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MODULE-5-PHARDOSE

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PHARMACEUTICAL DOSAGE FORMS
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I. INTRODUCTION
 Dosage Forms – drug products/preparations containing:
o Active Pharmaceutical Ingredient (API)/ Drug
o Exipients/Additives/Adjuncts
 Drug – any article intended for use in diagnosis, cure,
treatment, mitigation or prophylaxis in man and other animals
– affects the structure or any function of the body
 Excipients – inactive ingredients
o Role: drugs  more appealing and efficacious
o Use: solubilize, suspend, emulsify, dilute, stabilize,
preservatives, color, flavor, etc.
 Placebo – dosage form that does not contain an API
 Drug Delivery System – products that allow for uniform
release and targeting of drugs into body
 Cosmetics – any substance/preparation intended to be placed
in contact with external parts of human body or with teeth and
mucous membranes of oral cavity with a view exclusively or
mainly to cleaning them, perfuming them, correcting body
odors, changing their appearance, protecting them and/or
keeping them in good condition
 Compounding – preparation, mixing, packaging or labeling of
a drug to prepare an individualized drug treatment for a
patient
 REASONS FOR FORMULATING DOSAGE FORMS: appearance,
palatability, ease of administration, solubility, stability
II. SOLID DOSAGE FORMS
A. POWDERS
 intimate mixtures of finely divided drugs or chemicals in dry
form which may be used internally or externally
 size: sieve no.
o very coarse – no. 8
o coarse – no. 20
o moderately coarse – no. 40
o fine – no. 60
o very fine – no. 80
 Advantages: rapid dispersion of ingredients; flexibility in
compounding; good stability
 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)
o Pulverization by Intervention – addition of volatile
substance to gummy materials (ex. camphor + alcohol; I2
crystals + ether)
 Mixing/Blending
o Trituration – mortar and pestle
 Types of mortar and pestle
Glass – smooth non-porous surface; for simple
admixture; for chemicals that stain
Porcelain – rough inner surface; for comminction
Wedgewood – rougher surface; for crystalline
substances
o Spatulation – use of spatula; not for potent substances
o Sifting – use of sifter; not for potent substances
o Geometric Dilution – addition of an equal volume of diluent
to a potent substance placed in a mortar
o Tumbling – large containers rotated by a motorized process
 TYPES OF POWDER
o Bulk Powders – dispensed in large quantities
 Oral Powders – dissolved/dispersed in a liquid or mixed
with food before use
 Dentrifices – contain a soap, mild abrasive and
anticariogenic agent
 Dusting Powders – locally applied non-toxic powders that
have no systemic action
 Douche Powders – dissolve in warm water prior to use as
cleansing agent/antiseptic for a body cavity
 Insufflators – blown into body cavities using an insufflator
 Triturations – dilutions of potent powdered drugs (10%
API)
o Divided Powders/Chartulae – dispersed in individual doses
usually in folded papers
 TYPES OF POWDER PAPER
o White Bond Paper – opaque paper with no moisture
resistance
o Glassine Paper – glazed transparent moisture-resistant
paper
o Vegetable Parchment – thin, semi-opaque, moistureresistant paper
o Waxed Paper – transparent waterproof paper; suitable for
deliquescent and hygroscopic drugs
PAGE 1 OF 7
© MANOR REVIEW CENTER NOTES (K.L)
 Sublingual Tablets – dissolve rapidly under tongue for
systemic absorption (ex. Nitroglycerin, ISDN)
 Lozenges – candies that dissolve slowly in mouth for local
effect (ex. Strepsils® - dicholorobenzyl alcohol +
amylmetacresol)
TYPES:
 Troches – compressed lozenges
 Pastilles – molded lozenges
 Lollipops – lozenges on sticks
o Tablets Used to Prepare Solutions
 Effervescent Tablets – ex. Alka-Setlzer® - antacid + pain
reliever
 Compounding/Dispensing Tablets – contain a large
