume is directly 𝑉1 𝑉2 8. Grahams Law
proportional to moles =  The rate of the effusion of
𝑛1 𝑛2 𝑅1 𝑀𝑊1
Constant: P, R, T two gases (& diffusion) are
inversely proportional to 𝑅2 𝑀𝑊2
Variable: V, n
the square roots of their
Relationship: Direct
densities providing the Diffusion  gradual mixing of
temperature & pressure molecules of one gas w/
4. Combined/ Ideal Gas Law
are the same for two
 combination of Boyle’s, 𝑃1 𝑉1 𝑃2 𝑉2 the molecules of another
= gases. gas by virtue of their
Charle’s, Avogadro’s 𝑛1 𝑇1 𝑛2 𝑇2
kinetic properties
Ideal Gas  exist at STP
Effusion  passage of a gas
T= OC / 273 K
Ideal Gas Constant: R P= 1 atm
under pressure through a
R= 0.08206 Latm/ mol k = 760 mmHg
small opening
R= 8.314 J/mol k N= 1 mol
V= 22.4 L
5. Dalton’s Law of Partial Pressure

 State that the total 𝑃𝑡𝑜𝑡𝑎𝑙 = 𝑃𝑎 + 𝑃𝑏 + 𝑃𝑐 … 𝑃𝑥
pressure in a mixture of
gases is equal to the sum
of the partial pressure of
each
 gaseous mixtures
Partial Pressure  is the

pressure a gas would
exert if it alone
occupied the whole
volume of the mixture
III. SOLUBILITY Solutions  homogenous mixture of single phase system of two or more
substances
𝑎𝑚𝑜𝑢𝑛𝑡 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑒 -Solute  lesser amounts
𝑆𝑜𝑙𝑢𝑏𝑖𝑙𝑖𝑡𝑦 =  solid, liquid, gas
𝑣𝑜𝑙𝑢𝑚𝑒 𝑜𝑓 𝑠𝑜𝑙𝑣𝑒𝑛𝑡
𝑎𝑚𝑜𝑢𝑛𝑡 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑒 -Solvent  greater amounts
𝑀𝑜𝑙𝑎𝑟 𝑆𝑜𝑙𝑢𝑏𝑖𝑙𝑡𝑦 𝑆 =  liquid, solid, gas
𝑣𝑜𝑙𝑢𝑚𝑒 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑖𝑜𝑛
Molar Solubility= exponent stoichiometric coefficient
USP Terms of Solubility:
Ksp= solubility product constant Terms Parts of Solvent Required to
 product of the molar solubility each component praised to an Dissolve One part of Solute
experimental equal to their stoichiometric coefficient Very Soluble <1
Freely soluble 1-10
 Classification of Dispersed (Particulate) Systems: Soluble 10-30
Classes Definition Range of Examples Sparingly Soluble 30-100
Particle Size Slightly Soluble 100-1,000
1. Molecular is defined as a Less than Oxygen Molecules, Very Slightly Soluble 1,000-10,000
Dispersion mixture of two or 1 nm Ordinary Ions, Practically Insoluble or Insoluble  10,000
(True more components Glucose
Solutions) that form a
homogenous Types of Solution According to the Solubility of the Solute:
molecular  Saturated Solution  solution achieved the maximum solubility
dispersion or one- / in equilibrium
phase system  Unsaturated Solution  less solvent that solute
2. Colloidal  represents a 1nm to 0.5nm Colloidal Silver / dissolve solute in a concentration below
Dispersion system having a (100 angstrom Solutions,  Supersaturated Solution  contains more solvent that dissolve solute
or 10 cm
5
particle size Natural & Synthetic that it would normally contain at a definite
intermediate Polymers temperature.
between that of a
true solution & a Classification of Solvents:
coarse dispersion (a) Protophilic  capable of accepting protons
3. Coarse diameter of Greater Grains of Sand, Examples: Acetone, Ether, Liquid Ammoina
Dispersion particles being than 0.5 m Red Blood Cells, (b) Protogenic  proton-donating compound
larger than 0.5 m (10-5000 Most emulsions & Examples: Formic Acid, Acetic Acid, Sulfuric Acid,
angstrom) Suspension Liquid HCl, Liquid HF
(c) Amphiptrotic  proton acceptors & proton donors
 Types of Colloidal Systems: Examples: Water, Alcohols
(a) Lyophilic  solvent-loving colloids (d) Aprotic  neither accept nor donate protons
 systems containing colloidal particles that interact to an
appreciable extent with the dispersion medium
(b) Lyophobic  solvent-hating colloids Factors affecting Solubility:
 composed of material that have little attraction for the 1. Nature of Solute & Solvent
dispersion medium, due primarily to the absence of a (Polarity): Like dissolve like
solvent sheath around the particles Solubility  maximum amount of solute expressed in grams that
(c) Association  amphiphilic colloids can be dissolved in 100g of water
 characterized by having two distinct regions of Miscibility  ability of one substance to mix with another
opposing solution affinities substance (ex: liquid-liquid; liquid-gas)
 Properties of Colloids 2. Temperature
1. Optical: Faraday-Tyndall Effect  ability to scatter or disperse light temp: sobility of solid in liquid
2. Kinetic: Brownian Motion  colloidal particles appear as tiny points of temp:  solubility of a gas in liquid
light in constant motion when examined Exothermic  solubility: temperature (ex: Sodium Oxalate)
under ultra microscope Endothermic  solubility: temperature (ex: Ammonium
Diffusion  spontaneous movement of particles from a region Nitrate)
of higher concentration to one of lower  Sodium Chloride  neither endo & exo
concentration until equilibrium is achieved.
3. Electric: Nernst Potential  aka “Electrothermodynamic Potential” 3. Pressure (affects Gases only)
 difference in potential between the actual Henry’s Law of Gas solubility  solubility of gas: pressure
surface of the particle & the electroneutral states that the amount of gas dissolved in a solution in
region of the dispersion proportional to the partial pressure of the gas in
Zeta Potential  aka “Electrokinetic Potential” equilibrium w/ the solution
 difference in potential between the surface 4. Particle Size/ Surface Area
of the tightly-bound layers & the particle size: surface area: solubility
electroneutral region of the dispersion 5. Presence of Salts
 has more application in pharmacy (example: Salting-out  presence of salt decreases solubility
decreased zeta potential, results to Salting in  presence of salt increases solubility
flocculation) *Basic or Sub salt  is prepared by:
Partial hydrolysis of a normal salt
Partial Neutalization of a hydroxide
 Low-Molecular weight salts are salty.
 High-Molecular weight salts are bitter.
Different Expressions for concentration:
Molarity is the number of moles (gram molecular weight) of
solute in 1L solution
𝑚𝑜𝑙𝑒𝑠 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑒 𝑤𝑡/𝑀𝑊
𝑀 = =
𝐿 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑖𝑜𝑛 𝐿
Normality is the number of gram equivalent weight of a solute
in 1L solution
𝑀𝑊
𝑤𝑡/
𝑓
𝑁 =𝑀×𝐹 =
𝐿
𝑀𝑤
𝑚𝐸𝑞 𝑤/
𝑓
𝑁= =
𝐿 𝐿
𝑒𝑞𝑢𝑖𝑣𝑎𝑙𝑒𝑛𝑐𝑒 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑒
𝑁=
𝐿 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑖𝑜𝑛
Molality is the number of moles of solute in 1000 grams of
solvent
𝑚𝑜𝑙𝑒𝑠 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑒 𝑤𝑡/𝑀𝑊
𝑚 = =
𝐾𝑔 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑖𝑜𝑛 𝐾𝑔
Mole Fraction is the ratio of moles of one more constituents of a
solutions to the total moles of all constituents
𝑁𝐴 𝑁𝐴
𝑀𝐴 = =
𝑁𝑇 𝑁𝐴 + 𝑁𝐵
Mole Percent is obtained by multiplying mole fraction by 100
 Four Polymorphic Forms of Theobroma Oils:

Unstable Gamma Form Melts at 18C
Alpha Form Melts at 22C
Beta Form Melts at 28C
Stable Beta Form Melts at 34.5C
 Interfacial Phenomenon
Interfacial Phenomenon  attributed to the effects of the molecules
found at the interface (boundary b/w 2
phases)
 Interfacial Tension (L-L only)
 Surface Tension (S-L, L-G)
 Surfactant  Surface-active Agent
 lower the interfacial/ surface tension
Cohesion  attraction among similar molecules
Adhesion  attraction among different molecules
Wetting Phenomenon   contact angle;  wettability
Capillarity tendency of a liquid rises in a tube because of a
combination of adhesion to the walls of the tube and
cohesion between liquid particles
  adhesive force;  capilaarity
 Adsorption  binding of molecules to a surface
Hydrophilc-Lipophilic Balance (HLB) Values

HLB Range USE
0-3 Antifoaming Agent
4-6 w/o emulsifying Agent
7-9 Wetting Agent
8-18 o/w emulsifying Agent
13-15 Detergents
10-18 Solubilzing Agents
IV. COLLIGATIVE PROPERTIES
1. Vapor Pressure Lowering  the addition of a non-volatile solute lowers
the VP of the liquid
 when a nonvolatile solute is added to a
volatile solvent, the solute reduces the
escaping tendency of the solvent
thus, the vapor pressure of the solution is
lowered proportional to the relative number
solute molecules
 A liquid in a closed container will established an equilibrium with
its vapor.
 When equilibrium is reached, the vapor exerts a pressure (vapor
pressure)
 Volatile exhibits vapor pressure
 Nonvolatile  no measurable vapor pressure
Raoult’s Law  lowering of a vapor pressure of a solvent is equal to the
product of the mole fraction of the solute & vapor
pressure of the solvent.
 ?P=P of pure solvent x mole fraction of the solute
2. Boiling Point Elevation
Boiling Point  equilibrium between the liquid & the gas, point at
which the VP equals atmospheric P.
 is the temperature at which the vapor pressure of the
liquid becomes equal to the external atmospheric
pressure (1 atm= 760 mmHg)
The Boiling Point of a solution containing a nonvolatile solute would
be higher than the pure solvent because the solute would lower the
vapor pressure of the solvent
The higher the molecular weight, the higher the boiling point of the
liquid.
3. Freezing Point Depression
Freezing Point  is the temperature at which the solid & liquid phases
are in equilibrium under an external pressure of 1 atm
Presence of salt/ solute will cause lowering of freezing point
Ice cream making
?FP = kfm
Freezing point of water is 0C
Kf (freezing point depression constant)= 1.86C/m
Frezzing point of an Isotonic Solution= 0.52C/m
4. Osmotic Pressure  is the pressure required to offset the movement of
solvent through a semipermeable memebrane
Also defined as the pressure needed to prevent
osmosis
Osmosis  Greek:“Push” or “Impulse”
 net movement of solvent molecules through a
semipermeable membrane from a more dilute solution
to a more concentrated solution
V. ISOTONICITY
 Isotonicity Solutions
(1) Hypertonic Solutions  solutions with more solutes compared to
cell concentration
 solutions that freeze lower than -0.52C
Results: Crenation of the cells (Shrinkage)
(2) Hypotonic Solutions  solutions with less solutes compared to cell
concentration
 solutions that freeze higher than -0.52C
 Results: Swelling & lysis of the cell
(3) Isotonic Solutions  solutions for which a living cell does not gain or
lose water
 solutions with similar osmotic pressure as that
of boy fluids
 has similar concentration as 0.9% (w/v) NaCl
solution
 Methods of Adjusting Tonicity & pH

Class I Method: Addition of a Tonicity Adjusting Agent
(1) Cryospcopc Method ( Freezing Pint Depression Method)
(2) Sodium Chloride Equivalent Method ( E value Method)
E Value  gram of NaCl equivalent to 1 gram of
substance
Isotonic NaCl Concentration  0.9% (w/v) NaCl
Class II Method: Addition of Water & Dilution w/
Buffered Isotonic Solution
(1) White Vincent Method
(2) Sprowl’s Method
VI. pH & BUFFER
Acid-Base Equilibria
Acid-Base Theory
ACID BASE
Arrhenius yield H+ yield OH
Bronsted-Lowry proton donor proton acceptor
Lewis e- acceptor e- donor
Ionization  is the complete separation of ions in a crystal lattice

when a salt is dissolved
Dissociation  is the separation of ions in solution when the ions are
associated by interionic attraction
Basic Principles of Analysis

A. pH B. Buffer Capacity
 number of grams equivalent of H per liter of soln  ability/ degree (magnitude) of a buffer solution to resist
 pH = -log [H] changes in pH upon addition of acid/alkali
or pH = log 1/[H]  buffer action
pOH= -log[OH]  buffer efficiency
pH + pOH =14  buffer index
acidic = pH < 7.0, pOH >7.0  buffer value
basic= pH >7.0, pOH <7.0 Van slyke
neutral= pH=pOH=7.0  was responsible for a quantitative expression
 () value of pH is possible  amount in g/l of strong acid or a strong base required to be
 > 14 value is possible as well. added to a solution to change its pH by 1 unit.
 Protolysis  a process whereby a proton is transferred from one  higher buffer capacity, lower change in pH.
molecule to another.
 Autoprotolysis  a process whereby there is a transfer of a Maximum Buffer Capacity  occurs when pH = pKa
proton from one molecule to another identical molecule. The Higher the pKa, the stronger the base is.
 Amphoteric  properly where a substance can act either as acid
or base.
Buffers are solutions that have the property of resisting changes in

pH when acids or bases are added to them Pearson’s HSAB principle:
 this property results from the presence of a buffer pair “Hard acids are electron acceptor w/ high positive charges & relatively
which consists of either: small sizes while soft acids have low positive charges & relatively large
-weak acid & some salt of a weak acid sizes. “
/its conjugate base
Solubility of weak acids
 increases as the pH is increased
 in pharmarmecutical formulations may
be affected by the presence of
counterions.
-weak base & some salt of a weak base
/its conjugate acid
Henderson- Hasselbalch equation

aka “Buffe Equation”
pH = pka h log [salt]/[acid] or
pH = pka=log [conjugate base]/[base]
VII. RHEOLOGY
Rheology  Greek terms: rheos “to flow” & logos “study”
 scientific study of the deformation
& flow properties of matter
 elasticity, fluidity, viscosity
Viscosity  measure of the resistance to flow
Absolute Viscosity
Kinematic Viscosity Solids characterized as having fixed shapes
Relative Viscosity  nearly incompressible
Unit: Poise/ Centipoise  have strong intermolecular forces
Stokes/ Centistokes  very little kinetic energy
Methods of Determining Viscosity:  their atoms vibrate in fixed positions about an equilibrium
1. Capillary Viscometer (Ostwald) position, & so there is very little translational motion.
2. Falling Sphere (Hoeppler) (A) Crystalline  the molecules or atoms are arranged in repetitious
3. Cup & Bob (Coutte, Mac Michael, Searle ‘Brookefield – three-dimensional lattice units
rotating spindle/ Bob’ )  have definite geometric froms w/ 6 common
4. Plug Flow crystalline structures
5. Core & Plate (Ferranti-Shirley) Six Distict Crystal System:
Fluidity  reciprocal of viscosity 1. Cubic (sodium chloride) 4. Rhombic (iodine)
Poise  unit used to express kinematic viscosity 2. Tetragonal (urea) 5. Monoclinic (sucrose)
3. Hexagonal (iodoform) 6. Triclinic (boric Acid)
 Newtonian Flow  has linear relationship between shear rate & shear (B) Amorphous  aka “Glasses” or “Supercooled Liquids”
stress  non-crystalline; no definite order
 constant viscosity w/ increasing rate  have no definite & sharp melting points
 example: Water, Ethanol, Acetone,  Examples: Cocoa, Tannins
Glycerin, Benzene
 Non-Newtonian Flow Polymorphs  solids that have more than one crystalline form
A. Shear-dependent Viscosity  have different physical properties including different
1. Plastic Flow  aka Bingham Bodies melting points & solubilities
2. Pseudoplastic  shear-thinning  Examples: Theobroma Oils, Chloramphenicol,
 shear stress; viscosity Carbamazepine
3. Dilatant  shear-thickening 1. Enantiotropic  reversible change from one polymorphic form to
  shear stress;  viscosity another
B. Time-dependent Viscosity 2. Monotropic  transition in one direction only
1. Thixotropy  decreased viscosity w/ increased time of shear 3. Isotropic  properties are identical in all direction
 gel-sol transformation 4. Anisotropic  properties are different in all direction
2. Rheopexy  increased viscosity w/ decreased time of shear
 antithixotropy Amorphous Crystalline
 sol-gel transformation Solubility  
Reactivity  
Stability  
Melting Point  
X-ray Diffraction
 Method used to
differentiate
amorphous vs.
Crystalline “Noise” Definite Peaks
-no definite
peaks
Insulin  Amorphous: Rapid Acting

Crystalline: Long-acting
Amlodipine  Besylate: more stable
(innovator: Norvasc®, Amvasc®)
Camsylate
Cocoa Butter  suppository:  (most stable)
Azithromycin  Monohydrate: Azith®
Dihydarte (more stable): Zthromax®
VIII. MICROMERITICS
Micromeritics  study of small particles
*micro (small)
*meritics (measure)
Types of Properties of Particles:
(1) Fundamental  inherent in all individual particles
 Examples: Size, Shape, Density, Volume B. Porosity  study of voids
(2) Derived  combination of fundamental properties
 Examples: Bulk Density, Granule Volume, Porosity Types of Porosity
A. Particle Size (a) Intraparticle Porosity
Coarse >1000 m 𝑉𝑔 − 𝑉𝑏
%𝑖𝑛𝑡𝑟𝑎 = × 100%
Conventional 50-1000 m 𝑉𝑔
𝑖𝑛𝑡𝑟𝑎
Fine 1-50 m = × 100%
Very Fine 0.1- 1 m 𝑉𝑔
Ultra Fine <0.1 m
(b) Interparticle Porosity
𝑉𝑏 − 𝑉𝑔
Methods of Determining Particle Size %𝑖𝑛𝑡𝑒𝑟 = × 100%
𝑉𝑔
a. Official Method 𝑖𝑛𝑡𝑒𝑟
-Sieve Analysis = × 100%
𝑉𝑏
20
40 (c) Total Porosity
Increase mesh #,
60 𝑖𝑛𝑡𝑟𝑎 − 𝑖𝑛𝑡𝑒𝑟
decrease mesh size %𝑡𝑜𝑡𝑎𝑙 = × 100%
80 𝑉𝑏
Receiver 𝑉𝑏 − 𝑉𝑝
= × 100%
Mesh #: # of square openings per linear inch 𝑉𝑏
*disadvantage: Attribution of Particles
%total≠ % intra + % inter
Sample: 100 g powders cannot be!!
20 5g
40 15g
Smaller – lower Types of Volume:
60 25g
Larger – upper 1. True Volume/ Particle (Vp)
80 35g
CP 20g volume of the particles w/o voids
1. % is smaller than mesh 40 2. Granular Volume (Vg)
25 + 35 + 20 volume of particles + intraparticle spaces
× 100% = 80% volume of intraspace
100
2. % is larger than mesh 60 3. Bulk Volume (Vb)
5 + 15 + 25 volume of particle + intra + inter
× 100% = 45%
100  Vp + intra + inter
3. % is smaller than20 but larger than 80 Vg + inter
15 + 25 + 35
× 100% = 75%
100 C. Properties of Powders for Granulation
1. Fluidity
b. Optical Microscopy  use of a microscope to measure individual Angle of Repose  is the angle assumed by a cone-like pile of
particles powder relative to the horizontal base
 Advantage: Individual Particles can be seen  is a characteristics related to the interparticulate
 Disadvantage: Very Tedious, 2D-image only friction.
Three Measurements:  fixed funnel method
(a) Ferret Diameter  2 tangents separated 𝑕
by the longest distance tan 𝜃 =
𝑟
(b) Martin’s Diameter  distance that will bisect the 𝑜𝑝𝑝𝑜𝑠𝑖𝑡𝑒
𝑡𝑎𝑛𝑔𝑒𝑛𝑡 =
particle into halves 𝑎𝑑𝑗𝑎𝑐𝑒𝑛𝑡
(c) Projected Area of the Cycle  diameter of the circle that 2. Compressibility
will enclose the particles Carr’s Index Hausner’s Ration
c. Sedimentation Method 𝑉𝑜 − 𝑉𝑓 𝑉𝑜
 sedimentation rate or free fall velocity of particles 𝐶𝐼 = × 100% 𝐻𝑅 =
𝑉𝑜 𝑉𝑓
 apparatus: Andreasen Apparatus
 Principle: Stokes Law  Sedimentation Rate is directly Where: Vo= initial volume
proportional to the Density of Vf = final volume
Particle, Diameter of Particle, &
Gravitational pull. O = Vo= Vf (not compres.) >1 Vo >Vf (compressible)
d. Automatic Particles Counters 1-99  = Vo>Vf (compressible) 1 Vo=Vf (not compressible
 Coulter counter 100  =Vf=O <1 Vo<Vf 
Principle: Electric Resistance
HIAC/Royco Instrument
Principle: Light Blockage
Gelman Counter
Principle: Faraday-Tyndall Effect
IX. PHASE EQUILIBRIA
Phase Diagram  represents the states of matter that exist as

temperature & pressure are varied
 Gibb’s Phase Rule  used to determine the number of independent

variables (temp, pressure, conc) that must be set in
order to define a system
 F= C P + 2 (1-component)
 F= C P + 1 (2-component)
 F= C P (3-component)
F = degrees of freedom
C = number of components
P = number of phases
Triple Pointis the temperature and pressure at which the three phases  1-component System
(gas, liquid, and solid) of that substance coexist in
thermodynamic equilibrium.  2-component System
Critical Point a point on a phase diagram at which the liquid and gas  aka “Condensed System”
phases of a substance have the same density, and so are  system in which the vapor phase is ignored & only the solid
indistinguishable &/or liquid phases are considered
 Supercritical Fluid  may be formed when the temperature  under normal condition of 1 atm
& pressure of a liquid go beyond the  Phase Rule: F= C P + 1
critical points  Binodal curve  area within the curve represents a 2-phase
Critical Temperature  the temperature above which a gas cannot be system
liquefied  any point beyond it, is a single phase
Critical Pressure  the pressure to liquefy a gas at its critical temperature Critical Solution Temperature  temperature beyond which
every proportion of A & B will
exist as 1-phase
 maximum temperature to
 Latent Heat/ Molar Heat obtain a one phase system
 heat necessary for 1 mole of a gas, solid or liquid to change to Tie Line  line from which a system separates into phases of
another phase constant composition
 either gained or lost  used to approximate the proportions of components
 NOTE: without latent heat, no phase transition A&B existing at a particular temperature
Heat of Fusion  The heat absorbed as a substance changes phase from Conjugate Phases  phases of constant composition that
liquid to solid separate when a mixture is prepared
 aka solidification within the boundary of the 2-phase system
Heat of Vaporization  heat absorbed when a substance changes Eutectic Point  is the point where solid A, solid B, & the liquid
phase from liquid to gas phase co-exist
Heat of Sublimation  is the amount of heat needed to  3-phase co-exist
change solid to gas Ex of Eutectic Mixture: Camphor + Menthol + Phenol
 3-component System
 aka “Ternary System”
 temperature & pressure are both made constant
 consists of 2 liquids that are partially miscible to each other
& a 3rd component or co-solvent which has affinity to both
immiscible layers
Apex: 100% of each component
Base: opposite the apex; 0% of each component
 Phase  a homogenous, physically distinct portion of a system that

is separated from other portions of the system by bounding
surface
X. CHEMICAL KINETICS
Chemical Kinetics  is the study of the rates of reactions & the

mechanism by which these reactions occur
 Application in pharmacy:
Stability & bioavailability of
pharmaceutical Products
Rate of Reaction  aka “Degradation Rate”

 is the velocity with which the reaction occurs
 depends on:
- Reactant concentration
- Temperature
- pH
- Presence of solvents or additives
Order of Reaction is the way in which the concentration of the drug or
reactant in a chemical reaction affects the rate
 zero-order
 first-order
 second-order
Zero-Order the drug concentration changes with respect to time at

Reaction a constant rate
the rate of reaction is independent of the concentration
of the reactants
First-Order the rate of reaction is dependent on the concentration

Substrate  the interactant whose physical or chemical
Reaction of drug remaining
properties are observed experimentally
most drugs follow this order of reaction
PBE  Proton Balance Equation
Half-life (t1/2) is the period of time required for the amount or
concentration of a drug to decrease by
one-half or 50%
Shelf-life (t90)  is the period of time where 90% of the original
concentration is left & 10% is already degraded
PHARMACEUTICAL JURISPRUDENCE & ETHICS
Introduction:
Jurisprudence Statutory Laws Affect the Pharmacy Profession & Its Practice:
Jurisprudence  is defined as a system of laws. RA 5921 The Pharmacy Law June 23, 1969
 is the science of philosophy of laws (as amended by EO 174)
Legal principles that govern the manner in which in which RA 3720 Foods, Drugs, Devices & Cosmetic Act June 22, 1963
professionals practice can be divided into three basic (as amended by EO 175)
categories: EO 119 Reorganizing the Bureau of Food and Drugs, DOH
1. Statutes laws  laws that have been passed by AO 43 s. 1999 Current Good Manufacturing Practice for Cosmetic
legislative bodies such as the Senate & Products
the Congress. AO 42 s. 1982 Drug Registration of Herbal &/or Traditional Drugs,
 dictate the activities of person subject Both Local & Imported
to the law AO 55 s. 1988 Requirement for Labeling Material of
 enable regulatory agencies to function Pharmaceutical Products
pursuant to the mandate of a AO 64 s. 1989 Amendments of AO No. 55, s 1988
legislative body. AO 56 s. 1989 Revised Regulations for the Licensing of Drug
 provide penalties for whose who fail to Establishments & Outlets
comply with the law. AO 67 s. 1989 Revised Rules & Regulations for Registration of
2. Regulatory law  is promulgated by government Pharmaceutical Products
agencies for the enforcement & AO 4 s. 1992 Policy & Requirements for Availing of
understanding of the law. Compassionate Special Permit for Restricted Use of
3. Common law  encompasses those areas of law that Unregistered Drug & Device Product & Preparation
have evolved over hundred of years of AO 27 s. 2001 Rules & Regulations for Licensing Local
judicial decision. Manufacturers of Vaccines & Biological Products
AO 47-A s. 2001 Rules & Regulations on the Registration, Including
Ethics
Approval & Conduct of Clinical Trials, & Lot or Batch
Ethics  the moral principles of practice
Release Certification of Vaccines & Biologic
 is the science of morality
Products
Objectives of Ethics:
RA 8203 Special Law on Counterfeit Drugs Sept. 4, 1996
1. To make clear to us why one act is better than another
RA 6675 Generics Act of 1988 Sept. 13, 1988
2. To live an orderly social life
3. To appraise & criticize intelligently the moral conduct AO 62 s. 1989 Rules & Regulations to Implement Prescribing
& ethical system; & Requirements under the Generics Act of 1988
4. To seek the value of life. AO 63 s. 1989 Rules & Regulations to Implement Dispensing
Professional Ethics  is a branch of moral science that treats of Requirements under the Generics Act of 1988
the obligations which a member of a AO 90 s. 1990 Amendment to A.O. 62 s. 1989
profession owes to the public to his RA 6425 Dangerous Drug Act March 30, 1972
profession & to his clients. RA 9165 The Comprehensive Dangerous Drug Act of June 7, 2002
Bioethics  is the term used to describe the application o ethics 2002
to biological sciences, medicine & related fields. RA 7432 Senior Citizen Act Feb. 7, 1992
 is a systemic study of moral conduct in life sciences RA 9257 Expanded Senior Citizen Act of 2003 Feb. 26, 2004
& medicines RA 9994 Expanded Senior Citizen Act of 2010 July 27, 2009
Importance of Bioethics: RA 7581 The Price Act May 27, 1992
1. To provide awareness to the health team or workers of RA 7394 Consumer Act of Philippines April 13, 1992
the “do’s & don’t” of medical practice RA 9502 Universally Accessible Cheaper & Quality July 4, 2008
2. To enrich one’s competence by understanding that the Medicines Act of 2008
patient is a person & a holistic individual RA 9711 Food & Drug Administration Act of 2009 June 3, 2009
Universal Principles of Biomedical Ethics: EO 851 abolished FDA & created BFAD
a. Autonomy  a form of personal liberty, where the RA 8293 The Intellectual Property Code of the June 6, 1997
individual is free to choose & implements Philippines
one’s own decisions, free from deceit,
duress, constraint or coercion Other Administrative Orders
b. Veracity  binds both the practitioner & the patient in an AO 107 s. 1991 Guidelines on Dispensing Multiactive-Ingredient
association of truth. Fixed Dose Combination Drug Product
c. Beneficence  acts of mercy & charity or any action that
AO 220 Prescribes the condition & Requirement for GMP
benefits another or apply measures for Production records must be kept for 2 yrs after
the benefits of the sick batch distribution is completed
d. Nonmaleficence  means never to use treatment to Each critical step in production process must be
injure or wrong the sick performed & checked by 2 competent &
e. Confidentiality  is an important aspect of trust that responsible individual.
patients place in health care Other Executive Order
professionals EO 266 Institutionalizes the Continuing Professional
f. Justice  is the concept of fairness, just desserts and Education (CPE) Programs of the various
entitlements. Professional Regulatory Boards (PRBs) under the
g. Role Fidelity  means that the practitioner practice supervision of the Philippine Regulatory
faithfully within the constraints of the role Commission
July 25, 1995
makes CPE mandatory requirement for the
renewal of professional licenses
REPUBLIC ACT NO. 5921 –THE PHARMACY LAW (as amended by EO 174)
Title AN ACT REGULATING THE PRACTICE OF PHARMACY AND SETTING STANDARDS OF PHARMACEUTICAL EDUCATION IN THE
PHILIPPINES AND FOR OTHER PURPOSES,
Objectives To govern:
(a) the standardization and regulation of pharmaceutical education;
(b) the examination for registration of graduates of school of pharmacy and
(c) the supervision, control and regulation of the practice of pharmacy in the Philippines.
Composition of  Secretary of Education,
Council of  Undersecretary of Health Services,
 Food and Drug Administrator
Pharmaceutical  Chairman of the Board of Pharmacy
Education  PRC Pharmacy Board Chairman
 Dean of the College of Pharmacy, representing accredited private schools of pharmacy
 Representative of bona fide national pharmaceutical organization in the Philippines.
Functions of the a) To promulgate rules and regulations relative to Pharmaceutical Education in the Philippines:
Council b) To submit such rules and regulations, which shall have a binding effect, for implementation to the proper agencies such as the
Department of Education, the Board of pharmacy, the bona fide national pharmaceutical organizations in the Philippines and
others;
c) To recognize and accredit colleges of pharmacy in the different private colleges and universities; and
d) To approve the accreditation of community or prescription pharmacies, pharmaceutical manufacturing laboratories and hospital
pharmacies for purposes of pharmacy internship.
Composition of Chairman and two members
Board of Pharmacy
Qualifications of a) A natural-born citizen of the Philippines ;
Board Members b) A duly registered pharmacist and has been in the practice of pharmacy for at least ten years;
c) Of good moral character and of recognized standing in the pharmaceutical profession;
d) At the time of appointment, not a member of the faculty of any school, college or university offering courses in pharmacy or
college of pharmacy; and
e) A member of good standing of any bona fide national pharmaceutical association of the Philippines.
Powers and duties a) To examine applicants for the practice of pharmacy;
of the Board.- b) To issue certificates of registration of pharmacists;
c) To reprimand any pharmacist or to suspend or revoke his certificate of registration on the grounds as provided for in Section
thirteen hereof, after a formal administrative investigation has been conducted by it;
d) To promulgate from time to time the necessary rules &regulation for the effective enforcement of this Act, subject to the
approval of the President upon advice of the Commissioner of Civil Service;
e) To study the conditions affecting the practice of pharmacy in the Philippines;
f) To check the employment of qualified personnel in drug stores, hospital pharmacies, drug or pharmaceutical laboratories and
similar establishments for which the Board may designate inspectors from the Board of Pharmacy; and
g) To encourage the development of botanical gardens and their inspection, particularly the propagation of Philippine medical
plants with the cooperation of the Dept. of Agriculture and Natural Resources.
Grounds for a) Conviction by a court of competent jurisdiction of any violation as penalized in sections forty and forty-one hereof;
reprimand, b) Immoral or dishonorable conduct which includes conviction by a competent court of any criminal offense involving moral
suspension or turpitude;
revocation of c) Fraud or deceit in the acquisition of the certificate of registration;
registration d) Gross negligence, ignorance or incompetence in the practice of this profession resulting in the injury, damage or death of
certificate another;
e) Malpractice, including aiding or abetting the commission of criminal abortion or sex crimes through illegal compounding,
dispensing or sale of abortive or sex drugs, as the case may be;
f) Acting as a dummy of an alien or a person who is not qualified to establish and operate a retail drugstore;
g) Addiction to alcoholic beverage or to any habit- forming drug rendering him incompetent to practice his profession;
h) Insanity;
i) False or extravagant or unethical advertisements wherein other things than his name, profession, limitation of practice, office
and same address and the like are mentioned; and
j) Violations of any provision of the Code of Ethics which may be adopted as part of the Rules and Regulations of the Board.
Candidate for a. He shall be a natural-born citizen of the Philippines.
Board Examination b. He shall be of good moral character;
c. He shall have completed an Internship Program
d. He shall have graduated with a degree of Bachelor of Science in Pharmacy
Ratings required  General average of seventy-five per cent
 No ratings below fifty percent in more than 2 subjects
 Fails to pass in three successive attempts  need to attend a pre-board review course from a duly accredited college of pharmacy
Practice of  Prepare or manufacture, analyze, assay, preserve, store, distribute or sell any medicine, drug chemicals, cosmetics,
Pharmacy pharmaceuticals, devices or contrivances used in pursuance thereof
 Render pharmaceutical service in any office or drug and cosmetic establishment where scientific, technological or professional
knowledge of pharmacy is applied
 Engage in teaching scientific, technological or professional pharmacy subject in a college of pharmacy; or conduct
 Undertake scientific pharmaceutical research for biological and bacteriological testings and examinations.
Prerequisite for  At least twenty-one years of age
the Practice of  Has satisfactorily passed the corresponding examination given by the Board of Pharmacy
Pharmacy  Holder of a valid certificate of registration duly issued to him by said Board.
Definition of terms
a "Pharmacy" or "Drug Store" means a place of establishment where drugs, chemical products, active principles of drugs, pharmaceuticals, proprietary
medicines or pharmaceutical specialties, devices, and poisons are sold at retail and where medical, dental and veterinary
prescriptions are compounded and dispensed.
b. "Drug or Pharmaceutical Laboratory" or "Pharmaceutical Manufacturing Laboratory" means an establishment where pharmaceuticals, propriety
medicines or pharmaceutical specialties are prepared,
compounded, standardized and distributed or sold.
c. "Wholesaler" means and includes every person who acts as merchant, broker or agent, who sells or distributes for resale pharmaceuticals, propriety
medicines or pharmaceutical specialties.
e. "Drug" means (1) Articles recognized in the current official United States Pharmacopoeia or the United States Official National Formulary(USP-NF),
official Homeopathic Pharmacopoeia of the United States, official National Drug Formulary, or any supplement to any of them; and
(2) articles intended for use in the prevention of disease in man or animals;
(3) articles (other than food) intended to affect the structure or function of the body of man or animals; and articles intended for use as
a component of any articles specified in clauses (1), (2) or (3), but do not include devices or their components, parts or accessories.
f. "Pharmaceuticals", "Proprietary Medicines" or "Pharmaceutical Specialties" means any drug, preparation or mixture of drugs marked under a trade
name and intended for the cure, mitigation, treatment, or prevention of
disease in man or animals.
g. "Device" means instrument, apparatus, or contrivances including their components, parts and accessories, intended
(1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; or
(2) to affect the structure or any function of the body in man or animals.
h. "Biological Products" are viruses, sera, toxins and analogous products used for the prevention or cure of human diseases.
i. "Poison" is any drug, active principle or preparation of the same, capable of destroying life or seriously endangering health when applied externally to
the body or introduced internally in moderate doses.
j. "Cipher" means a method of secret writing that substitutes other letters or characters for the letter intended or transpose the letter after arranging them
in blocks or squares.
k. "Code" means a system of words or other systems arbitrarily used to represent words.
l. "Secret Keys" means characteristics styles or symbols kept from the knowledge of others or disclosed confidentially to but one or few.
 Detailman  represents any duly authorized manufacturer, dealer, distributor, representative or wholesaler of drugs, pharmaceuticals & biologic
products whose primary duty is to introduce the product made by the manufacturer
 graduate of a College of Pharmacy
 an initial fee of 150 pesos is needed upon registration
 to be employed, he needs to possess the necessary credentials issued by the Board of Pharmacy
 Administrative Investigation shall be conducted by all members of the BOP. In case of suspensions, it shall be for a period of not more than 6 months.
 The BOP, upon receipt of a formal complaint under oath against a pharmacist, shall furnish the latter a copy of the complaint which he shall answer
within 10 days from receipt.
 All prescriptions shall be attached to the prescription book & numbered consecutively & shall be preserved for two years.
 Record for sale of poisons must be kept for a period of 5 years.
Provisions Relative to Dispense of Violent Poisons  Every pharmacist who dispenses, sells or otherwise delivers any of the violent poisons intended for
medicinal use, to wit:
1. Arsenical preparations
2. Phosphorus
3. Corrosicve Sublimate
4. Atrophine
5. Strychnine
6. or Any of their salts
7. Hydrocyanic acid or Prussic acid
8. Oil of Mirbane (Nitro-benzene)
Label: Red Paper w/ the word “Poison” in large letters & a vignette representing a skull & bones.
The books kept for the purpose of recording the sale of poison & shall be preserved for a period of at least 5 years.
REPUBLIC ACT No. 3720 –FOOD, DRUGS, DEVICES, & COSMETICS ACT (as amended by EO 175)
Title AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADE AVAILABLE TO THE PUBLIC BY
CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO.
Objectives a) Establish standards and quality measures for foods, drugs, and devices and cosmetics.
b) Adopt measures to ensure pure and safe supply of foods and cosmetics, and pure, safe, efficacious and good quality drugs and
devices in the country.
c) Adopt measures to ensure the rational use of drugs and devices.
d) Strengthen the Bureau of Food and Drug
FDA Functions  To administer and supervise the implementation of this Act and of rules and regulation issued pursuant to the same.
 To provide for the collection of samples of food, drug and cosmetic.
 To analyze and inspect food, drug and cosmetic in connection with the implementation of this Act.
 To establish analytical data to serve as basis for the preparation of food, drug and cosmetic standards, and recommend standards of
identity, purity, quality and fill of container.
 To issue certificate of compliance with technical requirements to serve as bases for the issuance of license and spot-check for
compliance with regulations regarding operation of food, drug and cosmetics manufacturers and establishments.
 To levy, assess and collect fees for inspection, analysis and testing of products and materials submitting in compliance with the
provisions of this Act.
 To certify batches of antibiotics and antibiotic preparations
FDA Divisions  Inspection and Licensing Division
 Laboratory Division
Adulterated Drugs  If it consists in whole or part of any filthy, or decomposed substances
or Devices  It has been manufactured, prepared or held under unsanitary conditions
 It is composed of any poisonous or deleterious substances
 It contains any color other than a permissible one
 It purports to be an official drug and its strength differs from, or its safely, efficacy, quality or purity falls below the standards set
forth
 It has been mixed or packed or substituted so as to reduce safety, efficacy, quality, strength or purity
 Methods, facilities or controls used do not conform to current good manufacturing practices
Misbranded Drugs  Labeling is false or misleading
and Devices  It did not contain (a) the name and place of business of the manufacturer, importer, packer, or distributor, and
(b) an accurate statement of the quantity of contents in terms of weight, measure or numerical count.
 If any word or information required is not prominently placed with conspicuousness
 If it is for use of man and contains any quantity of narcotic or hypnotic substances
 It is not designated solely by a name recognized in an official compendium
 Unless its labeling bears (a) adequate directions for use, and
(b) such adequate warnings against use
 It purports to be the drug the name of which recognized in an official compendium
 It has been found to be a drug liable to deterioration unless its label bears a statement of precautions
 Its container is so made, formed of filled as to be misleading
 It is an imitation of another drug
 It is offered for sale under the name of another drug
 It is dangerous to health when use in dosage recommended or suggested in the labeling
 If it purports to be, or is represented as a drug composed wholly or partly
Definition of terms
(a) "Bureau" means the Bureau of Food and Drugs.
(b) "Secretary" means the Secretary of Health.
(c) "Department" means the Department of Health.
(d) "Person" includes individual, partnership, corporation and association.
(e) "Food" means (1) articles used for food or drink for man,
(2) chewing gum, and
(3) articles used for components of any such article.
(f) "Drugs" means
(1) articles recognized in the current official United States Pharmacopoeia-National Formulary (USP-NF), official Homeopathic Pharmacopoeia of the
United States, official National Drug Formulary, or any supplement to any of them: and
(2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than
food) intended to affect the structure of any function of the body of man or animals; and (4) articles intended for use as a component of any
articles specified in clauses (1), (2), or (3) but do not include devices or their components, parts or accessories.
(g) "Device" means instruments, apparatus, or contrivances, including their components, parts, and accessories, intended
(1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; or
(2) to affect the structure or any function of the body of man or animals.
(h) "Cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any
part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and
(2) articles intended for use as a component of any such articles.
(i) "Label" means a display of written, printed, or graphic matter upon the immediate container of any article and a requirement made by or under
authority of this Act that any word, statement, or other information appearing on the label shall not be considered to be complied with unless
such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such
article, or is easily legible through the outside container or wrapper.
(j) "Immediate container" does not include package liners.
(k) "Labeling" means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or
(2) accompanying such article.
l) "New drugs" mean:
(1) any drug the composition of which is such that said drug is not generally recognized among experts qualified by scientific training and experience to
evaluate the safety, efficacy, and quality of drugs as safe, efficacious and of good quality for use under the conditions prescribed, recommended,
or suggested in the labeling thereof.
(2) Any drug the composition of which is such that said drug, as a result of previous investigations to determine its safety, efficacy and good quality for
use under certain conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent
or for a material time under new conditions.
(3) "New drugs" shall include drugs
(a) containing a newly discovered active ingredient;
(b) containing a new fixed combination of drugs, either by molecular or physical combination;
(c) intended for new indications;
(d) in an additional new mode of administration; or
(e) in an additional dosage of strength of the dosage form, which meets the conditions as defined under the new drug.
The definition of "new drugs" covers, to the extent applicable, "new devices."
(n) "Food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming
a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing,
manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation
intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience
to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended
use.
o) "Batch" means a quantity of any drug or device produced during a given cycle of manufacture.
p) "Batch number" means a designation printed on the label of a drug or device that identifies the batch, and permits the productions history of the batch
including all stages of manufacture and control, to be traced and reviewed.
q) "Director" means Director of Bureau of Food and Drugs.
r) "Distribute" means the delivery or sale of any drug or device for purposes of distribution in commerce, except that such term does not include a
manufacturer or retailer of such product.
s) "Expiry or expiration date" means the date stated in the label of a drug or device after which the drug is not expected to retain its claimed safety,
efficacy and quality or potency or after which it is not permissible to sell the drug or device.
t) "Export" means to bring out of the Philippines by sea, land, or air.
u) "Import" means to bring into the Philippines by sea, land, or air.
v) "Manufacture", in relation to a drug, or device where applicable, means any and all operations involved in the production of a drug or device including
propagation, processing, compounding, formulation, filling packing, repacking, altering, ornamenting, finishing and labeling with the
ends in view of its storage, sale or distribution; Provided, that the term shall not apply to the compounding and filling of prescriptions
in drugstores and hospital pharmacies.
w) "New veterinary drugs" means drugs intended for use of animals including any drug intended for use in animal feeds but not including animal feeds
within the contemplation of the implementing rules and regulations.
Office Order No. 1 Series of 1988

