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PHARMACEUTICAL DOSAGE FORMS

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I. INTRODUCTION o Pulverization by Intervention – addition of volatile


substance to gummy materials (ex. camphor + alcohol; I2
 Dosage Forms – drug products/preparations containing:
crystals + ether)
o Active Pharmaceutical Ingredient (API)/ Drug
 Mixing/Blending
o Exipients/Additives/Adjuncts
o Trituration – mortar and pestle
 Drug – any article intended for use in diagnosis, cure,
 Types of mortar and pestle
treatment, mitigation or prophylaxis in man and other animals
Glass – smooth non-porous surface; for simple
– affects the structure or any function of the body
admixture; for chemicals that stain
 Excipients – inactive ingredients
Porcelain – rough inner surface; for comminction
o Role: drugs  more appealing and efficacious
Wedgewood – rougher surface; for crystalline
o Use: solubilize, suspend, emulsify, dilute, stabilize,
substances
preservatives, color, flavor, etc.
o Spatulation – use of spatula; not for potent substances
 Placebo – dosage form that does not contain an API
o Sifting – use of sifter; not for potent substances
 Drug Delivery System – products that allow for uniform
o Geometric Dilution – addition of an equal volume of diluent
release and targeting of drugs into body
to a potent substance placed in a mortar
 Cosmetics – any substance/preparation intended to be placed
o Tumbling – large containers rotated by a motorized process
in contact with external parts of human body or with teeth and
 TYPES OF POWDER
mucous membranes of oral cavity with a view exclusively or
o Bulk Powders – dispensed in large quantities
mainly to cleaning them, perfuming them, correcting body
 Oral Powders – dissolved/dispersed in a liquid or mixed
odors, changing their appearance, protecting them and/or
with food before use
keeping them in good condition
 Dentrifices – contain a soap, mild abrasive and
 Compounding – preparation, mixing, packaging or labeling of anticariogenic agent
a drug to prepare an individualized drug treatment for a  Dusting Powders – locally applied non-toxic powders that
patient
have no systemic action
 REASONS FOR FORMULATING DOSAGE FORMS: appearance,  Douche Powders – dissolve in warm water prior to use as
palatability, ease of administration, solubility, stability cleansing agent/antiseptic for a body cavity
 Insufflators – blown into body cavities using an insufflator
II. SOLID DOSAGE FORMS  Triturations – dilutions of potent powdered drugs (10%
A. POWDERS API)
o Divided Powders/Chartulae – dispersed in individual doses
 intimate mixtures of finely divided drugs or chemicals in dry
usually in folded papers
form which may be used internally or externally
 TYPES OF POWDER PAPER
 size: sieve no.
o White Bond Paper – opaque paper with no moisture
o very coarse – no. 8
resistance
o coarse – no. 20
o Glassine Paper – glazed transparent moisture-resistant
o moderately coarse – no. 40
paper
o fine – no. 60
o Vegetable Parchment – thin, semi-opaque, moisture-
o very fine – no. 80
resistant paper
 Advantages: rapid dispersion of ingredients; flexibility in
o Waxed Paper – transparent waterproof paper; suitable for
compounding; good stability
deliquescent and hygroscopic drugs
 Disadvantages: inaccuracy of dose; not suitable for dispersing
deliquescent and hygroscopic drugs
 COMPOUNDING:
o Trituration – mortar and pestle
o Levigation – forming a paste by addition of levigating agent
(ex. mineral oil, glycerin)

PAGE 1 OF 7 © MANOR REVIEW CENTER NOTES (K.L)


