MANUFACTURING PHARMACY
drugs is to be introduced in the body.
LABELLING REQUIREMENTS
PHARMACOLOGICAL CATEGORY
- This state the therapeutic action of
the product.
- Pertain to the Intended in mechanism
of action.
- Example: Verapamil classified as
CCB (Calcium Channel Blocker)
FORMULATION
- This refers to the list and amount of
active medicinal ingredients per
dosage unit expressed in the metric
system
- It intended to reflect the active
pharmaceutical ingredients
INDICATION
- This refers to the approved clinical
use of the product based on
substantial evidence of the efficacy
and safety of the drug in the given
dosage form.
- Example: Verapamil can
therapeutically use to diff. condition
like HTN, angina pectoris,
Supraventricular tachycardiac,
DOSAGE
- This refers to the amount of intake of
the drug at a given frequency
interval, condition, and time of
administration.
- Dose
- Time/Frequency
- It can cause underdosing or
overdosing of your medication.
MODE OF ADMINISTRATION
- This refers to the site and manner the
- Pertain to the route of administration.
- Most common is oral but it is
susceptible to the first pass
metabolism.
- And the best to reach rapid activity of
the drug is thru parenteral route.
WARNINGS
- This gives information about
occurrence of serious potential
hazards and side effects associated
with the use of the drug and
limitation of its use.
- It is possible or intending danger
associated with the use of drug.
- It can be any unpleasant or problem
that can be encountered during the
intake of medication.
CONTRAINDICATION
- This gives information in the
condition wherein the drug may
cause harm to the patient.
- It can be a symptom or a condition
that makes particular treatment or
procedure in advisable.
- Example: CCB’s are cardiac
suppressant, it contraindicated in
bradycardia or HTN bec. it can
worsen the condition.
PRECAUTION
- This gives instruction and special
care to avoid undesired effects and to
assure the safe and effective use of
the product.
- It is a measure taking in advance to
prevent the dangerous or unpleasant
effects of the drug.
PACKAGE INSERT
 - This contains information applying
only to the product and its active
substances.
- Give information to the product it
contains indication, route of
administration, dosage, side effects
and others.
LOT NUMBER
- This means any distinctive
combination of letters or number, or
both by which the complete history
of the product, control, packaging,
and distribution of a batch of a drug
is determined.
- Indicates the history of production.
- It’s stays on batch  indicates to the
manufacturing order.
EXPIRATION DATE
- This is the period beyond which a
pharmaceutical specialty is not
expected to have retained its
pharmacologic attributes to guarantee
its safety, strength, quality, and
purity.
- Also known as “Shelf-life” it based
on the Arrhenius Equation.
- It expressed the MM & Yr.
- The last date of the month it indicates
the expiration date.
NET CONTENT
- This is the total amount/quantity of
the dosage from a certain container of
a pharmaceutical product expressed
in metric system.
- The actual quantity present in
container.
STORAGE CONDITION
- This is the prevailing specified
temperature, humidity and other
environmental factors within a range
will ensure optimal stability based on
experimental evidence of the product.
Cold = NMT 8 °C
STORAGE TEMPERATURE
Refrigerator = 2-8 °C
Freezer = -20 to -10 °C
Cool = 8-15 °C
Room Temperature = known as “Ambient”
(temp prevailing in the area), 25 °C
- Actual stability study that conducted
in RT.
Controlled RT = 15-30 °C
Warm = 30-40 °C
Excessive Heat = > 40 °C
- Accelerated it conducted in EH
RAW MATERIAL/COMPONENT
- This means any ingredient intended
for the use in the manufacturing of
drug, including those that may not
appear in finished product.
- It includes packaging materials,
active ingredients, and excipients.
BATCH
- This means a specific homogenous
quantity of a drug produced
according to a single manufacturing
order during the same cycle of the
manufacture.
- Example: 100,000 tablets the
capacity of the machine (equipment)
is 50,000 it will be divided into 2
batches.
LOT
- This means a batch or any portion of
a batch of a drug produced by a
continuous process, an amount of
drugs is produced in a unit time or
 quantity in a manner that assures its
uniformity.
- It will indicate the number of batches
produce in the manufacturing order.
ACTIVE INGREDIENT
- This means any substance of a drug
which is intended to furnish
pharmacological activity.
- It pertains to API (Active
Pharmaceutical Ingredients)
- It is the one written in the box. It
intended in the primary packaging
material.
MATERIAL APPROVAL UNIT
- This means any organizational
element having the authority and
responsibility to approve or reject
raw materials, in-process materials,
packaging components and final
products.
- It’s under to Quality Assurance
Department.
- It is the one who check and monitor
in process it gives Green sticker if it
is approved. Red sticker if it is
rejected, Yellow sticker indicate
quarantine it will subject to testing
STRENGTH
- This means the concentration of a
known active drug substance in the
formulation.