Subject IMPLEMENTATION OF EXECUTIVE ORDER NO. 119, REORGANIZING THE BUREAU OF FOOD & DRUGS, DEPARTMENT OF HEALTH
Organization of 1) Office of the Director 5) Laboratory Services Division 7) Administrative Division
the BFAD  Director  Physico-Chemical Section  Planning & Budget Section
 Drug Information Unit  Microbiological section  Personnel Section
2) Regulation 1 (Outlets)  Toxicology Section  Cash Collection & Disbursement
 Inspection Section  Research Section Section
 Licensing Section  Experimental Animal Section  Accounting Section
3) Regulation 2 (Manufacturer) 6) Legal, Information, & Compliance  Supply & Property Section
 Inspection Section Division  Records & Communication
 Licensing Section  Legal, Research, & Investigational Section
4) Product Services Division Section  Building & facilities Maintenance
 Food Product Section  Public Assistance, Information & Section
 Drug & Medical Device Compliance
Product Section  Advertising & Promotion Section
 Cosmetic Product Section
 Household Hazardous
Substances Section
Regulation 1 Plans, directs & supervises the implementation of rules, regulations and standards operating procedures in inspections & licensing
(Outlets) of the following establishments:
A. Retail Drugstores D. Drug Department
B. Hospital Pharmacies  General Wholesaler
C. Retail Outlets For Non-Prescription Drugs  Distributor, Importer, Exporter Finished Products
E. Retailer Of Household Hazardous Substances
F. Distributor/ Importer/ Exporter Of Finished Food Products
Regulation 2 Plans, directs & supervises the implementation of rules, regulations and standards operating procedures in inspections & licensing
(Manufacturer) of the following establishments:
A. Drug Manufacturer D. Drug Department
B. Dug Assay Laboratory Importer/ Export In Bulk
C. Drug Producer Distributor/ Importer/ Exporter , which is at the same time a manufacturer
E. Food & Food Products Manufacturer/ Processor
F. Cosmetic Manufacturer
G. Household Hazardous Substance Manufacturer
ADMINISTRATIVE ORDER No. 55 s. 1988
Subject REQUIREMENTS FOR LABELLING MATERIALS OF PHARMACEUTICAL PRODUCTS
General Requirements
The minimum mandatory information that shall be included in the
labelling materials are: The principal display panel must:
1. Name of the product (Generic name alone or with Brand name, as a. Contain the particulars required under 2.1.1 to 2.1.6
the case may be) b. Comprise 40% of the total surface of the container, except in
2. Dosage form and strength
3. Pharmacologic category
the case of the rectangular container where the total area of
4. Rx symbol, in case of prescription drugs the principal display panel must equal to the product of the
5. Name and complete address of manufacturer and trader, when height and width of the entire side of the container. For any
applicable other shaped container presenting an obvious principal display
6. Net content panel such as the top of a triangular or circular container, the
7. Formulation
8. Indication(s) size of the area shall consist of the entire top surface.
9. Contraindication(s), precaution(s), warning(s) On the label of the immediate container outside of the principal display
10. Mode of administration/directions for use panel will appear the following information:
11. Batch and lot number  Formulation
12. Expiry/ expiration date and date of manufacture
 Indication(s)
13. Registration number
14. Storage conditions  Mode of administration/directions (s) for use
15. For Rx products: Foods, drugs and devices and Cosmetic Act  Batch and lot number
prohibits dispensing without prescription  Expiry/ expiration date and date of manufacture
All information required to appear on the label must be:  Registration number
a. Written in English or Filipino  Storage conditions
b. Clearly and prominently displayed
 For Rx: Foods, Drugs and devices and Cosmetic Act prohibits
c. Readable with normal vision without straining. The color contrast, the
position and spacing of the information must be taken into consideration dispensing without prescription
in complying with labeling requirements. Other information and additional detail shall appear on the other
labeling materials such as inserts/leaflets or wrapper cartons.
Specific Requirements
Rx symbol  should be printed in a type size no less than one fifth (1/5)
of the height of the principal displayed panel. Injections
Formulation  The name and quantity of all excipients in the product except
 Active ingredient(s) must be stated in their generic names (INN). where Section 6 applies.
 The amounts of the active ingredient(s) shall be expressed in the  Recommended routes of administration such as "intravenous",
metric system or unit of potency, when applicable, as specified in the "intramuscular", or "subcutaneous".
official compendia.  Where an antimicrobial agent is not included in the product, the
 The salt or chemical form(s) of active ingredient(s) must be stated, words "Use only once or discard any remaining portion"
when applicable.  Where the contents of the container are to be used on one
 Multiple components must be enumerated in the order of decreasing occasion only, the words "single use" or "single dose".
pharmacologic activity, when applicable.  Where the products consist of a concentrated solution for
Preparations using isoprophyl alcohol must be indicated on its label the injection, a direction not to administer the solution undiluted and
following additional information: a direction to dilute the solution with the specified diluents to the
1) "For use in the hospital or sickroom as a rundown or for general appropriate volume before use.
massage purposes. This compound made from isopropyl alcohol does Large Volume Injections
not contain nor is it offered as a substitute for ethyl or grain alcohol."  The names and quantities of all excipients and active substances in
2) "FLAMMABLE." the nominal volume of fluid in the container, listed in descending
3) "WARNING: For External Use Only." (To be printed in red color) and order of magnitude within each group of chemically similar
also, "Keep out of reach of Children." substances.
Batch/Lot Number  Where one or more substances are amino acids and/or protein, a
 The batch and/or lot number must be printed on each strip of ten statement of the total amount of nitrogen in the nominal volume
(10) blister units. of fluid in the container.
Expiry/Expiration Date  The nominal osmolality.
The expiry or expiration date shall be expressed in terms of the month  A statement which specifies whether the solution is nominally
and the year. In such cases, the last day of the month is assumed as "hypotonic" or "hypertonic".
the expiration date.  The nominal pH range of the solution.
Biological Products  The words "single use" or "single dose".
 The name and proportion of any antimicrobial agent in the product. Products for External Use
 The name of any adjuvant in the product or any substance which,  "FOR EXTERNAL USE ONLY" printed in red color must appear on
when administered with an antigen, modifies the immune response the principal display panel of the label.
to that antigen. Small Containers
 The name of the species of animal or organism from which the  Capacity of 10 milliliters or less and the container is enclosed in a
product has been prepared. primary pack.
 For monoclonal antisera, the name of the species source
 For viral vaccines produced in animal cells or cell cultures, the name
of the cell culture substrate
 The potency of biological products shall be expressed as potency unit
or weight of active substances per dose.
 The potency unit to be used shall be the International Unit has been
established.
 Date of manufacture which pertains to the date (month and year)
Exempted from Complying w/ the labeling Requirement:
 If the products are enclosed in a transparent covering
 If the products are compounded by the pharmacist
 If the products are used solely for investigational use
 If the products are donated by foreign agencies
Definition of Terms
1. "Labeling materials" includes the label on the immediate container, and the other printed materials that are made available with the product at the
time of purchase and/or where the product is used, such as the outer wrapper cartons, leaflet/package insert accompanying the
product, which provide the accurate and necessary detailed information for the identification and proper used of the product.
2. "Product" refers to pharmaceutical products which mean any pharmaceutical or biological product intended for used in the diagnosis, cure mitigation,
treatment or prevention of disease in human, or to affect the structure or any function of the human body.
3. "Brand Name" refers to the proprietary/trade name assign to the product by the drug establishment.
4. "Generic Name” refers to the identification of drugs and medicines by their scientifically and internationally recognized active ingredients determined
by the Bureau of Food and Drugs of the DOH.
5. "Pharmacologic category" refers to the classification of the product based on its therapeutic action as specified in the product registration.
6. "Formulation" refers to the name (s) and amount (s) of active medicinal ingredients per dosage unit expressed in the metric system.
7. "Indication" refers to the approved clinical use of the product based on substantial and scientifically supported evidence of the safety and efficacy of
the drug in the given dosage form.
8. "Dosage Form" means the pharmaceutical form of the preparation based on official pharmacopoeia.
9. "Mode of administration" refers to the site and manner the product is to be introduced in to or applied on the body.
10. "Warnings" refers to statements regarding the occurrence of potential hazards and side effects associated with the use of the product and the
limitation of its use.
11. "Contraindications" refers to statements regarding the conditions wherein the use of the product may cause harm to the patient.
12. "Precautions" refers to the instruction and special care required in the used of the product to avoid undesired effects and to ensure the safe and
effective use of the drug.
13. "Date of manufacture" for products other than biological products means the date (month and year) during which processing of the bulk product,
from which the goods are to be filled, is completed.
14. "Batch number" refers to any distinctive combination of letters and/or numbers, assigned to a particular batch herein defined as any product
produced during a given cycle of manufacture. The batch number permits the production history of the batch including all stages of
manufacture and control, to be traced and reviewed.
15. "Lot number or Control number” refers to any distinctive combinations of letters and/or numbers assigned to a particular lot, herein defined as a
portion of a batch.
Lot  means a batch or any portion of a batch of a drug produced by a continuous process, an amount of drug produced in a unit time or
quantity in a manner that assures its uniformity & in either case which is identified by a distinctive lot umber & has uniform character &
quality within specified limits
16. "Expiration” or "expiry date” refers to the date after which the product is not expected to retain its claimed safety, efficacy and quality or potency or
after which it is not permissible to sell, distribute or use said product.
17. "Net Content" refers to the total amount/quantity/number of the dosage form in a certain container of a product expressed in metric system.
18. "Storage condition" refers to the prevailing specified range temperature, humidity and other environmental factors within which optimal stability of
the product is ensured based on laboratory data.
19. "Principal display panel" refers to the part of a label that is most likely to be displayed, presented, shown or examined under customary condition of
display for retail use.
20. "Area of the principal display panel" refers to the area or surface of the container/package where the principal display panel is located.
21. "Primary pack" is the first pack containing the individually wrapped products, strip blister packs.
ADMINISTRATIVE ORDER No. 64 s. 1989 : Amendments of AO No. 55 s. 1988

List A (Annex A)
List of Pharmaceutical Products classified as Prohibited or Regulated by the DDB:
I. Prohibited Drugs II. Regulated Drugs
1. Alfentanil A. Available in the Market B. Not available in the Market
2. Codeine Sulfate 1. Amobarbital 1. Aobarbital
3. Codeine Phosphate 2. Amphetamine 2. Butabarbital
4. Dihydrocodeine 3. Barbital 3. Ethchlorvynol
5. Fentanyl Citrate 4. Chloral Hydrate 4. Pentobarbital/ Hydrocodone
6. Hydrocodone 5. Dexamphetamine 5. Mecloqualone
7. Morphine 6. Ephedrine 6. Methamphetamine
8. Opium 7. Ethinamate 7. Methaqualone/ Diphenhydramine
9. Opium/ Alcohol (Elixir Paregoric) 8. Flunitrazepam 8. Methylprylon
10. Pethidine (Meperidine) 9. Nitrazepam 9. pentobarbital
10. Paraldehyde 10. Pipradol
11. Pentozocine 11. Secobarbital
12. Pentothal
13. Propoxyphene
14. Pseudoephedrine
15. Heroin
List B
List of Products Requiring Strict Precaution in Prescribing, Dispensing, & Use
Subject REVISED REGULATIONS FOR THE LICENSING OF DRUG ESTABLISHMENTS AND OUTLETS
DRUG ESTABLISHMENTS  means any organization or company involved in the manufacture, importation, repacking, and/or distribution of drugs or
medicine
Types of Drug Establishments
Drug Manufacturer means any establishment engaged in operations involved in the production of a drug, including propagation, processing,
compounding, finishing, filling, packing, repacking, altering, ornamenting and labeling with the end in view of storage, distribution
or sale of the product: provided that for the purpose of this regulation the compounding and filling of prescriptions in drugstores
and hospital pharmacies shall not be considered as production operations.
Drug Trader means any establishment which is a registered owner of the drug product, procures the materials and packaging components, and
provides the production monographs, quality control standards and procedures, but sub-contracts, the manufacture of such product to a
licensed manufacturer. In addition, a trader may also engage in distribution, and/or marketing of its products.
Drug Distributor/Importer means any establishment that imports raw materials, active ingredients and/or finished products for its own use or for
wholesale distribution to other drug establishments or outlets.
Drug Distributor/Exporter means any drug establishment that exports raw materials, active ingredients and/or finished products to another country.
Drug Distributor/Wholesaler means any drug establishment that exports raw materials, active ingredients and/or finished products from local
establishments for local distribution on wholesale basis.
General Requirements
Application – any person desiring to operate or establishment a drug establishment shall file with the BFAD an application supported by the following
documents:
A standard petition form containing among others the name, age, citizenship and a passport size picture (5x5) of the petitioner
1. Proof of registration as an establishment, i.e.:
a) For single proprietorship an authenticated photocopy of the certificate of Business Name Registration issued by the Bureau
of Domestic Trade (BDT) of the Department of Trade and Industry.
b) For partnership, corporations and other juridical persons authenticated photocopies of the Certificate of Registration
issued by the Securities and Exchange Commission (SEC) and the Articles of Incorporation of Partnership.
2. A valid Certificate of Registration of the Establishment’s Filipino Pharmacist issued by the Professional Regulation Commission (PRC).
3. A Certificate of attendance to a BFAD – sponsored /accredited seminar on Licensing of Drug Establishments.
4. An affidavit of Undertaking providing that the applicant shall:
a) change the establishment's name if there is already a validly registered name similar to it.
b) display the duly approved LTO in a conspicuous place within the establishment.
c) notify BFAD in case of any change in the circumstances described in the application such as: change of location, change of
pharmacist, change in drug products.
5. List of products to be manufactured or distributed identified by their generic names and brand names if any.
6. An authenticated photocopy of contract of Lease for the space to be occupied if the applicant does not own it.
A certificate of continuing compliance with specific technical requirements (to be specified by BFAD according to section 2.2 below).
A Batch Distribution Record Book duly registered with BFAD.
A contingency plan or procedure for a systematic, effective and prompt recall in case any of its products is found violative and ordered recalled
from the market by the BFAD.
An orderly and secure system of filling up to date invoices from suppliers and buyers
Renewal of License to Operate (LTO)
The License to Operate shall have the following validities for all categories of drug establishments:
▪Initial Period (Initial Application) 1 year
▪Subsequent Period (Renewal Application) 2 years
At least one month prior to the expiration of the LTO, drug establishments shall apply to renew their license.
In considering the renewal application, BFAD shall ascertain the continued compliance by the establishment
The following grounds shall be Basis for Non-Renewal of LTO:
▪Failure to comply with BFAD standards and requirements.
▪Serious, repeated or rampant violation of existing laws, rules and regulations.
▪Persistent shortenings in demonstrating a capacity to perform in a manner that satisfactorily assures the safety, efficacy
and quality of its drug products.
Administrative Sanctions
Grounds for Revocation of LTO
▪Misrepresentation of any material fact in the application for LTO and in any documentation used as a basis for issuing the LTO.
▪For manufacturer and traders: any deficiency in GMP that is likely to result in adulterated, misbranded, substandard or unsafe products as
determined by BFAD. This includes among others, grossly inadequate premises, lack of key technical and professional personnel, lack of
key equipment in production or quality control, poor or inadequate process control and inadequate or improper documentation of the
production process.
▪For distributors: distribution of fake, misbranded, adulterated or unsafe drug products.
▪Violation of BFAD standards of quality, efficacy, purity and safety of drug products.
▪Sale or distribution of antibiotic products without batch certification by BFAD.
▪Failure to take adequate remedial or corrective measures for deficiencies identified in accordance with requirements of BFAD.
▪Failure to keep up to date, secure, orderly, and easily inspected records that would indicate continued compliance with standards.
Grounds for Suspension of LTO
▪Minor deficiencies in GMP or material management that need to be corrected but are not immediately or likely to result in adulterated,
misbranded, substandard or unsafe products as determined by BFAD. This includes, among others, poor housekeeping, inadequate
storage facilities, lack of minor equipment or requirement and other minor shortcomings.
▪Lapses in record keeping of invoices, receipts or distribution records.
Re-application after Revocation
No establishment whose LTO was revoked may apply for an LTO within 5 years after the revocation of its license.
DRUG OUTLETS  means drugstore, pharmacy and other business establishment w/c sells drugs or medicine
Types of Drug Outlets

Drugstores, Pharmacy or Botica, including Hospital Pharmacy/Dispensary means a drug outlet where registered drugs, chemical products, active
principles, proprietary medicines or pharmaceutical specialties and dental medicinal, galenical or veterinary
preparations are compounded and/or dispensed.
Retail outlet for non-prescription drugs including non-traditional outlets such as supermarkets and stores, means a drug outlet where registered non-
prescription or Over-the-Counter (OTC) drugs are sold in their original packages, bottles or containers or in
smaller quantities not in their original containers.
Specific Requirements:
Drugstore, Pharmacy or Botica Retail Outlets for Non-Prescription Drugs
A. Premises A. Premises
▪ A signboard in front of the place of business bearing the registered ▪ A signboard in front of the place of business bearing the registered
name of the drugstore. name of retail outlet and the symbol non-Rx or equivalent.
▪ A well-ventilated area not less than 15 sq. m. in floor area with 2.2.2.1.2. An adequate, well ventilated area with concrete, tile, or
concrete, tile or wooden flooring. wooden flooring.
▪ A place suitable for compounding prescription and for washing and ▪ A suitable and proper place for the adequate storage of
sterilizing bottles (compulsory only for hospital pharmacy) nonprescription drugs. When there are products sold other than
▪ A suitable and proper place for the adequate storage of drugs and drugs, area exclusively for drug products shall be allocated within
biological products as specification in the label. the premises.
▪ A suitable cabinet for hanging poisons and/or dangerous drugs. B. Reference Books and Documents
B. Reference Books and Documents ▪ Philippine National Drug Formulary (when available)
▪ Philippine National Drug Formulary (when available) ▪ R.A. 5921 Pharmacy Law and implementing rules and regulations
▪ United States Pharmacopoeia/National Formulary (USP-NF) (latest ▪ R.A. 6675, Generics Act of 1988 and relevant implementing rules
edition) and regulations.
▪ R.A. 3720, otherwise known as the Food, Drugs, and Devices and ▪ R.A. 3720, as amended or Food, Drugs, and Devices and Cosmetics
Cosmetics Act as amended and relevant implementing rules and Act as amended and relevant implementing rules and regulations
regulations. C. Record Book as required by BFAD for selected non-prescription drugs
▪ R.A. 6675, Generic Act of 1988 and relevant implementing rules subject to abuse as determined by BFAD and/or DDB.
and regulations. D. A full-time validly registered pharmacist physically present while the
▪ R.A. 5921 Pharmacy Law, as amended and relevant rules and retail outlets is open for business.
regulations E. Other Additional Requirements
▪ Remington’s Pharmaceutical Sciences (latest edition) ▪ Invoiced indicating the lot number or batch number of the
▪Goodman and Gillman Pharmacological Basis of Therapeutics manufacturer's stock pursuant to BFAD Memo Circular No.
(Latest Edition) 001 s. 1988
▪ Dry Seal or Rubber Stamp containing the name and address of the
C. Record Books Duly Registered with the BFAD drug outlet.
▪ Prescription F. Renewal of License to Operate (LTO)
▪ Dangerous Drug Book ▪In case of renewal of LTO the drug outlet must have a history of
▪ Exempt Preparation Book satisfactory performance, consistent with BFAD standards and
▪ Poison Books requirements, without any cases of serious violation of laws, rules
▪ Record Book for Selected Non-Prescription Drugs, subject to abuse and regulations.
as determined by BFAD and/or Dangerous Drugs Board (DDB) G. Administrative Sanctions
D. Utensils, Apparatus and Other Equipment ▪ Temporary Closure
▪ For all drugstores including hospital pharmacies, refrigerator for -Absence of pharmacist on three (3) inspections by BFAD
biologicals and other drug products needing refrigeration. inspector.
▪ For hospital pharmacy only: ▪ Suspension of License to Operate
-Prescription balance of one centigram sensitivity and a set of -Failure to produce invoices and receipts together with1st
weights. numbers, expiry dates for the drugs in stock.
-Glass volumetric measures a set of not less than six pieces from -Failure to properly record and keep a file of all prescriptions
15 ml to 1000 ml capacity. filled in the last two years.
-Mortar and pestle - a set of not less than three in assorted -Refusal to allow entry of BFAD inspectors.
sizes. ▪ Revocation of License to Operate
E. A full-time validly registered pharmacist physically present while the -Sale or offer for sale of adulterated, misbranded, sub-
drugstore is open to business. standard, unregistered expired and/or unsafe drugs or
F. Other additional Requirements products marked
▪ Invoices indicating the lot number or batch number of the "Not for Sale". 4.3.2. Failure to properly record
manufacturer's stock pursuant to BFAD Memo. Circular No. 001 dangerous drugs as determined by DDB.
s. 1983. -Lack of pharmacist.
▪ File of prescriptions filled consecutively numbered -Failure to take necessary remedial or corrective measures
▪ Dry Seal or rubber Stamp containing the name and address of the within the prescribed period
drug outlet.
▪ Red and White labels indicating name and address of drugstore.
Subject REVISED RULES AND REGULATIONS ON REGISTRATION OF PHARMACEUTICAL PRODUCTS
DEFINITION OF TERMS
1.1. "Registration" means the process of approval for the manufacture, importation, exportation, sale, offer for sale, distribution or transfer of
pharmaceutical products containing active ingredients) of known chemical structure and properties determined to be safe,
efficacious and of good quality according to standards of BFAD.
1.2. "Pharmaceutical Product" means any pharmaceutical or biological product containing active ingredients responsible for its desired effect intended
for use in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or function of the
body of man or animal.
1.3. “Drug for General Use" is a drug approved for sale to the general public without restriction other than the usual.
1.4. “Drug for Restricted use" is a drug approved for sale to the general public under certain conditions.
GENERAL STANDARDS (Requirement for product registration)
CLASSIFICATION
All pharmaceutical products shall be evaluated and registered on the basis of specific requirements and standards pertinent to such classification of
such products. All registered drug products shall be classified in terms of each of the following six categorizations:
3.1. Number of Active Ingredients
3.1.1. Single Ingredient
3.1.2. Fixed-dose combination of two or more ingredients
3.2. Available scientific evidence and experience on the drug's use
"Investigational Drug" refers to a new chemical or structural modification of a Tried and Tested or Established Drug proposed to be used
for a specific therapeutic indication. An investigational drug needs further clinical pharmacology studies (Phase I, II
or III) to determine its safety and efficacy, and meets the requirements of a new drug.
"New Drug" refers to a new chemical or structural modification of a Tried and Tested or Established Drug proposed to be used for a
specific therapeutic indication, which has undergone adequate clinical pharmacology Phase I, II and III studies but which
needs further Phase IV Clinical Pharmacology studies before it can be given regular registration.
"Tried and Tested Drug" is a drug which has been used for at least five (5) years and involving at least 5,000 patients.
"Established Drug" is a drug the safety and efficacy of which has been demonstrated through long years of general use and can be found
in current official USP-NF, and other internationally-recognized pharmacopoeia.
3.3. Pharmacologic/therapeutic category as specified in the Philippine National Drug Formulary
3.4. Source or circumstances of drug production
3.4.1. Imported as finished
3.4.2. Locally manufactured from imported materials
3.4.3. Locally manufactured from local materials
3.5. Brand identification and patent protection of the drug
3.5.1. Branded and patented
3.5.2. Branded and off patent
3.5.3. Unbranded and off-patent (generic drug)
3.6. Prescribing and dispensing regulations applicable
3.6.1. Over-the-counter (OTC) Drug or Non-Prescription
3.6.2. Ethical or Prescription Drug
3.6.3. Dangerous Drugs (List-A Drugs)
3.6.4. Drugs requiring strict precaution in prescribing and dispensing (List-B Drugs)
REQUIREMENTS AND STANDARDS FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS
Human Studies:
1. Clinical pharmacology
Phase I (tolerance and safety)
Phase II (safety and efficacy)
Phase III (controlled clinical trials)
Phase IV (provisional monitored release/post-marketing surveillance)
2. Bioavailability
3. Bioequivalence
Subject REGULATION PART C-10: DRUG REGISTRATION OF HERBAL AND/OR TRADITIONAL DRUGS BOTH LOCAL AND IMPORTED
Herbal and/or traditional drug means:
1. Articles recognized in the Philippine National Formulary
2. Articles intended for use in the diagnosis, cure mitigation, treatment or prevention of disease in man.
3. Articles (other than food) intended to affect the structure or any function of the body of man.
4. Articles intended for use as a component of any article specified in clause (1) (2) or (3).
The application for registration of herbal and/or traditional drug both local and importer shall be accompanied by the following requirements:
For locally manufactured herbal and/or traditional drug.
1. Application letter from the manufacturer
2. Full list and amount of all ingredients used as component of the finished product.
3. Technical specification of all the ingredients used as component.
4. Technical specification of description of the finished drug product.
5. Labels, labeling materials, package insert, brochures and other advertising materials to be used with the drug product.
6. Sufficient sample for laboratory analysis.
For foreign manufactured herbal and/or traditional drug product.
1. Application letter from importer attesting importation of the drug product.
2. Government certificate of clearance, acceptance or registry and free sale from the country of origin and duly authenticated by the territorial
Philippine Consulate.
3. Government certificate attesting the status of the manufacturer, competency and reliability of the personnel and facilities and duly
authenticated by territorial Philippine Consulate.
4. Some requirements enumerated in locally manufactured herbal and/or traditional drug product.
Quality Control Requirements (FDA Analysis):
1. Tests for the presence of synthetic drugs: 4. Analysis for impurities
a) Aspirin 5. Tablets
b) Acetaminophen a) Weight variation
c) Dipyrone b) Disintegration
d) Phenylbutazone c) Dissolution for pure active ingredient
e) Pyrazolone d) Content uniformity
f) Corticosteroid e) Hardness
g) Anabolic steroids 6. Liquids, suspensions, or syrups
h) Gonadal hormones a) Suspendibility
2. Test for the presence of heavy metals b) Homogeniety
a) lead c) Viscosity
b) mercury d) Standard plate count
c) arsenic e) Coliform count
d) cadmium f) Yeast count and mold count
3. Test for alcohol content – should not be more than 10% 7. Ointments, creams and other Semi-solid preparation
a) Impalpability
b) Homogeniety
c) Melting point
d) Sterility for ophthalmic preparations
8. Suppositories and pessaries melting point.
ADMINISTRATIVE ORDER No. 47-a , series of 2001
Subject RULES AND REGULATIONS ON THE REGISTRATION, INCLUDING APPROVAL AND CONDUCT OF CLINICAL TRIALS, AND LOT OR BATCH
RELEASE CERTIFICATION OF VACCINES AND BIOLOGIC PRODUCTS
DEFINITION OF TERMS (The following definitions are adopted) :
1.1. “Biologic” or “Biologic Product” means any attenuated or inactivated virus or bacteria, or sub-components attached to adjuvants, toxoids,
hyperimmune serum, and analogous products applicable to diagnosis, prevention, treatment or cure of disease or
injuries to man, obtained or derived from living matter - animals, plants or microorganisms, or parts thereof. It
includes preparations primarily designed to develop a type of immunity or preparations that are concerned with
immunity.
1.2. “Certificate of Product Registration (CPR)” is a document issued by the Bureau of Food and Drugs (BFAD) for the purpose of marketing, use or free
distribution of a product in the Philippines.
1.3. “Permit for Clinical Investigational Use (PCIU)” is a registration document issued by the BFAD for the purpose of allowing the conduct of Phase I,
Phase II and Phase III clinical trials of developmental or investigational biologic products in the
country.
1.4. “Developmental or Investigational Vaccine or Biologic” refers to a vaccine or biologic product that needs or is undergoing pre-clinical and clinical
studies to determine its safety, potency, efficacy, and therapeutic/prophylactic value. It
refers to a vaccine or biologic product which has never been registered or licensed by any
National Regulatory Authorities.
1.5. “National Regulatory Authority (NRA)” is the designated national control authority of vaccines and biological products of the exporting country or
country of origin that meets the criteria established by the World Health Organization (WHO), such as having
a documented licensing system and GMP guidelines, GMP inspectors, and the administrative capacity to
validate and issue the required certificates to other national regulatory authorities. It sets the standards and
requirements to which all manufacturers of vaccines and biological products are required to conform.
1.6. “New Vaccine or Biologic” refers to a vaccine or biologic product which has undergone adequate Phases I, II, and III clinical studies, but which
requires a Phase IV 2 clinical studies. It refers to a vaccine or biologic product which has never been registered or
licensed by any NRA for general use.
1.7. “Established Vaccine or Biologic” refers to a vaccine or biologic product which has undergone adequate Phase I, II, III and IV clinical studies. In
addition, it has been reviewed by the WHO Expert Committee on Biological Standardization and has
recommended sets of general and specific guidelines and requirements for the manufacture, control, and product
evaluation for registration or licensing by a national regulatory authority.
1.8. “Shared Product” refers to a finished product whose final phase of production, including labeling, is done by a local manufacturer using biological
materials, including naked or bulk biologic products, produced by another manufacturer. It also refers to a finished product
whereby some of the active components, as in mixed vaccines, were processed by another manufacturer or laboratory. A shared
product is a locally produced or manufactured biologic product.
1.9. “Specifications of Product” are the values and conditions of a product based on submitted documents and information that have been accepted by
the BFAD.
1.10. “Locally Manufactured Product” refers to biologic products, as bulk or finished products that were produced or manufactured in the Philippines.
1.11. “Reevaluation” means the reexamination of the quality, efficacy, safety, therapeutic/prophylactic value, and rational use of all vaccines and
biological products during the renewal of the CPR.
1.12. "Applicant for Clinical Trial Protocol Approval" –shall mean the sponsor of the clinical trial as defined by the International Committee on
Harmonization (ICH) or the WHO Code of GCP.
1.13. "Good Laboratory Practice (GLP)" –are standards and procedures whereby the laboratory achieves a defined, consistent and reliable standard in
performing laboratory test and activities.
1.14. "Good Manufacturing Practice (GMP) –is that part of quality assurance which ensures that products, including vaccines and biologics, are
consistently produced and controlled to the quality standards appropriate for their intended use, including
all phases of vaccine clinical trials, and as required by registration and marketing authorization.
1.15. "Good Clinical Practice (GCP)" –are standards and procedures for clinical trials that encompass the design, protocol approval, conduct, monitoring,
termination, audit, analyses, reporting, and documentation of human studies. It defines the responsibilities and
activities of the sponsor, principal investigator and monitor involved in clinical trials. The Code of GCP ensures that
the studies are scientifically and ethically sound, and all the clinical properties of the product under investigation
are properly documented.
1.16. "Phase I Clinical Vaccine Trial" –an initial test of investigational vaccine in healthy adult volunteers and, occasionally, in actual patients. The number
of subject is small. Safety evaluation, tolerability, immune response and dose findings are the primary objectives,
and attempt is made to establish the approximate levels of patient tolerance for single or multiple dosing. The
trial is done in 3 the country of origin of the product. A comparison group may receive the adjuvant as a placebo.
1.17. "Phase II Clinical Vaccine Trial" –is a study designed to evaluate the efficacy and safety based on dose/response, tolerability and acceptance of the
investigational vaccine or combination vaccine in a small number of a selected population for whom the vaccine or
combined vaccine is intended. The trial consists of two parts. The first part, known as Phase II a, consists of a
selected population that is artificially challenged. The second part, known as Phase II b, consists of a selected
population that harbors natural infection. A larger subject is enrolled in the second part. The studies are
randomized double-blind placebo-controlled.
1.18. "Phase III Clinical Vaccine Trial" is a study for the population at risk. The primary objective is to evaluate the efficacy, safety, tolerability, and
acceptance in a larger target population (community in situ) while monitoring for rare side effects or adverse
events. Different clinical endpoints shall be determined and established. The number of subject required may
vary, but are usually of larger sample size. An Extended Phase III Clinical Vaccine Trial may be considered. This
involves larger number of participants and under normal conditions of use (open population). Assessment of
additional endpoints to determine immune response vs. protection, efficacy in different subgroups, effects on
mortality, efficacy under controlled trials vs. effectiveness under routine use, required information to
recommend vaccination on a routine basis, logistics for mass vaccination and evaluation for alternatives, effects
on severity relapses, rare side effects or events, and establish the duration of protection are usually undertaken.
1.19. "Phase IV Clinical Vaccine Trial" –is a mandatory PMS study of newly registered biologic products or combined vaccines for a period of five years.
The primary objective is to determine and establish the public health impact of the vaccine or combined vaccine
– epidemiological impact on infectious and non-infectious disease(s) and the impact in terms of acceptance. In a
Phase IV Clinical Vaccine Trial, which may include the extended phase III clinical trial as part of it, the following
are some of the specific objectives: to determine and establish the efficacy of different vaccination schedules
(doses and intervals), long-term antibody kinetics vs. protection, evaluation under different conditions,
prediction/modeling in transmission/protection social acceptability if repeated vaccination is required, and
surveillance strategies (e.g. before-after trend analysis vs. stepped wedge design).
1.20. "Institutional Ethics Committee (IEC)" or “Institutional Ethics Review Board (IERB)” shall refer to the body formed by an establishment or institute
which ensures that the activities of the researchers and support staff engaged in the conduct of research
involving humans subjects are ethically and scientifically sound. The Department of Science and Technology
has a national ethics committee or ethics review board.
1.21. "Deviation Report" –is a written document prepared by the principal investigator and submitted to the monitor, sponsor, IEC and the BFAD which
details departures from protocol parameters which affect the results or outcome of a clinical trial or from the elements of GCP.
1.22. "Incident Report" –is a written document prepared by the principal investigator submitted to the monitor, sponsor, IEC and BFAD which details any
unforeseen, unexpected, rare, unusual, and life-threatening adverse reactions or adverse events, or process and procedures
performed incorrectly, such as injection of vaccines, which may affect the health of the subject or put the health of the subject
at risk.
1.23. "Amendment of Protocol" –means any changes in the protocol as approved by the BFAD, such as procedures, personnel, steps, process, equipment,
facility, clinical trial site, and subject.
1.24. “Summary Lot or Batch Protocol” is a document for each lot or batch of biologic and vaccine product that contains the following:
a) the summary information on the final lot or batch,
b) the detailed information of manufacture and control,
c) the manufacturer's certification to release the lot or batch, and
d) the Certificate of Lot or Batch Release issued by the National Regulatory Authority (NRA).
1.25. “Batch” or “Lot” is a defined quantity of starting materials or product manufactured in a single process or series of processes into a final dispensed
product having identical risks of contamination and expected to be homogenous.
MEMORANDUM CIRCULAR No. 19-A s. 1992