amount of API used by pharmacists in compounding
multiple dosage units
 Hypodermic Tablets – used by physicians to prepare
parenteral solutions
 Molded Tablets/Tablet Triturates
B. GRANULES
 prepared agglomerates of powders; size: sieve no. 4 to 12; for
tablet formulation: sieve no. 12 to 20
 Advantages: flow well compared to powders; less tendency to
cake or harden; more stable to humidity; more easily wetted
by liquids
 PREPARATIONS:
o Wet Granulation – most common; addition of liquid binder
o Dry Granulation – for moisture-sensitive and heat labile
materials; use compaction/compression forces
o Effervescent Granules – dissolved in water before use in
which CO2 gas is released to mask the unpleasant taste of
drug
 COMPONENTS:
o NaHCO3
o Citric acid  sticky
o Tartaric acid  crumble
 PREPARATION:
o Dry/Fusion Method – binder is 1 molecule of water in citric
acid
o Wet Method – binder is water + alcohol
C. TABLETS
 solid dosage forms which are prepared mainly by compression
or molding
 Advantages: precision and low content variability; low
manufacturing cost; easy to package and ship; simple to
identify; most stable of all oral dosage form; tamper proof
 Disadvantages: some drugs resist compression; some drugs
that require encapsulation prior to compression
 TYPES OF TABLETS:
o Tablets for Oral Ingestion
 Compressed Tablets – formed by compression; some are
scored
 Multiple Compressed Tablets – ex. layered tablets,
compression coated tablets
 Coated Tablets
 Sugar Coated Tablets – coated with a water soluble
sucrose-based solution
 Film Coated Tablets – coated with a thin layer of
polymer material
 Enteric-Coated Tablets – remain intact in stomach and
disintegrate in small intestine
o Tablets Used in the Oral Cavity
 Chewable Tablets – chewed in mouth before swallowing;
does not contain disintegrant; diluent: mannitol and
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)
D. CAPSULES
 solid dosage forms in which drug is endosed within either a
hard or soft soluble shell usually made of gelatin
o Gelatin – partial hydrolysis of collagen from the skin/bones
of animals
 Types:
Type A – acid hydrolysis
Type B – base hydrolysis
 Alternative: hydroxypropyl methylcellulose (HPMC) or
stach
Types of Capsules:
 Hard Gelatin Capsules – dry-filled or two-piece capsules (cap
and body)
o made of gelatin, sugar and water + colorant + opacifying
agent (TiO2) + SO2 [0.15%] (to prevent decomposition of gel)
o contains 12-16% moisture
o stored at 21-25oC/30-35% RH
o capsule sizes: (increase capsule size = decrease capacity)
 Human – No. 5 (smallest) – No. 000 (largest)
 Veterinary – No 10. – No. 12
 Soft Gelatin Capsules – one-piece capsules; contains nonaqueous liquids (vitamin e, cod liver oil, digoxin), suspensions,
pastes, and dry solids
o made of gelatin, plasticizer (glycerin, sorbitol) and
preservatives against fungi
o contains 6-10% moisture
o no specific sizes
PAGE 2 OF 7
© MANOR REVIEW CENTER NOTES (K.L)
E. ORAL MODIFIED-RELEASE SOLID DOSAGE
FORMS
 drug release features are based on time, course and locations
 Reasons:
o to prolong therapeutic effect to reduce dosing frequency
o to delay the effect
MTC
Cp
MEC
immediate
controlled
sustained
delayed
Time
onset
onset
 Types:
o Extended-Release – provides a prompt-desired effect
followed by a gradual release of remaining amount
 Problem: dose dumping
 Types:
Controlled Release – zero order
Sustained Release – first order
o Delayed-Release – drug release is other than the time of
prompt administration
o Repeat Actions – contains 2 single doses of a medication (1st
dose  immediate; 2nd dose  delayed)
o Targeted Release – drug release is isolated in a specific body
region/tissue  absorption and action
D. PHARMACEUTICAL INSERTS
 Suppositories – solid masses inserted into body cavities in
which they will melt at body temperature or dissolve into
aqueous secretions of body orfice
o Types: Rectal; Vaginal (Pessaries); Urethral (Bougies) – ex.