- Also known as “Potency”
- It is determining the percentage of
the active ingredients present in the
product.
- It is expressed in Metric system
(mg/ml/Units).
GENERIC NAME
- This means the concentration of a
known active drug substance in the
formulation.
- Also known as “International non-
proprietary name” INN, based on
USP/NF
- USP – official reference standard in
determining active ingredient.
TABLETS
- A solid dosage form which may or
may not contain medicinal substances
with or without diluents and prepared
either by molding or compression.
- Most commonly used dosage form in
the market, and commonly thru
compression.
Hopper – store granulation material or
PARTS OF TABLETTING MACHINE
compression.
Feed Frame – also known as “Shoe Frame”
- It distributes the granulation material
into die cavities.
Die Cavities – it controls the size and the
shape of the tablets
Punches – to compact/compress the
granulation material within the die cavities.
Cams – it guides the punches
TABLET EXCIPIENTS
DILUENT
- These are substances that make up
the major portion of the tablet.
- Also known as “bulking agent”
DILUENTS OR BULKING
SUBSTANCES
LACTOSE USP
- It is stable and does not react with
most medicinal substances
- its rapid solubility in water means
quick release of the drug substance
 - Non-hygroscopic and possess a high
melting point, so it is not softened by
frictional forces of machine
compression.
- It widely uses in the market.
- Advantages: inert
- High degree of solubility which
increase the bioavailability.
STARCH
- They are employed as binders and
disintegrants it contains water, to
stabilize hygroscopic drugs and
protect the tablets of such materials
from deterioration.
- Binder and disintegrant
- It can obtained/sources from wheat,
corn, rice, potato.
- It contains water approximately 12-
14%
SUCROSE
- Advantage: It is sometimes added to
provide additional sweetness, but its’
main use is as a binder because of its
cohesive property.
- Table sugar
- It can cause oxidation when it
contacts with acid or basic
substances, it will change into dark-
brown color.
MANNITOL
- This another sugar used for special
situations, due to its high cost. It as
sweet and obtained as powder or
granules.
- Most commonly diluent in chewable
tablets.
- It considered expensive.
Microcrystalline Cellulose
- a very expensive tablet diluent.
- Available as Avicel
Hydrolyzed starch with dextrose
- Its’ concentration is 95 to 96%
glucose; it contains 4 to 5%
polysaccharides.
- Known as Celutab in the market, it
also uses in chewable tablets because
of sweet test and pleasant
characteristics
OTHER COMMON DILUENTS
Lactose – anhydrous and spray dried lactose
Directly compressed starch – Sta Rx 1500
Hydrolyzed starch – Emdex and Celutab
Dibasic calcium phosphate dehydrates
Calcium sulphate dihydrate
Sorbitol
Sucrose – Sugartab, DiPac, Nutab
Dextrose
*The common denominator in tablet diluents
they have all sweet characteristics and it use
to mass the bitter test of the active
ingredients
TABLET EXCIPIENTS
BINDERS - These are substances that glue
powders together
Examples of raw materials employed as
binders are:
 Natural gums ex. Acacia, Tragacanth
10 – 25% concentration
 Sugars - Glucose
 Starch gelatin
 Polyvinyl pyrolidone (pvp) 21%
conc. alone
 In alcohol
 Cellulose derivatives ex. Ethyl
cellulose and methyl cellulose both
dissolves in chloroform
 Gelatin 10-20%
  Glucose 50%
 Polyvinylpyrrolidone (pvp)
 Starch paste 10-20%
 Sodium alginate
 Sorbitol
These are substances added to cause them to
“break apart” when placed in an aqueous
medium.
DISINTEGRANTS - These are substances
added to cause them to “break apart” when
placed in an aqueous medium
- Liberation = disintegration and
dissolution
Examples of raw materials employed as
disintegrant are:
 Starch – best disintegrant 5-20%
conc.
 Natural gums – swells in water
 Cellulose derivatives – commonly
used Avicel Na alginate
 Starch derivative = Primogel and
Explotab -1-8% pf tab. wt.
 Clays- Veegum HV, bentonite
 10% level in colored tablet only
 Cellulose
 Cellulose derivatives- Ac- Di-Sol
 (Na CMC)
 Alginate
 PVP (Polyvinylpyrrolidone), cross-
linked used as a binder
SUPERDISINTEGRANTS: SWELLS UP
TO TEN FOLD WITHIN 30 SECONDS
WHEN CONTACT WATER.
Example: Crosscarmellose (cross-linked
cellulose polysaccharide), Crosspovidone
(cross-linked povidone), sodium starch
glycolate - (cross-linked starch).