To ALL COSMETIC ESTABLISHMENTS AND PARTIES CONCERNED
Subject SPECIFIC STANDARDS AND REQUIREMENTS
Definition of Terms
a) Label - means a display of written, printed or graphic matter upon any article or any of its containers or wrappers or attached to or accompanying such
articles.
b) Principal display panel - means the part of the label that is most likely to be displayed, presented, shown or examined under customary conditions of
display for retail sale. This shall be large enough to accommodate all the mandatory label information required to be placed thereon with
clarity and conspicuousness and without obscuring designs, vignettes, or crowding.
c) Immediate container - means any form of packaging materials which enclose the articles.
d) Labeling - means all labels and other written, printed or graphic matter
(1) upon any article or any of its containers or wrappers, or
(2) accompanying such articles.
e) Inner label - means the label on or affixed to an immediate container.
f) Outer label - means all items used or attached to bind, enclose or contain the preparation in the final form for market presentation of the product.
g) Packaging material - means all items used or attached to bind, enclose or contain the preparation in the final form for market presentation of the
product.
MEMORANDUM CIRCULAR No. 4-A s. 1991
To Regional Health/Bureau/Service Directors, Chiefs of Hospitals and Medical Centers, Supply Officers, COA Auditors/ Importers/
Distributors/ Manufacturers of Medical Devices and Diagnostic Reagents
Subject AMENDING LIST 1-A AND LIST II OF MEMORANDUM CIRCULAR NO. 1 S. 1991 DATED 03 JANUARY 1991SUBJECT: REGISTRATION OF
MEDICAL DEVICES AND DIAGNOSTIC REAGENTS
LIST I-A. MEDICAL DEVICES REQUIRED TO BE REGISTERED
1. Absorbable Collagen Hemostatic Felt 25. Endotracheal Tube 50. Porcine Heart Valve51. Implantable
2. Absorbent Cotton, sterile & non-sterile 26. Exchange Transfusion Tray Prostheses
3. Arterial Venous Fistula Needle Set 27. Feeding Tube 52. Rectal Catheter
4. Elastic Bandage 28. Filter Set 53. Rectal Tube
5. Bandages with Plaster of Paris 29. Fluor Alloy Amalgam 54. Removable Skin Staple
6. Band-Aid Plastic Strip Plain Pad 30. Gauze Pads, sterile 55. Rotahalers
7. Bone Wax 31. Humidifier Mask 56. Scalp Vein Infusion Set
8. Blood Transfusion Set 32. Hypo-Allergenic Paper Tape 57. Scissors Skin Retractors
9. Catheters 33. Implantable Staple 58. Skin Traction Kit
10. Cervical Collar 34. Infusion Administration Set 59. Spinal Anesthesia Tray
11. Collagen 35. Intraocular Lenses 60. Stoma Bag
12. Condom 36. Intrauterine Device (IUD) 61. Stomach Tube
13. Contact Lenses (hard and soft and 37. I.V. Catheter Needles 62. Suction Catheter
disposable) 38. Ligating Clip Device 63. Surgical Blades, Disposable
14. Corset Cast 39. Lubricating Jelly 64. Surgical Gloves (Sterile & Unsterile)
15. Cosmetic Puffs Cotton 40. Lumbar Puncture Tray 65. Sutures
16. Cotton Buds 41. Nasal Oxygen Cannula 66. Suturing Needles
17. Cotton Swabs 42. Nebulizer with Aerosol Mask 67. Synthetic Cast Padding
18. Dental Filling Alloy 43. Orthoplast Cervical Collar 68. Syringes
19. Disposable Needles 44. Ostotomy set 69. Thermometers
20. Disposable Skin Stapler and Staples 45. Oxygen Catheter 70. Transfusion Set
21. Disposable Tissue Measuring Device 46. Oxygen Mask 71. Urethral Catheter
22. Drainage Pouches 47. Peridontal Bone Grafting Implant 72. Urinary Drainage Tube
23. Duodenal Tube 48. Peritoneal Dialysis Administration Set 73. Urine Collecting Bag
24. Earpiercing Device 49. Plaster
LIST I-B. DIAGNOSTIC REAGENTS REQUIRED LIST II PRODUCTS THAT ARE NOT REQUIRED TO
TO BE REGISTERED BE REGISTERED
1. HIV Testing Kits 1. Plastic Bags for Blood Transfusion 15. Surgical Instruments (e.g. scissors, foreceps,
2. Hepatitis B Testing Kits 2. Non-sterile Surgical Facemasks blade-holder, needle holder, clamps,
3. Blood Typing Seva 3. Surgical Caps (non-sterile) biopsy punches, retractors, scopes, etc.)
4. Pregnancy Test Kits 4. Tounge Depressors 16. Toothbrushes
5. Non-sterile Applicator Sticks 17. Dental Floss
6. Gauze (in bolts) 18. Heat Solution19. Mortuary Refrigerator
7. Anti Embolism Stocking 20. Abdominal Binder
8. Undercast Padding 21. Weighing Scale
9. Sputum Caps 22. Ice Bags
10. Rubber Stoppers 23. Urinal/Receptacles
11. Aluminum Seals 24. Splints
12. Vials (50, 10, 5 cc) 25. Plaster of Paris
13. Ampules (5, 10 mL amber/white) 26. Abdominal Pads
14. Laboratory Glasswares 27. Centrifuges & equipment
28. Anaerobic Generating System
29. X-Ray Films and Chemicals
30. Surgical Face Mask
REPUBLIC ACT NO. 8203 – SPECIAL LAW ON COUNTERFEIT DRUGS
Title AN ACT OF PROHIBITING COUNTERFEIT DRUGS, PROVIDING PENALTIES FOR VIOLATIONS AND APPROPRIATING FUNDS THEREFOR
Counterfeit drug/medicine refers to
 Medicinal products with the correct ingredients but not in the amounts as provided
 Wrong ingredients,
 Without active ingredients,
 With sufficient quantity of active ingredient, which results in the reduction of the drug’s safety, efficacy, quality, strength or purity
 Deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic
products
 Container or labeling bearing without authorization the trademark, trade name or other identification mark or imprint or any likeness to that which is
owned or registered in the bureau of patent, trademark and technology transfer (bpttt) in the name of another natural or juridical person;
 Drug product refilled in containers by unauthorized persons if the legitimate labels or marks are used;
 An unregistered imported drug product, except drugs brought in the country for personal use as confirmed and justified by accompanying medical
records;
 A drug which contains no amount of or a different active ingredient or less than eighty percent (80%) of the active ingredient it purports to possess
as distinguished from an adulterated drug including reduction or loss or efficacy due to expiration.
Brokering  shall refer to any act of facilitating the disposal or sale or counterfeit drugs, including acts of agency.
Business Establishment  shall refer to any entity, whether a single proprietorship, partnership, or corporation engaged in or doing business in the
Philippines
Owner  shall refer to a person or group of persons who is the unregistered owner of a license to operate a business undertaking in the Philippines or
the branch manager or operator, licensee, franchisee, or any person acting on behalf of he corporate entity.
Residence  shall refer to a private dwelling or abode where a person lives, either as owner or lessee
Additional to the Terms
(a) "Bureau or BFAD" shall refer to the Bureau of Food and Drugs
(b) "Constructive Knowledge" as here applied shall mean, that by exercise of reasonable care, one would have known the fact or suspect that the drug product he
or she has sold or in possession of is counterfeit, such as but not limited to the knowledge that the drug was not covered by any
sales invoice or evidence of delivery of purchase from a BFAD license drug establishment.
(c) "FDRO" shall mean Food and Drug Regulation Officer
(d) "LICD" shall mean Legal, Information and Compliance Division of the BFAD
(e) "Life saving drugs" shall refer to drug products indicated for life threatening condition(s)
(f) "LSD" shall mean Laboratory Services Division of BFAD
(g) "PSD" shall mean Product Services Division of BFAD
(h) "Unregistered imported drug product" as distinguished from counterfeit drug defined under Section 3 of R.A., shall refer to unregistered imported drug
product without a registered counterpart brand in the Philippines. If the unregistered imported drug product has a
registered counterpart brand in the Philippines, their product shall be considered counterfeit.
Prohibited Acts:
1. The manufacture, sale, or offering for sale, donation, distribution, trafficking, brokering, exportation, or importation of counterfeit drugs.
2. Possession of any such counterfeit drugs.
3. Forging, counterfeiting, simulating or falsely representing, or without proper authority
4. Photocopying, duplicating, altering, printing, transferring, obliterating or removing the approved label
5. Making, selling, or concealing any punch, dye or plate or any other equipment or instrument designed to print, imprint, or reproduce the trademark.
Parties Liable - The following persons shall be liable for violation(s) of this Act:
a) the manufacturer, exporter or importer of the counterfeit drugs and their agents:
b) the seller, distributor, trafficker, broker or donor and their agents
c) the possessor of counterfeit drugs
d) the manager, operator or lessee of the laboratory or laboratory facilities used in the manufacture of counterfeit drugs;
e) the owner, proprietor, administrator or manager of the drugstore, hospital pharmacy or dispensary, laboratory or other outlets or premises
where the counterfeit drug is found who induces, causes or allows the commission of any act herein prohibited;
f) the registered pharmacist of the outlet where the counterfeit drug is sold or found,
g) should the offense be committed by a juridical person the president, general manager, the managing partner, chief operating officer or the
person who directly induces, causes or knowingly allows the commission of the offense shall be penalized.
ADMINISTRATIVE SANCTIONS
Minimum Penalty: NLT 100,000, but NMT 500,000 pesos
 when the counterfeit drug products subject of the case are not life saving drugs and the volume of the said products is not worth
more than (PHP 100,000.00); or the number of drug product subject of the case it not more than three brands or generic products.
Medium Penalty: NLT 100,000, but NMT 300,000 pesos and permanent closure of establishment as well as the revocation of its license to do business shall
be the medium administrative penalty
 when the counterfeit drug products subject of the case are not life saving drugs and the volume of the said products is not worth (PHP
100,000.00) but not exceeding One Million Pesos (PHP 1,000,000.00) or the number of counterfeit drug products is more than three
brands or generic products.
Maximum Penalty: NLT 300,000 but NMT 500, 000 pesos and permanent closure of establishment concerned as well as the revocation of its license to do
business shall be the maximum administrative penalty
 when the counterfeit drug products are life saving drugs regardless of the volume; or the volume of the counterfeit drug products is
worth more than One Million Pesos (PHP 1,000,000.00)
Accessory Penalties:
Forfeiture
Confiscation
Destruction of product found to be counterfeit and the equipment, instrument and other articles used in violation of R.A. 820
Permanent disqualification
 If the seized drug was found to be counterfeit the business establishment must be directed for preventive closure for a period of 30 days.
REPUBLIC ACT NO. 6425 –THE DANGEROUS DRUG ACT
Definition of terms
(a) "Administer" refers to the act of introducing any dangerous drug into the body of any person, with or without his knowledge, by injection, ingestion or
other means or of committing any act of indispensable assistance to a person in administering a dangerous drug to himself;
(b) "Board" refers to the Dangerous Drugs Board created under Section 35, Article VIII of this Act;
(c) "Centers" refers to any of the treatment and rehabilitation centers for drug dependents referred to in Section 34, Article VII of this Act;
(d) "Cultivate or culture" means the act of knowingly planting, growing, raising or permitting the planting, growing or raising of any plant which is the
source of a prohibited drug;
(e) "Dangerous drugs" refers to either:
(1) "Prohibited drug," which includes opium and its active components and derivatives, such as heroin and morphine; coca leaf and its
derivatives, principally cocaine; alpha and beta eucaine; hallucinogenic drugs, such as mescaline, lysergic acid
diethylamide (LSD) and other substances producing similar effects; Indian hemp and its derivates; all preparations
made from any of the foregoing; and other drugs, whether natural or synthetic, with the physiological effects of a
narcotic drug;
(2) "Regulated drug," which includes self-inducing sedatives, such as secobarbital, phenobarbital, pentobarbital, barbital, amobarbital and any
other drug which contains a salt or a derivative of a salt of barbituric acid; any salt, isomer or salt of an isomer, of
amphetamine, such as benzedrine or dexedrine, or any drug which produces a physiological action similar to
amphetamine; and hypnotic drugs, such as methaqualone or any other compound producing similar physiological
effects;
(3) “Exempt Dangerous Drug Preparation” is any dangerous drug preparation which is compounded in such a way that it presents no or a
negligible risk of abuse & the dangerous drug it contains cannot be recovered by readily applicable means in quantity
liable to abuse so that the preparation does not give risk to public health or social problem & has therapeutic value, a
wide use for legitimate purposes & is much needed medicine required to be easily available to the public in medical
need thereof.
(f) "Deliver" refers to a person's act of knowingly passing a dangerous drug to another, personally or otherwise, and by any means, with or without
consideration;
(g) "Drug dependence" means a state of psychic or physical dependence, or both, on a dangerous drug, arising in a person following administration or use
of that drug on a periodic or continuous basis;
(h) "Employee" of a prohibited drug den, dive or resort includes the caretaker, helper, watchman, lookout and other persons employed by the operator of
a prohibited drug den, dive or resort where any prohibited drug is administered, delivered, distributed, sold or used, with or without
compensation, in connection with the operation thereof;
(i) "Indian hemp," otherwise known as "Marijuana," embraces every kind and class of the plant Cannabis sativa L. from which the resin has not been
extracted, including Cannabis Americana, Hashish, Bhang, Guaza, Churrus & Ganjah, and embraces every kind, class and character of
Indian hemp, whether dried or fresh, flowering or fruiting tops of the pistillate plant, and all its geographic varieties, whether as a
reefer, resin, extract, tincture or in any form whatsoever;
(j) "Manufacture" means the production, preparation, compounding or processing of a dangerous drug either directly or indirectly or by extraction from
substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical
synthesis, and shall include any packaging or repackaging of such substance or labeling or relabelling of its container; except that such
term does not include the preparation, compounding, packaging, or labeling of a drug or other substance by a duly authorized
practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice;
(k) "Narcotic drug" refers to any drug which produces insensibility, stupor, melancholy or dullness of mind with delusions and which may be habit-forming,
and shall include opium, opium derivatives and synthetic opiates;
(l) "Opium" refers to the coagulated juice of the opium poppy (papaver somniferum) and embraces every kind and class of opium, whether crude or
prepared; the ashes or refuse of the same; narcotic preparations thereof or therefrom; morphine or any alkaloid of opium; preparations in
which opium, morphine or any alkaloid of opium enters as an ingredient; opium poppy straw; and leaves or wrappings of opium leaves,
whether prepared for use or not;
(m) "Pusher" refers to any person who sells, administers, delivers, or gives away to another, on any terms whatsoever, or distributes, dispatches in transit
or transports any dangerous drug or who acts as a broker in any of such transactions, in violation of this Act;
(n) "School" includes any university, college, or institution of learning, regardless of the course or courses it offers;
(o) "Sell" means the act of giving a dangerous drug, whether for money or any other material consideration;
(p) "Use" refers to the act of injecting, intravenously or intramuscularly, or of consuming, either by chewing, smoking, sniffing, eating, swallowing, drinking,
or otherwise introducing into the physiological system of the body, any of the dangerous drugs.
Records Required Every pharmacist dealing in dangerous drugs shall maintain and keep an original record of sales, purchases, acquisitions and
of Pharmacists deliveries of dangerous drugs, indicating therein the license number and address of the pharmacist; the name, address and license
of the manufacturer, importer or wholesaler from whom dangerous drugs have been purchased; the quantity and name of the
dangerous drugs so purchased or acquired; the date of acquisition or purchase; the name, address and class A residence certificate
number of the buyer; the serial number of the prescription and the name of the doctor, dentist, veterinarian
or practitioner issuing the same; the quantity and name of the dangerous drug so sold or delivered; and the date of sale or delivery.
A certified true copy of such record covering a period of three calendar months, duly signed by the pharmacist or the owner of the
drug store or pharmacy, shall be forwarded to the city or municipal health officer within fifteen days following the last day of every
quarter of each year.
Composition of the (a) DOH Secretary or representative
Dangerous Drug (b) DOH Undersecretary or representative
(c) Executive Director of the Dangerous Drugs Board
Board (d) DOJ Secretary or representative Two regular members:
(e) Department of National Defense or representative
(f) DepEd Secretary or representative -President of Integrated Bar of the Philippines
(g) Department of Finance Secretary or representative -Chairman / President of a Non-Government Organization
(h) DSWD Secretary representative
 The Director of the National Bureau of Investigation shall be the permanent consultant of the Board.
Powers and Duties (a) Promulgate such rules and regulations as may be necessary to carry out the purposes of this Act, including the manner of
of the Board safekeeping, disposition, burning or condemnation of dangerous drugs under its charge and custody, and prescribe
administrative remedies or sanctions for the violation of such rules and regulations;
(b) Take charge and custody of all dangerous drugs seized, confiscated by or surrendered to any national, provincial or local law
enforcement agency, if no longer needed for purposes of evidence in court;
(c) Develop educational programs based on factual information and disseminate the same to the general public, for which purpose
the Board shall endeavor to make the general public aware of the hazards of dangerous drugs by providing, among others,
literature, films, displays or advertisements, and by coordinating with all institutions of learning as well as with all national and
local law enforcement agencies in planning and conducting its educational campaign programs;
(d) Provide law enforcement officers, school authorities and personnel of centers with special training in dangerous drugs control;
(e) Conduct scientific, clinical, social, psychological, physical and biological researches on dangerous drugs;
(f) Draw up, in consultation and in coordination with the various agencies involved in drugs control, treatment and rehabilitation,
both public and private, a national treatment and rehabilitation program for drug dependents; and call upon any department,
office, bureau, institution or agency of the Government to render such assistance as it may require, or coordinate with it or with
other such entities, to carry out such program as well as such other activities as it may undertake pursuant to the provisions of
this Act;
(g) Receive all donations for the purpose of carrying out the objectives of this Act;
(h) Subject to the civil service law and the rules and regulations issued thereunder, appoint such technical, administrative and other
personnel as may be necessary for the effective implementation of this Act;
(i) Receive, gather, collate and evaluate all information on the importation, exportation, production, manufacture, sale, stocks,
seizures of and the estimated need for dangerous drugs, for which purpose of the Board may require from any official,
instrumentality or agency of the Government or any private persons or enterprises dealing in, or engaged in activities having to
do with, dangerous drugs such data or information as it may need to implement this Act;
(j) Relay information regarding any violation of this Act to law enforcement agencies to effect the apprehension of offenders and the
confiscation of dangerous drugs and transmit evidence to the proper court;
(k) Conduct eradication programs to destroy wild or illicit growth of plants from which dangerous drugs may be extracted;
(l) Authorize, pursuant to the provisions of this Act, the importation, distribution, prescription dispensing and sale of, and other
lawful acts in connection with, dangerous drugs of such kind and quantity as it may deem necessary according to the medical
and research needs of the country, which authorization shall be required by the Commissioner of Internal Revenue as a basis for
the issuance of licenses and permits for such purposes in accordance with Republic Act No. 953;
(m) Encourage, assist and accredit private centers, promulgating rules and regulations setting minimum standards for their
accreditation to assure their competence, integrity and stability;
(n) Prescribe and promulgate rules and regulations governing the establishment of such centers as it may deem necessary, after
conducting a feasibility study thereof;
(o) Provide appropriate rewards to informers who are instrumental in the discovery and seizure of dangerous drugs and in the
apprehension of violators of this Act;
(p) Gather and prepare detailed statistics on the importation, exportation, manufacture, stocks, seizures of and estimated need for
dangerous drugs and such other statistical data on said drugs as may be periodically required by the United Nations Narcotics
Drug Commission, the World Health Organization and other international organizations in consonance with international
commitments.
REPUBLIC ACT NO. 9165 – COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002
Title AN ACT INSTITUTING THE COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002, REPEALING REPUBLIC ACT NO. 6425, OTHERWISE
KNOWN AS THE DANGEROUS DRUGS ACT OF 1972, AS AMENDED, PROVIDING FUNDS THEREFOR, AND FOR OTHER PURPOSES
Definition of terms
(a) Administer. – Any act of introducing any dangerous drug into the body of any person, with or without his/her knowledge, by injection, inhalation,
ingestion or other means, or of committing any act of indispensable assistance to a person in administering a dangerous drug to
himself/herself unless administered by a duly licensed practitioner for purposes of medication.
(b) Board. - Refers to the Dangerous Drugs Board under Section 77, Article IX of this Act.
(c) Centers. - Any of the treatment and rehabilitation centers for drug dependents referred to in Section 34, Article VIII of this Act.
(d) Chemical Diversion. – The sale, distribution, supply or transport of legitimately imported, in-transit, manufactured or procured controlled precursors
and essential chemicals, in diluted, mixtures or in concentrated form, to any person or entity engaged in the manufacture of any
dangerous drug, and shall include packaging, repackaging, labeling, relabeling or concealment of such transaction through fraud,
destruction of documents, fraudulent use of permits, misdeclaration, use of front companies or mail fraud.
(e) Clandestine Laboratory. – Any facility used for the illegal manufacture of any dangerous drug and/or controlled precursor and essential chemical.
(f) Confirmatory Test. – An analytical test using a device, tool or equipment with a different chemical or physical principle that is more specific which will
validate and confirm the result of the screening test.
(g) Controlled Delivery. – The investigative technique of allowing an unlawful or suspect consignment of any dangerous drug and/or controlled precursor
and essential chemical, equipment or paraphernalia, or property believed to be derived directly or indirectly from any offense,
to pass into, through or out of the country under the supervision of an authorized officer, with a view to gathering evidence to
identify any person involved in any dangerous drugs related offense, or to facilitate prosecution of that offense.
(h) Controlled Precursors and Essential Chemicals. – Include those listed in Tables I and II of the 1988 UN Convention Against Illicit Traffic in Narcotic Drugs
and Psychotropic Substances as enumerated in the attached annex, which is an integral part of this Act.
(i) Cultivate or Culture. – Any act of knowingly planting, growing, raising, or permitting the planting, growing or raising of any plant which is the source of a
dangerous drug.
(j) Dangerous Drugs. – Include those listed in the Schedules annexed to the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol,
and in the Schedules annexed to the 1971 Single Convention on Psychotropic Substances as enumerated in the attached annex
which is an integral part of this Act.
(k) Deliver. – Any act of knowingly passing a dangerous drug to another, personally or otherwise, and by any means, with or without consideration.
(l) Den, Dive or Resort. – A place where any dangerous drug and/or controlled precursor and essential chemical is administered, delivered, stored for
illegal purposes, distributed, sold or used in any form.
(m) Dispense. – Any act of giving away, selling or distributing medicine or any dangerous drug with or without the use of prescription.
(n) Drug Dependence. – As based on the World Health Organization definition, it is a cluster of physiological, behavioral and cognitive phenomena of
variable intensity, in which the use of psychoactive drug takes on a high priority thereby involving, among others, a strong desire
or a sense of compulsion to take the substance and the difficulties in controlling substance-taking behavior in terms of its onset,
termination, or levels of use.
(o) Drug Syndicate. – Any organized group of two (2) or more persons forming or joining together with the intention of committing any offense prescribed
under this Act.
(p) Employee of Den, Dive or Resort. – The caretaker, helper, watchman, lookout, and other persons working in the den, dive or resort, employed by the
maintainer, owner and/or operator where any dangerous drug and/or controlled precursor and essential chemical
is administered, delivered, distributed, sold or used, with or without compensation, in connection with the
operation thereof.
(q) Financier. – Any person who pays for, raises or supplies money for, or underwrites any of the illegal activities prescribed under this Act.
(r) Illegal Trafficking. – The illegal cultivation, culture, delivery, administration, dispensation, manufacture, sale, trading, transportation, distribution,
importation, exportation and possession of any dangerous drug and/or controlled precursor and essential chemical.
(s) Instrument. – Any thing that is used in or intended to be used in any manner in the commission of illegal drug trafficking or related offenses.
(t) Laboratory Equipment. – The paraphernalia, apparatus, materials or appliances when used, intended for use or designed for use in the manufacture of
any dangerous drug and/or controlled precursor and essential chemical, such as reaction vessel, preparative/purifying
equipment, fermentors, separatory funnel, flask, heating mantle, gas generator, or their substitute.
(u) Manufacture. – The production, preparation, compounding or processing of any dangerous drug and/or controlled precursor and essential chemical,
either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a
combination of extraction and chemical synthesis, and shall include any packaging or repackaging of such substances, design or
configuration of its form, or labeling or relabeling of its container; except that such terms do not include the preparation,
compounding, packaging or labeling of a drug or other substances by a duly authorized practitioner as an incident to his/her
administration or dispensation of such drug or substance in the course of his/her professional practice including research, teaching and
chemical analysis of dangerous drugs or such substances that are not intended for sale or for any other purpose.
(v) Cannabis or commonly known as "Marijuana" or "Indian Hemp" or by its any other name. – Embraces every kind, class, genus, or specie of the
plant Cannabis sativa L. including, but not limited to, Cannabis americana,hashish, bhang, guaza, churrus and ganjab, and embraces every
kind, class and character of marijuana, whether dried or fresh and flowering, flowering or fruiting tops, or any part or portion of the plant
and seeds thereof, and all its geographic varieties, whether as a reefer, resin, extract, tincture or in any form whatsoever.
(w) Methylenedioxymethamphetamine (MDMA) or commonly known as "Ecstasy", or by its any other name. – Refers to the drug having such chemical
composition, including any of its isomers or derivatives in any form.
(x) Methamphetamine Hydrochloride or commonly known as "Shabu", "Ice", "Meth", or by its any other name. – Refers to the drug having such chemical
composition, including any of its isomers or derivatives in any form.
(y) Opium. – Refers to the coagulated juice of the opium poppy (Papaver somniferum L.) and embraces every kind, class and character of opium, whether
crude or prepared; the ashes or refuse of the same; narcotic preparations thereof or therefrom; morphine or any alkaloid of opium;
preparations in which opium, morphine or any alkaloid of opium enters as an ingredient; opium poppy; opium poppy straw; and leaves
or wrappings of opium leaves, whether prepared for use or not.
(z) Opium Poppy. – Refers to any part of the plant of the species Papaver somniferum L., Papaver setigerum DC, Papaver orientale, Papaver bracteatum
and Papaver rhoeas, which includes the seeds, straws, branches, leaves or any part thereof, or substances derived therefrom, even for
floral, decorative and culinary purposes.
(aa) PDEA. – Refers to the Philippine Drug Enforcement Agency (implementing arm of DDB)
 shall take charge & have the custody of all dangerous dugs that are confiscated, seized, & surrender (issued within 24 hours)
(bb) Person. – Any entity, natural or juridical, including among others, a corporation, partnership, trust or estate, joint stock company, association,
syndicate, joint venture or other unincorporated organization or group capable of acquiring rights or entering into obligations.
(cc) Planting of Evidence. – The willful act by any person of maliciously and surreptitiously inserting, placing, adding or attaching directly or indirectly,
through any overt or covert act, whatever quantity of any dangerous drug and/or controlled precursor and essential chemical in the
person, house, effects or in the immediate vicinity of an innocent individual for the purpose of implicating, incriminating or imputing the
commission of any violation of this Act.
(dd) Practitioner. – Any person who is a licensed physician, dentist, chemist, medical technologist, nurse, midwife, veterinarian or pharmacist in the
Philippines.
(ee) Protector/Coddler – Any person who knowingly and willfully consents to the unlawful acts provided for in this Act and uses his/her influence, power
or position in shielding, harboring, screening or facilitating the escape of any person he/she knows, or has reasonable grounds to
believe on or suspects, has violated the provisions of this Act in order to prevent the arrest, prosecution and conviction of the
violator.
 penalty of 12 years & 1 day to 20 years of imprisonment & a fine of 100,000 pesos to 500,000 pesos
(ff) Pusher. – Any person who sells, trades, administers, dispenses, delivers or gives away to another, on any terms whatsoever, or distributes, dispatches
in transit or transports dangerous drugs or who acts as a broker in any of such transactions, in violation of this Act.
(gg) School. – Any educational institution, private or public, undertaking educational operation for pupils/students pursuing certain studies at defined
levels, receiving instructions from teachers, usually located in a building or a group of buildings in a particular physical or cyber site.
(hh) Screening Test. – A rapid test performed to establish potential/presumptive positive result.
(ii) Sell. – Any act of giving away any dangerous drug and/or controlled precursor and essential chemical whether for money or any other consideration.
(jj) Trading. – Transactions involving the illegal trafficking of dangerous drugs and/or controlled precursors and essential chemicals using electronic devices
such as, but not limited to, text messages, email, mobile or landlines, two-way radios, internet, instant messengers and chat rooms or
acting as a broker in any of such transactions whether for money or any other consideration in violation of this Act.
(kk) Use. – Any act of injecting, intravenously or intramuscularly, of consuming, either by chewing, smoking, sniffing, eating, swallowing, drinking or
otherwise introducing into the physiological system of the body, and of the dangerous drugs.
Possession of The penalty of life imprisonment to death and a fine ranging from Five hundred thousand pesos (P500,000.00) to Ten million pesos
Dangerous Drugs (P10,000,000.00) shall be imposed upon any person, who, unless authorized by law, shall possess any dangerous drug in the
following quantities, regardless of the degree of purity thereof:
(1) 10 grams or more of opium; 10 grams: Opium
(2) 10 grams or more of morphine; Morphine
Heroin
(3) 10 grams or more of heroin; Cocaine
(4) 10 grams or more of cocaine or cocaine hydrochloride; Marijuana Resin/ Oil
(5) 50 grams or more of methamphetamine hydrochloride or "shabu"; Ecstacy
(6) 10 grams or more of marijuana resin or marijuana resin oil; LSD
PMA
(7) 500 grams or more of marijuana; and TMA
(8) 10 grams or more of other dangerous drugs such as, but not limited to, GHB
methylenedioxymethamphetamine (MDA) or "ecstasy", 50 grams: Shabu
paramethoxyamphetamine (PMA), trimethoxyamphetamine (TMA), lysergic acid 500 grams: Marijuana
diethylamine (LSD), gamma hydroxyamphetamine (GHB), and those similarly
designed or newly introduced drugs and their derivatives, without having any therapeutic value or if the quantity
possessed is far beyond therapeutic requirements, as determined and promulgated by the Board in accordance to
Section 93, Article XI of this Act.
S licenses issued by S1 For persons dealing in exempt dangerous drug preparation
the DDB authorizing S2 For MD, DMD, VetMD to prescribe dangerous drug renewable very 3 calendar years
individual S3 For retail dealers of dangerous drugs
establishment to S4 For wholesaler of dangerous drugs
deal w/ Dangerous S5-I For importers of dangerous drugs
Drug Preparations S5-C For compounds, producers, & manufacturer
S6 For persons not registered as importer, manufacturer producer or compounder but lawfully entitled to obtain & use in a
laboratory dangerous drugs for purpose of research, instruction or analysis
S7 For importers & compounds, RM (1.0peso/100g) FG (1.5peso/100g)
 The original copy of the prescription of dangerous drugs is retained by the Pharmacist for a period of 5 years from the date of sale or delivery of such drugs
 Head of PDEA: Director General
 Permanent Consultant of DDB: NBI Director & PNP Chief
 Reporting to DDB record sales of dangerous drugs is done every 6 months.
 Any person who shall import or bring into the Philippines any dangerous drug (including Opium poppy), regardless of the quantity & purity shall have the
penalty of Life imprisonment to death & Fine of 500,000 pesos to 10M pesos.
 Any Person who shall import Controlled precursor & Essential Chemical, unless authorized by law, shall be punished by
imprisonment from 12 years & 1 day to 20 years & a fine of 100,000 pesos.
Maximum Penalty  shall be imposed on anyone who shall import into the Philippines any dangerous drugs &/or controlled precursor & Essential chemical
through the use of a diplomatic passport.
 shall be imposed if the sale, trading, administration, delivery or distribution of dangerous drugs &/or controlled precursor & essential
chemical transpires within 100 meters from the school.
 Penalty of Unlawful Prescription of Dangerous Drugs & Person who imports Prohibited Drugs: Life imprisonment to Death & Fine of 500,000 to 10M pesos
Hazardous Substances (PD 881)
 Strong Sensitizer  means any substance which will cause on normal living tissue, allergy or photodynamic quality of hypersensitivity which becomes evident
on reapplication of the substance
 Corrosive  any substance which on contact w/ living tissue will cause destruction of tissue by chemical action
 Irritant  any substance not corrosive which on immediate, prolonged or repeated contact w/ normal living tissue will induce a local inflammatory reaction
 Toxic  any substance which can cause injury or illness or death to man through ingestion, inhalation or absorption through any body surface
 Radioactive  any substance which emits ionizing radiation
REPUBLIC ACT NO. 6675 – GENERICS ACT
Title AN ACT TO PROMOTE, REQUIRE AND ENSURE THE PRODUCTION OF AN ADEQUATE SUPPLY, DISTRIBUTION, USE AND ACCEPTANCE
OF DRUGS AND MEDICINES IDENTIFIED BY THEIR GENERIC NAMES
Statement of  To promote, encourage and require the use of generic terminology in the importation, manufacture, distribution, marketing,
Policy advertising and promotion, prescription and dispensing of drugs
 To ensure the adequate supply of drugs with generic names at the lowest possible cost and endeavor to make them available for
free to indigent patients;
 To encourage the extensive use of drugs with generic names through a rational system or procurement and distribution;
 To emphasize the scientific basis for the use of drugs, in order that health professionals may become more aware and cognizant
of their therapeutic effectiveness, and
 To promote drug safety by minimizing duplication medications and/or use of drugs with potentially adverse drug interactions.
Components of the (a) Quality Assurance of Drugs
National Drug (b) Rational Use of Drugs by Health Professionals & Consumers
Policy (c) National Self-sufficiency in Pharmaceuticals
(d) Rationalization of the DOH’s Procurement Program
Penalty for 1. For the first conviction, he shall suffer the penalty of reprimand which shall be officially recorded in the appropriate books of the
Medical Professional Regulation Commission.
Practitioner 2. For the second conviction, the penalty of fine in the amount of NLTP 2,000.00 but NMT P 5,000.00
3. For the third conviction, the penalty of fine in the amount of NLT P 5,000.00 but NMT P 10,000.00 and suspension of his license to
practice his profession for thirty (30) days at the discretion of the court.
4. For the fourth and subsequent convictions, the penalty of fine of NLT P 10,000.00 and suspension of his license to practice his
processions for one year or no longer at the discretion of the court.
Violations on the  Imposing a particular brand or product on the buyer
part of dispensers  Inaccurate dispensing
(Pharmacist) &  Failure to post or make accessible the required up-to-date information on drug products
outlets  Failure to adequately inform the buyer on available products that met the prescription
 Failure to indicate the generic name/ official name designated by BFAD
 Failure to report to the nearest DOH office cases of Violative, Erroneous, &/ or wrong prescriptions w/in three months after
receipt of such prescription
ADMINISTRATIVE ORDER NO. 62

Series of 1989
SUBJECT RULES AND REGULATIONS TO IMPLEMENT PRESCRIBING REQUIREMENTS UNDER THE GENERICS ACT OF 1988 (R.A. 6675)
Definition of Terms
1.1 “Prescription” is the written order and instruction of a validly registered physician, dentists or veterinarian for the use of a specific drug product for a
specific patient. For the purpose of these Rules and Regulations, the doctor’s order on the patient’s chart for the use of specific drug(s)
shall be considered a prescription.
1.2 “Generic Prescribing” is prescribing of drugs or medicines using their generic name(s) or generic terminology.
1.3 “Dispensing” is the act by a validly-registered pharmacist of filling a prescription or doctor's order on the patient's chart.
1.4 “Generic Dispensing” means dispensing the patient's/buyer's choice from among generic equivalents, i.e., finished pharmaceutical products having
the same active ingredient(s), same dosage form and same strength as the prescribed drug.
1.5 “Generic name or generic terminology” is the identification of drugs and medicines by their scientifically and internationally recognized active
ingredients or by their official name as
1.6 Drugs means (1) “articles recognized in the current official United States Pharmacopoeia-National Drug Formulary (USP-NF), official Homeopathic
Pharmacopoeia of the United States, Official Philippine National Drug Formulary, or any supplement to any of them, and (2) articles
intended for use to diagnosis, cure, mitigation, treatment or prevention of disease in man or animals; and (3) articles (other than
food) intended to affect the structure or function of the body of man or animals; and (4) articles intended for use as a component of
any articles specified in clauses (1), (2) or (3) but do not include devices or their components, parts or accessories.
1.7 Drug product or medicine is the finished form that contains the active ingredient(s), generally, but not necessarily in association with inactive
ingredients
1.7.1 Prescription or ethical drugs are pharmaceutical products or drug preparation that are to be dispensed only upon written order of
a validly-registered licensed physician, dentist or veterinarian for the management or treatment of a
condition or disease.
1.7.2 Non-prescription or over-the-counter drugs are pharmaceutical products or drug preparations that can be dispensed even without
the written order of a validly registered licensed physician, dentist or veterinarian, for the use of
consumers for the prevention or symptomatic relief of minor or self-limiting ailments.
Guidelines On 2.1. Prescription or Ethical Drugs
Dispensing Based These drugs can only be dispensed upon a written order of a validly-registered physician, dentist or veterinarian.
on Prior Laws 2.2 Non-Prescription or Over-the-Counter (OTC) Drugs
These drugs may be dispensed even without a written order of a validly-registered physician, dentist or veterinarian in
duly licensed drug outlets. When dispensing OTC drugs without a doctor's prescription, the pharmacist shall give the
necessary information and direction for use of the drug.
2.3. All prescriptions dispensed in the drugstore, botica or hospital pharmacy shall be kept in file for two years and recorded in a
prescription book duly-registered by BFAD which shall be open for inspection to Food and Drug Inspectors at any time during
business hours of the outlet. . This prescription book shall be kept for two years after the last entry.
Erroneous, Violative and Impossible Prescriptions
Erroneous Prescriptions
 Where the brand name precedes the generic name
 Where the generic name is the one in parenthesis
 Where the brand name is not in parentheses
 Where more than one drug product is prescribed on one prescription form.
What to do with erroneous prescriptions
 Erroneous prescriptions shall be filed.
 Shall also be kept and reported by the pharmacist of the drug outlet or any other interested party to the nearest DOH office for appropriate action.
 Pharmacist shall advice the prescriber of the problem &/or instruct the customer to get a proper prescription.
Violative Prescriptions
 Where generic name is not written
 Where the generic name is not legible and a brand name which is legible is written
 When the brand name is indicated and instructions added (such as the phrase " no substitution") which tend to obstruct, hinder or prevent
proper generic dispensing.
What to do with violative prescriptions
 Violative prescriptions shall not be filed.
 They are kept and reported by the pharmacist of drug outlet or any other interested party to the nearest DOH office for appropriate action.
 The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.
Impossible Prescriptions
 When only the generic name is written but it is not legible.
 When the generic name does not correspond to the brand name
 When both the generic name and the brand name are not legible
 When the drug product prescribed is not registered with FDA
What to do with impossible prescriptions
 Impossible prescription shall not be filed.
 They shall be and reported by the pharmacistof drug outlet or any other interested party to the nearest DOH office for appropriate action.
 The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.