Alprostadil (for erectile dysfunction)
FEATURES
SHAPE
WEIGHT
SIZE
INTENDED USE
RECTAL
Bullet
Torpedo
Adult: 2g
Pedia: 1g
Adult: 32mm
Pedia: 16mm
Both
VAGINAL
Globular
Ovoid
Cone
5g
Varies
Local
URETHRAL
Pencil-like
Male: 4g
Female: 2g
Male: 140mm
Female: 70mm
Local
o SUPPOSITORY BASES
 Oleaginous Base
Cocoa Butter – most common base for rectal
suppository; solid at 32oC, melts at 34-35oC; exhibits
polymorphism (ȣ - least stable [18oC]; α; β’; β – most
stable [34.5oC]
Wecobee ® - from coconut
Witepsol ® - saturated PAs (C12-C18); major: lauric acid
Glyceryl Monopalmitate
 Water-Soluble/Miscible Base
Glycerinated Gelatin – most common base for pessaries
Polyethylene Glycol (PEG)
o PREPARATIONS:
 Hand Molding/Rolling/Shaping – oldest and simplest;
base is rolled into desired shape by hand
 Compression Molding – base is forced into molds;
problem: air entrapment
 Pour/Melt Molding – most common; base melted and
poured into molds
 Vaginal Tablets/Inserts – ovoid tablets inserted into the
vagina using a plastic inserter; contains antimicrobial agents
 Implants/Pellets – small, sterile cylinders or devices inserted
under the skin for prolonged and continuous absorption
o Norplant ® - levonorgestel (5 years)
o Leuprolide – prostate cancer (1 year)
III. SEMI-SOLID DOSAGE FORMS3
A. OINTMENTS
 semi-solid dosage forms applied externally on the skin or the
mucous membranes
 Types:
o Medicated – contains activated pharmaceutical ingredients
(API)
o Non-Medicated – used as base
 Ointment Bases:
o Oleaginous/Hydrocarbon Base – greasy, anhydrous,
emollient, occlusive, non-water washable
 Petrolatum/Yellow
Petrolatum/Petroleum
Jelly
(Vaseline®) – purified mixture of semisolid hydrocarbon
from petroleum
 White Petrolatum – decolorized
 Yellow Wax/Beeswax – wax obtained from the
honeycomb of Apis mellifera
 White Wax – bleached
 Yellow/Simple Ointment – yellow petrolatum + yellow
wax
 White Ointment – white petrolatum + white wax
o Absorption Base – greasy, emollient, occlusive, non-water
washable; can absorb small amounts of water  w/o
 Hydrophilic Petrolatum (Aquaphor®) – petrolatum +
cholesterol (emulsifying agent) + beeswax + stearyl
alcohol
 Anhydrous Lanolin/Woolfat – wax-like substance from
the wool of Ovis aries (sheep) containing 0.25% moisture
*Hydrous Lanolin – 25% moisture; Modified Lanolin –
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; nonocclusive; non-greasy; can be diluted with large amounts of
water
 Hydrophilic Ointment
o Water-Soluble Base – lipid-free; greaseless; waterwashable; non-occlusive; for incorporation of solid materials
 Polyethylene Glycol (PEG) Ointment – MW < 600 
liquids; MW > 100  wax-like solids; MW 600-1000 
semisolids
B. CREAMS
 semi-solid preparations containing APIs dissolved or dispersed
in w/o or o/w emulsion or water-washable base; preferred:
ease of spreadability
o Vanishing Creams – o/w base; large % water – ex. glycerin,
propylene glycol – + stearic acid
o Cold Cream/Petrolatum Rose Water Ointment – w/o base;
mineral oil  less rancid; white wax; spermaceti (cetyl
esters wax) + Na borate
C. GELS
 dispersion systems consisting of small inorganic particles or
large organic molecules dispersed throughout a liquid vehicle,
rendered jelly-like by addition of a gelling agent; thixotropy –
reversible gel-sol formation
IV. TRANSDERMAL DRUG DELIVERY SYSTEM
 controlled release DDS or patches which allow the passage of
drugs from the skin to the systemic circulation
 PARTS OF TDDS:
o Occlusive Backing Layer – prevents water loss and drug loss