 A portion of disintegrant is added
before granulation and a portion
before compression, which serve as
glidants or lubricant. Evaluation of
carbon dioxide in effervescent tablets
is also one way of disintegration,
common disintegration happens in 1-
30mins
LUBRICANTS - These are substances
prevent adhesion of the tablet material to the
surface of the dies and punches
 These are substances which:
 Improve the rate flow of
tablet granulation
 Prevent adhesion of the
tablet, material to the surface
of the dies and punches
 Reduce particulate friction
 Facilitate the ejection of the
tablets from the die cavities
Examples of raw materials employed as
lubricant are:
 Stearates of magnesium and zinc
 Talcum powder - asbestos (can cause
pulmonary nodule is carcinogenic)
 Sodium benzoate – usually used as
preservative
 Mixture of sodium benzoate and
sodium acetate
 Colloidal silicone dioxide – is
expensive
 Leucine
 Carbowax 400
GLIDANTS - These are substances which
improve the rate flow of tablet granulation
 Corn Starch 5-10% conc.
 Talc 5% conc
 Silica derivative
  Colloidal silicas such as Cab-O-Sil,
Syloid, and Aerosil. 0.25-3% conc.
COLORING AGENTS - These are
substances added to improve aesthetic
appearance. FDNC – Food, drugs and
Cosmetics. Yellow #5 has a problem in
market (tartrazine can cause severe allergic
reaction) Coloring agents are added to tablet
granulations for the following purposes:
 For improvement of aesthetic
appearance
 To provide control of the product
during its manufacturing
 As a means of identification.
FLAVORING AGENTS - These are
substances to mask the undesirable flavor of
certain medicaments
Examples of raw materials employed as
flavoring agents:
 Sugars (natural or artificial)
 Essential oils (peppermint,
 Lemon, orange, vanilla,
 Strawberry, banana, and the
 Likes)
 Fruit acids (citric acid, tartaric acid,
malic acid)
SWEETENING AGENTS
 For chewable tablets: Sugar,
mannitol (major diluent).
 Saccharin (artificial) 500x sweet that
sucrose but has a bitter after and also
banned due to it carcinogenic
property
 Aspartame (artificial) seen in
breverage is highly unstable bcs. Pf
presence of moisture
ARTIFICIAL SWEETENERS
a) Saccharin 300x sweeter than sucrose
b) Aspartame 180-200x sweeter than
sucrose
c) Acesulfame Potassium 200x sweeter
than sucrose mostly for bakery or
food industry only
d) Sucralose 600x sweeter than sucrose
e) Neotame 7000-13000x sweeter than
sucrose
f) Advantame 20000x sweeter than
sucrose
g) Stevia 200-400x sweeter than sugar
ADSORBENTS - These are substances of
holding quantities of fluids and moisture in
an apparently dry state.
Examples of raw materials employed as
adsorbents
 Carbonates of magnesium and
calcium
 Oxides of magnesium and aluminum
 Kaolin, bentonite
 Veegum
PLASTICIZERS - These are substances that
improve flexibility and elasticity of the
coating and thus provide durability.
Commonly used are castor oil and glycerin
OPAQUANT - These are substances that add
hiding or covering power to the coating
solution. Commonly used titanium dioxide.
FILM FORMERS - These are substances
capable of producing smooth, thin films
reproducible under conventional coating
conditions and applicable to a variety of
tablet shapes.
 Enteric – Shellar, Flakes and
cellulose acetate phthalate
 Non-Enteric – Methoxy, hydroxy
cellulose, Ethyl cellulose and
povidone
ALLOYING SUBSTANCES - These are
substances that provide water solubility or
permeability to the film to ensure penetration
by body fluids and therapeutic availability of
the drug. PEG
SURFACTANTS - These are substances that
enhance spreadability of the film during
application. Commonly used polyoxyethylene
sorbitan.
GLOSSANTS - These are substances that
provide luster to the tablets without a separate
polishing operation. Commonly used is
Beeswax
VOLATILE SOLVENTS - These are
substances that allow the spread of the other
components over other tablets while allowing
rapid evaporation to permit an effective yet
speedy operation. Ex, Alcohol+Acetone
TABLETTING PROCESSING
PROBLEMS
Capping - This is the partial or complete
separation of the top or bottom of a tablet
from the main body.
Lamination - This is the separation of tablet
into two or more distinct layers. Can be
prevented thru Friability test
Chipping - This is the removal of the edges
of the tablet.
CAUSES OF CAPPING, LAMINATION
AND CHIPPING:
 Entrapment of air among the tablet
granulations
 Wear and tear of the dies and
punches
 Carelessness in setting up the tablet
presses
 The setting of the sweep-off blade to
the high
TABLETTING PROCESSING
PROBLEMS
Picking - This is the removal of the material
from the surface of the tablet and its
adherence to the face of the punch.