Series of 1989
SUBJECT Rules and Regulations to Implement Dispensing Requirements under the Generics Act of 1988 (R.A. No. 6675)
Definition of Terms
1.1 “Dispensing” is the act by a validly-registered pharmacist of filling a prescription or doctor's order on the patient's chart.
1.2 “Generic Dispensing” means dispensing the patient's/buyer's choice from among generic equivalents, i.e., finished pharmaceutical products having the
same active ingredient(s), same dosage form and same strength as the prescribed drug.
1.3 “Partial filling of prescription" means dispensing less than the total number of units prescribed.
1.4 “Drug Outlet” means drugstore, pharmacy and other business establishment which sells drugs or medicines.

Series of 1989
SUBJECT Guidelines on Advertisement and Promotions to Implement The Generics Act Of 1988
Definition of Terms
1.1 “Advertisement” includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any
pharmaceutical product.
1.2 “Promotion” means the practice of giving temporary additional value to a brand, product, or service to achieve specific marketing objectives.
“Promotion” includes the distribution of free/sample pharmaceutical products.
1.3 “Pharmaceutical product” means any pharmaceutical or biological product intended for use in the diagnosis, cure, mitigation, treatment, or prevention
of disease or to affect the structure or any function of the body of man or animals.
1.4 “Prescription or Ethical Drugs” are pharmaceutical products or drug preparations that are to be dispensed only upon written order of a duly licensed
physician, dentist, or veterinarian for the treatment of a condition or a diagnosed disease of man or animals.
1.5 “Non-prescription Drugs” or “Over-the-Counter Drugs” are pharmaceutical products or drug preparations that can be dispensed even without the
written order of a duly-licensed physician, dentist, or veterinarian, for the use of consumers for the prevention of symptomatic relief
of minor or self-limiting ailments.
1.6 “Mass Media” means any publication, book, notice, handbill, poster, circular, pamphlet, letter, billboard, print media, radio, television, cinema, mobile
audiovisual units or any other widespread medium of information directed to the lay public.

Series of 1990
SUBJECT Amendment to A.O. 62 s. 1989 re: Rules and Regulations to Implement Prescribing Requirements
Generic Dispensing Flow Chart
If prescription is fully filled, retain prescription and file for 2 years.

If prescription is partially filled, indicate the number dispensed in prescription and return it to the patient.
REPUBLIC ACT NO. 7432 – SENIOR CITIZEN ACT
Title AN ACT TO MAXIMIZE THE CONTRIBUTION OF SENIOR CITIZENS TO NATION BUILDING. GRAND BENEFITS AND SPECIAL PRIVILEGES
AND FOR OTHER PURPOSES.
Declaration of a) to motivate and encourage the senior citizens to contribute to nation building;
Policies and b) to encourage their families and the communities they live with to reaffirm the valued Filipino tradition of caring for the senior
Objectives citizens.
In accordance with these policies, this Act aims to:
1) establish mechanisms whereby the contribution of the senior citizens are maximized;
2) adopt measures whereby our senior citizens are assisted and appreciated by the community as a whole;
3) establish a program beneficial to the se
Definition of Terms. -
“Senior Citizen” shall mean any resident citizen of the Philippines at least sixty (60) years old, including those who have retired from both government
officer and private enterprises, and has an income of not more than Sixty thousand pesos (P60,000.00 per annum subject to review by the
National Economic and Development Authority (NEDA) every three (3) years. 2
“Benefactor” shall mean any person whether related to the senior citizen or not who takes care of him/her as a dependent.
“Head of the Family” shall mean any person so defined in the National Internal Revenue Code
REPUBLIC ACT NO. 9257 – EXPANDED SENIOR CITIZENS ACT OF 2003

Title AN ACT GRANTING ADDITIONAL BENEFITS AND PRIVILEGES TO SENIOR CITIZENS AMENDING FOR THE PURPOSE REPUBLIC ACT NO.
7432, OTHERWISE KNOWN AS "AN ACT TO MAXIMIZE THE CONTRIBUTION OF SENIOR CITIZENS TO NATION BUILDING, GRANT
BENEFITS AND SPECIAL PRIVILEGES AND FOR OTHER PURPOSES"
REPUBLIC ACT NO. 9994 – EXPANDED SENIOR CITIZENS ACT OF 20010

Title AN ACT GRANTING ADDITIONAL BENEFITS AND PRIVILEGES TO SENIOR CITIZENS, FURTHER AMENDING REPUBLIC ACT NO. 7432, AS
AMENDED, OTHERWISE KNOWN AS "AN ACT TO MAXIMIZE THE CONTRIBUTION OF SENIOR CITIZENS TO NATION BUILDING, GRANT
BENEFITS AND SPECIAL PRIVILEGES AND FOR OTHER PURPOSES"
Declaration of Consistent with these constitutional principles, this Act shall serve the following objectives:
Policies and (a) To recognize the rights of senior citizens to take their proper place in society and make it a concern of the family, community,
Objectives and government;
(b) To give full support to the improvement of the total well-being of the elderly and their full participation in society, considering
that senior citizens are integral part of Philippine society;
(c) To motivate and encourage the senior citizens to contribute to nation building;
(d) To encourage their families and the communities they live with to reaffirm the valued Filipino tradition of caring for the senior
citizens;
(e) To provide a comprehensive health care and rehabilitation system for disabled senior citizens to foster their capacity to attain a
more meaningful and productive ageing; and
(f) To recognize the important role of the private sector in the improvement of the welfare of senior citizens and to actively seek
their partnership.
In accordance with these objectives, this Act shall:

(1) establish mechanisms whereby the contributions of the senior citizens are maximized;
(2) adopt measures whereby our senior citizens are assisted and appreciated by the community as a whole;
(3) establish a program beneficial to the senior citizens, their families and the rest of the community they serve: and
(4) establish community-based health and rehabilitation programs for senior citizens in every political unit of society."
Definition of terms. - For purposes of this Act, these terms are defined as follows:
(a) Senior citizen or elderly refers to any resident citizen of the Philippines at least sixty (60) years old;
(b) Geriatrics refer to the branch of medical science devoted to the study of the biological and physical changes and the diseases of old age;
Gerontology  is the scientific study of the biological, psychological, & sociological phenomena associated w/ old age & ageing & in determining
answers about the normal aging process rather than the disease
(c) Lodging establishment refers to a building, edifice, structure, apartment or house including tourist inn, apartelle, motorist hotel, and pension house
engaged in catering, leasing or providing facilities to transients, tourists or travelers;
(d) Medical Services refer to hospital services, professional services of physicians and other health care professionals and diagnostics and laboratory tests
that the necessary for the diagnosis or treatment of an illness or injury;
(e) Dental services to oral examination, cleaning, permanent and temporary filling, extractions and gum treatments, restoration, replacement or
repositioning of teeth, or alteration of the alveolar or periodont
ium process of the maxilla and the mandible that are necessary for the diagnosis or treatment of an illness or injury;
(f) Nearest surviving relative refers to the legal spouse who survives the deceased senior citizen: Provided, That where no spouse survives the decedent,
this shall be limited to relatives in the following order of degree of kinship: children, parents, siblings, grandparents, grandchildren,
uncles and aunts;
(g) Home health care service refers to health or supportive care provided to the senior citizen patient at home by licensed health care professionals to
include, but not limited to, physicians, nurses, midwives, physical therapist and caregivers; and
(h) Indigent senior citizen, refers to any elderly who is frail, sickly or with disability, and without pension or permanent source of income, compensation or
financial assistance from his/her relatives to support his/her basic needs, as determined by the Department of Social Welfare and
development (DSWD) in consultation with the National Coordinating and Monitoring Board.
Privileges for the Senior Citizens
The senior citizens shall be entitled to the following:
(a) the grant of twenty percent (20%) discount and exemption from the value -added tax (VAT), if applicable, on the sale of the following goods and
services from all establishments, for the exclusive use and enjoyment or availment of the senior citizen
(1) on the purchase of medicines, including the purchase of influenza and pneumococcal vaccines, and such other essential medical supplies,
accessories and equipment to be determined by the Department of Health (DOH).
The DOH shall establish guidelines and mechanism of compulsory rebates in the sharing of burden of discounts among retailers,
manufacturers and distributors, taking into consideration their respective margins;
(2) on the professional fees of attending physician/s in all private hospitals, medical facilities, outpatient clinics and home health care
services;
(3) on the professional fees of licensed professional health providing home health care services as endorsed by private hospitals or employed
through home health care employment agencies;
(4) on medical and dental services, diagnostic and laboratory fees in all private hospitals, medical facilities, outpatient clinics, and home
health care services, in accordance with the rules and regulations to be issued by the DOH, in coordination with the Philippine Health
Insurance Corporation (PhilHealth);
(5) in actual fare for land transportation travel in public utility buses (PUBs), public utility jeepneys (PUJs), taxis, Asian utility vehicles (AUVs),
shuttle services and public railways, including Light Rail Transit (LRT), Mass Rail Transit (MRT), and Philippine National Railways (PNR);
(6) in actual transportation fare for domestic air transport services and sea shipping vessels and the like, based on the actual fare and
advanced booking;
(7) on the utilization of services in hotels and similar lodging establishments, restaurants and recreation centers;
(8) on admission fees charged by theaters, cinema houses and concert halls, circuses, leisure and amusement; and
(9) on funeral and burial services for the death of senior citizens;
(b) exemption from the payment of individual income taxes of senior citizens who are considered to be minimum wage earners in accordance with
Republic Act No. 9504;
(c) the grant of a minimum of five percent (5%) discount relative to the monthly utilization of water and electricity supplied by the public
utilities: Provided, That the individual meters for the foregoing utilities are registered in the name of the senior citizen residing therein: Provided,
further, That the monthly consumption does not exceed one hundred kilowatt hours (100 kWh) of electricity and thirty cubic meters (30 m3) of
water: Provided, furthermore, That the privilege is granted per household regardless of the number of senior citizens residing therein;
(d) exemption from training fees for socioeconomic programs;
(e) free medical and dental services, diagnostic and laboratory fees such as, but not limited to, x-rays, computerized tomography scans and blood tests, in
all government facilities, subject to the guidelines to be issued by the DOH in coordination with the PhilHealth;
(f) the DOH shall administer free vaccination against the influenza virus and pneumococcal disease for indigent senior citizen patients;
(g) educational assistance to senior citizens to pursue pot secondary, tertiary, post tertiary, vocational and technical education, as well as short-term
courses for retooling in both public and private schools through provision of scholarships, grants, financial aids, subsides and other incentives to
qualified senior citizens, including support for books, learning materials, and uniform allowances, to the extent feasible: Provided, That senior
citizens shall meet minimum admission requirements;
(h) to the extent practicable and feasible, the continuance of the same benefits and privileges given by the Government Service Insurance System (GSIS),
the Social Security System (SSS) and the PAG-IBIG, as the case may be, as are enjoyed by those in actual service;
(i) retirement benefits of retirees from both the government and the private sector shall be regularly reviewed to ensure their continuing responsiveness
and sustainability, and to the extent practicable and feasible, shall be upgraded to be at par with the current scale enjoyed by those in actual
service;
(j) to the extent possible, the government may grant special discounts in special programs for senior citizens on purchase of basic commodities, subject to
the guidelines to be issued for the purpose by the Department of Trade and Industry (DTI) and the Department of Agriculture (DA);
(k) provision of express lanes for senior citizens in all commercial and government establishments; in the absence thereof, priority shall be given to them;
and
(l) death benefit assistance of a minimum of Two thousand pesos (Php2, 000.00) shall be given to the nearest surviving relative of a deceased senior citizen
which amount shall be subject to adjustments due to inflation in accordance with the guidelines to be issued by the DSWD.1avvphi1
In the availment of the privileges mentioned above, the senior citizen, or his/her duly authorized representative, may submit as proof of his/her
entitled thereto any of the following:
(1) an identification card issued by the Office of the Senior Citizen Affairs (OSCA) of the place where the senior citizen resides: Provided, That the
identification card issued by the particular OSCA shall be honored nationwide;
(2) the passport of the senior citizen concerned; and
(3) other documents that establish that the senior citizen is a citizen of the Republic and is at least sixty (60) years of age as further provided in the
implementing rules and regulations.
In the purchase of goods and services which are on promotional discount, the senior citizen can avail of the promotional discount or the discount
provided herein, whichever is higher.
The establishment may claim the discounts granted under subsections (a) and (c) of this section as tax deduction based on the cost of the goods
sold or services rendered: Provided, That the cost of the discount shall be allowed as deduction from gross income for the same taxable year that
the discount is granted: Provided, further, That the total amount of the claimed tax deduction net of VAT, if applicable, shall be included in their
gross sales receipts for tax purposes and shall be subject to proper documentation and to the provisions of the National Internal Revenue Code
(NICR), as amended."
Government Assistance. - The government shall provide the following:
(a) Employment
(b) Education
(c) Health
(d) Social Services At least fifty percent (50%) discount shall be granted on the consumption of electricity, water, and telephone by the senior citizens
center and residential care/group homes
(1) "self and social enhancement services" which provide senior citizens opportunities for socializing, organizing, creative expression, and self-
improvement;
(2) "after care and follow-up services" for citizens who are discharged from the homes or institutions for the aged, especially those who have
problems of reintegration with family and community, wherein both the senior citizens and their families are provided
with counseling;
(3) "neighborhood support services" wherein the community or family members provide caregiving services to their frail, sick, or bedridden
senior citizens; and
(4) "substitute family care " in the form of residential care or group homes for the abandoned, neglected, unattached or homeless senior
citizens and those incapable of self-care.
(e) Housing
(f) Access to Public Transport
(g) Incentive for Foster Care
(1) realty tax holiday for the first five (5) years starting from the first year of operation; and
(2) priority in the construction or maintenance of provincial or municipal roads leading to the aforesaid home, residential community or
retirement village.
(h) Additional Government Assistance
(1) Social Pension Indigent senior citizens shall be entitled to a monthly stipend amounting to Five hundred pesos (Php500.00) to augment the daily
subsistence and other medical needs of senior citizens, subject to a review every two (2) years by Congress, in consultation with
the DSWD.
(2) Mandatory PhilHealth Coverage
(3) Social Safety Nets
Office for Senior Citizens Affairs (OSCA)

Functions:
(a) To plan, implement and monitor yearly work programs in pursuance of the objectives of this Act;
(b) To draw up a list of available and required services which can be provided by the senior citizens;
(c) To maintain and regularly update on a quarterly basis the list of senior citizens and to issue national individual identification cards, free of charge,
which shall be valid anywhere in the country;
(d) To serve as a general information and liaison center for senior citizens;
(e) To monitor compliance of the provisions of this Act particularly the grant of special discounts and privileges to senior citizens;
(f) To report to the mayor, any individual, establishments, business entity, institutions or agency found violating any provision of this Act; and
(g) To assist the senior citizens in filing complaints or charges against any individual, establishments, business entity, institution, or agency refusing to
comply with the privileges under this Act before the Department of Justice (DOJ), the Provincial Prosecutor's Office, the regional or the municipal
trial court, the municipal trial court in cities, or the municipal circuit trial court.
REPUBLIC ACT NO. 7581 – THE PRICE ACT
Title AN ACT PROVIDING PROTECTION TO CONSUMERS BY STABILIZING THE PRICES OF BASIC NECESSITIES AND PRIME COMMODITIES
AND BY PRESCRIBING MEASURES AGAINST UNDUE PRICE INCREASES DURING EMERGENCY SITUATIONS AND LIKE OCCASIONS
Definition of Terms
(1) "Basic necessities" includes: rice; corn; bread; fresh, dried and canned fish and other marine products, fresh pork, beef and poultry meal; fresh eggs;
fresh and processed milk; fresh vegetables; root crops; coffee; sugar; cooking oil; salt; laundry soap; detergents; firewood;
charcoal; candles; and drugs classified as essential by the Department of Health;
(2) "Butter fund" means a contingent fund in the budget of the implementing agency which shall not be used in its normal or regular operations but only
for purposes provided for in this Act;
(3) "Implementing agency" means the department, agency or office of the Government which has jurisdiction over a basic necessity or prime commodity
as defined in this Act, which shall be:
(a) The Department of Agriculture, with reference to agricultural crops, fish and other marine products, fresh meat, fresh poultry and dairy
products, fertilizers, and other farm inputs;
(b) The Department of Health, with reference to drugs;
(c) The Department of Environment and Natural Resources, with reference to wood and other forest products; and
(d) The Department of Trade and Industry, with reference to all other basic necessities and prime commodities.
(4) "Panic-buying" is the abnormal phenomenon where consumers buy basic necessities and prime commodities grossly in excess of their
normal requirement resulting in undue shortages of such goods to the prejudice of less privileged consumers;
(5) "Person" means a natural person or juridical person;
(6) "Prevailing price" means the average price at which any basic necessity has been sold in a given time within a month from the occurrence of any of the
conditions enumerated under Section 6 of this Act;
(7) "Price ceiling" means the maximum price at which any basic necessity or prime commodity may be sold to the general public; and
(8) "Prime commodities" include fresh fruits; flour; dried processed and canned pork; beef and poultry meat; dairy products not falling under basic
necessities; noodles; onions; garlic; vinegar; patis; soy sauce; toilet soap; fertilizer; pesticides; herbicides; poultry; swine and
cattle feeds; veterinary products for poultry, swine and cattle; paper; school supplies; nipa shingles; sawali; cement; clinker; GI
sheets; hollow blocks; plywood; plyboard; construction nails; batteries; electrical supplies; light bulbs; steel wire; and all drugs
not classified as essential drugs by the Department of Health.
Illegal Acts of Price (1) Hoarding, which is the undue accumulation by a person or combination of persons of any basic commodity beyond his or their
Manipulation normal inventory levels or the unreasonable limitation or refusal to dispose of, sell or distribute the stocks of any basic
necessity of prime commodity to the general public or the unjustified taking out of any basic necessity or prime
commodity from the channels of reproduction, trade, commerce and industry.
(2) Profiteering, which is the sale or offering for sale of any basic necessity or prime commodity at a price grossly in excess of its
true worth. prima facie evidence of profiteering
(a) has no price tag;
(b) is misrepresented as to its weight or measurement;
(c) is adulterated or dilluted; or
(d) whenever a person raises the price by more than ten percent (10%)
(3) Cartel, which is any combination of or agreement between two (2) or more persons engaged in the production, manufacture,
processing, storage, supply, distribution, marketing, sale or disposition of any basic necessity or prime commodity
designed to artificially and unreasonably increase or manipulate its price.
Automatic Price (1) That area is proclaimed or declared a disaster area or under a state of calamity;
Control (2) That area is declared under an emergency;
(3) The privilege of the writ of habeas corpus is suspended in that area;
(4) That area is placed under martial law;
(5) That area is declared to be in a state of rebellion; or
(6) A state of war is declared in that area.
RA 9502  amended the following three acts:
RA 8293
RA 6675
RA 5921
AO 90 s. 1990  amended AO 62 s. 1989 in response to the request

of prescribing doctors to allow them to write
the name of more than one drug product on
the same page of a prescription form for a
particular patient.
RA 9211 (Tobacco Regulation Act of 2003)

 The electronic cigarette is not a proven nicotine replacement
therapy & WHO has no scientific evidence to confirm the
product’s safety & efficacy.
RATIONAL DRUG USE General Guidelines for Establishing the Philippine National Drug
A component of the Philippine national Drug Policy that attempts Formulary
to correct and limit inappropriate and wasteful utilization of Drug selection for the Philippine National Drug Formulary must be based
pharmaceuticals in the community through thorough legislation and on the following:
strategies (public education program) that tries to reach prescribers, 1. Relevance to disease which is indicated in the treatment of
dispensers and the consumers so they can use drugs properly, prevalent diseases.
correctly and sanely. The goal of this pillar is fulfillment the SANE 2. Efficacy and safety objectively obtained on pharmacologic
criteria in drug use: safety, affordability need and efficacy studies, which includes at least expanded Phase II clinical trials
and/or additional Phase III studies among Filipinos.
The rational use of drugs means that patients receive medicines
3. Quality control standards, including stability, and when
appropriate for their clinical needs, in doses that meet their individual necessary, bioavailability have to be met. The suppliers of
requirements, for an adequate period of time, and at the lowest cost to pharmaceutical products must provide documentation of the
them and their community. Irrational drug use by prescribers and product’s compliance with the requested specifications.
consumers is a very complex problem, which calls for the 4. Cost of the treatment regimen.
implementation of many different interventions at the same time. 5. Appropriateness to the capability of health workers at different
Efforts to promote rational drug use should also cover the use of level of health care must be considered.
traditional and herbal medicines. Key policy issues are: 6. Local health problems, the prevalent diseases or conditions on
 development of evidence-based clinical, as the basis for pharmacokinetic and pharmacodynamic parameters modifying
training, prescribing, drug utilization review, drug supply therapeutic response have to be considered.
and drug reimbursement; 7. Most favorable benefit/risk ratio is selected when several drugs
 establishment and support of drugs and therapeutics are available for the same therapeutic indication.
8. Preferential factors for evaluating therapeutically equivalent
committees;
drugs:
 promotion of the concepts of essential drugs, rational drug a. Drug with best understood beneficial properties and
use and generic prescribing in basic and in-service training limitations
of health professionals; b. Drug with clinical utility for treating more than one
 the need and potential for training informal drug sellers; condition
 continuing education of health care providers and c. Drug with most favorable pharmacokinetic
independent, unbiased drug information; properties
 consumer education, and ways to deliver it; d. Drugs in a dosage form easily dispensed by health
 financial incentives to promote rational drug use; staff or safely administered to the patient
e. Drugs with greater acceptability
 regulatory and managerial strategies to promote rational
f. Drugs with favorable stability
drug use g. Drugs for which local reliable manufacturing
facilities exist for its production
General Guidelines for proper drug use 9. Formulation as single compounds and fixed-ratio combinations
The essential drugs concept is central to a national drug policy are acceptable only when:
because it promotes equity and helps to set priorities for the health a. Use of more than one drug is clinically documented
care system. The core of the concept is that use of a limited number of b. Its therapeutic benefit is greater than the sum of
carefully selected drugs based on agreed clinical leads to a better each individual component
supply of drugs, to more rational prescribing and to lower costs. c. It is safer than the use of a single compound drug
d. It is cheaper or does not exceed the cost of the sum
The reasons are clear. Essential drugs that is selected on the basis of of individual products
safe and cost-effective clinical, give better quality of care and better e. Patient compliance is improved
value for money. The procurement of fewer items in larger quantities f. Satisfaction of majority of the population is
results in more price competition and economies of scale. Quality maintained
10. Period review of significant new therapeutic advances and
assurance, procurement, storage, distribution and dispensing are all
information is necessary.
easier with a reduced number of drugs. Training of health workers and 11. International Non-propriety Names for drugs should be used.
drug information in general can be more focused, and prescribers gain
more experience with fewer drugs and are more likely to recognize The PNDF is a component of the National Drug Policy which seeks to
drug interactions and adverse reactions. bring about the availability of safe, efficacious, and quality drugs at
affordable cost. Through the Essential Drug Concept, it is a step to
PHILIPPINE NATIONAL DRUG FORMULARY rationalize drug production, distribution, procurement and
consumption.
The Philippine National Drug Formulary is an integral component
of the National Drug Policy (NDP). It is a major strategy in the Philippine National Drug Formulary (PNDF)
promotion of rational drug use, by assuring the availability and  Is the Essential Drug List for the Philippines prepared by
accessibility of essential drugs of proven efficacy, safety and quality at the National Drug Committee (NDC) with consultation to
affordable cost. It is formulated by the Department of Health through different experts in the field of pharmaceutics, which is
the National Formulary Committee (NFC), mandated by the R.A. 6675 updated every year, consisting of:
also known as the Generics Act of 1988. a. Core List – drugs that are essential and are needed
by the majority of the population and should be
available at all times in appropriate dosage forms and
It was formulated utilizing submitted evidence tables, in sufficient quantities.
documentations and a series of deliberation meetings with a panel of b. Complimentary List – drugs that are needed for
experts and resource persons consisting of representatives from treating rare disorders, drugs with special
medical schools, Philippine Medical Association (PMA), academic, pharmaceutical properties and alternative drugs to be
specialty and sub-specialty societies, drug industry, government and used when there is no response in medicating Core
private hospitals, and other stakeholders. list drugs or when Core list drugs cannot be
administered for a reason or situation.
In 1993, by virtue of Executive Order No. 49 s.1993 and the
Philippine Health Insurance Act of 1995, the PNDF was officially
adopted as the basis for procurement of drug products within the Corazon C. Aquino declared publicly the Philippine National Drug
entire DOH. Policy (PNDP)
Five Pillars of PNDP are
(1) assurance of the safety, efficacy and usefulness of drug
products through quality control
(2) promotion of the rational use of drugs by health professionals
and the general public
(3) development of self reliance in local pharmaceutical industry
(4) targeted procurement of drugs by government and
(5) people empowerment.
Code of Ethics For Pharmacists
Preamble
Pharmacists are health professionals who help
individuals protect themselves against diseases,
maintain good health and make the best use of
their medication. The pharmacists ensure the
provision of safe, effective and quality drugs,
for improved patient care and quality of life.
This Code, prepared and supported by
pharmacists, is intended to state publicly the
principles that form the fundamental basis of
their roles and responsibilities which are based
on moral obligations and virtues and to guide
pharmacists in their relationship with patients,
health professionals and society.
1. A pharmacist places the well being of the patient

at the center of professional practice.
2. A pharmacist promotes the welfare of each
individual in a caring and compassionate manner.
3. A pharmacist serves the needs of the individual,
community and society and provides health for all.
4. A pharmacist respects the rights of patient and
upholds confidentiality of patient records.
5. A pharmacist acts with honesty, integrity and
professionalism in relationship with the patient
and other health professionals.
6. A pharmacist respects the abilities, values and
contributions of colleagues and other health
professionals and work with the closely to ensure
better patient care.
7. A pharmacist is committed to continuously
enhance professional competence.
8. A pharmacist, in coordination with the
government and other health professionals helps
in the formulation and implementation of health
care policies, standards and programs designed for
the benefit of society.
MANUFACTURING
-----------------------------------------------------------------
I. INTRODUCTION  Batch – specific quantity of product intended to have uniform

character and quality produced during a single manufacturing
 Manufacturing – large-scale production of drug products’
process
preparation, processing, packaging, labeling, repacking,
changing wrapper, label or container of any drug products  Lot – specific identified portion of a batch
o Manufacturing Activities  Batch/Lot Number – for identification and traceability of a
 Primary Manufacturing – manufacture of APIs and single batch/lot
excipients  Master Formula – contains formulation, manufacturing
 Secondary Manufacturing – manufacture of finished procedures, specifications, QA requirements and labeling of a
dosage form finished product
 Tertiary Manufacturing – packaging, labeling, and  Master Batch Record/Batch Manufacturing Record – ensures
repacking of bulk finished product that batches were properly made and QC tests were
 Toll Manufacturing – an arrangement whereby a performed; actual yield
competent company manufactures products for another  Standard Operating Procedures (SOPs) – step-by-step
company instruction for performing an operational task or activity
o Departments in a Manufacturing Plant  Manufacturing Order – give instructions to production
 Research and Development Department – formulates department to produce product
new products; reformulates new products; does chemical,  Overage – addition of an API in an unstable preparation to
pharmaceutical and physiological research; facilities: compensate for loss during manufacture
laboratory, pilot plant, library, animal house  Quarantine – designated area for holding of incoming
 Production Department – manufactures products components prior to acceptance testing and qualification for
according to schedule; warehousing (inventory control) use
and storage
APPROVED
 Quality Assurance Department – assures that all (green)
operations meet required standards for safety and
QUARANTINE
efficacy; ensures compliance to cGMP; conducts quality (yellow)
audit and monitoring; cooperates with regulatory
REJECTED
agencies; prepares SOPs (red)
 Quality Control Department – tests compliance of raw
materials, packaging materials, and finished products;  Validation – documented evidence that a system does what it
conducts sampling of materials to be tested; performs is supposed to do (consistency and quality)
IPQC and environmental testing
 Marketing Department – studies current market trends, II. PACKAGING, LABELING AND STORAGE OF
consumer behavior and product status in market;
promote and advertisement DRUG PRODUCTS
 Regulatory Department – ensures compliance of I. PACKAGING
company and its products with all pertinent regulations - an economic way of protecting, preparing, identifying, and
and laws about drugs and their marketing containing drug products
 Engineering Department – installs, maintains and repairs  Parts – container and closure
of equipment and premises; safety  Types of Packaging:
 Medical Department – concerned with physical o Primary Packaging – immediate container; in direct contact
examination and medical treatment of employees; with product; affects stability; may provide means of
performs clinical studies; publishes house organ/paper administration; (ex. bottles; caps; liners; filler; desiccant)

o Secondary Packaging – outer packaging; encloses primary  Polymers for Plastic
packaging; optional; (ex. carton box; sticker label; inserts; NO. PLASTIC USE
conjugated box) 1 polyethylene for beverages
terephtalate
2 high-density hard thermoset for solid
II. CLASSIFICATION OF CONTAINERS polyethylene dosage forms
 According to Protection Ability 3 polyvinyl chloride for blister packs
4 low-density thermoplastic for squeeze
o Well-Closed – protects content from extraneous solids polyethylene bottles and medicine
o Tight – protects contents from extraneous solids, liquids, droppers
and vapors; protects from deliquescence, efflorescence, 5 polypropylene high temperature resistance
evaporation o Foils, Films and Laminates – low cost; flexibility; heat-
o Hermetic – impervious to air or any other gas sealability; decoration; (ex. strip and blister packs; sachets;
o Light-Resistant – protects from photochemical degradation liners for containers)
(ex. amber bottles) o Rubber – (ex. stoppers for vials; bulbs for pipers; plugs for
o Child-Resistant – difficult for children under 5 years of age syringes)
to open; (ex. press down and turn; squeeze and turn; alight o Metal – aluminum; tin; (ex. collapsible tubes; aerosol cans;
the arrows; latch top) crimp for vials)
o Tamper-Resistant – uses an indicator which if breached or
missing can provide evidence that tampering has occurred; III. LABELLING
(ex. shrink seal/wrap; breakable caps; tape seal; bottle seal;  Label – display of written, printed or graphic matter on
aerosol  only true temper-resistant packaging) immediate container
 According to Quantity Held  Labelling Material – all labels and other written, printed or
o Single Unit – holds a single dose only; non-resealable; no graphic matter (1) upon any item or any of its containers or
antimicrobial agent; water: WFI or SWFI; USP limit: 1000 mL wrappers; (2) accompanying any such items
o Multiple Unit – holds more than single dose; resealable;  Principal Display Panel
with antimicrobial agent; water: BWFI; USP limit: 30 mL o Name of Product – generic and brand name (helvetica
 According to Material Used medium; universe medium)
o Glass – most widely used; major component: SiO2 o Dosage Form and Strength
 Advantages: strength and rigidity; inertness; barrier o Pharmacologic Category
protection o Rx Symbol – prescription drugs
 Disadvantages: fragility; heavy weigh; leaching of alkali o Name and Address of Manufacturer Trader or Distributor
 Types of Glass: o Net Content
 I – Highly Resistant Borosilicate Glass – with boric acid o Other Info – formulation; indications; contraindications;
 high resistance; for buffered and non-buffered precaution; warnings; directions for use; batch/lot number;
aqueous parenteral solutions registration number (OR#); storage conditions
 II – Treated Soda-Lime Glass – surface is treated with
SO2  dealkalized; for buffered acidic aqueous IV. STORAGE CONDITIONS
STORAGE CONDITION TEMPERATURE (oC)
parenteral solutions
COLD NMT 2-8
 III – Soda-Lime Glass – low resistance; for FREEZER -10-20
reconstituted dry solids and non-aqueous liquids REFRIGERATOR 2-8
 IV – NP – general purpose soda-lime glass; for oral solid COOL 8-15
and liquid dosage forms and external preparations ROOM TEMPERATURE temp prevailing in area
o Plastic – organic polymers of HMW CONTROLLED ROOM TEMPERATURE 20-25
WARM 30-40
 Advantages: durability; light weight; low cost
EXCESSIVE HEAT >40
 Disadvantages: permeability; environmental; leaching of
additives
 Types of Plastic: III. MANUFACTURE OF TABLETS
 Thermoplastic – soft when heated and hard when I. TABLET COMPONENTS
cooled; flexible and squeezable  Activated Pharmaceutical Ingredients (API) – choice of
 Thermoset – permanently hard; rigid excipients should consider compatibility with API
 Diluent/Filler – inert substance added to increase tablet size
which is practical for compression; (ex. lactose; sucrose and
glucose; starch; dibasic CaHPO4; anhydrous/spray-dried

lactose; microcrystalline cellulose (Avicel®); mannitol and II. PROCESSES IN TABLET MANUFACTURE
xylitol)