B. GRANULES  Sublingual Tablets – dissolve rapidly under tongue for
systemic absorption (ex. Nitroglycerin, ISDN)
 prepared agglomerates of powders; size: sieve no. 4 to 12; for
 Lozenges – candies that dissolve slowly in mouth for local
tablet formulation: sieve no. 12 to 20
effect (ex. Strepsils® - dicholorobenzyl alcohol +
 Advantages: flow well compared to powders; less tendency to
amylmetacresol)
cake or harden; more stable to humidity; more easily wetted
TYPES:
by liquids
 Troches – compressed lozenges
 PREPARATIONS:
 Pastilles – molded lozenges
o Wet Granulation – most common; addition of liquid binder
 Lollipops – lozenges on sticks
o Dry Granulation – for moisture-sensitive and heat labile
o Tablets Used to Prepare Solutions
materials; use compaction/compression forces
 Effervescent Tablets – ex. Alka-Setlzer® - antacid + pain
o Effervescent Granules – dissolved in water before use in
reliever
which CO2 gas is released to mask the unpleasant taste of
 Compounding/Dispensing Tablets – contain a large
drug
amount of API used by pharmacists in compounding
 COMPONENTS:
multiple dosage units
o NaHCO3
 Hypodermic Tablets – used by physicians to prepare
o Citric acid  sticky
parenteral solutions
o Tartaric acid  crumble
 Molded Tablets/Tablet Triturates
 PREPARATION:
o Dry/Fusion Method – binder is 1 molecule of water in citric
acid D. CAPSULES
o Wet Method – binder is water + alcohol  solid dosage forms in which drug is endosed within either a
hard or soft soluble shell usually made of gelatin
C. TABLETS o Gelatin – partial hydrolysis of collagen from the skin/bones
 solid dosage forms which are prepared mainly by compression of animals
or molding  Types:
 Advantages: precision and low content variability; low Type A – acid hydrolysis
manufacturing cost; easy to package and ship; simple to Type B – base hydrolysis
identify; most stable of all oral dosage form; tamper proof  Alternative: hydroxypropyl methylcellulose (HPMC) or
 Disadvantages: some drugs resist compression; some drugs stach
that require encapsulation prior to compression Types of Capsules:
 TYPES OF TABLETS:  Hard Gelatin Capsules – dry-filled or two-piece capsules (cap
o Tablets for Oral Ingestion and body)
 Compressed Tablets – formed by compression; some are o made of gelatin, sugar and water + colorant + opacifying
scored agent (TiO2) + SO2 [0.15%] (to prevent decomposition of gel)
 Multiple Compressed Tablets – ex. layered tablets, o contains 12-16% moisture
compression coated tablets o stored at 21-25oC/30-35% RH
 Coated Tablets o capsule sizes: (increase capsule size = decrease capacity)
 Sugar Coated Tablets – coated with a water soluble  Human – No. 5 (smallest) – No. 000 (largest)
sucrose-based solution  Veterinary – No 10. – No. 12
 Film Coated Tablets – coated with a thin layer of  Soft Gelatin Capsules – one-piece capsules; contains non-
polymer material aqueous liquids (vitamin e, cod liver oil, digoxin), suspensions,
 Enteric-Coated Tablets – remain intact in stomach and pastes, and dry solids
disintegrate in small intestine o made of gelatin, plasticizer (glycerin, sorbitol) and
o Tablets Used in the Oral Cavity preservatives against fungi
 Chewable Tablets – chewed in mouth before swallowing; o contains 6-10% moisture
does not contain disintegrant; diluent: mannitol and o no specific sizes
xylitol
 Rapidly/Orally Disintegrating Tablets – liquefy on tongue
before swallowing (ex. Resperidone, Ondasetron)
 Buccal Tablets – dissolve slowly in cheeks/buccal pouch
for systemic absorption (ex. Progesterone)

PAGE 2 OF 7 © MANOR REVIEW CENTER NOTES (K.L)


E. ORAL MODIFIED-RELEASE SOLID DOSAGE polymorphism (ȣ - least stable [18oC]; α; β’; β – most
stable [34.5oC]
FORMS Wecobee ® - from coconut
 drug release features are based on time, course and locations Witepsol ® - saturated PAs (C12-C18); major: lauric acid
 Reasons: Glyceryl Monopalmitate
o to prolong therapeutic effect to reduce dosing frequency  Water-Soluble/Miscible Base
o to delay the effect Glycerinated Gelatin – most common base for pessaries
Polyethylene Glycol (PEG)
o PREPARATIONS:
MTC  Hand Molding/Rolling/Shaping – oldest and simplest;
base is rolled into desired shape by hand
Cp  Compression Molding – base is forced into molds;
problem: air entrapment
MEC  Pour/Melt Molding – most common; base melted and
poured into molds
immediate
controlled  Vaginal Tablets/Inserts – ovoid tablets inserted into the
sustained
delayed vagina using a plastic inserter; contains antimicrobial agents
 Implants/Pellets – small, sterile cylinders or devices inserted
under the skin for prolonged and continuous absorption
Time
o Norplant ® - levonorgestel (5 years)
onset onset o Leuprolide – prostate cancer (1 year)
 Types:
o Extended-Release – provides a prompt-desired effect III. SEMI-SOLID DOSAGE FORMS3
followed by a gradual release of remaining amount
 Problem: dose dumping
A. OINTMENTS
 Types:  semi-solid dosage forms applied externally on the skin or the
Controlled Release – zero order mucous membranes
Sustained Release – first order  Types:
o Delayed-Release – drug release is other than the time of o Medicated – contains activated pharmaceutical ingredients
prompt administration (API)
o Repeat Actions – contains 2 single doses of a medication (1st o Non-Medicated – used as base
dose  immediate; 2nd dose  delayed)  Ointment Bases:
o Targeted Release – drug release is isolated in a specific body o Oleaginous/Hydrocarbon Base – greasy, anhydrous,
region/tissue  absorption and action emollient, occlusive, non-water washable
 Petrolatum/Yellow Petrolatum/Petroleum Jelly
(Vaseline®) – purified mixture of semisolid hydrocarbon
D. PHARMACEUTICAL INSERTS from petroleum
 Suppositories – solid masses inserted into body cavities in  White Petrolatum – decolorized
which they will melt at body temperature or dissolve into  Yellow Wax/Beeswax – wax obtained from the
aqueous secretions of body orfice honeycomb of Apis mellifera
o Types: Rectal; Vaginal (Pessaries); Urethral (Bougies) – ex.  White Wax – bleached
Alprostadil (for erectile dysfunction)  Yellow/Simple Ointment – yellow petrolatum + yellow
FEATURES RECTAL VAGINAL URETHRAL
wax
SHAPE Bullet Globular Pencil-like
Torpedo Ovoid  White Ointment – white petrolatum + white wax
Cone o Absorption Base – greasy, emollient, occlusive, non-water
WEIGHT Adult: 2g 5g Male: 4g
washable; can absorb small amounts of water  w/o
Pedia: 1g Female: 2g
SIZE Adult: 32mm Varies Male: 140mm  Hydrophilic Petrolatum (Aquaphor®) – petrolatum +
Pedia: 16mm Female: 70mm cholesterol (emulsifying agent) + beeswax + stearyl
INTENDED USE Both Local Local
alcohol
o SUPPOSITORY BASES
 Anhydrous Lanolin/Woolfat – wax-like substance from
 Oleaginous Base the wool of Ovis aries (sheep) containing 0.25% moisture
Cocoa Butter – most common base for rectal *Hydrous Lanolin – 25% moisture; Modified Lanolin –
suppository; solid at 32oC, melts at 34-35oC; exhibits without free lanolin alcohols and excess detergents

PAGE 3 OF 7 © MANOR REVIEW CENTER NOTES (K.L)


o Water-Removable Base – o/w; water-washable; non- IV. TRANSDERMAL DRUG DELIVERY SYSTEM
occlusive; non-greasy; can be diluted with large amounts of
 controlled release DDS or patches which allow the passage of
water
drugs from the skin to the systemic circulation
 Hydrophilic Ointment
 PARTS OF TDDS:
o Water-Soluble Base – lipid-free; greaseless; water-
o Occlusive Backing Layer – prevents water loss and drug loss
washable; non-occlusive; for incorporation of solid materials
o Drug Matrix System – stores API
 Polyethylene Glycol (PEG) Ointment – MW < 600 
o Adhesive Layer – ensures continuous drug absorption
liquids; MW > 100  wax-like solids; MW 600-1000 
o Release Liner – removed before use to enable drug release
semisolids
 EXAMPLES:
o Scopolamine (Transderm Sccp®) – 1st TDDS developed; for
B. CREAMS motion sickness
 semi-solid preparations containing APIs dissolved or dispersed o Nitroglycerin – angina
in w/o or o/w emulsion or water-washable base; preferred: o Clonidine – 1st TDDS for hypertension
ease of spreadability o Fentanyl – opioid analgesic
o Vanishing Creams – o/w base; large % water – ex. glycerin, o Estradiol and Testosterone – hormone replacement therapy
propylene glycol – + stearic acid
o Cold Cream/Petrolatum Rose Water Ointment – w/o base; V. LIQUID DOSAGE FORMS SINGLE PHASE
mineral oil  less rancid; white wax; spermaceti (cetyl
Solutions – liquid preparations containing one or more
esters wax) + Na borate
substances dissolved in a suitable solvent
 Advantages: completely homogenous dose; immediate
C. GELS availability for absorption; flexible
 dispersion systems consisting of small inorganic particles or  Disadvantages: degrade more rapidly; interact with other
large organic molecules dispersed throughout a liquid vehicle, component; bulky
rendered jelly-like by addition of a gelling agent; thixotropy – DESCRIPTIVE TERMS PARTS OF SOLVENT REQUIRED FOR
reversible gel-sol formation 1 PART OF SOLUTE
Very Soluble <1
Freely Soluble 1-10
D. PASTES Soluble 10-30
 semi-solid preparations applied on skin and contain a large Sparingly Soluble 30-100
proportion of solid material (≥25%) and therefore stiffer than Slightly Soluble 100-1,000
ointments Very Slightly Soluble 1,000-10,000
Insoluble >10,000
 Use: to prolong contact of drug
 Water Official Types:
 Zinc Oxide Paste (ZnO) – treatment of diaper rash
o Purified Water – distillation; reverse osmosis; ion exchange
o Water for Injection – purified water that is pyrogen-free
E. PLASTERS o Sterile Water for Injection – water for injection that is
 solid or semisolid adhesive masses spread on a backing of sterilized
paper, fabric, moleskin or plastic o Bacteriostatic Water for Injection – sterile water for
 Use: to prolong the contact of drug and affords protection injection with antimicrobial agent (benzyl alcohol); not for
 Salicylic Acid Plaster – keratolytic (10-40% salicylic acid) neonates
o Sterile Water for Inhalation
F. GLYCEROGELATIN o Sterile Water for Irrigation
 plastic masses applied on skin with a fine brush
 contains: 40% glycerin, 35% water, 15% gelatin, 10% AI A. AQUEOUS SOLUTIONS
 Zinc Gelatin Boot – treatment of varicose ulcers  Aromatic Water/Medicated Waters – clear, saturated
aqueous solutions of volatile oils or other aromatic substances;
o Use: flavored/perfumed vehicles
G. POULTICES/CATAPLASM
o Preparations:
 soft, moist masses of meal, herbs, seeds, etc.; applied hot in a
 Distillation – not economical; only method for: Strong
cloth
Rose Water, Orange Flower Water
 Use: to localize infectious materials and counterirritant
 Simple Solution – with or without dispersant (ex. talc)
 Kaolin Poultice – treatment for boils and anti-inflammatory o Problem: Salting out – insoluble layer at top

PAGE 4 OF 7 © MANOR REVIEW CENTER NOTES (K.L)


 Diluted Acids – aqueous solutions prepared by dissolving  Solution without Heat – prevents sucrose inversion
concentrated acids in water; strength: 10% w/v; (ex. Diluted  Percolation – slow rate (1mL/min); to prevent bubbles
HCl – treatment for achlorhydria; taken with straw) (oxidation)
 Astringent – locally applied solutions that precipitate proteins  Reconstitution – addition of sugar to a medicated liquid;
and cause constriction of the skin addition of medicated liquid to syrup
o Aluminum Acetate Topical Solution – wet dressing in  Honeys – somewhat allied to syrups but using honey as base
contact dermatitis  Mucilages – thick, viscid, adhesive liquids
o Calcium Hydroxide Topical Solution – more soluble in cold o PREPARATIONS:
water  Dispersion of gums in water
o Coal Tar Topical Solution – for eczema  Extraction of mucilaginous principles
 Antibacterial Topical Solutions o Use: suspending agent
o Hydrogen Peroxide Topical Solution o ex.: Acacia Mucilage, Tragacanth Mucilage
2H2O2 –(catalase)--> O2^ + 2H2O (3% = 10 volumes –  Jellies – class of gels in which structural coherent matrix
antiseptic); (6% = 20 volumes – bleaching agent) contains a high portion of water; use: lubricant, contraceptive,
o Povidone-Iodine Topical Solution (Betadine®) – complex of topical anesthetic (Lidocaine Jelly)
10% I2 and polyvinyl pynolidone (PVP)
o Thiomersal Topical Solution (Merthiolate®) – contains 0.1% C. HYDROALCOHOLIC SOLUTIONS
thimerosal – organic, mercurial antibacterial
 Elixirs – clear; sweetened hydroalcoholic solutions intended
 Douche – aqueous solutions used as cleansing agent or
for oral use; alcohol: 5-40%; self-preserving at ≥10% alcohol
antiseptic for a body cavity
o PREPARATIONS:
o Eye Douche – removes foreign particles and discharges
 Simple Solution
o Pharyngeal Douche – throat
 Admixture of 2 Medicated Liquids
o Vaginal Douche – maintain the acidic pH of the vagina (ex.
o Types:
pH Care® - chlorhexidine gluconate)
 Medicated Elixir – digoxin, phenobarbital,
 Enemas – rectal solutions employed mainly to evacuate the diphenhydramine, dexamethasone
bowel (evacuation enema) or to affect a local or systemic  Non-Medicate Elixir – aromatic elixirs, iso-alcoholic elixir
disease by absorption (retention enema) – better solvent; higher content
o Fleet® Enema – sodium phosphates enema; evacuation
 Tinctures – hydroalcoholic solutions prepared from vegetable
enema
drugs or chemical substances; alcohol content varies; strength:
o Sulfasalazine Enema – ulcerative colitis; retention enema
10% w/v
 Gargles – used for treating pharynx and nasopharynx by o PREPARATIONS:
forcing from lungs through solution held in throat  Process P – percolation (ex. Belladonna Tincture)
 Mouthwashes – used by swishing the liquid in oral cavity to  Process M – maceration (ex. Sweet Orange Peel Tincture)
cleanse mouth or treat diseases of oral cavity  Simple Solution – Iodine Tincture (2% in 50% alcohol);
Green Soap Tincture; Compound Benzoin Tincture
B. SWEET AND OTHER VISCID AQUEOUS o Opium Tincture – Laudanum
SOLUTIONS o Camphorated Opium Tincture – Paregoric
 Spirits/Essences – hydroalcoholic solutions of volatile oil;
 Syrups – concentrated solutions of sucrose or other sugars in
alcohol content: 50-90%
water
o PREPARATIONS:
o Types:
 Simple Solution – aromatic ammonia spirit
 Simple Syrup/Syrup NF – 85% w/v or 65% w/w; sp. gr. =
 Solution with Maceration – peppermint spirit
1.313; self-preserving at ≥65% sugar; poor solvent for
 Chemical Reaction – ethyl nitrite spirit
drugs
 Distillation – brandy (spiritus vini vitis); whisky (spiritus
 Flavored Syrups
frumenti)
Orange and Cherry – acidic medium
 Fluidextracts – “100% Tinctures”  too potent and too bitter;
Cocoa – bitter
hydroalcoholic solutions from vegetable drugs (ONLY)
Raspberry – sour and salty
prepared by percolation
Ora-Sweet® - for compounding
o PREPARATIONS:
 Medicated Syrup – simple/flavored syrups + APIs
 Process A – must be assayed; percolation
o PREPARATIONS:
 Process E – alternative to process E; percolation (shorter
 Solution w/ Heat – fastest methods; problem:
diameter and longer in length)
overheating  sucrose inversion/caramelization
 Process D – boiling water
PAGE 5 OF 7 © MANOR REVIEW CENTER NOTES (K.L)
o Cascara Sagrada Fluidextract – cathartic  Lotions – liquid suspensions applied externally on body
o Calamine Lotion – antipruritic; ZnO + ferric oxide; trituration
D. NON-AQUEOUS SOLUTIONS o White Lotion – chemical reaction; ZnSO4 + sulfurated potash
 Liniments/Embrocations – alcoholic or oleaginous solutions  Mixtures – liquid preparations containing more than one
containing more than one API and are usually rubbed on the active ingredient dissolved or dispersed in al liquid vehicle
skin o Bordeaux Mixture – CuSO4 + CaO; algaecide in pools
Types: o Kaopectate – Kaolin + Pectin; antidiarrheal
o Alcoholic – penetrating action; rubefacient and
counterirritant B. EMULSIONS
o Oleaginous – massage; less irritating  two-phase systems prepared by combining 2 immiscible
 Collodions – clear liquids prepared by dissolving 4% pyroxylin liquids; internal/discontinuous/dispersed phase;
(cotton [cellulose tetranitrate; soluble guncotton, collodion external/continuous/dispersion medium
cotton, nitrocellulose] +HNO3 + H2SO4) in 3:1 ether and  Types:
alcohol; use: water repellent protective o Oil in water (o/w)
Types: o Water in oil (w/o)
o Flexible Collodion – +3% castor oil  flexible; +2% camphor o Multiple Emulsion – w/o/w or o/w/o
 waterproof o Microemulsion – transparent; most stable
o Salicylic Acid Collodion – keratolytic  Emulsifying Agent – reduce the interfacial tension by forming
 Extracts a film at interface
o METHODS OF EXTRACTION:  HLB System – increase in HLB value = increase in hypophillic
 Maceration – soaking ACTIVITY HLB VALUE
 Digestion – maceration with gentle heat Antifoaming 1-3
W/O Emulsifier 3-6
 Infusion – maceration in hot or cold water Wetting Agent 7-9
 Decoction – boiling in water O/W Emulsifier 8-18
 Percolation – column/percolator Detergents 13-16
Solubilizer 15-20
o TYPES:
 Semi-Liquid Extract – liquid/syrupy; no solvent is removed  PREPARATIONS:
 Pilular/Solid Extract – plastic; nearly all solvent is o Dry Gum/Continental Method – 4(oil): 2(water): 1(gum); oil
removed + gum, then add water all at once; w/o
 Powdered Extract – dry powders; all solvent is removed o Wet Gum/English Method – 4(water): 2(oil): 1(gum); water
+ gum, then add oil gradually in small portions; o/w
o Forbes Bottle Method – for volatile oils and less viscous oils;
VI. LIQUID DOSAGE FORMS: DISPERSED 3:2:1 or 2:2:1
PHASE o Nascent Soap/In Situ Soap Method – fats/fixed oils +
aqueous solution of alkali; emulsifier: salt of free fatty acid
A. SUSPENSIONS
 liquid preparations consisting of solid particles (suspensoids) VII. STERILE DOSAGE FORMS
dispersed throughout a liquid vehicle A. STERILE PRODUCTS
Types:  Parenterals – injectable
o Gels  Ophthalmic – eyes
PHENOMENA IN GELS:  Otic – not always
 Imbibition – no increase in size
 Inhalationals
 Swelling – increase in size
 Irrigation
 Syneresis – gel shrinks
 Dialysis
 Xerogel – formed when only framework remains
 Implants
o Al(OH)3 Gel – antacid; Betamethasone Gel; Tretinoin Gel
 Magmas/Milk – two-phased gels in which gel mass consist of
small distinct particles and therefore whitish in color
o PREPARATIONS:
 Hydration – MgO + H2O
 Chemical Reaction – MgSO4 + NaOH
o Milk of Magnesia – antacid; Bentonite Magma – suspending
agent
PAGE 6 OF 7 © MANOR REVIEW CENTER NOTES (K.L)
B. PARENTERAL ROUTES VIII. AEROSOLS
 Intravenous (IV) – veins; most common and important; 100%  pressurized dosage forms upon actuation will deliver a fire
bioavailability; bolus or infusion mist of the product (liquid/solid drug in a gaseous medium)
 Intramuscular (IM) – mild-deltoid muscle  2mL; gluteus  Types:
medius – children, gluteus maximus – adults  5mL; ex. o Space Spray – airborne mist
vaccines o Surface Spray – surface
 Subcutaneous (SC/SQ) – under skin (lower abdomen, upper  Components:
arm, thigh); maximum volume: 1.3mL; ex. insulin o Product Concentrate – APIs, surfactant, antioxidant,
 Intradermal (ID) – most superficial skin layer (anterior perfume
forearm)  0.1mL; ex. skin test o Propellant – expels product
 Intraarterial  Liquefied Gas – propane, butane, isobutene,
 Intracardiac hydrofluorocarbons, dimethyl ether
 Intraspinal  Compressed Gases – CO2, N2, N2O
 Intrathecal  AEROSOL CONTAINER ASSEMBLY
 Intraarticular o Pressurizable Container
 Intrasynovial  Tin-Plated Steel – most widely used
 Epidural  Aluminum – seamless and more inert
 Glass
o Valve – regulates flow
C. OFFICIAL INJECTIONS o Actuator – pressed to activate valve assembly
 Injection – solution o Stern – supports actuator and delivers product in proper
 For Injection – for reconstitution form
 Injectable Emulsion o Gasket – prevents leakage of contents
 Injectable Suspension o Spring – retraction of actuator
 For Injectable Suspension – for reconstitution o Mounting Cup – exposed to formulation and supports valve
o Housing – supports actuator, stern, and dip tube
o Dip Tube – conveys product from bottom to valve at top
D. COMPONENTS
 Active Pharmaceutical Ingredient (API)
 Solvent/Vehicle
o Water: WFI, SWFI, BWFI
o NaCl Injection
o Ringer’s Injection – NaCl, KCl, CaCl2 (electrolyte replenisher)
o Lactated Ringer’s Injection – NaCl, KCl, CaCl2, Na lactate –
systemical alkalizer
o Fixed Vegetable Oils – cottonseed, corn, peanut, sesame
o Alcohol, glycerin, Ethyl Oleate, Isopropyl Myristate
 Buffers – maintain the required pH
 Tonicity Adjusters – reduce the pain
 Preservatives
 Nitrogen Gas – headspace

PAGE 7 OF 7 © MANOR REVIEW CENTER NOTES (K.L)

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