Sticking - This is the adhesion of tablet
granulation into the wall.
CAUSES OF PICKING AND STICKING:
- Difficulty cleaning the monograms
with enclosed areas, such as the
letters A or B; and monograms with
sharp angles, such as the letters M or
W.
TABLETTING PROCESSING
PROBLEMS
Mottling - This is the unequal distribution of
color of the tablet with light or dark areas
standing out, in an otherwise uniform surface.
CAUSES OF MOTTLING:
- Colored adhesive solutions are not
distributed well
- Colored adhesive solutions are added
while hot into a much cooler
mixtures. (such as in small particles)
ORANGE PEEL EFFECT
-->This is the roughness of the tablet
surface due to failure of spray
droplets to coalescence.
 If not perfect can cause roughness
as drying for tablet
BRIDGING
 this is the filling-in of the score
line or intended logo or scar line on
the tablet by the film
TABLET EROSION
this is the disfiguration of the core
tablet when subjected for too long
 -->when tablet is totally dissolve it
didm’t form
BLOOMING
this is the fading or dulling of a
tablet color after a prolonged period
of storage at high temp.
When tablet expose at high
temperature
CRAKING/ SPLITTING
this occur when the film coating
the tablet cracks in the crown area or
splits around the edges.
BLUSHING
This is haziness or appearance of
white specks in the film
white lines it precipitates film
BLISTERING
 This occurs when elasticity or
adhesive properties are compromised
in which the film become detached
from the tobler’s substrate
or a detachment of a film
STEPS IN SUGAR COATING
1. SEALING- prior to applying any
sugar/ water syrup, the tablet comes
must be sealed, thoroughly dried and
free of all residual solvents. ( 2x must
be sealed)
--- aka: WATERPROOF
2. SUBCOATING- the actual start of
sugar coating process and provides
the rapid build up necessary to round
up tablet edge. (to standardized the
size of tablets)
----COMMON USE: GELATIN
ACACIA SOLUTION AND
OTHERS CaCO3,TALC
3. SYRUPING- often critical in the
successful completion of sugar
coating process and involves multiple
application of syrup solution (60-
70% solid) containing requisite
coloring matter.
--- 3 PHASES:
1. CROSSING PHASE – adding
colorant
2. HEAVY PHASE – syrup
concentration
3. REGULAR PHASE- prior to
finishing
4. SMOOTHING OR
GROSSING/FINISHING-
specifically for smoothing and filling
the irregularity on the surface
generated during subcoating.
( irregular shape can smoothen)
5. POLISHING- this is achieve by
apllying the mixture of waxes like
beeswax, carnuba wax, condelia wax
or hard paraffin wax to tablets.
(impart sheen/ glossiness)
6.
7. PRINTING- the thickness of the
coat would be obliterate any
embossing to if markings are
required in the tablets. (it is optional
only and purpose for good
appearance added to aesthetics)
3 MAJOR PROCESS:
1. PAN COATING
2. PAN SPRAYING
3. AIR SUSPENSION
METHOD OF TABLET COMPRESSION
1. WET GRANULATION- most
widely used method for tablet
compression (oldest)
ADVANTAGES
- Improve compression/ adhesion
- For high doses of drugs is used for
having poor flow of powder
DISADVANTAGES
- Considered costly
- Time consuming
- Also it used to fluident granulation
and spray dryer
2. DRY GRANULATION- it is least
desirable of all methods of
granulation
-aka: DOUBLE/ FORCE
COMPRESSION
- use only for powder with inherent
binding property
-USED: SLUGGING/ ROLLER
COMPACTION
ADVANTAGES
- For water and heat materials only
DISADVANTAGES
- Requires heavy duty compression
- Problem for color distribution
SEMI-SOLID
3. DIRECT COMPRESSION- is
preferred methos that applicable to
granular chemicals that possess free-
flowing and cohesive properties.
Examples:
- Anhydrous lactose
- Spray dried lactose
- Crystalline sorbitol
- Avicel
- Chemicals: NaCl, KCl, NaBr
TYPE OF DRUG RELEASE
SYSTEMS
1. EXTENDED RELEASE
- PROLONG ACTION OF DRUGS
- This allows reduction in dosing
frequency from that necessitated by
conventional dosage form
- AKA: Modified release reaction
- EXAMPLES: metformin, Morphine
2. DELAYED RELEASE
- This is designed to release the drug at
a time other than promptly after
administration
- For enteric coated used
- EXAMPLE: NSAIDS, Aspirin
3. TARGETED RELEASE
- This describes drug release directed
toward isolating or concentrating a
drug in a body region, tissue or site
for absorption or for drug action
- EXAMPLES: Sublingual, buccal
(rapid onset action)
4. ORALLY DISINTEGRATING
TABLETS(ODT)
- IThas been developed to disintegrate
rapidly in the saliva after oral
administration
- No need water only saliva can
- EXAMPLES: fentanyl,
Amphetamine, Loratidine
TYPES OF OINTMENT BASE
( OINTMENTUM)
1. WATER SOLUBLE BASE /
GREASELESS OINTMENT
BASE
- They are often referred to as
greasless
- Water washable and do not contain
oleaginous substance.