Dispensing Milling Mixing Granulation Tableting Coating
Binders – imparts cohesiveness to powders causing them to
form granules; (ex. starch paste; acacia; tragacanth; gelatin;
 Dispensing – first step in any manufacturing process; weighing
sucrose; cellulose; PVP)
and measuring
 Disintegrant – facilitates breakup of a tablet when in contact
o Objective: accuracy of weight  uniform dose
with water in the GIT
o Methods:
o MOA: swelling – starch paste; wicking – Avicel®
 hand scooping and weighing
o Types: internal – added prior to granulation; external –
 weighing with material lifting assistance
added prior to compression
 automated dispensaries
o Double Disintegrant – divide disintegrant into 2 portions
o Issues: weighing accuracy; dust control (dust collecting
 Superdisintegrant – 2-4%; newer class of disintegrants which assistance); lot control of each ingredient; material
are effective at much lower levels; (ex. sodium starch glycolate
movement (WH  DA  PA)
 Primojel®, Explotab®; croscarmellose sodium;
 Milling – particle size reduction, sizing, crushing, grinding.
crospovidone)
Pulverization
 Antifrictionals/Flow Activators – hydrophobic powders added o Objective: easier and more uniform mixing
prior to compression to reduce friction and improve flow
o Equipment:
properties; included at concentrations < 1%  Cutter Mill – cuts particles using knives; for fibrous
o Lubricant – facilitates ejection from die cavity; (ex. purified
materials
talc; PEG and laurlyl sulfates  hydrophilic lubricants; Mg
 Edge Runner Mill – crushes materials by 2 rotating wheels
stearate)
 Hammer Mill – uses a high speed rotor to which swinging
o Anti-Adherent – reduces sticking to punch faces or die walls;
hammers are fixed
(ex. purified talc; Mg stearate)
 Fluid Energy Mill – uses air with very high pressure
o Glidant – enhances flow; (ex. colloidal talc; colloidal SiO2; Ca  Roller Mill – consists of rotating cylindrical rolls
& Mg silicate; Mg stearate)  Ball Mill – consists of a rotating cylindrical roll filled with
 Colorants balls
o Dyes – water-soluble colorants used as solutions (ex. FD&C
 Mixing – process of blending materials together into one mass
dyes) o Objective: obtain dosage units each of which contains same
FD&C DESIGNATION NAME COLOR
amount of API
Blue No. 1 Brilliant blue FCF Blue
Blue No. 2 Indigotine Indigo o Equipment:
Green No. 3 Fast green FCF Turquoise  Batch Type Mixer – all ingredients are loaded together,
Red No. 3 erythrosine Pink mixed and discharged as a single batch
Red No. 40 Allura red AC Red Rotating Shell/Tumbling Mixers
Yellow No.5 tartrazine Yellow o Drum Type Blenders – cylindrical-shaped; horizontal
Yellow No. 6 Sunset yellow FCF orange axis; poor cross flow; remedy: Baffles Slantea
o Lakes – water-insoluble dyes that have been absorbed on o Double Cone Blender – good cross flow
hydrous oxide usually alumina, used as dry powders o V-Shell Blender – twin-shell blender; solid-solid
 Flavors blending; alternately combines and draws apart
o Salty – cinnamon; orange; cherry; butterscotch materials
o Bitter – chocolate; cherry; raspberry; mint Fixed Shell Mixers
o Sour – raspberry; lemon; fruity o Ribbon Blender
o Oily – mint; lemon; orange o Sigma Blade Mixer
o Unpleasantly Sweet – vanilla; fruity o Planetary Mixer
 Sweeteners o Vertical Impeller Mixer
o Artificial Sweeteners  Continuous Mixer – for high volume products; materials
 Sucralose – 1000x travel from charging port to discharge nozzle
 Saccharin – 500x  Granulation – powder size enlargement to granules
 Na saccharin – 300x o Objective: better flowability and compressibility
 Acesulfame K – 180-200x o Types:
 Aspartame – 180-200x  Good Granules – pass through sieve #20 but not through
 Na cyclamate – 30x sieve #40
 Fine Granules – pass through sieve #40

o Methods:  Lamination – separation into 2 or more distinct horizontal
 Wet Granulation – addition of liquid binder to powders; layers
most common method  Chipping – removal of small portion (tablet edges)
Disadvantages: labor-intensive; time-consuming; not  Cracking – fine cracks on surface; cause: deep concave
for moisture or heat-sensitive drugs punches
Steps:  Sticking – adhesion to die wall
 Picking – adhesion to punch faces (pinholes)
screening damp
blending of dry
ingredients
addition of liquid
binder*
mass (seive #6 or  Double Impression – due to free rotaion of punches with
#8)
engraving on faces
drying
granulation
screening dry addition of  Mottling – uneven color distribution
granules (seive lubrincant and
(moisture
content: 0.5-1%)
#12-#20) external lubricant  Coating – application of coating material to a moving bed of
solids with concurrent use of heated air
*Moisture Content: 31-35%; Underwet – too soft; Overwet – too hard o Equipment:
 Fluid Bed Granulation – can accomplish both dry mixing  Standard Coating Pan – consists of a rotating circular
and wet granulation efficiently and in much less time metal pan with ducts (ex. Peilegrini Pan; immersion
compared to traditional method tube/sword system)
 Dry Granulation – double compression on pre- Methods:
compression method; powder mixture is compacted into o Pan Pouring – for viscous solutions; problem: surface
large pieces and subsequently broken down into granules; erosion
for moisture and heat-sensitive materials o Pan Spraying – increases efficiency
Disadvantages: dusty and uneven color  Perforated Coating Pan – exhaustion is through the
Processes: perforations (ex. Accela-Cota Pan; Driacoater; Giatt
o Slugging – formation of slugs; breakdown slugs  Coater)
granules: oscillating granulator  Fluid Bed Coater – air suspension coating or Wurster
o Roller Compaction – formation of sheets; chilsonator process
roller compactor o Types of Coating:
 Tableting – compression of tablet components within a die  Sugar Coating – oldest method
cavity by pressure exerted by movement of 2 punches Disadvantages: large increase in weight (>50%); time-
o Parts of Tableting Machine: consuming; requires expertise
 Hopper – holds materials Steps:
 Feed Shoe – transfers materials into die
colar
 Die – defines size and shape of tablet sealing subcoating smoothing
coating
 Punches – compress materials within die
 Cam Tracks – guide movement of punches polishing
o Types of Tableting Machine:
 Single Station – involves movement of both punches o Sealing – water proofing; strengthens tablet core;
 Multiple Station – involves movement of both punches agents: shellac, cellulose acetate phthalate (CAP),
o Requirement of Tableting: polyvinyl acetate phthalate (PVAP), zein
 Flowability – facilitates transfer o Subcoating – rounds off tablet edges; most critical
Flow Problems: step; step that adds most weight (50-100%); agents:
o Arching/Bridging – arch-shaped obstruction forms alternate layers of gum and dusting powder
above hopper outlet o Smoothing – smoothes out subcoated surface;
o Rat-Holing – discharge takes place only above hopper agents: 60-70% syrup solution
outlets o Color Coating – critical step  color and elegance;
 Compressibility – forms a stable, compact mass when agent: 60-70% syrup + colorant
pressure is applied  Grossing – develops color
Direct Compression – tablet processing without  Heavy Syruping – builds up color
granulation; require a very critical selection of  Regular Syruping – final color
excipients  good flowability and compressibility; (ex. o Polishing – produces gloss/shine; agents: beeswax,
KCl, NaCl, NaBr; diluents: anhydrous lactose, Avicel®) carnauba wax, candelila wax, hard paraffin wax
o Tablet Defects:
 Capping – partial or complete separation of top or bottom
crown

 Film Coating – minimal increase in weight (2-3%); easier o Coating – modifies solubility characteristics (ex. shellac;
and faster cellulose acetate phthalate; salol)
o Components:
 Film Former – smooth, thin films; (ex. celluloses, II. SOFT GELATIN CAPSULES
methacrylate; PVA; PVP  formed, filled and sealed in a single operation
 Plasticizer – flexibility and elasticity; (ex. castor oil,  Methods:
glycerin, phthalate; esters) o Plate Process – oldest method which uses gelatin sheets
 Surfactant – spreadability; (ex. polyonyethylene o Rotary Die Process – uses gelatin ribbons brought together
sorbitan derivatives) between 2 rotating discs
 Alloying Substance – water solubility/permeability; o Reciprocating Die Process – uses different filling method
(ex. PEG)
 Glossant – luster or shine; (ex. beeswax) V. MANUFACTURE OF SEMI-SOLID DOSAGE
 Volatile Solvent/Vehicle – (ex. alcohol and acetone)
o Coating Defects: FORMS
 Mottling – uneven color distribution I. OINTMENTS
 Sweating – oily film or droplets of liquid  Methods:
 Bridging – markings are obscured o Incorporation – use of ointment roller mills to mix heat-
 Blooming – white spots on surface or dull film sensitive ointment bases
 Flaking – due to rapid drying o Fusion – use of stem-jacketed kettler to melt anhydrous
 Blistering – reduced adhesion of film ointment bases and cooling gradually until congealed
 Wrinkling – due to improper drying/film former
defect II. GELS
 Orange Peel – rough; non-glossy film surface (due to  Gelling Agents:
inadequate spreading); remedy: add polysorbate o Alginic acid
surfactant o Celluloses
o Colloidal SiO2
IV. MANUFACTURE OF CAPSULES o Tragacanth
o Mg Al silicate
I. HARD GELATIN CAPSULES
o Carbomer – swells in water at basic pH (Carbopol®);
 HGC shells are manufactured in a separate operation from
neutralized: methanolamine
filling
 Pin Method/Reciprocating Die Method – most common
method VI. MANUFACTURE OF LIQUID DOSAGE
 Steps in filling HGCs: FORMS
I. EQUIPMENT
supply rectification separation
 Mixing Tanks – usually made of stainless steel, jacketed and
have built-in agitation system
o Grades: SS 304; SS 316 – most inert
filling joining/closing finishing
 Mixers
o Mechanical Stirrer – mixers with various impellers mounted
 Encapsulating Machines: Lilly; Parke-Davis; Macofar; Farmatic on shafts; problem: vortex formation  remedy: buffers,
 Methods: Anger/Spindle Dosing; Tamping and Disc Dosing; slanted (45o)
Accogel Process  dry powders to SCG o Colloid Mill – for comminution of solids or dispersion of
 Finishing – cleaning and polishing; (methods: pan polishing; suspensions
cloth dusting; brushing) o Homogenizer – compresses liquid with high pressure by a
 Special Techniques: strong spring mechanism
o Sealing o Ultrasonifier – user ultrasonic energy to produce emulsion
 Gelatin Banding – seals with a band of gelatin
 Heat Welding – fuses cap to body through double wall II. COMPONENTS
thickness  APIs
 Thermal Coupling – uses liquid wetting agent to lower  Solvent of Vehicle
melting point between cap and body then bonds  Buffers
o Imprinting – empty capsules  Viscosity Enhancers

 Humectants o Dispersion Methods – suspensoids are wetted first before
 Colorants, Flavors, and Sweeteners, Perfumes dispersing into vehicle
 Stability Enhancers:
o Preservatives – prevent microbial growth V. EMULSIONS
 ex. parabens; methyl – molds (short); propyl – yeasts and  Types:
bacteria (short); benzyl alcohol; benzoic acid and Na o Natural – acacia; tragacanth; celluloses; agar; pectin;
benzoate; sorbic acid and K sorbate; chlorobutanol; gelatin; wool fat
benzalkonium Cl; thimerosal and phenylmercuric NO3 o Finely Divided Solids – bentonite; Mg(OH)2; Al(OH)3; Mg
o Antioxidants – prevent oxidation trisilicate
 True Antioxidants – react with free radicals; (ex. vit. E; o Synthetic Surfactants
BHT; BHA; alkyl gallates)  Anionic – effective at basic pH; (ex. soaps; alkyl SO4;
 Reducing Agents – (ex. vit. C; sulfites) sarcosinates)
 Antioxidant Synergists – react with heavy metals; (ex.  Cationic – effective at acidic pH; (ex. benzalkonium Cl;
EDTA; citric acid; tartaric acid) cetnorionium Cl)
 Amphoteric – both anionic and cationic; (ex. betaine;
III. SOLUTIONS lecithin)
 Manufacturing Procedure:  Non-Ionic – not affected by pH; (ex. Span® – sorbitan
esters [lipophilic]; Tween® – polysorbates [hydrophilic];
storage
dispensing mixing
and aging
filtration filling cetyl alcohol; cocamide DFA)
 Considerations:
o Dispensing o Emulsions are unstable
o Mixing – dissolution of solutes; ↑solubility = speed of o Internal Phase – 40-60%
agitation, temperature, particle size, pH, complexation o Oil Phase – high grade mineral oil
o Storage and Aging – optional step; improves flavor or odor o Ideal Mixing Temperature – 70-72oC
of volatile oils o If perfume were to be added: o/w (40-45oC); w/o (near room
o Filtration temperature)
 Types:  Instabilities:
Parallel – passes thru and filter medium o Sedimentation – ↓ internal phase
Series – 2 or more filter media o Creaming – ↑ internal phase
 Filter Media: o Breaking/Cracking – separation into a layer due to
Filter Paper/Cloth – non-sterile products coalescence of internal phase
Membrane Filter – sterile products; Bubble Point Test o Phase Inversion – w/o ↔ o/w
 to test efficiency of membrane filter
 Methods: gravity; vacuum; pressure VII. MANUFACTURE OF STERILE DOSAGE
o Filling
 Methods: FORMS
Gravimetric – large containers and high viscosity I. STERILIZATION METHODS
Volumetric – constant volume using piston action METHOD MOA BI
Moist Heat – autoclave protein Bacillus
Constant-Level – container is used to control fill
or steam under pressure coagulation stearothermophirus
(121oC, 15psi, 15-20
IV. SUSPENSIONS minutes)
 Formulation Dry Heat – oven 160- oxidation Bacillus subtilis
o Suspending Agents – viscosity enhancers; (ex. acacia; 170oC, 2-4 hours
Membrane Filtration – physical
tragacanth; celluloses; bentonite; magma; veegum; agar;
for heat-labile solutions separation
carrageenan; gelatin) Gas – ethylene oxide or alkylation Bacillus subtilis
o Wetting Agents – displace air from cervices of hydrophobic β-propiolactone
solids to allow penetration of water; (ex. glycerin; PPG; PEG; Ionizing Radiation – DNA mutation Bacillus purnilus
syrup)) gamma or cathode rays
o Flocculating Agents – decrease zeta potential causing
aggregation to avoid formation of cake; (ex. NaCl; KCl) II. DEPYROGENATION
 Formation:  180oC for 4 hours
o Precipitation Method – by organic solvent; by changing pH;  250oC for 45 minutes
by double decomposition  650oC for 1 minute

III. STERILE PRODUCTIO AREA
 Clean Rooms – room in which concentration of airborne
particles is controlled; positive pressure air flow
o HEPA filter – removes 99.97% of particles (≥ 0.3 µm) from
air; Diocylphthalate Test – QC test for HEPA filter
 Airlock – space with interlocked doors
 Parts:
o Ante Room – for cleaning and wearing of PPE (class 100,000/
ISO class 8 – NMT 100,000 particles [≥ 0.5 µm] per cubic foot
of air)
ISO CLASS PARTICLES PRESENT PER
CUBIC FOOT OF AIR
3 1
4 10
5 100
6 1,000
7 10,000
8 100,000
o Buffer Area – for staging of supplies and equipment (class
10,000)
o Compounding Area – (class 100)
 Laminar Air Flow Hoods – vertical or horizontal flow
 Barrier Isolators – for hazardous materials
o Aseptic Filling Area – packaging; (class 100)
o Quarantine Area – for staffing prior to testing
o Finishing Area
IV. MANUFACTUING PROCEDURE
dispensing and
compounding filtration
cleaning
filling sealing
 Dispensing and Cleaning

 Compounding – Sterile Solids: Spray Drying; Freeze
Drying/Lyophilization
 Filtration – Sterile Solutions: Clarification – 2-3µm; Cold
Filtration – 0.2-0.3µm
 Filling
o Sterile Solids – Wet Weight Filling
o Sterile Liquids – Volumetric Filling – most common;
Gravimetric Filling
 Sealing
o Vials – siliconization or halogenization
o Ampules
 Tip/Bead Sealing – melt tip to form a bead
 Pull Sealing – melt below tip then pull away

1. Castor oil belongs to what type of laxative? 4. The Research Department of a pharmaceutical
A. Bulk-forming laxatives manufacturing establishment is important in:
B. Saline laxatives A. Developing new products
C. Stimulant laxatives B. Improving existing new products
D. Emollient laxatives C. AOTA
D. NOTA
Types of Laxatives Mechanism of Examples
Action The following are the different tasks of the research
Bulk-forming Forms bulk by Polycarbophil, department
absorbing water psyllium  Develop new products
Saline Draws water into Sodium  Improve already existing products
intestinal tract by biphosphate  Do market research, pharmaceutical research,
osmosis chemical research (includes analysis, synthesis and
Stimulant Stimulates the Phenolphthlein, identification of products)
intestinal wall Castor oil  Physiologic research (effect on animals, toxicity or
Emollient Softens stool by Docusate sodium allergic reactions)
lubrication
5. The following are responsibilities of Production

2. Emulsions containing volatile oils may be prepared by: Department:
A. Continental method A. Receiving materials and supplies
B. Dry Gum Method B. Warehouse and storage
C. Bottle Method C. NOTA
D. Wet gum D. AOTA
The Bottle Method, also known as the Forbes The following are the tasks of the production
Method, is a variation of the dry gum method. It is used for department:
the extemporaneous preparation of emulsions from volatile  Receiving materials and supplies
oils or oleaginous substances of low viscosities. In this  Warehousing and storage
method, the components are placed in a bottle and shaken.  Manufacture of products
 Packaging and production control
In the Continental or Dry Gum Method, the
emulsifying agent is mixed with the oil before the addition of
water. It is also referred to as the 4:2:1 method. Remember: 6. The Quality Department often called the heart and life of
EA + O + W = emulsion the company is in charge of:
A. Ensuring uniform production of high quality
In the English or Wet Gum method, the emulsifying B. Safeguarding public health
agent is added to water to form a mucilage, and then the oil C. Ensuring that minimum standards of the products comply
is slowly incorporated to form the emulsion. Remember: with the FDA requirements
W + EA = mucilage + oil = emulsion D. AOTA
The quality control department is in charge of the

3. This is used to solidify glycerine suppositories following:
A. AOTA  Assurance of uniform quality products
B. Glycerol triacetate  Ensure public safety
C. Stearic acid  Dose sampling, assaying, and systematic recording
D. Sodium stearate and compiling
 Ensure minimum standards of the product comply
Glycerin suppositories are composed of glycerine, with FDA
sodium stearate and water and are generally used a
cathartic. Sodium stearate is used as the solidifying agent
while glycerine is the hydrophilic base.
7. The Medical Department of a pharmaceutical
manufacturing establishment is in charge of:
A. Clinical studies
B. Preparation of new package inserts Insufflators are the simplest devices for oral or nasal
C. AOTA inhalation of dry solids. Disadvantages such as lack of
D. NOTA pharmaceutical elegance, less convenient in application than
other topical preparations and non-uniformity of dose
The medical department does the following: delivered (especially if the powder contained a drug which
 Physical and medical examination of employees had systemic effect) lead to decline of its use
 Medical treatment of employees
 Conduct clinical studies
 Preparation of literature and inserts 11. Powders for compression must possess fluidity and:
 Publish house organ A. Compressibility
 Take charge of scholarships B. Flowability
C. Adhesiveness
D. Solubility
8. Irregular agglomerates of small particles which behave as
single layer particles are known as: Fluidity is important so that the material can be
A. Bulk powders transported through the hopper of a tableting machine. It is
B. Granules also essential so that adequate filling of the die occurs in the
C. Lines tableting machine to produce tablets of consistent weight.
D. NOTA Compressibility which is defined as the property of
forming a stable, intact compact mass when pressure is
Generally, granules are prepared by moistening the applied, is also essential. It is known in nearly all cases that
desired powder mixture and passing the moistened mass granulation improves compressibility.
through a screen mesh size that will produce the desired size
granules. Some of the advantages of granules are as follows:
 Flow well compared to powders 12. An ideal drug delivery system is:
 Generally more stable physically and chemically A. Capable of controlled delivery rates
than are the corresponding powders from which B. Not highly sensitive to physiological variable
they are prepared C. Applicable to a wide variety of drugs
 Less likely to cake or harden upon standing D. Any of the above
 More easily wetted by a solvent
Drug delivery system refers to the technology
utilized to present the drug to the desired body site for drug
release and absorption. The first drugs delivery was the
9. Powders and granulated products are often dispensed as:
syringe, invented in 1865, used to deliver medication by
A. Bulk powders and granules for internal use
injection.
B. Divided powders and granules for internal uses
The following are attributes of an ideal drug delivery
C. Dusting powders for internal uses
system:
D. Both A and B
 Capable of controlled delivery rates to
Generally, dispensing of powdered drugs in bulk accommodate the pharmacokinetics of various
amounts is limited to non-potent substances. The mixed drugs (flexible programming)
ingredients are packaged into a suitable bulk consider such  Capable of precise control of a constant delivery rate
as a wide mouthed jar (precise programming)
Powders that should be administered in controlled  Not highly sensitive to physiological variables such
dosage or those containing potent substances are usually as gastric motility and emptying pH, fluid volume
divided amounts individual doses are separately packed. and content of gut disease state
 The system is predicated on physicochemical
properties
 The system is capable of a high order of drug
10. Dosage form used to administer medicated powders
dispersion
blowing into air, nose or throat.
A. Oral powders  Drug stability is maintained or enhanced
B. Aerosols  The controlling mechanism adds little mass to the
C. Insufflations dosage form
D. Any of the given  Applicable to a wide range and variety of drugs
13. A sustained drug release system can be achieved through redispersed upon the gentle shaking of the
this formulation method container
A. Use of coating  The characteristics of the suspension should be such
B. Embedding the drug in a matrix that the particle size of the suspensoid remains fairly
C. Microencapsulation constant throughout the long periods of
D. All of the above undisturbed standing
 The suspension should pour readily and evenly from
Formulation methods used to obtain the desired the container
drug availability rate from the sustained action dosage forms
include:
 Increasing the particle size of the drug and/or 16. The term used for the coalescence of oil globules in an oil-
dosage form in-water emulsion
 Embedding the drug in a matrix A. Creaming
 Coating the drug or a dosage form containing the B. Cracking
drug C. Phase inversion
 Chemically reacting the drug with materials such as D. Flocculation
an ion exchange resin
Another name for cracking is breaking or
coalescence. The coalescence of oil globules in an o/w
14. For liquids which are _____________, a gravity-operated emulsion is resisted by the presence of a mechanically strong
filling set-up is used absorbed layer of emulsifier around each globule. This is
A. Free flowing achieved either by the presence of a condensed mixed
B. Foaming monolayer of lipophilic or hydrophilic emulgents or by a
C. Viscous multimolecular film of a hydrophilic material.
D. Either A or B Creaming is the separation of an emulsion into two
regions one of which is richer in the dispersed phase than the
Gravity filling which is used for free flowing liquids is other.
relatively slow. It is accomplished in this simple manner: the Flocculation involves the aggregation of the
liquid reservoir is positioned above the filling line with a hose dispersed globules into loose clusters within the emulsion.
connection from the reservoir to a shut off device at the
filling line. The shut off device is usually hand operated, and
the bottles are filled to graduations on the bottles 17. Test used to determine phase inversion in emulsion
Viscous liquids are filled using a pressure-operated A. Dye test
filling set-up. The pressure pump filter often is operated B. Torque
semi-automatically and differs from the gravity filter C. Incompatibility
principally in the liquid is under pressure. It is usually D. AOTA
equipped with an overflow tube connected to a receiver to
prevent excess filling of container. Phase inversion involves the conversion of an o/w
emulsion to a w/o or vice versa. The dye test can be used to
detect phase inversion through the use of water-soluble and
15. All of the following are attributes of a good suspension oil-soluble dyes, one of which will dissolve in and color the
except: continuous phase. Other methods to detect emulsion type
A. Must settle slowly are as follows:
B. Must be packed attractively
C. Must be easily redisperse upon shaking Test Results
D. NOTA Dilution Test Emulsion can be diluted only
with the external phase
The important characteristics of a pharmaceutical CoCl2/ filter paper Blue to pink when o/w
suspension are therapeutic efficacy, chemical stability of the emulsion is added
components of the preparation, permanency of the Fluorescence o/w dot pattern; w/o
formulation and aesthetic appeal. Other attributes of a good fluoresce through out
suspension are: Conductivity o/w – conducts electricity;
 A properly prepared pharmaceutical suspension w/o – no conduction
should settle slowly and should be readily
18. This process of drying involves sublimation of water from A hermetic container is impervious to air or any
a product after it is frozen other gas under the ordinary or customary conditions of
A. Lyophilization handling, shipment, storage and distribution
B. Freeze drying A well-closed container protects the contents from
C. Tyndallization extraneous solids and from loss of the article under the
D. A and B ordinary or customary conditions of handling, shipment,
storage and distribution
Freeze-drying or lyophilisation essentially consists A tight container protects the contents from
of: contamination by extraneous solids, liquids or vapour, from
a. Freeze the aqueous product at a temperature below its loss of the article and from efflorescence, deliquescence or
eutectic temperature customary condition of handling, shipment, storage and
b. Evacuating the chamber usually below 0.1 torr (100um Hg) distribution and is capable of tight reclosure
c. Subliming ice on a cold condensing surface at a A light-resistant container protects the contents
temperature below that of the product, the condensing from the effects of light by virtue of the specific properties of
surface within the chamber or in a connecting surface the material of which it is composed including any coating
d. introducing heat to the product under controlled applied to it
conditions, thereby providing energy for sublimation at a
rate designed to keep the product below its eutectic
temperature. 21. Highly resistant borosilicate glass is also known as:
The advantages of lyophilization: A. Type I
 Stabilization of heat and oxygen labile drugs B. Type II
 Often more rapid solubility C. Type III
 Greatly reduced levels of particulate matter D. NP
 Elegant appearance
In type I or borosilicate glass, the alkaline element in
ordinary soda lime glass is largely eliminated by the use of
19. Importance of a package includes: boric oxide to neutralize the oxides of potassium. Type I glass
A. For convenience is less brittle and has low thermal expansion and can be used
B. For legal compliance with safety over a wide temperature range.
C. For protection The other types of glass are
D. AOTA  Type II glass is treated soda lime glass
 Type III glass is soda lime glass
The following are the characteristics of a package:  NP stands for non-parenterals
 Economical and therefore contribute to overall
profitability
 Provide protection against climatic, biological, 22. This medium is used for the disintegration plain uncoated
physical and chemical hazards tablets
 Provide and acceptable presentation which will A. Simulated Gastric Fluid, TS
contribute whilst at the same time maintaining B. Simulated Intestinal Fluid, TS
adequate identification and information C. Distilled Water
 It must contribute in terms of convenience and D. Potable Water
compliance
 Protection is almost invariably the most critical The disintegration medium for plain uncoated tables
factor since it controls the total shelf-life of the is Distilled Water. Uncoated USP Tablets have disintegration
product time standards as low as 5 minutes, but the majority of the
tablets have a maximum disintegration time of 30 minutes.
To be in compliance with the USP standards, the tablets
20. Type of container which is impervious to air or any other must disintegrate and all particles must pass through the
gas under ordinary or customary conditions 10mesh screen in the time specified. If any residue remains, it
A. Well-closed must have a soft mass with to palpably firm core.
B. Tight Simulated Gastric Fluid and Simulated Intestinal
C. Hermetic Fluid are both used for the disintegration of enteric coated
D. Light-resistant tablets. Enteric coated tablets should not disintegrate in
Simulated Gastric Fluid in 2 hours but should disintegrate in
Simulated Intestinal Fluid in 1 hour
23. Component of closure that is inserted in a cap to effect a of manufacture until its chemical or biological activity is not
hermetic seal between the closure and the container: less than 90% of labelled potency and its physical
A. Cap characteristic have not changed appreciably deleteriously.
B. Liner Overage is added to a pharmaceutical formulation
C. Liner seal to keep the content of the active ingredient within the limits
D. Stopper compatible with therapeutic requirements for a
predetermined period of time. It is limited to a maximum of
The liner is a multilayered structure of resilient 30% over the labelled potency of an ingredient.
packaging made of pulp (board), foil or plastic and it is used
to produce a hermetic seal between the closure and the
container. 26. This test makes use of the lysate of horseshoe crab and is
The cap material may be plastic or foil used to test for the presence of pyrogens
The inner seal can be wax paper, foil or plastic line A. Pyrogen test
glued on or heat seated to provide tamper evidence B. LAL test
The coil absorbs force, shock to prevent damage C. A and B
during shipment. It is usually made of cotton D. NOTA
Limulus Amebocyte Lysate is obtained from

24. The following are examples of tamper-resistant aqueous extracts of the circulating amebocytes of the
packaging, except: horseshoe crab, Limulus polyphemus, and which have been
A. Film wrappers prepared and characterized for uses a an LAL reagent. The
B. Blister reaction is characterized by the formation of a firm gel that
C. Strip remains when inverted through 180 degrees. A negative
D. NOTA result is characterized by the absence of such a gel or by the
formation of a viscous gel that does not maintain its
A tamper resistance package is defined as one integrity. This test is more sensitive than the pyrogen test.
having an indicator or barrier to entry, if breached or missing In the USP Pyrogen Test, healthy, mature rabbits
can reasonably be expected to provide visible evidence to are used to determine the absence of presence of pyrogens
consumers that tampering has occurred. Below are the that can be tolerated by the rabbit.
examples:
 Film wrappers
 Bubble packs 27. This type of defect is not likely to reduce materially the
 Shrink seals/bands usability of the unit of product for its intended purpose
 Foil/ paper or plastic pouches A. Critical defect
 Breakable caps B. Major defect
 Sealed Tubes C. Minor defect
 Sealed cartons D. AOTA
 Blister/ strip packs
 Bottle seals A minor defect is a departure from established
 Tape seals standards having the little bearing on the effective use of an
 Aerosol containers operation or unit.
A critical defect is a defect that judgment and
experience indicate is likely to result to hazardous or unsafe
conditions for individuals using, maintaining or depending
25. It is defined as the capacity of a drug to remain within
upon the products or a defect that judgment and experience
specifications established to assure its identity, strength,
indicate is likely to prevent performance of the tactical
quality and purity.
function of the major end item.
A. Stability
A major defect is a defect other than critical that is
B. Shelf-life
likely to result in failure or to reduce materially the usability
C. Overage
of a product for its intended purpose.
D. AOTA
Stability has been defined as the ability of particular

formulation in a specific container to remain within its 28. USP sterilization techniques include the following except:
physical, chemical, therapeutic and toxicological A. NOTA
specifications. It has also been defined as the time from date B. Sterilization by ionizing radiation
C. Sterilization by filtration penetration to the film to ensure penetration of the drug.
D. NOTA Polyethylene glycol (PEG) is an example of an alloying
substance.
All of the methods in the choices are sterilization A film former is capable of producing smooth, thin,
techniques. The table below shows the different sterilization reproducible under conventional coating conditions and
techniques: applicable to a variety of tablet shapes. Cellulose acetate
phthalate is an example of a film former.
Technique Method A plasticizer produces flexibility and elasticity of the
Steam sterilization 121 degrees Celsius coating and thus provides durability. An example of a
Gas sterilization Material can’t withstand high plasticizer is castor oil.
temperature in steam and A surfactant is used to enhance the spreadability of
dry heat. Uses ethylene the film during application. Examples are Spans and Tweens.
oxide or propylene oxide
Dry heat sterilization Temperature in empty
chamber is 4-15 degrees 31. Rapid drying leads to this film coating problem
Celsius when the unit is A. Blistering
operating at 250 degrees B. Sweating
Celsius C. Flaking
Sterilization by filtration Sterilization of heat labile D. Blooming
solutions by physical
removal of the contained Blistering is caused by too rapid evaporation of the
microorganisms solvent from the core and the effect of high temperature on
Sterilization by ionizing Uses gamma radiation and the strength, elasticity and adhesion of the film. This usually
radiation electron beam radiation or happens when coated tablets require further drying in ovens.
mechanical acceleration of
electrons
32. Which of the following is not an adhesive?
A. Starch powder
29. Tyndallization is performed at: B. Sucrose syrup
A. 100°C for 30 minutes C. Liquid glucose
B. 100°C for 1 hour D. NOTA
C. A and B
D. NOTA The substances that act as adhesives to bind
powders together in the wet granulation are known as
Tyndallization is also known as binders. Starch is a good and popular binder and needs to be
intermittent/fractional/discontinuous steam distillation. This present in an amount equal to 2%. It is incorporated in water.
sterilization technique which uses steam intermittently and Other examples are:
performed at a temperature of 100°C for 30 minutes or at  Acacia mucilage (up to 20%)
30°C for 1 hour. In tyndallisation, a fluid medium is healed in  Gelatin (5-20%)
the steam environment at atmospheric pressure for 20-45  Glucose (up to 50%)
minutes for three successive days. Germination of surviving  Polyvinylpyrolidone (2-10%)
spores is presumed to occur at room temperature between  Starch mucilage (5-10%)
heatings. The more susceptible vegetative forms are killed  Sucrose (up to 70%)
when the medium is heated.
33. This disintegrant has a surfactant effect

30. This filmcoating material provides water permeability to A. Starch
film B. Sodium lauryl sulphate
A. Film former C. Methylcellulose
B. Plasticizer D. AOTA
C. Alloying substance
D. Surfactant The function of a disintegrant in a formulation is to
promote breakup of the tablets when places in an aqueous
The function of an alloying substance is to provide environment. The disintegration increases the surface area
water solubility or permeability to the film to ensure of the tablet fragments and promotes rapid release of the
drug. Methylcellulose is a synthetic substitute for natural vertically delivers water in drops each of which weighs
gums. It is used as a dispersing, thickening, emulsifying, between 45-55mg. One mL of water approximately weighs
sizing and coating agent. It is also used therapeutically as a about 1 gram or 1000mg and the average weight of one drop
bulk laxative in the treatment of chronic constipation of water is 50mg, therefore, 1000mg + 50mg = 20 drops of
Examples: water.
 Cation exchange resins
 Cross linked PVP
 Modified starches 37. Inspissation is a method of fractional sterilization
 Cellulose materials performed at the temperature
A. 60°C
B. 100°C
34. The most common diluents used for chewable tablets. C. 121.o °C
A. Sorbitol D. NOTA
B. Mannitol
C. Lactose Inspissation (60°C) is a fractional method of
D. Dextrose sterilization relatively effective in reducing the number of
vegetative forms of microorganisms, but and unreliable
Chewable tablets are intended to disintegrate against spores. The process of inspissations consists of
smoothly in the mouth at a moderate rate either with or heating materials in water bath or inspissator
without actual chewing. Mannitol, a white crystalline discontinuously for 4-7 days, once per day for 30-60 minutes
hexahydric alcohol is the diluents of choice for chewable at less than 100°C (the highest nondegrading tolerable
tablets. It is about 70% as sweet as sucrose with a cool taste temperature). It is generally used for the heat sensitive
and mouth feel. It is also used as an excipient in the pharmaceuticals to which a bacteriostatic agent is usually
preparation of chewable tablets containing moisture added.
sensitive drugs because it is non-hygroscopic.
38. Petroleum jelly belongs to what class of ointment bases?