o Drug Matrix System – stores API
o Adhesive Layer – ensures continuous drug absorption
o Release Liner – removed before use to enable drug release
 EXAMPLES:
o Scopolamine (Transderm Sccp®) – 1st TDDS developed; for
motion sickness
o Nitroglycerin – angina
o Clonidine – 1st TDDS for hypertension
o Fentanyl – opioid analgesic
o Estradiol and Testosterone – hormone replacement therapy
V. LIQUID DOSAGE FORMS SINGLE PHASE
Solutions – liquid preparations containing one or more
substances dissolved in a suitable solvent
 Advantages: completely homogenous dose; immediate
availability for absorption; flexible
 Disadvantages: degrade more rapidly; interact with other
component; bulky
DESCRIPTIVE TERMS
Very Soluble
Freely Soluble
Soluble
Sparingly Soluble
Slightly Soluble
Very Slightly Soluble
Insoluble
D. PASTES
 semi-solid preparations applied on skin and contain a large
proportion of solid material (≥25%) and therefore stiffer than
ointments
 Use: to prolong contact of drug
 Zinc Oxide Paste (ZnO) – treatment of diaper rash
E. PLASTERS
 solid or semisolid adhesive masses spread on a backing of
paper, fabric, moleskin or plastic
 Use: to prolong the contact of drug and affords protection
 Salicylic Acid Plaster – keratolytic (10-40% salicylic acid)
F. GLYCEROGELATIN
 plastic masses applied on skin with a fine brush
 contains: 40% glycerin, 35% water, 15% gelatin, 10% AI
 Zinc Gelatin Boot – treatment of varicose ulcers
PARTS OF SOLVENT REQUIRED FOR
1 PART OF SOLUTE
<1
1-10
10-30
30-100
100-1,000
1,000-10,000
>10,000
 Water Official Types:
o Purified Water – distillation; reverse osmosis; ion exchange
o Water for Injection – purified water that is pyrogen-free
o Sterile Water for Injection – water for injection that is
sterilized
o Bacteriostatic Water for Injection – sterile water for
injection with antimicrobial agent (benzyl alcohol); not for
neonates
o Sterile Water for Inhalation
o Sterile Water for Irrigation
A. AQUEOUS SOLUTIONS
G. POULTICES/CATAPLASM
 soft, moist masses of meal, herbs, seeds, etc.; applied hot in a
cloth
 Use: to localize infectious materials and counterirritant
 Kaolin Poultice – treatment for boils and anti-inflammatory
 Aromatic Water/Medicated Waters – clear, saturated
aqueous solutions of volatile oils or other aromatic substances;
o Use: flavored/perfumed vehicles
o Preparations:
 Distillation – not economical; only method for: Strong
Rose Water, Orange Flower Water
 Simple Solution – with or without dispersant (ex. talc)
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
concentrated acids in water; strength: 10% w/v; (ex. Diluted
HCl – treatment for achlorhydria; taken with straw)
 Astringent – locally applied solutions that precipitate proteins
and cause constriction of the skin
o Aluminum Acetate Topical Solution – wet dressing in
contact dermatitis
o Calcium Hydroxide Topical Solution – more soluble in cold
water
o Coal Tar Topical Solution – for eczema
 Antibacterial Topical Solutions
o Hydrogen Peroxide Topical Solution
2H2O2 –(catalase)--> O2^ + 2H2O (3% = 10 volumes –
antiseptic); (6% = 20 volumes – bleaching agent)
o Povidone-Iodine Topical Solution (Betadine®) – complex of
10% I2 and polyvinyl pynolidone (PVP)
o Thiomersal Topical Solution (Merthiolate®) – contains 0.1%
thimerosal – organic, mercurial antibacterial
 Douche – aqueous solutions used as cleansing agent or
antiseptic for a body cavity
o Eye Douche – removes foreign particles and discharges
o Pharyngeal Douche – throat
o Vaginal Douche – maintain the acidic pH of the vagina (ex.
pH Care® - chlorhexidine gluconate)
 Enemas – rectal solutions employed mainly to evacuate the
bowel (evacuation enema) or to affect a local or systemic
disease by absorption (retention enema)
o Fleet® Enema – sodium phosphates enema; evacuation
enema
o Sulfasalazine Enema – ulcerative colitis; retention enema
 Gargles – used for treating pharynx and nasopharynx by
forcing from lungs through solution held in throat
 Mouthwashes – used by swishing the liquid in oral cavity to
cleanse mouth or treat diseases of oral cavity
B. SWEET AND OTHER VISCID AQUEOUS
SOLUTIONS
 Syrups – concentrated solutions of sucrose or other sugars in
water
o Types:
 Simple Syrup/Syrup NF – 85% w/v or 65% w/w; sp. gr. =
1.313; self-preserving at ≥65% sugar; poor solvent for
drugs
 Flavored Syrups
Orange and Cherry – acidic medium
Cocoa – bitter
Raspberry – sour and salty
Ora-Sweet® - for compounding
 Medicated Syrup – simple/flavored syrups + APIs
o PREPARATIONS:
 Solution w/ Heat – fastest methods; problem:
overheating  sucrose inversion/caramelization
 Solution without Heat – prevents sucrose inversion
 Percolation – slow rate (1mL/min); to prevent bubbles
(oxidation)
 Reconstitution – addition of sugar to a medicated liquid;
addition of medicated liquid to syrup
 Honeys – somewhat allied to syrups but using honey as base
 Mucilages – thick, viscid, adhesive liquids
o PREPARATIONS:
 Dispersion of gums in water
 Extraction of mucilaginous principles
o Use: suspending agent
o ex.: Acacia Mucilage, Tragacanth Mucilage
 Jellies – class of gels in which structural coherent matrix
contains a high portion of water; use: lubricant, contraceptive,
topical anesthetic (Lidocaine Jelly)
C. HYDROALCOHOLIC SOLUTIONS
 Elixirs – clear; sweetened hydroalcoholic solutions intended
for oral use; alcohol: 5-40%; self-preserving at ≥10% alcohol
o PREPARATIONS:
 Simple Solution
 Admixture of 2 Medicated Liquids
o Types:
 Medicated
Elixir
–
digoxin,
phenobarbital,
diphenhydramine, dexamethasone
 Non-Medicate Elixir – aromatic elixirs, iso-alcoholic elixir
– better solvent; higher content
 Tinctures – hydroalcoholic solutions prepared from vegetable
drugs or chemical substances; alcohol content varies; strength:
10% w/v
o PREPARATIONS:
 Process P – percolation (ex. Belladonna Tincture)
 Process M – maceration (ex. Sweet Orange Peel Tincture)
 Simple Solution – Iodine Tincture (2% in 50% alcohol);
Green Soap Tincture; Compound Benzoin Tincture
o Opium Tincture – Laudanum
o Camphorated Opium Tincture – Paregoric
 Spirits/Essences – hydroalcoholic solutions of volatile oil;
alcohol content: 50-90%
o PREPARATIONS:
 Simple Solution – aromatic ammonia spirit
 Solution with Maceration – peppermint spirit
 Chemical Reaction – ethyl nitrite spirit
 Distillation – brandy (spiritus vini vitis); whisky (spiritus
frumenti)
 Fluidextracts – “100% Tinctures”  too potent and too bitter;
hydroalcoholic solutions from vegetable drugs (ONLY)
prepared by percolation
o PREPARATIONS:
 Process A – must be assayed; percolation
 Process E – alternative to process E; percolation (shorter
diameter and longer in length)
 Process D – boiling water
PAGE 5 OF 7
© MANOR REVIEW CENTER NOTES (K.L)
o Cascara Sagrada Fluidextract – cathartic
D. NON-AQUEOUS SOLUTIONS
 Liniments/Embrocations – alcoholic or oleaginous solutions
containing more than one API and are usually rubbed on the
skin
Types:
o Alcoholic – penetrating action; rubefacient and
counterirritant
o Oleaginous – massage; less irritating
 Collodions – clear liquids prepared by dissolving 4% pyroxylin
(cotton [cellulose tetranitrate; soluble guncotton, collodion
cotton, nitrocellulose] +HNO3 + H2SO4) in 3:1 ether and
alcohol; use: water repellent protective
Types:
o Flexible Collodion – +3% castor oil  flexible; +2% camphor
 waterproof
o Salicylic Acid Collodion – keratolytic
 Extracts
o METHODS OF EXTRACTION:
 Maceration – soaking
 Digestion – maceration with gentle heat
 Infusion – maceration in hot or cold water
 Decoction – boiling in water
 Percolation – column/percolator
o TYPES:
 Semi-Liquid Extract – liquid/syrupy; no solvent is removed
 Pilular/Solid Extract – plastic; nearly all solvent is
removed
 Powdered Extract – dry powders; all solvent is removed
VI. LIQUID
PHASE
DOSAGE
FORMS:
DISPERSED
A. SUSPENSIONS
 liquid preparations consisting of solid particles (suspensoids)
dispersed throughout a liquid vehicle
Types:
o Gels
PHENOMENA IN GELS:
 Imbibition – no increase in size
 Swelling – increase in size
 Syneresis – gel shrinks
 Xerogel – formed when only framework remains
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
 Lotions – liquid suspensions applied externally on body
o Calamine Lotion – antipruritic; ZnO + ferric oxide; trituration
o White Lotion – chemical reaction; ZnSO4 + sulfurated potash
 Mixtures – liquid preparations containing more than one
active ingredient dissolved or dispersed in al liquid vehicle
o Bordeaux Mixture – CuSO4 + CaO; algaecide in pools
o Kaopectate – Kaolin + Pectin; antidiarrheal
B. EMULSIONS
 two-phase systems prepared by combining 2 immiscible
liquids;
internal/discontinuous/dispersed
phase;
external/continuous/dispersion medium
 Types:
o Oil in water (o/w)
o Water in oil (w/o)
o Multiple Emulsion – w/o/w or o/w/o
o Microemulsion – transparent; most stable
 Emulsifying Agent – reduce the interfacial tension by forming
a film at interface
 HLB System – increase in HLB value = increase in hypophillic
ACTIVITY
Antifoaming
W/O Emulsifier
Wetting Agent
O/W Emulsifier
Detergents
Solubilizer
HLB VALUE
1-3
3-6
7-9
8-18
13-16
15-20
 PREPARATIONS:
o Dry Gum/Continental Method – 4(oil): 2(water): 1(gum); oil
+ gum, then add water all at once; w/o
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;
3:2:1 or 2:2:1
o Nascent Soap/In Situ Soap Method – fats/fixed oils +
aqueous solution of alkali; emulsifier: salt of free fatty acid
VII. STERILE DOSAGE FORMS
A. STERILE PRODUCTS







PAGE 6 OF 7
Parenterals – injectable
Ophthalmic – eyes
Otic – not always
Inhalationals
Irrigation
Dialysis
Implants
© MANOR REVIEW CENTER NOTES (K.L)
B. PARENTERAL ROUTES
VIII. AEROSOLS
 Intravenous (IV) – veins; most common and important; 100%
bioavailability; bolus or infusion
 Intramuscular (IM) – mild-deltoid muscle  2mL; gluteus
medius – children, gluteus maximus – adults  5mL; ex.
vaccines
 Subcutaneous (SC/SQ) – under skin (lower abdomen, upper
arm, thigh); maximum volume: 1.3mL; ex. insulin
 Intradermal (ID) – most superficial skin layer (anterior
forearm)  0.1mL; ex. skin test
 Intraarterial
 Intracardiac
 Intraspinal
 Intrathecal
 Intraarticular
 Intrasynovial
 Epidural
 pressurized dosage forms upon actuation will deliver a fire
mist of the product (liquid/solid drug in a gaseous medium)
 Types:
o Space Spray – airborne mist
o Surface Spray – surface
 Components:
o Product Concentrate – APIs, surfactant, antioxidant,
perfume
o Propellant – expels product
 Liquefied Gas – propane, butane, isobutene,
hydrofluorocarbons, dimethyl ether
 Compressed Gases – CO2, N2, N2O
 AEROSOL CONTAINER ASSEMBLY
o Pressurizable Container
 Tin-Plated Steel – most widely used
 Aluminum – seamless and more inert
 Glass
o Valve – regulates flow
o Actuator – pressed to activate valve assembly
o Stern – supports actuator and delivers product in proper
form
o Gasket – prevents leakage of contents
o Spring – retraction of actuator
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
C. OFFICIAL INJECTIONS





Injection – solution
For Injection – for reconstitution
Injectable Emulsion
Injectable Suspension
For Injectable Suspension – for reconstitution
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
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© MANOR REVIEW CENTER NOTES (K.L)
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