- EXAMPLES: hydrous lanolin, cold
cream
-
2. ABSORPTION BASE
- Used as pharmaceutical adjuncts to
incorporate small volumes of
aqueous solution to hydrocarbon
bases
DISADVANTAGES
- NOT EASY TO REMOVE FROM
SKIN
- EXAMPLE: hydrophilic petrolatum,
lanolin (w/o)
3. WATER REMOVABLE BASE
- Also water washable since readily
washed from the skin or clothing, an
attribute makes more acceptable for
cosmetic reasons.
- EXAMPLE: hydrophilic ointment,
vanishing cream
4. HYDROCARBON
- Aka: OLEAGINOUS OINTMENT
BASES.
- Made of animals fats
- Not water washable
- Used as emollient and occlusive
improperty
- EXAMPLE: petrolatum,
white/yellow ointment and white
petrolatum
2 METHODS OF OINTMENT USE:
- INCORPORATION (mortar and
pestle)
- FUSION (applies heat)
TYPES OF SUPPOSITORY BASE
1. OLEAGINOUS BASE/ FATTY
BASE
- Obtain vegetable fats
- Used as lubricant and emollient
- EXAMPLE: wecobee(balm oil),
witepsol,coca butter(rectal
suppository) Betapolymorphism at
37degree celcius.
2. WATER SOLUBLE/WATER
MISCIBLE BASE
- Highly polar compound
- EXAMPLE: gelatin suppository,
Polyethyleneglycol, glycerinated
gelatin
3. MISCELLANEOUS BASE
- Combination of oleaginous and water
soluble
- EXAMPLE: Polyoxyl 40
3 METHODS SUPPOSITORY:
1. FUSION ( COMMERCIAL
METHOD)
2. COMPRESSION ( BUT IN
HOSPITAL AND COMMUNITY
ONLY USE HAND ROLLING)
TYPES OF SUPPOSSITORY:
1. RECTAL – torpedo / bullet shape
Use: cocoa butter
2. VAGINAL- Pessaries / Oviform
shape
Use: water soluble base (PEG,
Glycerinated gelatin)
3. URETHRAL- Bougies /Pencil shape
LIQUID DOSAGE FORMS
AEROSOLS –pressured dosage forms that
upon actuation emit fine dispersion of liquid
and or solid materials containing one or more
active ingredients in gaseous medium.
- Dispersing medium active
component: Liquid and solid
- Have propellant
- EXAMPLE: LIQUEFY( CFC –
FREON),
COMPRESS GASES (CO2, N+ gas)
PARTS of AEROSOL:
VALVE – basic part and package is
emiited
ACTUATOR – allows to dispense
 DIPTUBE- convase the liquid form concentrated acids with purified
bottom container to dispensing water
Metered dose inhalation- made for - Express 10% conc. Except ( Acetic
Al- it is strong and less reactive acid -6%, Dil. HCl- 36-38%, Dil.
Glass container- highly incompatible HNO3- 69-71%)
Aerosols –made in tin it is light and - This was express in w/v officially.
inexpensive widely use
LIQUID DOSAGE FORMS
AROMATIC WATER
AEROSOLS
- AKA MEDICATED WATER
These are pressured dosage forms that upon
- These are clear, aqueous solutions
actuation emit a fine dispersion of liquid and
saturated with volatile oils .
/or solid materials containing one or more
- Main used of: flavorant but also can
active ingredients in gaseous medium.
use as perfume in high concentration
 Dispersing medium (GAS) but the
3 METHODS USED AROMATIC
active component can be a liquid or it
WATER;
can solid
1. DISTILLATION/ COHOBATION  Provide rapid onset of action because
– 1 or 2x small quantity they are devoid of first pass
2. SOLUTION METHOD – 2mg/2ml metabolism
of volatile oil in 1 L of H2O  ADVANTAGE: Aerosols
3. ATLERNATE METHOD- have lower adverse drug effect
triturate 2mg/2ml volatile oil with
Components:
talc.(AS CLARIFYING AGENT)
1. Propellant – supplies the necessary
COLLOIDIONS
force to expel the product
- These are liquid preparations o Liquefied gases – CFC
composed of pyroxillin dissolved in a (Chlorofluorocarbon): Preon
solvent mixture usually composed of o Compressed gases: Carbon
alcohol and ether with or without dioxide or nitrogen gas
added medicinal subsntaces. 2. Valve – basic part of aerosols; It
- PYROXILLLIN AKA: Soluble gun contains the package where it is
cotton contain with Nitric acid + immitted
H2SO4 3. Actuator – it allows the product to
- MARKET : FLEXIBLE dispensed in desired form
(COLLOIDON + CASTOR OIL + 4. Dip tube – it condensed the liquid to
CAMPHOR) the bottom of the container to the
- CAMPHOR OF WATER PROPANE dispensing valve; Container is made
of TIN which is light, relatively and
DILUTED ACID inexpensive; MOST WIDELY
- These are aqueous solutions prepared USED.