35. Defect characterized by small pinholes on the surface of A. Water soluble bases
poorly manufacture tablets. B. Hydrocarbon base
A. Mottling C. Absorption base
B. Picking D. Water removable base
C. Capping
D. Compacting Ointment bases are classified into four general
groups:hydrocarbon, absorption, water-soluble and water
Picking is the term used to describe small pinholes removable bases.
on the surface of a tablet usually caused by overwetting or
excessive film lackness. In this case, the tablets stick to each HYDROCARBON (OLEAGINOUS) BASES
other or to the coating pan and on drying, at the same point - Water free and used chiefly for their emollient
of contact, a piece of the film may remain adhered to the pan effect, act as occlusive dressings
or to another tablet, giving a poked appearance to the tablet  Petrolatum (Yellow Petrolatum, Petroleum
surface and resulting in a small area of the cone. Jelly)
 White Petrolatum
 Yellow Ointment
36. The USP medicine dropper when held vertically delivers  White Ointment
how many drops of water?  Paraffin
A. 15 drops of water  Mineral Oil
B. 18 drops of water
C. 25 drops of water ABSORPTION BASES
D. 20 drops of water  Hydrophilic Petrolatum
 Anhydrous Lanolin
The USP Medicine Dropper consists of a tube made  Lanolin
of glass or other suitable transparent material that generally  Cold Cream
is fitted with a compatible bulb and while varying in capacity
constricted at the delivery and to be round opening having WATER REMOVABLE BASE
an external diameter of about 3mm. The dropper when held  Hydrophilic ointment
WATER SOLUBLE BASE 42. Function of colors and dyes in tablet formulations include
 Propylene glycol ointment the following except
A. To disguise off-colored drugs
B. To disguise unpleasant tasting drugs
39. Used as a viscosity builder for ophthalmic preparations C. To provide product identification
except: D. To produce more elegant product
A. Polyethylene glycol
B. Polyvinyl alcohol The use of coloring agents in pharmaceutical
C. Polyvinyl pyrrolidone preparations is important for purposes of aesthetics as
D. Glycerol sensory adjuncts to the flavours employed and for purposes
of product distinctiveness. Coating of drugs usually disguises
In the preparation of ophthalmic solutions, a the unpleasant taste of drugs
suitable grade of methylcellulose or other thickening agent is
frequently added to increase the viscosity and thereby aid in
holding the drug in contact with the tissues so as to enhance 43. The containers used to package drugs may consist of
therapeutic effectiveness. Hydroxypropyl methylcellulose several components. This term best describes the release of
and polyvinyl alcohol can also be used. an ingredient from packaging components into the actual
product
A. Sorption
40. This suppository base does not melt at body temperature B. Leaching
A. Cocoa butter C. Permeation
B. Witepsol bases D. Porosity
C. Wecobee bases
D. Polyethylene glycol Compounds leached from plastic containers are
generally polymer additives as the plasticizers, stabilizers or
Polyethylene glycol are polymers of ethylene oxide antioxidants. Temperature, excessive agitation and the
and water, prepared to various chain lengths, molecular stabilizing effect of the contents on one or more of the
weights and physical states. PEG suppositories do not melt polymer additives may influence leaching.
at body temperature but rather dissolve slowly in the body Sorption is the opposite of leaching. It is binding of
fluids. Therefore the base need not be formulated to melt at molecules to polymer materials.
body temperature but mix with mucous secretions upon their Permeation is the process of solution and diffusion.
dissolution. PEG suppositories do not leak from the orifice as The material that penetrates initially dissolves in the plastic
do many cocoa butter-based suppositories. material on one side and diffusing through the other side.
Porosity is characterized by minute holes or cracks
that are present and through which gas or moisture vapour
may move directly.
41. Normal moisture content of hard gelatin capsules
A. 2-5%
B. 12-16%
C. 20-24% 44. This small scale section of the manufacturing research
D. 25-30% division serves as a testing ground for developing
manufacturing procedure for a commercial size of
Normally, hard gelatine capsules have a moisture pharmaceutical product
content of 13-16%. Gelatin is stable in air when dry but is A. Research and development
subject to microbial decomposition when it becomes moist B. Central Research
or when it is maintained in aqueous solution. If stored in an C. Production Facility
environment of high humidity, additional moisture is D. Pilot plant
absorbed by the capsules and they may become distorted
and lose their rigid shape. An environment of extreme The pilot plant’s primary function is to facilitate the
dryness may cause some of the moisture normally present in transfer of a product from the laboratory into production. Its
the gelatine capsules to be lost, and the capsules to become effectiveness is determined by the ease with which new
brittle and to crumble when handled. products or processes are brought into routine production.
45. Buffers for parenterals except 48. The USP requirement for ophthalmic preparations is
A. Citrates A. Sterility
B. Tartrates B. Isotonicity
C. Acetates C. Clarity
D. Lactates D. Non-pyrogenicity
To maintain product stability of many drugs, a The most important and most exacting step in the
certain pH is required. Parenteral products should be formulation and manufacture of ophthalmic products is
formulated to possess sufficient buffer capacity to maintain sterility. The application of a variety of sterilization
proper product pH. Buffer systems for parenterals consist of procedures such as dry heat, steam under pressure, ethylene
either a weak base or the salt of a weak base and a weak acid oxide, filtration irradiation and sterilizing solutions is
and the salt of a weak acid. Buffers commonly used for required in the manufacture of ophthalmic preparations.
injectable products are acetates, citrates and phosphates. Sterilization is a major assurance of the quality of an
ophthalmic product. Lack of sterility could lead to the loss of
an eye.
46. One of the following is not a depyrogenation method
A. Filtration through asbestos
B. Heating at high temperature 49. This method of reducing granules is best suited for non-
C. Distillation volatile fatty materials
D. Autoclaving A. Slugging
B. Spray drying
Pyrogens which are products of the metabolism of C. Spheronization
microorganisms produce a marked rise in temperature, chills, D. Spray congealing
body aches, cutaneous vasoconstriction and a rise in arterial
blood pressure. The temperature in an autoclave will not Spray congealing techniques are applicable to
destroy during a normal cycle. waxes, alcohols, polymers and sugars which are solid at room
Distillation frees water from pyrogens so that the temperature but meltable at reasonable temperature.
condensed molecules have gone through the vapour state Microencapsulation by spray congealing techniques can be
protected from inadvertent contamination and id the accomplished with spray drying equipment when the
distillate has been stored in a sterile condition. protective coating is applied as melt. Coating solidification is
Adequate cleaning and heating at temperature of accomplished by spraying the hot mixture into air stream.
160°C for 3 to 4 hours or 269°C for 45 minutes may render
containers free from pyrogens. Recent studies have shown
that 650°C for 60 seconds will destroy the pyrogens. 50. This method of compression is best suited for two or
Adsorption on the surface of selected adsorbants more components which are chemically incompatible:
can sometimes remove pyrogens from solutions. A. Wet granulation
B. Direct compression
C. Layered compression
47. Which of the following is not an advantage of the use of D. Multiple layered compression
parenterals?
A. Immediate physiologic action The advantages of layered compression are as
B. Accuracy of dosage follows:
C. Ease and convenience of administration  Two incompatibilities drugs may be kept separate
D. To slow the onset and prolong the duration of action by interposing a center, inert layer between them
 Each layer may have a separate color which can
Advantages of parenterally administered drugs serve as a means of identification
include primarily the following:  Accurate control of the delayed or prolonged action
 Rapid onset portion of the tablet is feasible
 Predictable effect  Multilayer presses have greater hourly output than
 Predictable and nearly complete bioavailability the compression centers
 Avoidance of the GIT, hence the problems of
variable absorption, drug inactivation and GI
distress
 Provides reliable drug administration in very ill or
comatose patients
51. This equipment provides the shortest drying time for wet Disintegrants are materials that help the tablet to
granulations break up and dissolve to release the medicament. Examples
A. Drying oven are starch derivatives, gums, alginates (sodium alginates and
B. Incubator alginic acid) and clays (bentonite and veegum)
C. Fluid bed dryer Glidants are used in order for granules to flow from
D. Sun drying a hopper on to the tablet press to the dies and for consistent
uniform fill and improve flow characteristics of the
The advantage of a fluid bed dryer is that efficient granulations. Talc is an example of a glidant.
heat and mass transfer give high drying rates so that drying
times are shorter than static bed convection driers. A batch
of tablet granules, for example, can be dried in 20-30 minutes 54. The pressure required to push the air through a liquid
whereas a compartment drier would require several hours. saturated filter
Apart from obvious economic advantages, the heating time A. Bubble point
of thermostatic materials is minimized. B. Flash point
C. Saturation point
D. AOTA
52. Mixing equipment for solid materials except
A. Sigma blade mixer The bubble point is the pressure required to push air
B. Ribbon blender through a liquid saturated filter and is a function of the
C. Twin shell V blender porosity rating. Until this point is reached, the filter pores
D. AOTA retain liquid and unless there is rupture larger than the pore
diameter, air pressure will hold indefinitely. Filtration at
The sigma blade mixer deals with stiff pastes and pressures lower than the bubble point of the membrane
ointments and its action depends on the close intermeshing prevents air from passing through the filter at the end of the
of the two blades which resemble the Greek letter ∑ in shape. filtration cycle and excessive foaming is therefore avoided. It
Therefore, it is used mainly for the mixing of semisolids. is also a useful criterion for testing membrane efficiency.
The ribbon blender consisting of a horizontal tank Flash point is a test for the flammability and
usually opening at the top and fitted with helical blades that combustibility of aerosols.
are mounted on a shaft blades that are mounted on a shaft
through the long axis of the tank and are often both right and
left hand twist 55. Filtration of a solution to a high degree of clarity
The twin shell V blender having form of a cylinder A. Polishing
that has been cut in half at approximately a 45 degrees angle B. Dialysis
with its long axis, and then rejoined to form a “V” shape is C. Clarification
rotated so that the material alternately is collected in the D. Dissolution
bottom of the V and then split into two portions when the V
is inverted. Polishing may be accomplished in several ways:
1.) by settling and subsequent decantation
2.) by centrifugation
53. Tablet excipient used to make a reasonably sized tablet 3.) by filtration
A. Binders Filtration is the only practical method when large
B. Diluents volumes of liquid are involved.
C. Disintegrants The term clarification applies when the solid do not
D. Glidants exceed 1.0% and filtrate is the primarily product.
Diluents or bulking agents are substances that

usually make up the major portion of the tablet. The principal 56. This part of the tablet compression equipment stores
substance used is Lactose, USP. Other example of diluents materials to be compressed
include starches, mannitol, sorbitol and microcrystalline A. Hopper
cellulose. B. Feed frame
Binders are substances that bind powders together C. Die
and make them cohesive. They are the adhesive in the D. Punch
formulation. Examples are acacia, sucrose, starch paste,
gelatine solutions, PVP and hydroxypropylmethylcellulose.
 Hopper - for storing the materials for compression
 Feed frame - for distributing the materials into the
dies
 Dies – for controlling the size and shape of the tablet
 Punches – for compacting the materials within the
dies; they also shape the tablet
PRACTICE SET 9. The insoluble dyes or lakes used for coloring tablets
contain
1. An inert gas that is usually incorporated in ampul A. Aluminum hydroxide
A. Hydrogen B. Potassium hydroxide
B. Oxygen C. A and B
C. Nitrogen D. Ferric oxide
D. Ethylene oxide
10. Which method of producing granules is best suited for
2. A document which gives a detailed instruction or receipt non-volatile fatty acids?
for a product to be manufactured is the A. Slugging
A. Prescription B. Spray drying
B. Formula order C. Spheronization
C. Master formula D. Spray congealing
D. Compound sheat
11. Powdered and granulated products have the following
3. Parenteral substances are filtered for advantages except:
A. Clarification A. Recommended for dispensing potent drugs with a low
B. Filtration dose
C. Obtaining polished solution B. Suitable for drugs which are inactivated in the stomach
D. Any of the above C. None of the above
D. As convenient as liquid products
4. Smallest size for hard gelatine capsules is
A. 000 12. Gradual sedimentations in liquid product is due to:
B.5 A. Chemical reaction
C. 3 B. Decomposition
D. 1 C. Bacterial growth
D. Any of the above
5. Type of emulsion which is potentially useful for prolonged
action or parenteral preparations 13. Gradual sedimentation is due to:
A. o/w A. Exposure to light
B. w/o B. Incompatibilities
C. Multiple emulsion C. A and B
D. Any of the above D. NOTA
6. Control limit within 3 standard deviation of the mean 14. The responsibility of an organization to determine that
A. Acceptable limit system facilities and written procedures are both adequate
B. Warning limit and followed in final dosage form all the applicable
C. Action limit specifications
D. Any of the above A. Quality control
B. Quality assurance
7. Manufacturing tanks of most pharmaceutical liquids C. Both A and B
should be made of D. NOTA
A. Galvanized iron
B. Glass 15. The quality of a medicinal and related product is the sum
C. Stainless steel of all factors which will contribute directly or indirectly to the
D. Plastic products:
A. Safety
8. The tank used in compounding ointments is B. Effectiveness
A. Transport C. Acceptability
B. Steam jacketed D. AOTA
C. Storage
D. All of the above 16. Factors that accelerate instability include
A. Gravity
B. Agitation
C. Packaging
D. AOTA
25. The QC manager is in-charge of the following sections
17. Factors that accelerate instability include: except:
A. pH A. Specification and analytical development
B. Humidity B. Analytical laboratory
C. Radiation C. Research and Development section
D. AOTA D. Biological testing
18. Any unknown random cause which is inevitable and can 26. Total quality means:
be predicted A. Production is responsible for quality
A. Change cause B. QC’s strict adherence to standards
B. Assignable cause C. Quality is everybody’s business
C. AOTA D. AOTA
D. NOTA
27. The following are functions of the specifications and
19. Fines are used to analytical development section except:
A. Fill interparticulate spaces A. To develop new assay methods for in-house use
B. Form bridges between tablets B. To furnish data that will aid in analyzing product
C. NOTA performance in the market
D. A and B C. To validate existing and tentative procedures for testing
D. To coordinate with research, production, sales and
20. Flowers of sulfur is prepared by: management towards improvement of a product.
A. Sublimation
B. Evaporation 28. Standard operating procedure is:
C. Filtration A. A step by step method on how to go about a job
D. Precipitation B. Done to facilitate recall
C. Concerned with record keeping
21. Cerates are made by: D. AOTA
A. Maceration
B. Fusion 29. One of the following is used as a clarifying agent for liquid
C. Emulsification preparations:
D. Ignition A. Parabens
B. Citrates
22. Rule of thumb is for testing C. Gelatin
A. Ampules D. PEG
B. Hypodermic tablets
C. Compressed tablets 30. Investigations on specific physiological action of a
D. Tablets substance that affects life’s processes, isolation, such as
enzymes, vitamins, hormones, etc.
23. Provides sterile environment for a confined space: A. Pharmaceutical Research and Development
A. Laminar flow hood B. Pharmacological Research
B. Air filter C. Clinical Research
C. UV light D. Biochemical research
D. Gamma radiation
31. Department in a pharmaceutical firm that conducts
24. To control raw material and finished products in the check-ups of its employees preparation of “literature” or
warehouse, the practice of: “package inserts” and publication of clinical researches and
A. First in, first out investigations
B. Statistical quality control A. Medical Department
C. Last in, first out B. Personnel Department
D. AOTA is strictly d0ne C. R and D Department
D. Pharmacological Research
32. The complete obstruction or elimination of microbial life: 40. Presentation samples of all pharmaceutical products
A. Asepsis should be kept by Quality control and monitored yearly for
B. Disinfection sign of deterioration. The length of time these samples
C. Sterilization should be stored:
D. Sanitation A. I year
B. 2 years
33. Which of the following drug substances is not suited for C. 3 years
powder dosage form? D. 1 year after expiration date of the product
A. Anhydrous material
B. Eutectic mixture 41. Functions of package include:
C. Bulky materials A. To provide presentation
D. Efflorescent materials B. To provide containment
C. For communication
34. Using a sampling plan by square root system, the sample D. AOTA
size required for 90 containers of Ascorbic acid powder is:
A. 9 containers to be sampled 42. Amaranth USP is used in pharmacy as a/an:
B. 10 A. Flowering agent
C. 11 B. Preservative
D. 7 C. Coloring agent
D. Anti-oxidant
35. Antibiotics and insulin products can be released for
distribution by: 43. The number of linear openings per square inch
A. Quality control of the company A Sieve
B. Marketing department of the company B. Mesh
C. FDA C. A and B
D. AOTA D. NOTA
36. The percentage allowance for error in high speed 44. Suppositories which are administered vaginally
automatic filling machine is: A. Bougies
A. 0.5 – 1.0 % B. Pessaries
B. 3.0 – 5.0% C. A and B
C. 0.10% D. NOTA
D. 102.0%
45. Areas of concern during production of parenterals include
37. Pfizer tester that determines force to break a tablet is to A. Production facilities
measure disintegration: B. Components
A. Hardness C. Production procedures
B. Thickness D. AOTA
C. Friability
D. Disintegration 46. Material of choice for uniforms used in parenteral
production
38. This dosage form does not have to conform with USP A. Cotton
disintegration time B. Rayon
A. Film tablet C. Linen
B. Sugar coated D. Dacron
C. Enteric coated tablet
D. Chewable tablet 47. Package component used to counteract moisture
brought to the container system
39. Minimum satisfactory hardness of tablets A. Coil
A. 2kg B. Dessicant
B. 3 kg C. Closure
C. 4 kg D. AOTA
D. 5 kg
48. Lubricants may be added through ANSWER KEY:
A. Bolting 1. C 26. C
B. Spraying 2. B 27. B
C. A and B 3. D 28. A
D. NOTA 4. B 29. C
5. C 30. D
49. The USP recommended excess for multiple dose 6. A 31. A
parenterals 7. C 32. C
A. 1-3% 8. B 33. B
B. 6-8% 9. A 34. B
C. AOTA 10. D 35. C
D. NOTA
11. D 36. C
12. D 37. D
50. Punches in tablet making control
13. C 38. D
A. Hardness
14. B 39. A
B. Size and shape
C. Solubility 15. D 40. D
D. Color 16. D 41. D
17. D 42. C
18. A 43. B
19. D 44. B
20. A 45. D
21. B 46. D
22. C 47. B
23. A 48. C
24. A 49. B
25. C 50. B
Module 5
Pharmaceutics
Drug Delivery System, Manufacturing, Physical Pharmacy,

Jurisprudence
Kathreen Mae D. Cascabel

BSPharmacy
Drug Delivery System
DRUG
o Article intended for the use in diagnosis, mitigation, cure, treatment, or prevention of disease in man/animals
o Article (other than food) intended to affect the structure of any function of the body of human beings or animals
o Component which produces pharmacologic activity (Active Pharmaceutical Ingredient)
o Therapeutic moiety
EXCIPIENTS
o Inactive ingredient present in DF
DOSAGE FORM
o Formulation containing a specific quantity of AI(s) in combination with one or more excipients
DRUG PRODUCT/MEDICINE
o Final dosage form that contains the API, generally, but not necessarily, in association with other ingredients
DRUG DELIVERY SYSTEMS

o Physical carriers used to deliver medications to specific areas
o Means of administering drugs to the body in a safe, efficient, reproducible and convenient manner
USP Requirements
1. Natural products should be free from Salmonella spp.
2. Oral Solutions and suspensions should be free from E. coli.
3. Topical products must be free from Pseudomonas aeruginosa
4. Urethral, vaginal and rectal should be free from total microbial count
o
Manufacturing
The complete set of activities to produce a drug that comprise production and QC from dispensing of materials to the
release for distribution of the finished product (AO 43 s 1999)
Drug Establishment
o any organization or company involved in the manuf, import, packaging and/or distribution of drugs or
medicines (AO 56 s 1989)
Manufacturer Production of drug AO 56 s 1989 and IRR of RA 9711

Trader Registered owner, subcontracts the manufacturer, may AO 56 s 1989 and IRR of RA 9711
also engage in distribution and marketing
Distributor/ Imports/exports for own use or wholesale distribution IRR of RA 9711
Importer/Exporter to other establishments
Distributor/ Procures from a local establishment for local IRR of RA 9711
Wholesaler distribution on wholesale basis
Intermediate Product
more stages of production
Bulk Product
packaging
Finished Product
Good Manufacturing Practice (GMP)

o Part of QA which ensures that products are consistently produced and controlled to the quality standards
appropriate to their intended use (WHO, 2007)
o System of QA aimed at ensuring that products are consistently manufactured to a quality appropriate for their
intended use and is concerned with both manuf and QC processes and procedures (AO 43 s 1999)
o Examples: US FDA, WHO, EU, ASEAN, PIC/S
o PIC/S GMP 2009 (Pharmaceutical Inspection Convention/Co-operation Scheme)
PACKAGING (Primary or Secondary)
CONTAINER – holds the drug product and is or may be in direct contact with the drug product
Well-closed - protects from extraneous solids and loss of article
Tight - protects from contamination by extraneous liquid, solids, vapors, loss,
efflorescence, deliquesence, or evaporation
Hermetic - impervious to air or any other gas
Single-dose - holds a quantity intended for single dose; cannot be resealed
Multiple-dose - permits withdrawal of successive portions
Single-unit - holds a quantity of a drug intended for admin as a single dose promptly after opening
Multiple-unit - contains more than a single unit or dose
Light-resistant
Child-resistant - not for under 5 years old
Tamper-evident - uses an indication or barrier to entry distinctive by design
Compliance packaging
PACKAGING MATERIALS
1. Glass – available in white flint (clear), amber, or colored
I – borosilicate
II – treated SL (exempted form water attack test)
III – soda lime
NP – gen. SL
2. Plastic
Polyethylene, Polyvinyl chloride, Polypropylene, Polystyrene
Problems: Permeability, Leaching, Sorption, Light transmission, Alteration upon storage
3. Metal – tin, aluminum, aluminum alloy

4. Paper and Board – labels, cartons, layer boards
5. Films, foils and laminations – sachets, seals, strips, blisters
6. Rubber – closure for sterile products
STORAGE CONDITIONS
TERM CONDITION
Cold Not exceeding 8°C
Freezer -25 to -10°C
Refrigerator 2 to 8 °C
Cool 8 to 15°C
Controlled Room Temperature 2 to 8°C but allows excursions between 0 to 15°C
Room Temperature 20 to 25°C (prevailing in working area)
Warm 30 to 40°C
Excessive Heat Above 40°C
Dry Place Does not exceed 40% of average RH at Controlled RT
Monograph Document that specifies all the tests to be conducted on a product and/or appropriate
references containing details of procedure and expected result
Certificate of Document with the results of all tests conducted on material to show compliance or non-
Analysis compliance with the standard specifications
Formula This is concise and precise statement of the ingredients that comprise the product,
together with the percentage and/or weight of each.
Raw material This should enumerate the characteristics of all the materials that go into the product and
specification the permissible range of purity of each ingredient.
Standard Operating This is a step by step method on how to go about a job.

Procedure
Finished product This should cover all characteristics that affect the proper performance, purity, safety and
specification stability of the product.
Sample Finite number of objects selected from a batch
STABILITY
o Capacity of drug to remain within specifications
o Minimum Acceptable Potency Level: 90% Labeled Potency
OVERAGE – excess medicaments in manufacturing unstable drugs
A 15% decrease in potency of antibiotics is considered admissible for unstable antibiotics, but the ff overages
normally should not exceed:
1. 15% - dry DFs
2. 20% - fluids
3. 25% - ointment, suppositories, aerosols, creams, and foams
SOLID DOSAGE FORMS
POWDERS
o Intimate mixtures of dry, finely divided drugs and or chemicals (internal or external use)
o Adv: flexibility in compounding | D/A: easily wetted by liquids, inaccuracy of dose, not for hygroscopic
Comminution of Drugs
• Trituration or Comminution – mortar and pestle (small scale)
• Milling – cutter mill, roller mill, hammer mill (large scale)
• Levigation – form a smooth paste (L agent: mineral oil, glycerine, propylene glycol)
• Pulverization with Intervention – addition of a volatile solvent (camphor + OH, iodine crystals + ether)
Particle Size
Very Coarse (no. 8)
Coarse (no. 20)
Substances that form eutectic mixtures:
Moderately Coarse (no. 40)
Camphor
Fine (no. 60) Menthol
Very Fine (no. 80) Thymol
Aspirin
Blending Powders Phenyl salicylate
• Trituration
Inert diluents to prevent eutexia:
• Spatulation Light magnesium oxide
• Sifting/Lifting Magnesium carbonate
• Tumbling
• Geometric dilution – for potent substances
Types of Powders:
Medicated Powders – intended to be used internally or externally
Aerosol Powders – administered by inhalation with the aid of dry-powder inhalers
Bulk Powders – medicated preparations provided to the patient in bulk (non-potent medicaments)
1. Oral – also antibiotic syrups reconstituted before use
2. Dentifrices – cleansing and polishing the teeth; may contain fluoride
3. Douches – intended for the cavity
4. Dusting Powders – formulated in sifter-top
5. Insufflations – medicated powders designed to be blown into the ear, nose, throat or
body cavities by means of a device known as an insufflator
6. Triturations – the finely powdered, medicinal substance is ground for a certain time in
a mortar and pestle with a certain proportion of sugar and milk
Divided Powders – “chartula” each dose is separately wrapped in paper or sealed in a sachet (for potent)
1. White bond – no moisture-resistant properties
2. Vegetable parchment – limited moisture resistant qualities
3. Glassine – moisture-resistant paper
4. Waxed – waterproof
CAPSULE
o SDF in which medicinal agents and or inert substances are enclosed in a small shell of gelatin
o Gelatin is prepared by the enzymatic hydrolysis of collagen, which is the main protein constituent of connective
tissues in animal bones and skin
Gelatin A (acid hydrolysis of porcine skin)
Gelatin B (base hydrolysis of bovine bones)
o Bloom strength – measure of gelatin rigidity (HGC: 200-250g; SGC: 150g)
Hard Gelatin Capsules (Dry Filled Capsules)

used in extemporaneous compounding Capsule Size Capacity (mL)
shell made from gelatin + sugar + water 000 (veterinary) 1.40
parts: capsule body and cap 00 0.95
0 0.68
+ 0.15% sulfur dioxide to prevent decomposition during manufacture
1 0.50
12-15/13-16% moisture
2 0.37
3 0.30
Processes:
4 0.21
1. Punch Method 5 0.13
2. Hand-operated Filling Machine
Soft Gelatin Capsules

made of gelatin + glycerin or polyhydric alcohol (sorbitol) for elasticity and plasticity
5-8/6-10% moisture
Used for:
Water-immiscible volatile and non-volatile liquids
Water-miscible non-volatile liquids
Water-miscible and relatively non-volatile compounds
Processes:
1. Plate process (Upjohn Co.)
2. Rotary die process (Robert P. Scherer, 1933)
3. Reciprocating die process – Norton Capsule Machine; vertical; continually open and close
4. Accogel Capsule Machine ( Lederle Laboratories, 1948) – can fill dry powder into softgels
TABLET - mixture of active substances and excipients, usually in powder form, compacted into a solid
COMPRESSED TABLETS (made by Wet granulation, Dry granulation, Direct compression)

Sugar Coated (SCT) - sugar fpr palatability; adds 50% to tablet bulk
Chewable Tablets - broken and chewed before ingestion; mannitol (50% of tablet bulk); xylitol (sugar free)
Film Coated (FCT) - coated with a thin layer of a polymer capable of forming a skinlike film; less bulky
Enteric Coated (ECT) - disintegrate in intestinal fluid; delayed release
Multiple Compressed (MCT) - compressing the fill material more than once
a. Layered (multiple layered)
b. Press-coated/Dry coated (tablet within a tablet)
Controlled Release (CR) - aka prolonged release or sustained release; releases the med over a period of time
Tablets for Solution - ex. Halazone tablets and KMnO4 tablets for solution
Effervescent Tablets - compressed granular effervescent salts; Na bicarbonate + citric acid + tartaric acid
Buccal Tablets - dissolved at the buccal/cheeks of the mouth
Sublingual Tablets - dissolved under the tongue
Immediate Release - designed to release their medication with no rate controlling features
Modified Release - have drug release features based on time, course, and/or location
Extended Release - aka Controlled Release; release medication over an extended period
Delayed Release - release at a time other than promptly after administration
Repeat Action - 2 single doses, one for immediate, another for delayed
Targeted Release - directed towards a region, tissue, or site of absorption
MOLDED TABLETS/TABLET TRITURATE (small, usually cylindrical tablet w/ small amounts of potent drugs)
Dispensing Tablets (DT) - aka Compounding Tablets; for extemporaneous compounding, never dispensed as DF
Hypodermic Tablets (HT) - no longer used because of the difficulty in achieving sterility
Vaginal Tablets - aka Vaginal inserts; bullet or ovoid shaped inserted for local or systemic effects
OTHER SOLID DOSAGE FORMS FOR ORAL ADMINISTRATION

Contains one or more medicinal agents in a flavoured, sweetened base intended to dissolve
Lozenges
slowly in the mouth
Lollipops Sugar based lozenges on a stick and contain fentanyl citrate
Troches Compressed lozenges; discoid shaped
Molded lozenges
Pastilles
Softer and has a higher concentration of sugar or gelatin
Inserts SDF other than suppositories for insertion to body orifices
Small, sterile SDF containing a concentrated drug for SC implantation where it continuously
Implants/Pellets
release the medication over long periods
EXCIPIENTS
ESSENTIAL COMPONENTS
Diluent/Bulking Agent Advantages Disadvantages
Lactose Inexpensive Lubricants required
Readily soluble Binders may have to be added when
Coarse granular (60-80) High MP (202°C) other substances interfere with
Regular (100) cohesion
Spray-dried (100-120) Advantages of spray-dried:
Flows readily (spherical granules)
Flow maintained even when wet
granulated
No need for binders
For direct compression method
Starches Also used as binders and disintegrants
Provide moisture balance even though
moisture content is 12-14%
Stabilize hygroscopic drugs (protect
them from deterioration)
Mannitol For water-sensitive drugs Expensive
For chewable (sweet, negative heat of
solution – cooling sensation)
Sorbitol For direct tableting Very hygroscopic above 65% RH
Sucrose Provide additional sweetness Somewhat hygroscopic (should only be
Serves as binder (cohesive) in small ratio)
Contributes to dissolution (readily Turns brown with acidic or basic subst
soluble)
Microcrystalline Cellulose For direct compression Needs lubricant (when drug is present)
(Avicel) At 5-15% conc in wet granulations: Expensive
a. Minimizes tablet hardening
b. Reduces mottling
Binders/Granulators – provide mechanical strength

Starch Paste 10-20% w/w
Aqueous gelatin solution 10-20% w/w
Aqueous glucose solution 25-50% w/w
Alcoholic solution of ethylcellulose 5% w/w
Others Acacia, Alginic acid, Compressible sugar (Nu-Tab), Povidone
Disintegrants
Starches Corn and Potato
Clays Bentonite and Veegum
Cellulose Methylcellulose, Sodium Carboxymethylcellulose, Microcrystalline cellulose (Avicel)
Algins Alginic acid and sodium alginate
Gums Locust bean, karaya, guar, tragacanth, agar
Effervescent mixtures Disintegrates rapidly
COMPRESSION AIDS
Glidants Enables to flow from hopper Silicon dioxide (Cabosil)/Colloidal silica

Cornstarch
Talc
Lubricants Prevent adhesion to dies and punches Talc
Reduce friction Stearates
Release tablet from die Mineral oil
May improve flow Stearic acid
Antiadhesives Prevent residue films on punches Magnesium stearate
Talc
SUPPLEMETARY COMPONENTS
Colors FD&C # Name

Lakes (Al(OH)3; insoluble in water) Blue #1 Brilliant Blue
Blue #2 Indigotine
Pastel shades - colorants of choice (least likely to show mottling)
Green #3 Fast Green
Red #2 Amaranth
Approaches to add colorants: Red #3 Erythrosine
1. Incorporate soluble dye (0.3% max) before granulation Red #40 Allura Red
2. Adsorb the dye on starch or Ca sulfate Yellow #5 Tatrazine
3. Blended dry with portion of diluent dry mixing Yellow #6 Sunset Yellow
Flavors Sweet Honey, fruits, berries, maple, vanilla

Oils and spray dried beadlets Bitter Chocolate, anise, cherry mint, nut, fennel
Never added during wet processing (volatile) Sour Citrus, rootbeer, anise, cherry, strawberry, licorice
Salty Butterscotch, maple, peach, melon, raspberry
Metallic Grape, lemon, lime
Alkaline Chocolate, cream, vanilla, mint
Sweetening agents Diluents Sucrose, Lactose, Dextrose

Saccharin 250-500x, bitter aftertaste
Aspartame 200x
Mannitol 70%
Xylitol sugar free
Na cyclamate
Sucrose Disadvantage: cap-locking (syrups/LDFs)
Adsorbents
Silicon dioxide Can hold up to 50% of its weight in water
Others Mg carbonate/ hydroxide, Bentonite, Kaolin, Mg Al silicate, Tricalcium phosphate, dried starch
Parts of Tablet Press
1. Hopper - stores materials for compressing
2. Feed frame - distributes materials into dies
3. Dies - controls the size and shape of the tablet
4. Punches - compacts materials within the dies (also controls shape)
5. Cams - guide the punches
Types of Tablet Press

1. Single-punch press/eccentric press – about 200 tabs per min
2. Rotary press/multi station press – over 10,000 tabs per min
Tablet Manuf: Powder mixing Granulation Die filling Powder/granule compression Tablet ejection
Common Tablet Processing Problems

1. Chipping - separation of small piece of tablet surface after ejection
2. Capping - partial or complete separation of top and bottom from the main body
3. Lamination - 2 or more distinct layers
4. Picking - removal from tablet surface and adherence to the face of the punch
5. Sticking - adhesion to die wall
6. Mottling - unequal color distribution
7. Bridging - stick to the sides of the hopper
8. Weight variation
9. Hardness variation
10. Double impression
GRANULES
o moistening the desired powder and passing the moistened mass thru screen in the 4 to 12 mesh sieve;
o consists of powder particles that have been aggregated to form a larger particle (0.2-4mm)
o Must possess: Fluidity and Compressibility
Effervescent Granulated Salts (sodium bicarbonate, citric acid, and tartaric acid)
Citric acid only – sticky | Tartaric acid only – crumble
Prepared by: Fusion method or wet method
Wet granulation (widely used) Dry granulation/Fusion/Force Compression

1. Wet massing 1. Roller compaction/Roll press
2. Fluidized bed 2. Slugging (“slug” is a large crude tablet,
25mm in diameter by 10-15mm thick)
Mill Weigh Mix Granulate Screen Weigh Mix Slug Screen
Dry Dry screen Lubricate Compress Disintegrant/Lubricant Compress
Other granulation processes:

1. Spheronization - uses Marumerizer machine (Elanco)
2. Spray-drying - bring together highly dispersed liquid and hot air evaporation & drying
3. Spray-congealing - aka spray chilling; no heat applied
TABLET COATING
Pan coating - sugar and film; coating pans provided with hot and cold air
Air suspension coating - film; coating material is atomized and applied to tablets as they are suspended (chamber)
Dip coating - placed in baskets and dipped into containers of coating solutions
Compression coating - for two incompatible drugs
1. Sugar Coating
a. Sealing /Waterproofing (shellac, cellulose acetate phthalate, polyvinyl acetate phthalate, zein)
b. Subcoating (gelatin, acacia gum, Ca carbonate, talc)
c. Syruping/Smoothing/Color – cover and fill imperfections
Grossing
Heav syruping
Regular sruping
d. Finishing
e. Polishing (beeswax, carnauba wax)
f. Imprinting
2. Film Coating (Pan pour, Pan spray, Fluidized bed) – involves the deposition of a thin film of polymer
Film former Produce smooth, thin films Cellulose Acetate Phthalate
Alloying substance Provide water solubility/permeability Polyethylene glycol
Plasticizer Flexibility and elasticity Castor oil, Propylene glycol, PEGs
Surfactant Enhance spreadability of the film Polyoxyethylene sorbitan derivatives
Opaquants, Colorants Aesthetic Titanium dioxide, FD&C, D&C
Sweeteners, Flavors Patient acceptability Saccharin, Vanillin
Glossant Luster Beeswax
Volatile solvent Spread of other components over the tab Alcohol + Acetone
Film coating problems:

Picking - small flaking
Peeling - large flaking
Orange-peel effect - roughness of surface due to failure of spray droplets to coalesce
Mottling - uneven color distribution
Bridging - filling in of score lie or logo
Tablet erosion - disfiguration of the core when subjected in the coating for too long
3. Microencapsulation – modified form of film-coating differing only in particle size

4. Press/Compression coating – compact of granular material around an already preformed tablet core
5. Electrostatic coating – to apply films in conductive materials
6. Laminated coating – provide a second action or layer of medicament
7. Enteric Coating – Shellac, Hydroxypropyl methylcellulose phthalate, polyvinyl acetate
phthalate, diethyl phthalate, cellulose acetate phthalate
SEMI-SOLID DOSAGE FORMS
OINTMENTS - Semisolid preparations for external application to the skin or mucous membrane
Preparation:
1. Incorporation – trituration in a mortar or an ointment slab
2. Fusion – melted together and cooled until congealed
Ointment Bases Description Examples

Emollient
Petrolatum/Petroleum jelly
Protect against escape of moisture
White petrolatum
Oleaginous/Hydrocarbon Occlusive dressings
Yellow/Simple ointment
Remain on skin w/o drying
White ointment
Difficult to wash off
Permit incorporation of aqueous solutions Lanolin (0.25% water)

resulting in w/o emulsion (Anhydrous) Hydrophilic petrolatum
Absorption (anhydrous)
Permit incorporation of additional quantities of Anhydrous lanolin (25-30%)
aqueous solutions (w/o emulsions) Cold cream
O/W emulsions resembling creams

Hydrophilic ointment
Water-removable/Washable Easily washed
Vanishing cream
Can absorb serous discharges
No oleaginous components
Completely water-washable
Water-soluble/Greaseless Soften greatly with water PEG (Carbowax)
Large amounts of water is NOT added
For incorporation of solid substances
CREAMS
o Semisolid preparations containing one or more medical agents dissolved or dispersed in either a W/O emulsion or
another type of water washable base (O/W)
o O/W Type: Shaving creams, hand creams and foundation creams
o W/O Type: Cold creams (+ Na borate as antifungal preservative) and Emollient creams
o Vanishing creams: o/w containing large percentage of water and stearic acid
GELS
o Dispersions of small or large molecules in an aqueous liquid vehicle rendered jellylike by adding a gelling agent
Synthetic macromolecules - Carbomer 934
Cellulose derivatives - Carboxymethylcellulose, hydroxypropylmethylcellulose
Natural gums - tragacanth
o Singe Phase Gels macromolecules are uniformly distributed throughout a liquid
o Two-phase Systems/Magma if particles of dispersed phase are relatively large; has small distinct particles
DRESSING – resemble ointments, for burns; remain semisolid at body temperature, liquefy at 50°C
PASTES – for skin application, thicker, stiffer, less greasy, more absorptive of serous secretions than ointments
PLASTERS – semisolid or solid adhesive masses spread on a backing of paper, fabric, moleskin, or plastic adhesive
GLYCEROGELATINS – long-term, applied with a fine brush
gelatin (15%)
glycerin (40%)
water (35%)
medicinal substance (10%)
TERMS:
Imbibition – taking up liquid without measurable increase in volume
Syneresis – gel sinks, loss of liquid
Swelling – taking up liquid with increase in volume
Thixotropy – reversible gel-sol formation with no volume or temperature changes
Xerogel – liquid is removed, framework remains
TRANSDERMAL PREPARATIONS
o With penetration enhancers Example Transdermal Preparations
– Dimethyl sulfoxide (DMSO)
– Ethanol Scopolamine - motion sickness
– Oleic acid Nitroglycerin - angina
– Acetone Clonidine - hypertension
– Azone Nicotine - smoking cessation adjunct
– Propylene glycol Estradiol - menopausal symptoms
– Urea Testosterone
– Dimethyl acetamide Contraceptives
– SLS
– Poloxamers (SPANS, TWEENS, Lecithin, Terpenes)
o Advantages:
– Avoid GI absorption difficulties
– Substitute for oral
– Avoid first pass effect
– Noninvasive
– Extended therapy with single application
– Extends half-life of drugs
– Can be terminated rapidly
– Easily identified in emergencies
o Disadvantages:
– Only for potent drugs
– Contact dermatitis
SUPPOSITORIES AND INSERTS
SUPPOSITORIES – intended for insertion to body orifices

Stiffening agents: Cetyl alcohol, Cetyl ester wax, Microcrystalline wax, Paraffin, Stearyl alcohol, White/Yellow wax
Sodium stearate – solidifier for glycerine suppositories
Synonym Weight Length Shape Example
Vaginal Pessaries 5g 70 mm Globular, oviform, cone Glycerinated gelatin
Urethral Bougies 4g 140 mm Pencil PEG
Rectal 2g 32 mm Cylindrical with ends tapered Cocoa butter
Bullet/torpedo
Suppository Bases
1. Fatty/Oleaginous Bases
• Cocoa butter – exhibits polymorphism (melts at 30 to 36°C)
Phenol and Chloral hydrate (lowers MP of cocoa butter)
Remedy: Cetyl ester wax (20%) or Beeswax (4%) – solidifiers
• Wecobee oil – coconut oil
• Witepsol oil – fatty acid (c12-c18)
• Hydrogenated FAs of vegetable oils (Palm kernel oil and cottonseed oil)
• Glyceryl monopalmitate, glyceryl monostearate
2. Water-soluble and Water-miscible Bases

• Glycerinated gelatins – gelatin (20%) glycerin (70%) medication (10%); vaginal, hygroscopic
• Polyethylene glycols – does not melt at body temp; dissolve in body fluids
3. Miscellaneous Base
• mixtures of oleaginous and water-miscible bases
• Polyoxyl 40 stearate (MP: 39 to 45°C)
Preparation:
1. Hang molding
2. Cold Compression
3. Fusion/Melt molding/Pour molding
Packaging
1. Tightly closed glass containers
2. Compartmented boxes
3. Opaque material (metallic foil)
4. Continuous strip
5. Slide boxes
6. Plastic boxes
LIQUID DOSAGE FORMS
Solutions - liquid preparation which contains one or more substances dissolved in a suitable solvent
Solubility – maximum concentration to which a solution can be formed Methods of Preparing Solutions
Very soluble <1 Simple Solution
Freely soluble 1-10 Application of Heat
Soluble 10-30 Addition of a Co-Solvent
Sparingly soluble 30-100 Rigorous Agitation
Slightly soluble 100-1,000 Solution by Extraction
Very slightly soluble 1,000-10,000 o Liver solution
Practically insoluble >10,000 Solution by Chemical reaction
o MgCO3 + Citric Acid
Mg Citrate + CO2
WATER
o most commonly used solvent
o USP recognizes 7 types of water for DF preparation
Purified water Obtained by distillation, ion-exchange, reverse osmosis, etc.

ph 5-7 Preparation of aqueous dosage forms EXCEPT parenterals
Purified water FREE of pyrogens

WFI Obtained by distillation or reverse osmosis
For parenterals that are to be sterilized after preparation
WFI sterilized and packaged into single-dose containers < 1 Liter

SWFI
Used for already sterilized and packaged medication
SWFI that contains antimicrobial agent

BWFI
Single or multi-dose containers < 30 mL
Distillation or reverse osmosis and rendered sterile inhalation

SWF Inhalation
Not for parenterals
WFI sterilized and suitably packaged

SWF Irrigation “For irrigation use only, Not for injection”
Agua Oxinada
Burrow’s Solution (Aluminum Acetate Solution)
PW sterilized and suitably packaged

Sterile Purified Water
Not for parenterals
AQUEOUS SOLUTIONS (clear liquid prescriptions, and homogeneous in nature)
Used both as a vehicle and as a solvent for the desired flavoring or medicinal
Waters
ingredients
Aromatic Waters A clear saturated aqueous solution (unless otherwise specified) of volatile oils or other
(medicated aromatic or volatile substances
waters)
Preparation of Aromatic Waters:
Flavored vehicle for
water soluble drugs
1. Distillation/Cohobation (Stronger Rose Water NF)
2. Solution Method
Aqueous phase in (Dissolve 2mg/mL v.o in 1L water; stay overnight and filter off excess oil)
some emulsions or 3. Alternate Solution Method
suspensions
(Triturate 2mg/2mL v.o with talc clarifying agent; dissolve in 1L water and filter)
Aqueous Acids
Prepared by diluting the corresponding concentrated acids with purified water
(diluted acids)
Solutions Homogeneous mixture composed of two or more substances
Douches Directed against a part or into a body cavity for cleansing and antiseptic action (using
bulb syringe)
Evacuation enemas (Fleet Enema)

Enemas
Absorption/Retention enemas (Aminophylline)
Affect locally the site of disease (Hydrocortisone Enema)
Aqueous solutions frequently containing antiseptics, antibiotics and/or anesthetics

Gargles used for treating the pharynx and nasopharynx by forcing air from the lungs through
the gargles which is held in the throat (Golden Gargle: Fe + K + CO3 -2, Bactidol)
Mostly aqueous solution with some alcohol or glycerine present usually pleasantly
Mouthwashes flavored and often colored; employed for deodorant, refreshing or antiseptic effect
Local anti-infective - hexetidine and cetylpyridine chloride
Prepared from fresh ripe fruit, is aqueous in character and is used in making syrups
Juices
which are employed as vehicles (preservative: Benzoic acid)
NON-AQUEOUS SOLUTIONS
Alcoholic and Hydroalcoholic solutions

Elixirs Clear, pleasantly flavored, sweetened hydroalcoholic liquids for oral use
(5-40% OH) Contain alcohol and are thus incompatible with acacia, tragacanth and inorganic salts from
aqueous solutions as precipitation may occur
Aromatic Less sweet and less viscous than syrup
Elixir 22% 10-20% alcohol – self-preserving
Preparation of Elixirs:
1 Simple solution with agitation
2 Admixture of 2 or more liquid ingredients
Spirits Alcoholic or hydroalcoholic solutions of volatile substances
/Essences When mixed with water or other aqueous preparation, the volatile substances in spirits
(over 60%) generally separate from solution and form milky preparation
Preparation of Spirits
1 Simple Solution w/Agitation – Aromatic Spirit of Ammonia
2 Solution with Maceration – Peppermint Spirit
3 Chemical Reactions – Ethyl Nitrite Spirit/Amyl nitrite Spirit
4 Distillation
Brandy (Spiritus Vini Vitis) – distillation of fermented juice or ripe grapes
Whisky (Spiritus Frumenti) – fermented malted grain
Ethereal Solutions
Colloidons Liquid preparations containing pyroxylin in a mixture of 3 parts ether and 1 part alcohol
Pyroxylin (soluble gun cotton, nitrocellulose, collodion cotton) is obtained by the action of a
mixture of nitric and sulfuric acids on cotton
Flexible Colloidon – 2% camphor (water proof)

3% castor oil (flexibility)
Salicylic Acid Colloidon – flexible colloidon + 10% SA
Glycerine Solutions
Glycerites Solutions or mixtures of medicinal substances in nlt 50% by weight of glycerine; hygroscopic
Oleaginous Solutions
Liniments Intended to be rubbed on the skin (Embrocation)
Oleovitamins Fish-liver oils diluted with edible vegetable oil or solutions of the indicated vitamins (A and D)
Oleates Formed by reacting alkaloids, basic oxides or hydroxides with oleic acid
Toothache
Temporary relief of toothache by a small pledget of cotton (Clove oil, which contains eugenol)
Drops
Medicated Solutions for Vaporization
Inhalations Administered by the nasal route or oral respiratory route for either a local or systemic effect
Carried into the respiratory passage by the use of special delivery systems (ex. Aerosols)
Inhalants Carried by an air current into the nasal passage by virtue of the drug’s high vapour pressure
Topical Solutions
Sprays Aqueous or oleaginous solutions in the form of coarse droplets or finely divided powders
(usually to the nasopharyngeal tract or through the skin)
Astringents Constrict pores and precipitate proteins
Aluminum acetate, Aluminum subacetate , Calcuim hydroxide topical solution
Local Anti- These kill microorganisms when applied to the skin or the mucous membranes
infectives Povidone iodine, Thimerosal , Hydrogen peroxide topical solution
Extractives
These are preparations obtained from plants and animals with the aid of a solvent
Separation of medicinally active portions from inactive components
Methods of Extraction
1. Maceration Solid + solvent in stoppered container; allowed to stand for a period of time
2. Digestion Maceration with gentle heating
3. Percolation Maceration which involves the use of a percolator
4. Decoction Boiling in water for 15 minutes
5. Infusion Maceration in hot or cold water
Extracts Concentrated preparations of vegetable or animal drugs obtained by removal of active
constituents with suitable menstrua (6x as potent as crude drug); usually by percolation
3 forms of extracts
1. Semi-liquid Syrupy consistency
2. Pillular/Solid Plastic consistency; for ointments and suppositories
3. Powder For manufacture of tablets and capsules
Fluid Extracts Liquid preparation of vegetable drugs containing alcohol as solvent (100% tincture)
(1ml/1g drug)
Preparation of Fluid Extracts
A: Sets first 85% of the percolate & collect the weak percolate until exhaustion
C: Commercial
D: Boiling water (menstruum), alcohol (preservative)
E: Alternative for A; conducted in a longer column
Tinctures Alcoholic or hydroalcoholic solutions prepared from vegetable materials or from chemical subs
(15% to 80%)
Preparation
1. Process P (percolation) Belladona tincture
2. Process M (maceration) Sweet orange peel tincture
3. Simple solution Iodine tincture
SWEET OR VISCID SOLUTIONS
Syrups Concentrated aqueous preparations of a sugar or sugar substitute with or without added
60-80% flavoring agents and medicinal substances
Simple Syrup – concentrated solution of sucrose in purified water
Medicated Syrup – syrup containing a therapeutic or medicinal agent
Flavored Syrup – intended to serve as pleasant tasting vehicle or flavorant for medicines
Preparation of Syrups
1 Solution with the aid of heat
2 Solution by agitation
3 Reconstitution – addition of sucrose to a prepared medicated or flavored liquid
4 Percolation – passage of a solvent thru a bed of sucrose at 1mL/ min (Ipecac syrup)
Syrup/Simple syrup
- nearly saturated solution of sucrose (85% w/v or 65% w/v with a sp.gr. of 1.3)
- No need for preservative if it is to be used soon
- Sucrose substitutes: Sorbitol, Glycerine, Propylene glycol
- Nonglycogenetics: Methylcellulose, hydroxyl ethylcellulose
- Add 5 to 10% ethanol to prevent bacterial growth in surface dilution
Honeys Thick liquid preparations somewhat allied to the syrups, differing in that honey, instead of
syrup, is used as a base (invert sugar, chief constituent of honey)
Example: Squill Oxymel (oxymel mixture of honey and acetic acid)
Mucilages These are thick, viscid adhesive liquids prepared by:

Dispersion of gums in water
Extraction of mucilages and its principles from vegetable materials
Prone to decomposition (decrease in viscosity on storage) and they should never be made in
larger quantities than can be used immediately, unless preservative (benzoic acid) is added
Jellies Class of gels in which the structural coherent matrix contains a high portion of liquid (water)
Formulation
1. Solvent (aqueous & nonaqueous)
2. Co-solvent (ethanol, sorbitol, glycerine, propylene glycol)
3. Buffer (carbonates, citrates, gluconates, lactates, phosphates, tartrates, acetates)
4. Solubilizer (surfactants, cyclodextrins, complexing agents)
5. Density modifier (dextrose)
6. Isotonicity modifier (NaCl, dextrose, boric acid)
7. Viscosity enhancer (sucrose, PVP, HEC, carbomer)
8. Antifungal Preservative (parabens, benzoic acid, Na benzoate, Na propionate)
9. Antimicrobial Preserv. (benzalkonium Cl, Cetylpyridinum Cl, Chlorobutanol, Phenol, Thimerosal)
10. Antioxidant (Na meta/bisulphite, BHA, BHT, ascorbic acid, Na formaldehyde sulfoxylate)
11. Sweetener (sucrose, sorbitol, mannitol, xylitol, glycerine, aspartame, acesulfame K)
12. Coloring (natural, synthetic)
13. Flavoring (natural, artificial)
Sweet Honey, fruits, berries, maple, vanilla
Bitter Chocolate, anise, cherry mint, nut, fennel
Sour Citrus, rootbeer, anise, cherry, strawberry, licorice
Salty Butterscotch, maple, peach, melon, raspberry
Metallic Grape, lemon, lime
Clarification – removal/separation of a solid from a liquid, or a fluid from another fluid (by filtration or centrifugation)
Types of Filtration
1. Solid/fluid
2. Solid/gas
3. Fluid/fluid
Types of Filtration Equipment

1. Gravity filters
2. Vacuum filters
3. Pressure filters
Types of Industrial Centrifuge

1. Perforated - basket centrifuges/centrifugal filters (for separation of crystalline materials)
2. Tubular - bowl centrifuges/centrifugal sedimenters (for liquid-liquid separation)
Filter media
1. Filter cloth (woven)
Stainless wire
Cotton
Nylon (unaffected by microbes, can be autoclaved)
2. Nonwoven
Felt (for gelatinous solutions – ex. Asbestos pad)
Kraft paper (bonded fabric)
3. Membrane filter
4. Filter aids
Diatomite (diatomaceous earth, infusorial earth, celite, super cel)
Perlite
Cellulose
Asbestos
Carbon
Thrombus – within vessel
Emboli – carried by blood
STERILE PREPARATIONS
o Subject to special requirements in order to minimize the risks of microbe contamination, and of particulate and
pyrogen contamination
Parenterals - injection through one or more layers of skin or mucous membranes

Intravenous - vein; butterfly
Sterile Intra-articular - joint
Pyrogen-Free Intraspinal - spinal column Sites of IM injection:
Isotonic Intrathecal - spinal fluid
Adults: Upper Quadrant of Gluteus maximus
Intracardiac - heart Infants: Deltoid, Midlateral muscles of the thigh
Intramuscular - muscle
Intradermal/Intracutaneous
Subcutaneous/Hypodermic
Nasal Solutions - Administered to the nasal passages in drops or sprays
Otic - For instillation into the ear
Ophthalmic - For instillation into the eye
Irrigating Solutions - Wash or bathe surgical inclusions, wounds or body tissues “Not for injection, For Irrigation only”
VEHICLES
1. Water (specifically Water for Injection)
– Most frequently employed vehicle
– Total solids content: 10ppm
– Electrolytic measurement of conductivity: nmt 1 micromho (1 megohm, approx. 0.1 ppm NaCl)
2. Nonaqueous Solvents
– Polyethylene glycol, Propylene glycol, Fixed oils
PYROGENS
o Lipid substances associated with a carrier molecule, usually a polysaccharide but may be a protein
o Product of microbial metabolism (produces febrile reactions about an hour after injection)
Official tests:
1. Bacterial Endotoxin Test
Uses Limulus Amebocyte Lysate (LAL) from the horseshoe crab, Limulus polyphemus
Quantities defined in Endotoxin Units (EU)
3. Pyrogen Test
Done in rabbits
Nmt 10ml/kg IV within a period of nmt 10 minutes
Pass if: no rabbit shows individual rise in temp 0.6°C or above, sum does not exceed 1.4°C
Depyrogenation Method:
1. Adequate washing with detergent + dry heat sterilization for glasswares and equipment
2. Distillation for water
3. Adsorbents for antibiotics
ADDITIVES
Phenylmercuric nitrate
Thimerosal
p-hydroxybenzoic acid
Antibacterial/Antifungal For multiple-dose containers
phenol
Benzyl alcohol
Chlorobutanol
Ascorbic acid
Na meta/bisulfite
Na formaldehyde sulfoxylate
Reducing Agents
Thiourea
Hydrogen peroxide
Oxalic acid
Ascorbic acid esters
Blocking agents (blocks oxidation) Butylhydroxytoluene
Tocopherols
Ascorbic acid
Antioxidants Citric acid
Synergists (increases antoxidant effect) Citraconic acid
Phosphoric acid
Tartaric acid
Chelating agets Ethylenediaminetetraacetic acid salts
Nitrogen
Inert gases (displace oxygen)
Carbon dioxide
Acetates
Buffers Maintain required pH Citrates
Phosphates
Tonicity Contributors Isotonicity to reduce pain on injection site NaCl
CONTAINERS
Glass – Silicon dioxide tetrahedron; manufactured from glass tubings or by molding; Rubber closures to seal
I – borosilicate
II – treated SL (exempted form water attack test)
III – soda lime
NP – gen. SL
PRODUCTION Bubble test
1. Compounding - Measures efficiency
2. Filtration - membrane filter (3 microns); sterilization by filtration (0.3 microns) of membrane filters
3. Filling
4. Sealing - Ampuls – high temperature gas-oxygen flame (Tip/bead seal and Pull seal)
Leaker’s test (0.5 to 1% methylene blue) – not for vials and bottles
5. Sterilization
Sterilization Equipment Biologic Indicators Temp Time
Steam Autoclave B. stearothermophilus 121°C
Dry Heat Oven B. subtilis 150-170°C Nlt 2 hours
Ionizing Radiation Gamma and cathode rays Both + B. pumilus
UV light 2537 Å
Millipor Membrane filter
Gas Ethylene oxide B. stearothermophilus 50-60°C 4-16 hours
Beta propiolactone
Formaldehyde
Sulfur dioxide
Ethylene dioxide (plastics)
Tyndallization/ 100°C 30 mins
Intermittent Sterilization 80°C 1 hour
For 3 days
Surface disinfection
Clean Area
- An area, room, or zone, with defined environmental control of particulate and microbial contamination,
constructed and used in such a way as to reduce the introduction, generation and retention of contaminants
within the area
Airlock
- Enclosed space with two or more doors, which is interposed between two or more rooms, for the purpose of
controlling the airflow between those rooms when they need to be entered
Clean areas are classified according to the required characteristics of the environment:
Grade A
- High risk operations (filling, stopper bowls, open ampoules and vials, aseptic connections)
- Provided with laminar air flow work station with a HEPA filter (0.45m/s)
Most drugs: Horizontal airflow, positive pressure facility
Chemotherapeutic drugs: Vertical airflow, negative pressure facility
Curvilinear
Grade B
- For aseptic preparation and filling
- The background environment for grade A zone
Grades C & D
- Clean areas for carrying out less critical stages in the manufacture of sterile products
The description for clothing required for each grade:

Grades A & B
- Headgear should totally enclose hair and, where relevant, beard and mustache; it should be tucked into the
neck of the suit
- A face mask should be worn to prevent shedding of droplets
- Appropriate sterilized, non-powdered rubber or plastic gloves and sterilized or disinfected footwear should be
worn
- Trouser-legs should be tucked inside the footwear and garment sleeves into the gloves
- Protective clothing should shed virtually no fibers or particulate matter and retain particles shed by the body
Grade C
- Hair and where relevant beard and mustache should be covered
- A single or two-piece trouser suit, gathered at the wrists and with high neck and appropriate shoes or
overshoes should be worn; should shed virtually no fibers or particulate matte
Grade D
- Hair and where relevant beard and mustache should be covered
- A general overprotective suit and appropriate shoes or overshoes should be worn
- Appropriate measures should be taken to avoid any contamination from outside the clean area
US FED STD 209E cleanroom standards
3
maximum particles/ft ISO
Class
≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥5 µm equivalent
1 35 7.5 3 1 0.007 ISO 3
10 350 75 30 10 0.07 ISO 4
100 3,500 750 300 100 0.7 ISO 5
1,000 35,000 7,500 3000 1,000 7 ISO 6
10,000 350,000 75,000 30,000 10,000 70 ISO 7
6
100,000 3.5×10 750,000 300,000 100,000 700 ISO 8
DISPERSE SYSTEMS
Coarse Dispersions 10-50 μm Suspensions and Emulsions
Fine dispersions 0.5-10 μm Gels and Magmas
Colloidal dispersions 1 nm – 5μm
SUSPENSION (>0.5 mcm) – Two-phase system consisting of finely divided solid dispersed in a solid, liquid or gas
Properties:
- Settle slowly, easily dispersed with gentle shaking. Problem: Caking
- Particle size should remain fairly constant in long periods of undisturbed standing
- Pour slowly and evenly in the container
Particle Size Reduction:

1. Micropulverization
2. Fluid energy grinding/Jet milling/ Jet micronizing
3. Spray-drying
Preparation:
1. Comminute
2. Wetting agent – Levigation to displace air in the crevices of the particle to make drug penetrable
(surfactants with HLB 7-9, hydrophilic colloids, alcohol, glycerine, glycols)
3. Suspending agent dispersed in the vehicle is added to the melted powder by geometric dilution
Polysaccharides Acacia, tragacanth, alginic acid, xanthan
Cellulose derivatives Methyl-, hydroxyethyl-, Na carboxymethyl- (carmellose Na), Avicel
Hydrated silicates Bentonite, Veegum (Mg Al silicate), hectorite
Misc Carbomer, colloidal silicon dioxide, PVP
4. The product is brought to final volume using the vehicle
5. Homogenize (homogenizer, colloid mill)
Gels Semisolid system consisting of either suspension made up of small inorg particles or large
inorg molecules interpenetrated by liquid
Gelling agents: mostly less than 10%
Single Phase Gels No apparent boundaries exist between the macromolecules and the liquid
Milks & Magmas (Two-phase) Differ from gels mainly in that the suspended particles are larger
Lotions Liquid or semiliquid preparations which contain one or more active ingredients in a vehicle
Jellies Class of gels in which the structural coherent matrix contains a high proportion of liquid
Mixtures Aqueous liquids containing suspended insoluble material intended for internal use
(Kaopectate, Bordeaux mixture- CuSO4)
Instability of Gels
a. Syneresis - shrinking, some liquid is pressed out
b. Bleeding - liberation of oil or water due to deficient gel structure
c. Swelling - taking up of liquid with volume increase
d. Imbibition - taking up of liquid without volume increase
EMULSION (down to 0.1-100 mcm but optimum is between 0.5 to 2.5 mcm)
o Two-phase system prepared by combining two immiscible liquids, one of which is dispersed uniformly throughout
the other
3 phases:
o dispersed phase/internal phase/continuous phase (O/W)
o dispersion medium/external phase/discontinuous phase (W/O)
o emulsifying agent – for stability
Synthetic and Semisynthetic Surfactants

Anionic Soaps, Sodium Lauryl Sulfate
Cationic Quaternary ammonium compounds, cetrimide
Non-ionic Sorbitan esters (Spans), polysorbates (Tweens)
Amphteric Lecithin
Naturally-occurring
Polysaccharides Acacia, tragacanth, methylcellulose, carmellose sodium
Sterol-containing Beeswax, anhydrous lanolin
Finely-divided solids Bentonite (Al silicate), veegum (MgAl silicate), colloidal silicon dioxide
Theories of Emulsification
1. Surface Tension Theory - surfactant lowers surface tension
2. Oriented-Wedge Theory - monomolecular layers of emulsifying agent curved around a droplet of IP
3. Plastic/Interfacial Film Theory - emulsifying agent at the interface between the oil and water
Types of Emulsions:
4. O/W
5. W/O
6. Multiple emulsions – O/W/O or W/O/W
7. Microemulsions – appear transparent or translucent and have droplet diameter in the nm size range,
thermodynamically and optically stable
Methods of Preparation: (mortar and pestle, mechanical blender, hand homogenizer, mixing tanks)
1 Dry gum/Continental/4:2:1 – 4 oil + 1 emulsifier + 2 water rapidly (4:1:2)
2 Wet gum/English – 2 water + 1 emulsifier + 4 oil slowly (2:1:4)
3 Forbes Bottle Method – extemporaneous compounding of emulsion from volatile oils
4 Nascent soap/In Situ Method – alkali OH + FA (Calcium soap and soft soap)
Problems:
Creaming – upward movement, reversible
HLB SYSTEM
Cracking/Breaking – complete separation, irreversible
Sedimentation – downward movement, reversible Antifoaming 1-3
W/O 3-6
Wetting 7-9
O/W 8-18
Solubilizers 15-20
Detergents 13-16
COLLOIDAL DISPERSIONS/SOL (1 nm – 5μm)
AEROSOL
o Colloidal systems consisting of very finely subdivided liquid or solid dispered in and surrounded by a gas
o Products which depend upon the power of a liquefied or compressed gas to dispense the active ingredient(s) in a
finely dispersed mist, foam or semisolid
o MDI’s: < 10 micrometers, usually 3-6 micrometers for maximum therapeutic response
o Explodes when exposed to temp >49°C. Ideal: 15-30°C
Types of Aerosols
1. Space Sprays <50 micrometers
2. Surface sprays 50-200 micrometers
3. Foams
Components:
1. Product Concentrate
2. Propellant
Chlorofluorocarbon (CFC) Trichloromonofluoromethane, Dichlorodifluoromethane,
Dichlorotetrafluoroethane
Hydrochlorofluorocarbons (HCFC) Chlorodifluoromethane, Trifluoromonofluoroethane,
and Hydrofluorocarbons (HFC) Chlorodifluoroethane, Difluoroethane, Heptafluoropropane
Hydrocarbons Propane, Isobutane, Butane
Compressed Gases nitrogen, nitrous oxide, and carbon dioxide
Valves
1. Conventional/Continuous spray valve
2. Metered valve
Valve Assembly – regulates the flow of product concentrate from the container
Actuator Release contents by pressing down
Stem Supports the actuator, delivers the formulation to the chamber of the actuator
Gasket Prevent leakage when valve is still closed
Spring Holds the gasket in place, allows retraction of actuator when pressure is released thereby returning
the valve to the closed position
Mounting Cup Holds the valve in place (aka ferrule)
Housing Below the mounting cup; link between the dip tube and the stem and actuator
Dip Tube Extends from the housing down into the product concentrate, brings the formulation from the
container to the valve
Containers
1. Tin-plated steel - most widely used; light weight, relatively inexpensive
2. Aluminum - more resistant to corrosion (subject to corrosion by water and ethanol – needs coating)
3. Stainless steel - very resistant to corrosion (no coating required); withstand high pressures; expensive
4. Glass containers - often coated with plastic to resist impact; transparent
5. Plastic containers - not extensively used (polyethyleneterephthalate/PET is used for non-pharmaceuticals)
Two methods are used to manufacture aerosols: the cold fill process (-34.5 to -40°C) and the pressure fill process
COSMETICS
o External application to the human body for cleansing, beautifying, promoting attractiveness, altering appearance
CREAMS AND LOTIONS

Cosmetic Cream – soft viscous liquid or semisolid emulsion of the O/W or W/O type
Lotion – fluid or thixotropic emulsion or suspension
1. Cleansing creams and lotions (Beeswax-borax emulsion/Cold cream) To prepare C&L:

2. Emollient creams and lotions – to prevent dryness 1. Prepare oil phase
3. Hand creams and lotions – to moisturize 2. Prepare water phase
4. Suntan creams and lotions (sunblock) 3. Add water to oil
5. Skin lightener 4. Milling
5. Fill and Pack
6. Shaving creams
FACE POWDERS
o Has the ability to complement skin color by imparting a velvet like finish
ROUGE
o Any cosmetic product used to tint the face a shade of red (iron oxides are used)
LIPSTICKS
o Composed essentially of an oil-wax base still stiff enough to form a stick, with a red staining dye dissolved or
dispersed in oil, red pigments suspended therein, suitably perfumed and flavoured
o Color grinding Mixing Molding Flaming
EYE MAKE-UP
1. Eyeshadow - cream, stick, liquid, poweder or pressed cake
2. Mascara - cake, cream, or liquid, applied with a “wand”; with added fibers for lengthening
3. Eyebrow makeup - crayon, extruded pencil, stick, cream, or pressed cake
4. Eyeliner - liquid, cream or pressed cake applied with a brush or pencil
5. False eyelashes
6. Cover-makeup/Concealer
7. Makeup remover
8. Eye cream or eyestick
DENTRIFICES
o Intended for use with toothbrush for the purpose of cleaning surfaces of the teeth
o Fluoride compounds are added for effective control of dental caries or tooth decay
DEPILATORIES
o Epilation – removing intact hair by uprooting (wax rosin or adhesive semisolid)
o Depilation – result of chemical degradation of the human fiber
SHAMPOO
o Preparation of surfactant in a suitable form which when used under the conditions specified will remove surface
grease, dirt, skin debris from the hair shaft and scalp
o With sequestering agents like EDTA to hinder formation of insoluble Ca or Mg soap curd
ANTIPERSPIRANT AND DEODORANTS

o Deodorants – mask, remove, or decrease perspiration odors
o Antiperspirants – reduce perspiration without stopping it
o Aluminum sulfate reduces total bacterial count in the axilla of over 95%
o Aluminum chlorhydrate (20%) is most widely used
NAIL LACQUER OR ENAMEL

o Must contain a film former (Nitrocellulose)
FRAGRANCE/PERUME
o Concentrated alcoholic blend of fragrant materials
o Perfume oil is the base used to impart fragrance (best incorporated at the earliest period of manufacture)
Fragrance Type Description

Oriental A blend of fragrant complexes culminating in an intense heavy full-bodied fragrance
Cologne blend Any harmonious combination whose fragrance are derived from citrus oils
Bouquet Harmonious combination of two or more floral notes
Floral Fragrance of an existing known flower type
Chypre Mossy-woody complex with a characteristic sweet citrus top note
Fougre Combines a dominant sweet note with a mossy, lavender, citrus character
Spice blend Either floral spice (carnation) or herbal spice
Wood blend Dominated by woody notes
Amber Heavy full bodied powdery, warm scent tone
Definition Examples
Top Notes Most volatile products Lemon oil, Lavender oil, Anise oil
Leave the skin readily
Middle Notes Intermediate tenacity Thyme oil, Neroli oil, Rose oil
and volatility
Base Notes Low volatility and high Musk
aka Fixatives tenacity Dried secretion from the preputial follicles of
the male musk deer of Asia (Moschus spp)
Civet
A glandular secretion appearing in an outwardly
discharging pockets of Civet cats (Paradoxurus
hermaphroditus)
Ambergris
Most valuable material
Pathologic product formed in the stomach of
spermwhale when it feeds on squid or cattlefish
Physical Pharmacy
Application of physical and chemical principles and laws in the pharmaceutical sciences
To understand and develop dosage forms and drug delivery systems
FORCES OF ATTRACTION
Atom – basic unit of matter | proton, neutron, electron
INTRAMOLECULAR FORCES – within molecules

1. Ionic Bond - transfer
2. Covalent Bond - sharing
a. Polar (unequal)
b. Nonpolar (equal)
INTERMOLECULAR FORCES – between molecules; physical attraction

1. Van der Waals
a. Keesom (Dipole-dipole)
o Orientation/Alignment effect
o 1-7 kcal/mole
b. Debye (Dipole-Induced Dipole)

o Induction
o 1-3 kcal/mole
c. London Dispersion (Induced dipole-Induced dipole)

o Very close proximity internal vibration will cause dispersion of charges
o 0.5-1 kcal/mole
2. Ion-Dipole - polar molecules are attracted to positive or negative charges (salt & water)
3. Ion-Induced Dipole - induced by the close proximity of a charged ion to a nonpolar molecule (I2 + KI)
4. Hydrogen Bond - between H and electronegative atom (F, O, N, Cl, S) ; can be intramolecular (A=T)
Physical Properties of Systems

1. Additive Property - depends on sum | molecular weight
2. Constitutive Property - type and arrangement | optical rotation, refractive index
3. Colligative Property - number of components | VPL, BPE, FPD, OP
Types of Properties
1. Extensive/Extrinsic - dependent on size/amount | length, volume
2. Intensive/Intrinsic - independent | specific gravity, viscosity
Density = mass per unit volume (M/V)

Specific gravity = density of sample/density of standard
1. Pycnometer method
2. Mohr Westphal Balance
3. Plummet method (Archimedes principle: buoyancy – wt of immersed is equal to displaced)
Specific volume = reciprocal of specific gravity, opposite of density
STATES OF MATTER
PLASMA (Mesophase/Liquid Crystal)

1. Smectic - soap like, mobile in two directions
2. Nematic - thread like, mobile in three directions
3. Cholesteric - special case of nematic type
Methods of forming liquid crystals:

1. Lyotropic (using solvent)
2. Thermotropic (using heat)
SUPERCRITICAL FLUID STATE (Between liquid and gas)
GASES
o Have kinetic energy that produces rapid motion
o Held together by weak intermolecular forces
o Capable of filling all available spaces (Compressible)
Kinetic Theory of Gases:

1. Distances are much greater than the sizes of the molecules. Volume is negligible.
2. Do not attract one another but rather move independently from each other
3. Molecules are in constant, random motion.
4. Collisions are perfectly elastic.
5. Average kinetic energy is directly proportional to the absolute temperature.
10
Gas molecules are in rapid and continuous motion at ordinary temp & pressure (0.1-1 km/sec | 10 collisions/sec)
IDEAL GAS NON-IDEAL (REAL) GAS

Point mass (so small, nearly zero) Point mass but attracts
No volume Has volume
Collisions are “elastic” (not sticky, no attractive and repulsive Has attractive and repulsive forces
force)
Kinetic energy remains constant Kinetic energy decreases
Moves in random motion Moves in random slow motion until forms solid
Does not condense Condenses and sublimes
Follows ideal gas equation: PV = nRT Van der Waals equation: (P + an2/V2) (V – nb) =nRT
GAS LAW FORMULA CONSTANT
𝟏
Boyle's/Mariotte 𝑷₁𝑽₁ = 𝑷₂𝑽₂ 𝑜𝑟 𝑷 ∝𝑽 Temperature
𝑽₁ 𝑽₂
Charles' = 𝑜𝑟 𝑽∝𝑻 Pressure
𝑻₁ 𝑻₂
𝑷₁ 𝑷₂
Gay-Lussac's = 𝑜𝑟 𝑷∝𝑻 Volume
𝑻₁ 𝑻₂
𝑷₁𝑽₁ 𝑷₂𝑽₂
Combined =
𝑻₁ 𝑻₂
𝐿.𝑎𝑡𝑚
R = 0.08206
𝑚𝑜𝑙.𝐾
At STP:
Ideal 𝑷𝑽 = 𝒏𝑹𝑻 T = 273.15 K
P = 1 atm
V = 22.4 L
𝒂𝒏𝟐
(𝑷 + ) (𝑽 − 𝒏𝒃) = 𝒏𝑹𝑻
𝒗𝟐
Real/Van der Waals
an2 = internal pressure per mole
nb = incompressibility
𝑷𝒔𝒐𝒍𝒖𝒕𝒊𝒐𝒏 = 𝑿𝒔𝒐𝒍𝒗𝒆𝒏𝒕 𝑷𝒔𝒐𝒍𝒗𝒆𝒏𝒕
Rauolt’s Temperature
X = mole fraction
Henry’s Law of Gas

𝑷𝒓𝒆𝒔𝒔𝒖𝒓𝒆 ∝ 𝑺𝒐𝒍𝒖𝒃𝒊𝒍𝒊𝒕𝒚 Temperature
Solubility
Total pressure in a mixture is equal to the sum of
Dalton’s Law of Partial
the partial pressures of each gas
Pressures
𝑃𝑡 = 𝑃1 + 𝑃2 + 𝑃3 … ….
Volume of gas at STP is directly proportional to the
Avogadro’s number of moles k = 6.022 X 1023
𝑽₁ 𝑽₂ 𝑽
= 𝑜𝑟 𝑽 ∝ 𝒏 𝑜𝑟 =𝒌
𝒏₁ 𝒏₂ 𝒏
Rate of diffusion and speed gas are inversely
proportional to the square root of their density
Graham’s
1
𝑅𝑎𝑡𝑒𝑑𝑖𝑓𝑓𝑢𝑠𝑖𝑜𝑛 ∝
√𝑑𝑒𝑛𝑠𝑖𝑡𝑦
LIQUIDS
o Possess less kinetic energy than gases
o Occupy a definite volume
o Take the shape of the container
o Incompressible
Vapour Pressure – pressure of the saturated vapour above a liquid resulting from the escape of surface liquid molecules
Clausius – Clapeyron Equation – relation of vapour pressure and absolute temp of liquid
𝑷𝟐 ∆𝑯𝒗 (𝑻𝟐 − 𝑻𝟏 )
𝒍𝒐𝒈 =
𝑷𝟏 𝟐. 𝟑𝟎𝟑 𝑹𝑻𝟏 𝑻𝟐
∆𝐻𝑣 = molar heat of vaporization

𝐜𝐚𝐥 𝑱
R = molar gas constant (𝟏. 𝟗𝟖𝟕 𝐦𝐨𝐥.𝐊 𝐨𝐫 𝐨𝐫 𝟖. 𝟑𝟏𝟒 𝒎𝒐𝒍.𝑲
)
Classification of Dispersed System

1. True solution <1 nm
2. Colloidal dispersion 1 nm –0.5 μm
3. Coarse dispersion larger than 0.5 μm (emulsions and suspensions)
SOLUTIONS
o A mixture of two or more components that form a homogenous molecular dispersion or one-phase system
(Particle size: <1 nm)
Solvent – phase of the solution; usually constitutes the largest proportion of the system
o Protophilic or basic solvent