by diluting corresponding o METERED DOSE
INHALER – made of
 Aluminum, because it is
strong and less reactive
o If highly incompatible the
components of aerosol it
used GLASS.
AROMATIC WATERS
 Also known as Medicated Water
These are clear, aqueous solutions saturated
with volatile oils.
USED:
 Flavorant
 Perfume
3 Method of preparing aromatic water
1. Distillation (Cohobation) – redistilled the
delicate drugs one or two times with
small quantity of volatile substances
 Example: Strong Rose Water
2. Solution method – re-dissolved 2mg/2mL
of volatile oil in one liter of water. (Stand
the solution overnight and the filter the
following oil)
3. Alternate method – triturate the
2mg/2mL of volatile oil with talc. Talc is
clarifying agent, after triturate it is
dissolved in 1 liter of water.
COLLOIDIONS
These are liquid preparations composed of
pyroxillin dissolved in a solvent mixture
usually composed of alcohol and ether with
or without added medicinal substances.
 Pyroxillin also known as “Soluble
Gun Cotton”
o Reaction of cotton with nitric
acid + sulfuric acid
 In the market there are flexible
colloidion
o Colloidon + castor oil +
camphor
o Add camphor for water
propane
o Castor oil for flexibility
DILUTED ACIDS
These are aqueous solutions prepared by
diluting the corresponding concentrated acids
with purified water.
 Express in 10% concentration except
acetic acid (6%),
 hydrochloric acid (36-38%)
 Diluted nitric acid (69-71%)
 OFFICIAL diluted acid is express in
percentage which is W/V
DOUCHES
These are aqueous solution directed against a
part or into a cavity in the body.
 Well known Dobell’s solution – it is
made of Sodium tetraborate
o Given through ophthalmic or
vaginal route
 Also, Benzalkonium chloride
o Vaginal douches
ELIXIRS
These are clear, sweetened hydroalcoholic
solutions intended for oral use.
 5-40% alcohol
 Aromatic elixir (22% alcohol)
a) High alcoholic (75-78%)
b) Low alcoholic (8-10%)
EMULSIONS
 Oil/Water/Gum (Emulsifying agent)
 PARTICALES SIZE OF
EMULSION (0.1-100 microns)
These are dispersion in which the dispersed
phase is composed of small globules of a
liquid distributed throughout a vehicle in
which it is immiscible.
 1. Internal phase / Dispersed phase/  4:2:1
Discontinuous phase b. Dry Gum Method
2. External / dispersing medium/  The other name is “Continental”
continuous phase – SOLVENT  Gum + oil then gradually add
the water product is Water in
EX: O/W – internal is oil and the oil emulsion
water is external.  Similarly, it is 4:2:1
c. Bottle Method
Problem:  Forbes Bottle Method is used
 Cracking – separates into its for extemporaneous preparation
ingredients of volatile oil or oleaginous
 Creaming – a motion droplets tend substances
to rise to the top of container  3:2:1
 Phase inversion – nagkapalit; d. Nascent Soap Method
instead of oil in water preparation  “In situ soap method” it is
prepared by mixing equal amount
THEORIES OF EMULSIFICATION of oil and lime water (calcium
o Plastic theory – It states that hydroxide)
interface exists between the oil and  For external used
the water as a thin layer of film
adsorbed on the surface of the drops.
o Oriented wedge theory – This is GRIFFIN HLB VALUE
based on the presumption that certain
HLB Value Description
emulsifying agents orient themselves (Hydrophilic
about and within a liquid in a manner lipophilic balance)
reflective of their solubility in that 0-3 Antifoaming
particular liquid. agents
o Surface tension theory – The use of 4-6 Tweens (water in
emulsifiers and stabilizers lowers the oil emulsion)
interfacial tension if the two 7-9 Wetting agents
immiscible liquids, reducing the 8-18 Spans (oil in water
repellent force between the liquids emulsion)
and diminishing each liquid’s 10-18 Solubilizing agents
attraction for its own molecules. 13-15 Detergents

METHODS OF PREPARATION OF
EMULSIONS ENEMAS

a. Wet Gum Method These are rectal injections employed to

 “English Method” – added
Emulsifier to form mucilage
 If there is mucilage gradually
add oil to the preparation
therefore the product is oil in
water emulsion
evacuate the bowel, influence the general
system by absorption, or to affect a local
disease.
1. Retention enema – action is for local
and systemic
 2. Evacuation enema – the purpose is FLUID EXTRACTS
eradication of worms or it can be
These are liquid preparations of vegetable
done prior to surgery
drugs prepared by percolation that contains
EX: Monobasic phosphate (Fleet
the therapeutic constituents of 1 gram of the
enema)
standard drug that it represents.
 1 g/ 1 mL
EXTRACTS
3 methods of percolation
These are concentrated preparations of
 Process A – 85% of percolate and
vegetable or animal drugs obtained by
then collect the weak percolate until
removal of the active constituents of the
exposure.
respective drugs with suitable menstruum.
 Process E – is alternative for process
Components of drug extraction A, but in process E uses percolator
with long column
1. Menarche – undissolved portion after
 Process D – use of boiling water as
the extraction
menstruum
2. Menstruum – solvent
GARGLES
Extract are classified as:
These are aqueous solutions frequently
1. Semi-liquid – syrupy consistency
containing antiseptics, antibiotics and/or
2. Pillurlar – extract with plastic
anesthetics used for treating the pharynx and
consistency
the nasopharynx.
3. Powdered extract – are used in
making tablets and capsules  Bactidol (hexetidine)
 Golden gargle – contains Iron,
Method of extraction:
Potassium, and carbonate.
a. Maceration – solid powder and a
solvent is place in a stopped
container and stand it for a period of GELS
time
These are semisolid systems consisting of
b. Digestion – maceration with gentle
dispersions made up of either small inorganic
heat
particles or large organic molecules enclosing
c. Percolation – is a form of
and interpenetrated by a liquid.
maceration but it uses percolator and
the flow rate is 1mL per minute PROBLEMS IN GELS
d. Decoction – extracting the water
soluble and heat stable constituents. A. IMBIBITION – thicking up of a
It is done by boiling in water for 15 liquid without increase in the volume.
minutes. B. SWELLING – if there is increase in
e. Infusion – maceration with hot or volume
cold water. Infusion it presents 15 C. SYNERESIS – squeezing out of a
grams of drugs in 100 mL of dispersing medium. It involved gel
solution. shrinking.
 D. THIXOTROPHY – irreversible gel
sol formation without change in
volume
EX: Bentonite magma – Solid upon
standing but liquid upon shaking
E. XEROGEL – it is formed when
liquid is removed from a gel and only
a frame work remains.
CLASSIFICATION OF GELS
A. INORGANIC – 2 phase system
 Bentonite magma
 Aluminum hydroxide
B. ORGANIC – 1 phase
 Tragacanth
 Carbopol
C. HYDROGELS – obtained from
natural and synthetic gums
 Pectin
 Methyl cellulose
 Tragacanth jelly
D. ORGANOGELS – obtained from
animals or vegetables fats
 Lard
 Cocoa butter
LINIMENTS
 Also known as Embrocation
These are alcoholic or oleaginous solutions or
emulsions of various medicinal substances
intended to be rubbed on the skin.
 Used as Rubefacient and
counter irritants
Classes:
1. Alcoholic – allows more penetration
to the skin
2. Oleaginous – requires massage or
rubbing
LOTIONS
These are liquid or semi-liquid preparations
that contain one or more active ingredients in
an appropriate vehicle.
 Commonly used for external
used
Method of preparation
1. Trituration – used of mortal and
pestle
 Calamine Lotion (Zinc oxide
and Ferric oxide) – Anti-
itching or Antipuritic
2. Chemical
 White Lotion (Zinc oxide
and Zinc sulfate)
MAGMAS & MILK
These are aqueous suspensions of insoluble
inorganic drugs and differ from gels mainly
in that the suspended particles are layers.
 2 phase system
 Mostly composed of
floccules of small distinct
particles
Process:
1. Hydration
 Milk of magnesia (Antacid
and Laxative)
2. Chemical reaction
 Magnesium sulfate + sodium
hydroxide = Magnesium
hydroxide
MOUTHWASH
These are aqueous solutions, which are most
often used for their deodorant, refreshing, or
antiseptic effect.
 LISTERINE – it has
antiseptic property it
produces freshing effect
SPIRITS  Simple syrup
2. Agitation without heat
 Also known as Essences
3. Reconstitution – addition of sucrose
 They are made of 60%
to medicated liquid
alcohol 4. Percolation – pass the solvent in the
These are alcoholic or hydro-alcoholic bed of sucrose at a 1 mL per minute
solutions of volatile substances. rate

 Used as flavorant
 Vehicle
TINCTURES
 It is stored in amber
container (light resistant) These are alcoholic or hydroalcoholic
solutions prepared from vegetable materials
or from chemical substances.
SUSPENSIONS
 Express in 10 grams of
These are preparations containing finely
standard drug per 100 mL
divided drug particles distributed somewhat
 10% weight per volume
uniformly throughout a vehicle in which the
 Commonly tincture contains
drug exhibits a minimum degree of solubility.
15-80% of alcohol
 Particle size is greater than 1
Methods:
micrometer
 Auxiliary label: SHAKE 1. Maceration – sweet orange peel
WELL BEFORE USED tincture
2. Percolation – belladonna
Common problem: 3. Simple solution – Iodine tincture (2%
a. Sedimentation – particles tend to iodine in 50% ethanol)
accumulate in the bottom of the container
b. Caking – formation of cake or cement;
irreversible in nature TYPES OF CONTAINERS
SYRUPS A. WELL-CLOSED CONTAINER
 Container that protects the
These are concentrated, viscous aqueous
content from extraneous
solutions of sugar or a sugar substitute with solid or from the loss of
particle under ordinary
or without flavors and medicinal condition
substances. B. TIGHT CONTAINER
 It protects the content from
 Simple syrup – 85% of contamination by extraneous
sucrose (table sugar) liquid, solid or vapor.
C. HERMETIC CONTAINER
Different preparation:
 It is a container that is
1. Agitation with the aid of heat – to impervious to air or other
prevent caramelization any gases.
 D. LIGHT-RESISTANT CONTAINER
 Other name is “Amber
Glass”
 It protects the content from
exposure to light because it
can cause oxidation.
OFFICIAL TYPE OF GLASS
CONTAINERS (USP)
A. TYPE 1 (Borosilicate Glass)
 Applicable for parenteral
preparations
 Least reactive container
available in the market
 Contains Boron – it lowers
the thermal expansion of
Pyrex glass and Duran glass
 Indicated for basic and
alkaline drugs
B. TYPE 2 (Alkalinized Soda Lime
Glass)
 High among of sodium
hydroxide and calcium
hydroxide
 It is not resistant to leaching
 It performs with Water
Attack Test
 Indicated for acidic drug
 For parenteral preparations
C. TYPE 3 (Soda Lime Glass)
 Intended for powders which
is intended to be
reconstitution
 Buffer
D. TYPE NP (Non-parenteral)
 For tablets, capsule and
transdermal dosage form
 General test for glass container is
POWDER GLASS TEST (Type 1, 3,
and NP)
POWDERS
Mixtures of finely divided drugs or chemicals
in dry form which can be used internally or
externally.
Type of powder:
1. Hydroscopic in nature – it absorbs
moisture but does not dissolved on it
2. Deliquescent – is a powder absorb
moisture and dissolved on it
3. Efflorescent – the release of water of
crystallization
4. Effervescent – it releases carbon
dioxide in water
 EX: Sodium bicarbonate,
Tartaric acid and citric acid
COMMINUTION PROCESS
 The reduction of particle size
1. Trituration
 Mortal and pestle
2. Pulverization
 Intervention
3. Levigation
 Levigating agent
4. Milling
 Miller
TYPES OF POWDERS
1. Bulk Powders
 It is not potent, it is available
in large quantities
 Dendrites, insufflation,
dusting
2. Divided Powders
 Potent substances
 Also known “Chartulae”
 Prepared in individualize
paper tabs
METHODS OF BLENDING OF
POWDERS
 A. Geometric Dilution – intended for  It used sorbitol or glycerin as
potent powder mix with large amount plasticizer
of diluents
Method producing capsule:
 AKA 1:10 ratio
B. Sifting – intended to produce light, 1. Plate process
fluffy powders 2. Rotary or reciprocating die process
C. Spatulation – suitable for powder  Commercially used.
that form eutectic mixture
 Eutectic – lowering the How to check the integrity of capsule?
melting point  To measure the rigidity of gelatin
D. Trituration – reduction of particle capsules it perform the Bloom’s
size and mixing of powders Strength.
 AKA 1:10 dilution
E. Tumbling – process involved in
mixing powders in a large container
rotated by electric motor

CAPSULES
Solid dosage form in which one or more
medicinal and/or inert substance are enclosed
within a small edible shell usually made of
gelatin.
TYPES OF CAPSULES
1. Hard Gelatin
 Also known as “Dry filled
capsule”
 It is made of 12-25% moisture
 Commonly composed of gelatin,
water, sugar, colorant and
titanium dioxide
 It has 2 parts:
 Head
 Cup
 Smallest size is 5
 Largest 000
2. Soft Gelatin
 Composed of 6-10% of water