Proton-accepting (acetone, ether, and liquid ammonia)
o Protogenic solvent
proton-donating (formic acid, acetic acid, sulfuric acid, liquid HCl, and liquid HF)
o Amphiprotic solvents
act as both (water and the alcohols)
o Aprotic solvents
neither accept nor donate protons; neutral (hydrocarbon)
Solute – molecules or ions dispersed throughout the solvent

Non-electrolytes – do not yield ions in solution, no electric current
Electrolytes – forms ions in solution, conductor
Weak (partial ionization)
Strong (complete ionization)
Dissolution – transfer of molecules or ions from a solid state into solution
Solubility – extent of dissolution
Very soluble Less than 1 part

Freely soluble 1-10
Soluble 10-30
Sparingly soluble 30-100
Slightly soluble 100-1,000
Very slightly soluble 1,000-10,000
Practically insoluble More than 10,000 parts
Saturated solution – the solute is in equilibrium with the solid phase

Unsaturated or subsaturated solution –solute concentration is below necessary
Supersaturated solution – solute concentration is above necessary
Solubility can also be expressed in terms of molality, molarity, and percentage strength.
Molality – no. of moles of solute in 1 kg of solvent
Molarity – no. of moles of solute in 1 L of solution
Percentage strength – signifies the no. of grams of solute per 100 g of solution
Factors that affect Solubility

1. Temperature
Endothermic dissolution - heat is absorbed, ↑ temp, ↑ solubility
Exothermic dissolution - heat is released, ↓ temp, ↑ solubility (CaOH)
2. pH – Critical pH (pHc) or the pH of precipitation (pHp)

Critical pH for a weak acid - pH below which WA precipitates from solution undissociated
Critical pH for a weak base - pH above which WB precipitates from solution undissociated
3. Presence of Salts
Salting-in (added salt increases hydrophilicity of the solution)
Salting-out (added salt reduces the available amount of water solute precipitates)
4. Particle Size
5. Concentration
6. Pressure (Henry’s Law)
COLLIGATIVE PROPERTIES OF SOLUTIONS
Colligative Property Notes Formula
Vapor Pressure Lowering The addition of a non-volatile solute lowers Raoult’s Law – lowering of a vapor
the VP of a liquid pressure of a solvent is equal to the
A liquid in a closed container will establish product of the mole fraction of the
an equilibrium with its vapor solute and vapor pressure of the solvent
When equilibrium is reached, vapor exerts a
pressure (vapor pressure) – 𝜟𝑷 = 𝑷° × 𝒎𝒐𝒍𝒆 𝒇𝒓𝒂𝒄𝒕𝒊𝒐𝒏
VOLATILE – exhibits VP
NONVOLATILE – no measurable VP
Boiling Point Elevation BP – temp at which liquid pressure is equal to ∆𝑇𝑏 = 𝐾𝑏 𝑚

atmospheric pressure (1 atm = 760 mmHg)
𝟏𝟎𝟎𝟎 𝒘𝟐
∆𝑻𝒃 = 𝑲𝒃
The boiling point of a solution containing a non- 𝒘𝟏 𝑴𝑾𝟐
volatile solute would be higher than the pure
solvent because the solute would lower the Kb = ebullioscopic/molal BPE constant
vapour pressure of the solvent (0.52 °C/m)
m = molality
w1 = weight of solvent
w2 = weight of solute
MW2 = molecular wt of solute
Freezing Point Depression FP – temp at which the solid and liquid phases ∆𝑇𝑓 = 𝐾𝑓 𝑚
are in equilibrium under an external pressure
𝟏𝟎𝟎𝟎 𝒘𝟐
∆𝑻𝒇 = 𝑲𝒇
In general, solutions have a lower freezing point 𝒘𝟏 𝑴𝑾𝟐
than the pure solvent
Kf = cryoscopic/FPD constant
Applications: (Kf = 1.86°C/m)
Salt is spread on roads to melt ice
Ethylene glycol as “anti-freeze”
Osmotic Pressure Osmosis – movement of water across a
semipermeable membrane from low to high 𝝅𝑽 = 𝒏𝑹𝑻 𝑜𝑟 𝝅 = 𝑴𝑹𝑻
concentration
π = osmotic pressure in atm
This is the pressure required to offset the V = volume in L
movement of solvent thru a s. membrane n = no of moles of solute
𝐿.𝑎𝑡𝑚
Also defined as the pressure required to prevent R = gas constant (0.08205 )
𝑚𝑜𝑙.𝐾
osmosis in solutions. T = absolute temperature
Hypertonic – causes crenation

Hypotonic – causes swelling/lysis
Isotonic – 0.9% (w/v) NaCl
METHODS OF ADJUSTING ISOTONICITY
Class I: Addition of a tonicity adjusting agent
1. Freezing Point Depression Method/Cryoscopic
Isotonic freezing point depression – 0.52°C
2. Sodium Chloride Equivalent Method/E Value

E value – gram of NaCl equivalent to 1 gram of a substance
Step 1. Calculate the amount of NaCl represented by the ingredients
Step 2. Calculate the amount of Nacl that would make the volume of solution specified isotonic
Step 3. Subtract Step 1 from Step 2.
Step 4. If agent other than NaCl (boric acid, dextrose, Na or K nitrate), divide the amount of NaCl
(Step 3) by the NaCl equivalent (E value) of the other substance.
Class II: Addition of water and dilution with buffered isotonic solution
1. White Vincent Method
𝑽𝑯𝟐𝑶 = 𝒘𝒕 × 𝑬 𝒗𝒂𝒍𝒖𝒆 × 𝟏𝟏𝟏. 𝟏
2. Sprowl’s Method – simplified White Vincent method

𝑽𝑯𝟐𝑶 = 𝟎. 𝟑 × 𝑬 𝒗𝒂𝒍𝒖𝒆 × 𝟏𝟏𝟏. 𝟏
ACID-BASE EQUILIBRIA
Ionization – complete separation of ions in a crystal lattice when salt is dissolved
Dissociation – separation of ions in solution when the ions are associated by interionic attraction
Theory Acid Base

+ + -
Arrhenius Yields H or H3O OH
Bronsted-Lowry Theory Proton donor Proton acceptor
-
Lewis Theory E acceptor E- donor
Pearson’s HSAB Hard acids are e- acceptor with high positive
charges and relatively small sizes while soft
acids have positive charges and relatively small
pH – the negative logarithm of the H+ concentration

𝒑𝑯 = −𝒍𝒐𝒈 [𝑯+]
Sorensen’s pH scale
Neutral = 7
Acidic < 7
Basic > 7
For weak acids 𝐻𝐴 + 𝐻2 𝑂 ↔ 𝐻3 𝑂+ + 𝐴−

For weak bases 𝐵 + 𝐻2 𝑂 ↔ 𝑂𝐻 − + 𝐵𝐻 +
Water Ionization 𝐻2 𝑂 + 𝐻2 𝑂 ↔ 𝐻3 𝑂+ + 𝑂𝐻 −
pH Calculations
Strong Acids 𝒑𝑯 = −𝒍𝒐𝒈 [𝑯+]
Strong Bases 𝑝𝐻 = −𝑙𝑜𝑔 [𝑂𝐻 −] or 𝒑𝑯 = 𝟏𝟒 − (−𝒍𝒐𝒈 [𝑶𝑯− ])
1
Weak Acids 𝑝𝐻 = 2 𝑝𝐾𝑎 − 𝑙𝑜𝑔𝐶𝑎
𝑏𝑎𝑠𝑒 1
Weak Bases 𝑝𝐻 = 𝑝𝐾𝑤 − 𝑝𝐾𝑏 + 𝑙𝑜𝑔 𝑠𝑎𝑙𝑡
or 𝑝𝐻 = 𝑝𝐾𝑤 − 2 (𝑝𝐾𝑏 − 𝑙𝑜𝑔𝐶𝑏)
BUFFERS
Solutions that have the property of resisting changes in pH when acids or bases are added to them
This property results from the presence of a buffer pair which consists of either:
- Weak acid and some salt of a weak acid or its conjugate base
- Weak base and some salt of a weak base or its conjugate acid
Henderson-Hasselbach Equation
𝑠𝑎𝑙𝑡
Weak acids 𝑝𝐻 = 𝑝𝐾𝑎 + 𝑙𝑜𝑔
𝑎𝑐𝑖𝑑
𝑏𝑎𝑠𝑒
Weak bases 𝑝𝐻 = 𝑝𝐾𝑤 − 𝑝𝐾𝑏 + 𝑙𝑜𝑔 𝑠𝑎𝑙𝑡
Buffer Capacity (Buffer action/Buffer efficiency/Buffer index/Buffer value)

Ability of a buffer solution to resist changes in pH
Approximate formula
[𝒔𝒂𝒍𝒕]+[𝒃𝒂𝒔𝒆]
𝒑𝑯 = 𝒑𝑲𝒂 + 𝒍𝒐𝒈 [𝒂𝒄𝒊𝒅]−[𝒃𝒂𝒔𝒆]
Exact formula/Koppel-Spiro Van Slyke’s Equation

𝑲𝒂 [𝑯𝟑 𝑶+]
𝜷 = 𝟐. 𝟑𝑪 (𝑲 + 𝟐
𝒂 +[𝑯𝟑 𝑶 ])
Where C = total buffer concentration, that is, the sum of the molar concentrations of the acid and the salt.
Maximum Buffer Capacity

- occurs when pH = pKa
- 𝜷𝒎𝒂𝒙 = 𝟎. 𝟓𝟕𝟔 𝑪
INTERFACIAL PHENOMENA
o Attributed to the effects of the molecules found at the interface between 2 phases
o Interfacial Tension (L-L)
o Surface Tension (S-L, L-G)
Surfactants
Surface active agents
Lowers the interfacial/surface tension
Griffin HLB System (higher-hydrophilic, lower lipophilic)
Anti-foaming 1-3
W/O 3-8
Wetting agent 7-9
O/W 8-16/9-12
Detergent 13-16
Solubilizer 16-19
Absorption - entry into the system

Adsorption - adherence to surface
Adsorption Isotherm Theories:
Freundlich Isotherm
- Adsorption of gas is infinite
- ⬆P, ⬆adsorption
Langmuir Isotherm
- Limited adsorption
- Monomolecular layer is formed
- the amount of adsorbate on the adsorbent as a function of its pressure (if
gas) or concentration (if liquid) at constant temperature.
Cohesion - same molecules
Adhesion - different molecules
Capillarity - tendency to rise up a normal tube
Wetting - made by liquid or solid surface | ⬆contact angle, ⬇wettability | 0° - complete wettability
COLLOIDAL DISPERSION
A system having a particle size intermediate between that of a true solution and a coarse dispersion
colloidal system, solution, dispersion, aerosols, emulsions, foams, hydrosols
1nm – 0.5mc
CLASSES
1. Lyophilic
Spontaneous
Thermodynamically stable
2. Lyophobic
Nonspontaneous
Thermodynamically unstable
3. Association colloids/Amphiphilic colloids

Involves surfactants which can accumulate and form a micelle (colloidal sized particles)
METHODS OF PREPARATION
1. Condensation
Principle: small particles –(condensed) colloidal particles
2. Deflocculation /Dispersion
Principle: bigger particle –(broken down) colloidal particles
3. Peptization
Similar to the principle of salting-out
(+) electrolyte solution will cause the precipitation of colloidal sized particles
PROPERTIES
1. Optical
Faraday-Tyndall Effect – ability to scatter or disperse light (foggy street)
2. Kinetic
Brownian motion – colloidal particles appear as tiny points of light in constant motion when examined
under an ultramicroscope
Diffusion – spontaneous movement of particles from a region of higher concentration to one of lower
concentration until equilibrium is achieved
3. Electric
Nerst Potential / Electrothermodynamic potential
- difference in potential between the actual surface of the particle and the electroneutralregion of
the dispersion
Zeta Potential / Electrokinetic Potential

- difference in potential between the surface of the tightly-bound layersand the
electroneutralregion of the dispersion (⬇zeta potential results to flocculation)
COARSE DISPERSIONS
A system with particles being larger than 0.5 mcm
Emulsions and suspensions
SUSPENSION – insoluble particles are dispersed in a liquid medium (< 0.1 nm)
Properties of Suspended Particles:

Sedimentation rate Settling
Deflocculated Slower “hard cake”
Flocculated Faster -
dispersed
Instability of Suspensions
a. Aggregation - globules come together but do not fuse (aka agglomeration)

b. Sedimentation - downward monevent
c. Caking
EMULSIONS
Instability of Emulsions
a. Flocculation - formation of lumps

b. Creaming - upward or downward movement of the internal phase
c. Coalescence - globules come together and fuse
d. Cracking - total separation of two phases)
e. Breaking
f. Phase inversion
SEMISOLIDS
Gel – consists of a condensed mass enclosing and interpenetrated by a liquid

Jelly – coherent matrix is rich in liquid
Xerogel – liquid is removed, framework remains
Instability of Gels
e. Syneresis - shrinking, some liquid is pressed out
f. Bleeding - liberation of oil or water due to deficient gel structure
g. Swelling - taking up of liquid with volume increase
h. Imbibition - taking up of liquid without volume increase
RHEOLOGY
o Scientific study of the deformation and flow properties of matter
o Elasticity, fluidity (ɸ), viscosity (ɳ) and plasticity
Viscosity (ɳ)
1. Resistance to flow
2. Reciprocal of fluidity; ɳ = 1/ɸ
3. Ratio of the shear stress (F) to the shear rate (G)
4. = where: F is shear stress (force per unit area); G is shear rate (velocity gradient)
CLASSES
1. Absolute viscosity =
Units: poise (dyne sec/cm2 or g/cm sec) or centipoises
Using capillary viscometer:
𝟏 𝒑𝟏 𝒕𝟏
=
𝟐 𝒑𝟐 𝒕𝟐
2. Kinematic viscosity = 𝒏 𝒑𝟏𝒕𝟏

units: stokes(s); centistokes(cs)
3. Relative viscosity (ɳrel) = 𝒏𝟏 𝒏𝟐
VISCOMETERS
1. Ostwald viscometer (Modern adaptation: Ostwald-Cannon-Fenske Viscometer)
2. Falling Sphere Viscometer (Hoeppler Falling-ball Viscometer)
3. Cup-and-bub Viscometer
Courette type (Mac Michael Viscometer)
Searle Type (Rotovisco Viscometer, Stormer Viscometer, Brookfield Viscometer)
4. Cone-and-Plate Viscometer
5. Ferranti-Shirley Cone-and-Plate Viscometer
FLOW SYSTEMS
1. Newtonian Flow
Has linear relationship between shear rate and shear stress
Constant viscosity with increasing rate
Eg: ethanol, water, acetone, glycerin, benzene
2. Non-Newtonian Flow
Shear-Dependent Viscosity
Plastic
- Simplest type of non-Newtonian behavior in which the curve is linear only at values ofF,
beyond its yield value.
- Yield value is the force that should be exceeded for a bingham body (plastic) to flow
- Eg: gels, ointments, margarine
Pseudoplastic
- Non-linear; “shear-thinning”
- ⬆G (shear rate); ⬇ ɳ
- Eg: catsup and toothpastes
Dilatant
- Non-linear; “shear-thickening”
- When stress is removed, a dilatant system returns to its original state of fluidity.
- ⬇G, ⬆ ɳ
- Eg: paint, starch paste
Time-Dependent Viscosity
Thixotropy
- Breakdown of structure (shear-thinning) that does not reform immediately when stress is
removed or reduced
- Thixotropy is an isothermal and comparatively slow recovery (on standing of a material) of a
consistency lost through shearing
- ⬆time, ⬇ ɳ
- Shows a hysteresis loop, that is, the curve obtained on increasing shear stress is not
superimposable with that obtained on decreasing shear stress.
Rheopexy
- A phenomenon in which a solid forms a gel more readily when gently shaken or otherwise
sheared than when allowed to form the gel while the material is kept at rest
- ⬆time, ⬆ɳ
SOLIDS
o Characterized of having fixed shapes, nearly incompressible
o Have strong intermolecular forces, very little kinetic energy
o Their atoms vibrate in fixed positions about an equilibrium position, there is very little translationalmotion
CRYSTALLINE
The molecules or atoms are arranged in repetitious three-dimensional lattice units
Solvates –aka “pseudopolymorphs”; crystals having solvent molecules
Types based on geometric forms
Cubic -NaCl
Tetragonal –Urea
Hexagonal –Iodoform
Rhombic –Iodine
Monoclinic –sucrose
Triclinic -boric acid
Types based on forces of attraction

1. Covalent crystals – covalent bond (diamond, graphite, quart)
2. Ionic crystals – (NaCl)
3. Molecular crystals – Van der Waals & H-bonding (sucrose, ice)
4. Metallic crystals – solid in their elemental forms (elemental iodine)
Properties
Polymorphism- a solid may exist in more than one crystalline form
Example: theobroma, cocoa butter
Form Melting Point (in °C)
Gamma (most unstable) 18
Alpha 22
Beta’ 28
Beta (most stable) 34.5
Polymorphic Changes & Properties

Enantiotropic Change is reversible
Monotropic Change is unidirectional
Isotropic Similar (identical) properties in all directions
Anisotropic Different Properties in various directions along the crystal
Amorphous Crystalline
Random unoriented molecules Fixed geometric patterns
Glass and Plastics Ice and NaCl
Arranged in random manner Orderly arranged units, incompressible
No definite MP Definite MP, pass sharply from solid to liquid
MICROMERITICS
o Study of small particles
Types of Properties of Particles
Particle Sizes
1. Fundamental
Coarse >1000 μm
Inherent in all individual particles
Conventional 50-1000 μm
Eg: size, shape, density, volume Fine 1-50 μm
2. Derived Very Fine 0.1-1 μm
Combination of fundamental properties Ultra-Fine <0.1 μm
Eg: bulk density, granule volume, porosity
Methods of Determining Particle Size

1. Optical microscopy
Use of microscope to measure individual particle
Adv: individual particles can be seen
Disadv: very tedious, 2D-image only
3 Measurements
Ferret diameter – 2 tangents separated by the longest distant
Martin Diameter – distance what will bisect the particle into halves
Projected Area of the Circle – diameter of the circle that will enclose the particle
2. Sieve analysis
USP method
Sieve # (Mesh #) - number of openings per linear inch
Disadv: attrition of particles
3. Sedimentation method
Sedimentation rate or free fall velocity of particles
Apparatus: AndreasenApparatus / Pipet
Principle: Stoke’sLaw
4. Automatic particle counter

Coulter counter - Principle: electric resistance (↑ER ↑PS)
HIAC/Royco Instrument - Principle: Light blockade (↓light ↑PS)
Gelman Counter - Principle: Faraday –Tyndall Effect
Particle Volume
𝑇𝑟𝑢𝑒 𝑣𝑜𝑙𝑢𝑚𝑒 = 𝑣𝑜𝑙𝑢𝑚𝑒 𝑜𝑓 𝑝𝑎𝑟𝑡𝑖𝑐𝑙𝑒 ( 𝑝)
𝑟𝑎𝑛𝑢𝑙𝑒 𝑣𝑜𝑙𝑢𝑚𝑒 ( 𝑔) = 𝑝 + 𝑖𝑛𝑡𝑟𝑎𝑠𝑝𝑎𝑐𝑒
𝐵𝑢𝑙 𝑣𝑜𝑙𝑢𝑚𝑒 ( 𝑏) = 𝑔 + 𝑖𝑛𝑡𝑒𝑟𝑠𝑝𝑎𝑐𝑒𝑠
Particle Density
𝑇𝑟𝑢𝑒 𝑑𝑒𝑛𝑠𝑖𝑡𝑦 = 𝑚𝑎𝑠𝑠 𝑝
𝑟𝑎𝑛𝑢𝑙𝑒 𝐷𝑒𝑛𝑠𝑖𝑡𝑦 = 𝑚𝑎𝑠𝑠 𝑔
𝐵𝑢𝑙 𝑑𝑒𝑛𝑠𝑖𝑡𝑦 = 𝑚𝑎𝑠𝑠 𝑏
Porosity – measure of total voids/ spaces
𝑏− 𝑔
𝑖𝑛𝑡𝑒𝑟𝑠𝑝𝑎𝑐𝑒 = 𝑥 100
𝑏
𝑔− 𝑝
𝑖𝑛𝑡𝑟𝑎𝑠𝑝𝑎𝑐𝑒 = 𝑥 100
𝑔
𝑏− 𝑝
𝑡𝑜𝑡𝑎𝑙 = 𝑥 100
𝑏
Properties of Powders For Granulation

1. Fluidity
2. Compressibility
Angle of Repose
𝒉𝒆𝒊𝒈𝒉𝒕
= 𝒕𝒂𝒏−𝟏 𝒓𝒂𝒅𝒊𝒖𝒔
Carr’s Compressibility Index

𝑽𝒊 − 𝑽𝒇
𝑪 = 𝒙 𝟏𝟎𝟎
𝑽𝒊
𝒕𝒂𝒑𝒑𝒆𝒅 − 𝒃𝒖𝒍𝒌
𝑪 = 𝒙 𝟏𝟎𝟎
𝒕𝒂𝒑𝒑𝒆𝒅
Hausner’sRatio
𝑯𝑹 = 𝑽𝒐 𝑽𝒇
𝑯𝑹 = 𝒕𝒂𝒑𝒑𝒆𝒅 𝒃𝒖𝒍𝒌
PHASE EQUILIBRIA
Phase Diagram
o Represents the states of matter that exist as temperature and pressure are varied.
o It is a graphic way to summarize the conditions under which equilibria exist between the different states of
matter.
o Such a diagram also allows us to predict which phase of a substance is present at any given temperature and
pressure.
Latent Heat/ Molar Heat

Heat necessary for 1 mole of a gas, solid or liquid to change to another phase
Either gained or lost
NOTE: without latent heat, no phase transition
Molar Heat of Fusion (ΔHf) - Heat required to convert 1 mole of solid to liquid
Molar Heat of Sublimation (ΔHs) - Heat required to convert 1 mole of solid to gas
Molar Heat of Vaporization (ΔHv) - Heat required to convert 1 mole of a liquid to gas
Gibb’s Phase Rule

Used to determine the number of independent variables (temperature, pressure, concentration) that must be
set in order to define a system
F = C –P + 2 (1 component system)
F = C –P + 1 (2 component system)
F = C –P (3 component system)
F: Degrees of Freedom
C: number of Components
P: number of Phases
One Component System
Eg: water
Calculate F.
G; L; S bivariant
G-L; L-S; G-S univariant
G-L-S invariant
Two-Component System
Aka Condensed system
System in which vapour phase is ignored and only the solid and/or liquid phases are considered
Liquid-Liquid System
Binodal curve
- area within the curve represents a two phase system; Any point beyond it is a single phase
Critical solution temperature (upper consolute temperature)
- temperature beyond which every proportion of A & B will exist as 1-phase; maximum temperature to
obtain a one phase system
Tie Line
- line from which a system separates into phases of constant composition; used to approximate the
proportions of components A & B existing at a particular temperature
Conjugate phases
- phases of constant composition that separate when a mixture is prepared within the boundary of the
2-phase system
The Lever Arm Rule
𝒘𝒕 𝒐𝒇 𝒑𝒉𝒂𝒔𝒆 𝒍𝒆𝒏𝒈𝒕𝒉 𝒐𝒇 𝒐𝒑𝒑𝒐𝒔𝒊𝒕𝒆 𝒂𝒓𝒎

=
𝒘𝒕 𝒐𝒇 𝒑𝒉𝒂𝒔𝒆 𝒍𝒆𝒏𝒈𝒕𝒉 𝒐𝒇 𝒐𝒑𝒑𝒐𝒔𝒊𝒕𝒆 𝒂𝒓𝒎
Solid-Liquid System
Eutectic Point
- Is the point where solid A, solid B and the liquid phase co-exist
- 3-phases co-exist
Eutexia
- phenomenon of lowering the melting point due to combinations of components (thymol-salol;
camphor-menthol)
Three Component System

1. Ternary system
2. Temperature are pressure are both made constant
3. Consists of two liquids that are partially miscible to each other and the third component acts as co-solvent
which has the affinity to both immiscible layers
4. Phase Rule: F = C –P
5. Apex - 100% of each component
6. Base - opposite of apex; 0% of each component
CHEMICAL KINETICS
o Study of the rates of reactions and the mechanism by which these reactions occur
o Application in pharmacy: stability and bioavailability of pharmaceutical products
Rate of Reaction / Degradation Rate

- Velocity with which the reaction occurs
- Depends on:
Reactant concentration
Temperature
pH
presence of solvents or additive
Order of Reaction – the way in which the concentration of the drug or reactant in a chemical reaction affects rate
Zero-order Reaction
- the drug concentration changes with respect to time at constant rate
- the rate of reaction is independent of the concentration of the reactants 𝑪 = −𝒌𝟎 𝒕 + 𝑪𝟎
- eg. Alcohol, aspirin, phenytoin
First-order Reaction
𝑪 = 𝑪𝟎 𝒆−𝒌𝒕
- the rate of reactions dependent on the concentration of drug remaining
or
- most drugs follow this reaction
- Ex: t1/2: 2 hrs
𝒍𝒏𝑪 = −𝒌𝒕 + 𝒍𝒏𝑪𝟎
Second-order Reactions
- reaction is dependent on the squared amount of drug remaining
- no application in pharmaceutical dosage form
Half-life (t ½ )
- the period of time required for the amount or concentration of a drug to decrease by one-half or 50%. the time
required for one-half of the material to disappear
Order Half-life Equation
𝟎. 𝟓𝑪𝒐
Zero
𝒌
𝟎. 𝟔𝟗𝟑
First
𝒌
𝟏
Second
𝑪𝒐𝒌
Shelf-life (t90)
- “expiration-dating period”
- the period of time where 90% of the original concentration is left and 10% is already degraded
𝟎.𝟏𝟎𝟓
- 𝑻𝟗𝟎 =
𝒌
S1 Dealer
S2 Prescriber
S3 Retailer
S4 Wholesaler
S5-I Importer
S5-C Compounder
S6 Researcher
S7 Importer & Compounder
*Renewal: not later than Jan. 31
Jurisprudence
“system of laws”
“science of philosophy of laws”
ETHICS
“science of morality”
“moral principles of practice”
RA Name Date
5921 Pharmacy Law (EO 174) June 23 1969
3720 Foods, Drugs, Devices, and Cosmetics Act (EO 175) June 22 1963
8203 Special Law on Counterfeit Drugs
6425 Dangerous Drugs Act March 30 1972
9165 Comprehensive Dangerous Drugs Act June 7 2002
953 Narcotics Drug Law June 20 1953
9211 Tobacco Regulation Act June 23 2003
6675 Generics Act of 1988 Sep 13 1988
7432 Senior Citizens Act 2.7 & 4.23 1992
9257 Expanded Senior Citizens Act Feb 26 2004
9994 Expanded Senior Citizens Act of 2010 Feb 15 2010
7876 Senior Citizen Center Act Feb 14 1995
8423 TAMA (Traditional and Alternative Medicines Act) Dec 9 1997
7581 Price Act May 27 1992
9502 Cheaper and Quality Medicines Act of 2008 June 6 2008
9184 Procurement Act Jan 10 2003
7394 Consumer Act April 13 1992
9711 FDA Act of 2009 Aug 18 2009
8981 PRC Modernization Act Dec 5 2000
8172 ASIN Dec 20 1995
8293 Intellectual Property Code Jun 6 1997
AO Name Date
220 cGMP (AO 43 – cGMP for DRUGS) June 13 1974
79 Transitional Remedial Labeling Sep 18 1989
184 Registration of Herbal Products (AO 42)
172 Registration of Herbal Medicines (AO 42)
62 Prescribing Requirements March 15 1989
63 Dispensing Requirements March 16 1989
55 Labeling of Pharmaceuticals Dec 7 1988
56 Licensing of Drug Establishments and Outlets Jan 3 1989
51 Compliance of 6675
EO Name Date
851 Creation of BFAD June 22, 1973
266 Institutionalization of CPE July 25, 1995
174 Latest Amendment of 5921
175 Latest Amendment of 3720
119 Reorganization of BFAD
302 Philippine Pharmacopoeia
PD Name Date
223 Creation of PRC June 22, 1973
907 Honor Graduate Eligibility March 11, 1976
1926 5 4 years Baccalaureate Study
1363 RE: Citizenship Requirement for PLE
RA 5921 (as amended by EO 174) THE PHARMACY LAW
AN ACT REGULATING THE PRACTICE OF PHARMACY AND SETTING STANDARDS OF PHARMACEUTICAL
EDUCATION IN THE PHILIPPINES AND FOR OTHER PURPOSES
Objectives (a) the standardization and regulation of pharmaceutical education

(b) the examination for registration of graduates of schools of pharmacy and
(c) the supervision, control and regulation of the practice of pharmacy in the Philippines
Composition of CHED Secretary: Patricia Licuanan

Council of DOH Undersecretary: Enrique Tayag
Pharmaceutical BFAD Director: Kenneth Hartigan Go
Education PACOP President: Vicky Mendoza
BOP Chairman: Mildred Oliveros
PPhA Chairman: Olivia Limuaco
UP Dean: Imelda Pena
Dean Private Colleges
PRC Board of Chairman and two members with a 3 year term:
Pharmacy (a) Natural born citizen of the Philippines;
(b) Registered and practicing for at least 10 years;
(c) Of GMC and of recognized standing in the pharmaceutical profession;
(d) At the time of appointment, not a member of the faculty of any pharmacy school
(e) A member of any national pharmaceutical association of the Philippines.
RA 3720 (as amended by EO 175) FOODS, DRUGS, AND COSMETICS ACT

AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADE
AVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL
ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO, AND FOR OTHER PURPOSES
Objectives (a) Establish standards and quality measures for food, drug, and cosmetic.
(b) Adopt measures to insure pure and safe supply of food, drug, and cosmetics
(c) Adopt measures to ensure rational use of drugs and services
(d) Strengthen the BFAD
*includes definitions of adulterated and misbranded drugs and devices
BFAD Functions (a) Administer and supervise the implementation of this Act and of the rules and regulation
(b) Provide for the collection of samples of food, drug and cosmetic
(c) Analyze and inspect food, drug and cosmetic
(d) Establish analytical data to serve as basis for the preparation of food, drug and cosmetic standards,
and to recommend standards of identity, purity, quality and fill of container
(e) Issue certificate of compliance
(f) Levy, assess & collect fees for inspection, analysis and testing of products & materials
(g) Certify batches of anti-biotic and anti-biotic preparations
BFAD Divisions (a) Inspection and Licensing Division

(b) Laboratory Division
AO 56 s of 1989
REVISED REGULATIONS FOR THE LICENSING OF DRUG ESTABLISHMENTS AND OUTLETS
Types of Drug Drug Manufacturer

Establishments Drug Trader
Drug Distributor/Importer Drug Distributor/Exporter
Drug Distributor/Wholesaler
Requirements for A. Premises
Drug Outlets Signboard in front of the place of business bearing registered name of drug store
A well-ventilated area not less than 15 sq. m. with concrete, tile or wooden flooring
A place suitable for compounding prescription and for washing and sterilizing bottles
(compulsory only for hospital pharmacy).
A suitable and proper place for the adequate storage of drugs and biological products as
specified on the label
A suitable cabinet for keeping poisons and/or dangerous drugs
An adequate water supply
B. References/Documents
Philippine National Drug Formulary (when available)
United States Pharmacopeia/National Formulary (USP-NF) (latest edition)
R.A. 3720, R.A. 6675, R.A. 5921
Remington’s Pharmaceutical Sciences (latest edition)
Goodman & Gilman — Pharmacological Basis of Therapeutics (latest edition)
C. Record Books Registered with BFAD

Prescription Book
Dangerous Drug Book
Exempt Preparation Book
Poisons Book
Record Book for Selected Non-Prescription Drugs
RA 6425 THE DANGEROUS DRUGS ACT

RA 9165 COMPREHENSIVE DANGEROUS DRUGS ACT
Dangerous Drugs Prohibited Drug
Opium and its derivatives, Coca leaf and its derivatives
Regulated Drug
Barbiturates, Benzodiazepines, Amphetamine, such as benzedrine or Dexedrine, Methaqualone
Records Required Original record of sales, purchases, acquisitions and deliveries of dangerous drugs, indicating therein
of RPh the license number and address of the pharmacist; the name, address and license of the
manufacturer, importer or wholesaler from whom dangerous drugs have been purchased; the
quantity and name of the dangerous drugs so purchased or acquired; the date of acquisition or
purchase; the name, address and class A residence certificate number of the buyer; the serial number
of the prescription and the name of the doctor, dentist, veterinarian or practitioner issuing the same;
the quantity and name of the dangerous drug so sold or delivered; and the date of sale or delivery.
A certified true copy of such record covering a period of three calendar months, duly signed by the
pharmacist or the owner of the drug store or pharmacy, shall be forwarded to the city or municipal
health officer within fifteen days following the last day of every quarter of each year.
RA 6675
AN ACT TO PROMOTE, REQUIRE AND ENSURE THE PRODUCTION OF AN ADEQUATE SUPPLY,
DISTRIBUTION, USE AND ACCEPTANCE OF DRUGS AND MEDICINES IDENTIFIED BY THEIR GENERIC
NAMES
Prohibited Acts:
1. Code - system of words to represent words
2. Cipher - method of secret writing
3. Secret Keys - confidential to one or few
Components of 1. Quality Assurance of Drugs

the National 2. Rational Use of Drugs by Health Professionals and Consumers
Drug Policy 3. National self-sufficiency in Pharmaceuticals
4. Rationalization of the DOH’s Procurement Program
AO 62 s of 1989 RULES AND REGULATIONS TO IMPLEMENT PRESCRIBING REQUIREMENTS UNDER THE
GENERICS ACT OF 1988
Generic names shall be used
Generic name must be written in full but salt may be abbreviated
Generic name must be clearly written on the prescription immediately after Rx
Brand name should be in parentheses and under generic name
Violative Prescriptions
generic name is not written;
generic name is not legible, brand name is legible
brand name is indicated and instructions added, such as 'No Substitution'
Impossible Prescriptions
only generic name is written but illegible
generic does not correspond with the brand
both generic and brand are not legible
product not registered with BFAD
Erroneous Prescriptions
brand name precedes the generic name
generic name is the one in parenthesis
brand name is not in parenthesis
more than one drug product is prescribed in one prescription form
AO 63 s of 1989 RULES AND REGULATIONS TO IMPLEMENT DISPENSING REQUIREMENTS UNDER THE

GENERICS ACT OF 1988
Generic dispensing – dispensing the patient’s choice from among generic equivalents
Inform the patient of all available drug products generically equivalent to the prescribed drug
All drug outlets shall post in a conspicuous place in their establishment a list of drug products
using their generic and brand names
RA 7432 SENIOR CITIZENS ACT 65 y.o 20% + 12% VAT

RA 9257 EXPANDED SSA 65 y.o 20% non-VAT
RA 9994 EXPANDED SSA of 2010 60 y.o 20% non-vat

PDDS Manuf Juris Toxicology Pacop

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1.

D 3. Spirit of peppermint is prepared by:

D 4. Brandy is made from:

E 5. Preservative added to syrup:

C 6. Levigation is often applied in:

D 7. General formula for infusions uses a strength of:

B 8. One of the following is not a biological product:

B 9. Concentration of “Diluted Alcohol” by volume is:

B 10. Aromatic water may be prepared by triturating the oil with:

C 11. Phenol produces a clear solution with:

C 12. One of the following is not a process of extraction:

E 13. Separation of immiscible liquids may be carried out by:

D 15. Triturations usually have a strength of:

B 16. A small scale comminution is:

A 18. Chemical change caused by heat:

C 19. One of the following has strength of 10% opium:

B 20. Glycerin suppositories are solidified by the use of:

E 21. Tablet is the preferred form as dosage form because of:

A 23. The preservatives for juices:

C 24. Purity means:

D 25. The HLB system is used to classify:

B 26. Most drugs are:

B 27. The usual purpose of chilling medication prior to administration is to increase:

C 28. The U. S. P. Pyrogen test is performed on:

B 30. The process of grinding substances to a very fine powder is termed:

A 31. An aqueous solution which serves as a cleansing or an antiseptic agent directed

B 32. The official hydrogen peroxide solution U. S. P. is also known as:

A 33. A synonym for cold cream, U. S. P. is :

B 34. Container impervious to air:

B 35. The term “impalpable” refers to s substance that is:

C 36. Cyanocobalamin is:

C 37. The non-aqueous vehicle used in injection:

D 39. Bulk powders are:

D 40. Oleoresins are:

A 41. A chromagen is:

A 42. Alcohol is a specific potentiating agent when used with it:

B 43. Rancidity of fats may be due to:

C 44. This is a tool for monitoring drug utilization:

A 45. These are roles of the pharmacists except:

C 46. These are developing trends in a pharmacist’s function except:

A 47. OTC drugs are:

D 50. Spans and Tweens are:

C 51. Which of the following is not a method of splitting emulsions:

B 52. The term PSIG in reference to aerosols means:

A 53. A disadvantage of sodium saccharin as a sweetening agent is :

B 59. Upon exposure to air, Aminophylline solutions may develop:

A 60. A chelate must always contain a:

D 61. Official forms of water include:

C 62. Insulin preparations are usually administered by:

A 64. The term piggyback is most commonly associated with:

B 65. The designation “minibottles” refers to:

A 66. The term venoclysis is most associated with:

A 68. The busher injection is:

D 69. Valium (diazepam) is available in which of the following dosage forms?

A) Maalox B) Amphojel C) Mylanta D) Titralac

B 71. The shaft portion of the needle is called the :

D 77. Purified water may be prepared by:

D 78. Syrups may be prepared by: