Ointments, creams, and gels

Semisolid dosage forms intended for topical

application skin, surface of the eye, nasally,

vaginally, rectally
Unmedicated
-

Used for physical effects as

protectants and lubricants

Topical prep
-

Both local and systemic effect

Systemic effect
-

from petroleum
o Unctuous mass
o Varying colors yellowish to light amber
o 38C to 60C melts
o Used alone or in combination
o Yellow petrolatum; petroleum jelly
o Vaseline (Cheesebrough-Ponds)
YELLOW OINTMENT, USP
o Purified wax obtained from honeycomb
of the bee Apis mellifera
o Preparation:
1. Melt yellow wax on water bath
2. Add petrolatum until mixt uniform
3. Cool and stir until congealed
o Simple ointment
o Slightly greater viscosity than plain

petrolatum
WHITE OINTMENT, USP
o Differs from yellow oint by substitution of

Should be considered if pt is
pregnant or nursing
o

Drugs can enter fetal blood supply &

breast milk

distinction:
Topical dermatological product
-

Deliver drug INTO THE SKIN

treating dermal disorders

Skin as target organ

o For physical effects or as vehicle

o Classified by USP into 4 groups:
1) OLEAGINOUS BASES
o hydrocarbon bases
o Emollient effect
o Protect against escape of moisture
o Occlusive dressing
o Remain on skin without drying out
o Insol with H2O difficult to wash off
o Incorporation w/ H2O & aq prep
Only in small amts
w/ some difficulty
o Incorporation of powdered subs
Liquid petrolatum (mineral oil)
levigating agent
PETROLATUM, USP
o Purified mixt of semisolid HCs obtained

white wax & white petrolatum in the

Transdermal product
-

Deliver drug THROUGH THE SKIN

wax

(percutaneous absorption)
to general circulation causing systemic effects
-

Skin not being target organ

OINTMENTS
Semisolid prep intended for external application
to the skin or mucous membrane
Medicated or not
Unmedicated ointments
o For physical effects
Protectant
Emollient
Lubricant
Ointment bases

formula
White wax bleached & purified yellow

2) ABSORTION BASES
o Two types:
o a.) W/O emulsions that permit
incorporation of aq solns
(eg. Hydrophilic petrolatum)
o b.) W/O emulsions that permit
incorporation of addtnal

o
o
o
o

quantities of aq solns
(eg. Lanolin)
emollient
dont provide degree of occlusion
afforded by oleaginous bases
not easily removed with water washing
because external phase is oleag
pharmaceutical adjuncts

to incorporate small vol of aq

solns to HC bases
HYDROPHILIC PETROLATUM, USP
o Preparation:
1. Melt stearyl alcohol & white wax on

steam bath
2. Add cholesterol with stirring until
dissolved
3. Add white petrolatum
4. Allow mixture to cool with stirring to
o

congeal
Aquaphor and Aquabase
Variations of hydrophilic
petrolatum have the capacity to

oleaginous ointment base

Eucerin, 50% W/O emulsion
LANOLIN, USP
o Anhydrous lanolin
o Obtained from wool of sheep Ovis aries
o Purified waxlike subs that has been
cleaned, deodorized, decolorized
o Nmt 0.25% water
o Additional water may be added
MODIFIED LANOLIN, USP
o Lanolin processed to reduce the
contents of free lanolin alcohols &
any detergent & pesticide residues
3) WATER-REMOVABLE BASES
o O/W emulsions
o Creams
o Easily washed off from skin
External phase is aq
Water-washable bases
o May be diluted with h2o or aq solns
o Absorb serous discharges
HYDROPHILIC OINTMENT, USP
o Stearyl alcohol & white petrolatum

absorb 3x weight in water

Useful to help incorporate
water-soluble drug
Tobramycin SO4 to an

(oleaginous phase)
melted together at 75C
Other ing (aq phase) dissolved in water

& added
o Sodium lauryl sulfate
Emulsifying agent
o Methylparaben & Propylparaben
Antimicrobial preservatives
4) WATER-SOLUBLE BASES
o Do not contain oleaginous components
o Completely water washable
o Greaseless
o Soften greatly w/ addn of h2o

Large amts of aq soln are not

effectively incorporated
o Mostly used for incorporation of solids
POLYETHYLENE GLYCOL OINTMENT, NF
o PEG polymer of ethylene oxide & h2o
o H(OCH2CH2)nOH
n = ave no. of oxoethylene groups
o PEG with m.w. below 600
Clear colorless liquids
o Above 1,000
Waxlike white materials
o In between
Semisolids
o Greater m.w. greater viscosity
o NF viscosity ave m.w. 200 to 8,000
o PEG 3350 (s) + PEG 400 (l)
400 g/600 g
Very pliable semisolid ointment
o Firmer ointment
Equal parts of the two
o When aq solns are to be incorporated
50 g PEG 3350 + equal amt of
stearyl alcohol
Final product firmer

Selection of the Appropriate Base

1.
2.
3.
4.
5.

Desired release rate of the drug subs

Desirability of topical/percutaneous drug abs
Desirability of occlusion or moisture from skin
Stability of drug in oint base
Effect, if any, of drug on consistency or other

features of oint base

6. Desire for a base easily removed by washing
with water
7. Characteristics of the surface to w/c it is applied
Ointment
-

Applied to dry scaly skin

Cream
-

Weeping or oozing surfaces

Lotion
-

Intertriginous areas, where friction may occur

Preparation of Ointments
-

Two general methods: incorporation & fusion

1) Incorporation

o
o

o
o

special lid
Mixing blade to mix ingredients

in dispensing container
Manually or via computer

o
o

o
o

o
o

spatulation or mortar and pestle

o Mortar and pestle method
Preferred when large vol of liq
Liq more captive on oint slab
Incorporating a gummy material
o Camphor
o Pulverization by intervention
Dissolved in solvent
Spread on pill tile
Solvent allowed to evaporate
leaving thin film of material onto

large spatula with smaller one

Hard rubber or silicone spatula
Oint base on one side & powder

which other ingredients are

software
Incorporation of solids
o Spatulation
Stainless, long, broad blade
Remove accumulation of oint in

components on the other side

Geometric dilution
Levigating
Mineral oil
External phase oil
Glycerin
External phase water
Should be equal vol to the solid
Solid first dissolve in solvent
Soln added to ointment base by

spread
Trituration with spatula

Incorporation of liquids

Only added after due consideration of

an oint bases capacity to accept vol

an ointment slab
Nonabsorbent parchment paper
Ointment parchment pad
Not too long contact of ointment
May soften and tear
Ointment mill
Unguator
Electronic mortar & pestle
Plastic ointment jar with a

Small scale, extemporaneous compounding

o Mortar and pestle
o Spatula to rub ingredients together on

required
Oleaginous ointments
Only very small amt of aq soln
may be incorporated
Hydrophilic ointment bases
Readily accept aq solns
Adding aq prep to hydrophobic base
Incorporate first into minimum
amt of hydrophilic base
All bases have their limits to retain liq
Too soft or semiliquid
Alcoholic solns of small volume
Added easily to oleaginous
vehicles or emulsion bases
Natural balsams
Peru balsam
Mixed w/ eq portion of castor oil
before incorporation into base
Ointment or roller mills
Force coarsely formed
ointments through stainless

steel or ceramic rollers

Small ointment mills
Product development

laboratories
Small-batch manufacture or
compounding

2) Fusion
-

Melting together and cooled with constant

stirring until congealed
Components not melted
o Added to congealing mixture
Heat-labile substances & volatile components
o Added last when temp low enough not
to cause decomp or volatilization
Small scale
o Porcelain dish or glass beaker
Large scale
o Large steam-jacketed kettles
Components that dont lend well to mixture by
incorporation
o Beeswax
o Paraffin
o Stearyl alcohol
o High m.w. PEG
Material w/ highest MP melted
at lowest req temp

constant stirring on cooling

Alternative method:
Melting components w/ lowest

o
-

Addnal materials added w/

MP first
Add remaining components in

order of MP or all together

Lower temperature is usually sufficient

to achieve fusion
Preparation of ointments having emulsion bases
o Both melting and emulsification
Water-immiscible components
(oil and waxes) melted together

at 70C to 75C
Aq soln of heat-stable, water-sol

Minimum Fill
-

Determination of net weight or volume of

contents of filled containers

To ensure proper contents compared w/ label

Packaging, Storage, and Labeling

-

components is prepared &

heated at same temp

Slowly add aq soln w/

mechanical stirring
Temp maintained 5-10 mins
If aq soln colder than oleaginous melt
Some waxes will solidify

Products should be routinely tested

Dermatologic products
o P. aeruginosa and S. aureus
Rectal, urethral, vaginal use
o Yeasts and molds

Ointments & other semisolid prep

o Large-mouth ointment jars
o Metal or plastic tubes
Semisolid prep
o Well-closed containers,cool place
Light-sensitive prep
o Opaque or light-resistant containers
USP
o label including proper storage conditns,
dosing and administration

COMPENDIAL REQUIREMENTS FOR OINTMENTS

Microbial Content
-

Topical prep
o Not required to be sterile
Prep prone to microbial growth
o Must contain antimicrobial preservative
Prep that contain water
o Support microbial growth
Antimicrobial preservatives
1. Methylparaben
2. Propylparaben
3. Phenols
4. Benzoic acid
5. Sorbic acid
6. Quaternary ammonium salts
Bethamethasone Valerate Ointment, USP
o Staphylococcus aureus
o Pseudomonas aeruginosa
Microbiological Attributes of Nonsterile
Pharmaceutical Products
o Strict adherence to environmental
control and application of good
manufacturing practices
Testing or raw materials
Use of acceptable water
In-process controls
Final product testing

Additional standards
-

Examine for viscosity & in vitro drug release

o To ensure within-lot & lot-to-lot unif
In vitro drug release tests
o Diffusion cell studies
o Determine drugs release profile from
semisolid prouct
CREAMS

Dissolved or dispersed in either

W/O emulsion, O/W emulsion,
or in another type water-washable bases
Vanishing cream
o O/W emulsion
o Large percentages of h2o and strearic
acid or other oleaginous components
After application h2o evaporates
leaving thin residue film
Preferred by many pt and physicians
o Easier to spread and remove
Relatively soft, spreadable consistency
Cold cream
o W/O cream
Hydrophilic ointment
o O/W cream
o

Generally described either washable/nonTerm cream without further qualification

o Water-washable formulation
generally inferred

Preparation of Creams
-

Creams may be formulated from

1. Variety of oils (mineral & veg)
2. Fatty alcohols
3. Fatty acids
4. Fatty esters
Solid excipients melted at the time of prep
Emulsifying agents
1. Nonionic surfactants
2. Detergents
3. Soaps

Soaps
o From fatty acid in the oil phase
o
o

phase in situ during prep

1) Separate lipid portion (h2o-insol components)
& aq portion (h2o-sol)

3) Phases mixed & stirred until ambient temp or

macromolecules and liquid

Two-phase system
o Consisting of floccules of small distinct

congealed
Traditionally, aq phase added to lipid phase
Comparable results reverse procedures
High-shear homogenization
o Reduce particle or droplet size
o Improve the physical stability of the
resultant dosage form
-

APIs
o

Added to phase where it is sol at

beginning of process
Added after cream prepared by
suitable dispersion process
levigation, or milling with a roller mill
Usually require addition of preservative
o Unless comp immediately prior to use
o Consumed relative short period of time
o

pentaerythritol
NF monographs carbomers:
1. 910
2. 934
3. 934P
4. 940
5. 941
6. 1342
Concentration of 0.5% to 2.0% in water
Carbomer 940
Highest viscosity
Between 40,000 to 60,000

centipoises as a 0.5% aq disp

Single-phase gels
o No apparent boundaries between

2) Both heated above MP of the highest melting comp

Carbomers
o High m.w. h2o-sol polymers of
acrylic acid cross-linked with
allyl ethers of sucrose and/or
o

hydrolyzed by a base dissolved in aq

Synthetic macromolecules
Carbomer 934
Cellulose derivatives
Carboxymethylcellulose
Hydroxypropyl methylcellulose
Natural gums
Tragacanth

particles
o Magma
Milk of Magnesia (magnesia magma)
o Consists of gelatinous mass of Mg(OH)2
Thixotrope
o Gels may thicken on standing
o Must be shaken before use to liquefy gel
and enable pouring
Solvents
o Alcohol
o Propylene glycol
Antimicrobial preservatives
o Methylparaben
o Propylparaben
o Chlorhexidine gluconate
Stabilizers
o Edetate sodium

GELS
-

Jellies
Dispersions of small or large mol in an
aq liquid vehicle rendered jellylike by
gelling agent

Androgel 1.62%
o Topical use
o Clear colorless gel
o Contain testosterone

Replacement therapy in adult males

def./absence endogenous testosterone

o 20 mg testosterone per pump actuation
o od am shoulers & upper arm
Topical oromucosal routes
Antibiotic-containing gels
o Admin by treat infusion in vet med
to treat mastitis

Preparation of Gels
-

(eg. by heating starch)

Cross-linking the dispersed molecule
by changing pH (carbomers) or
reducing cont phase (jellies formed w/ sucrose)
Care should be taken to ensure APIs uniformity
by dispersing them by vigorous mixing/milling
or shaking if prep less viscous

Tight containers to prevent water loss

Avoid freezing gels
TRANSDERMAL PREPARATIONS

Addition of penetration enhancers

1. Dimethyl sulfoxide
2. Ethanol
3. PPG
4. Glycerin
5. PEG
6. Urea
7. Dimethylacetamide
8. Sodium lauryl sulfate
9. Poloxamers
10. Spans
11. Tweens
12. Lecithin
13. Terpenes
Pluronic lecithin organogel
o Consists Pluronic (poloxamer) F127 gel
usually 20% to 30% conc mixed at 1:5
w/ mixt of isopropyl palmitate & lecithin
o Aids in rapid penetration of many active

PASTES, PLASTERS, AND GLYCERGELATINS

Pastes
-

Larger proportion of solid material (ie 25%)

than ointments, therefore stiffer
Levigating agent

Because of stiffness
o Remain in place after application
o Effectively employed to absorb
serous secretions
Stiffness and impenetrability
o Not suited on hairy parts of body
Zinc oxide paste (Lassars Plain Zinc Paste)
o 25% each ZnO and starch
with white petrolatum
o Very firm and better able to protect skin
and absorb secretions than ZnO oint

Plasters
-

Adhesive masses spread on backing of

paper, fabric, moleskin, or plastic
Provide prolonged contact at the site
Unmedicated plasters
o Provide protection or mechanical
support at site
Adhesive tape used to be official under title
adhesive plaster
Medicated plasters
o Provide effects at site

Salicylic acid plaster

On toes removal of corns
Keratolytic action
Remove horny layers
10% to 40%

Glycerogelatins
-

Plastic masses containing

o 15% gelatin
o 40% glycerin
o 35% water
o 10% added medicinal subs i.e. ZnO
Softening gelatin in h2o about 10 mins Steam
until gelatin dissolved Add glycerin w/ med

drugs through skin

MISCELLANEOUS SEMISOLID PREPARATIONS:

Portion of the base often used rather

than liquid, which would soften paste

Dispersing molecule in the continuous phase

Packaging and Storage

-

subs Allow to cool w/ stirring until congeal

Applied to skin for the long term
Melted before application, cooled slightly above
body temp, apply with fine brush
Hardens, usually covered w/ bandage, for weeks
Zinc gelatin official
o Varicose ulcers
o Zinc gelatin boot
ability to form pressure bandage

Packaging Semisolid Preparations

-

Topical dermatologic products

o Jar, tubes, or syringes
Ophth, nasal, vaginal, rectal
o Always in tubes or syringes
Ointment jars
o Clear or opaque glass or plastic
o Green, amber, blue
Opaque jars
o For light-sensitive products
o Porcelain white, dark green, or amber
0.5 oz to 1 lb
Tested for compatibility and stability for intended
product
o Stability testing filled containers (20C)
o Under accelerated stability testing
conditions (40C and 50C)

Tubes
o Light in weight, relatively inexpensive
o Convenient for use, compatible
o Provide greater protection against
external contamination & envi conditns
Ointment tubes
o Aluminum or plastic
o Ophth, rectal, vaginal, aural, nasal
With special applicator tips
o Tubes of aluminum
Coated with:
Epoxy resin
Vinyl, or
Lacquer
Eliminate interaction between
o

contents and tube

Plastic tubes
1. High-/low-density

Transparency
High degree product chemical
compatibility

closures
Single-dose tubes
o Prepared with tearaway tip
Metered-dose, tamper-evident, and childresistant closures
Standard sizes of empty tubes
o 1.5, 2, 3.5, 5, 15, 30, 45, 60, 120 g
Ointments, creams, and gels
o 5, 15, 30 g tubes
Ophthalmic ointments
o In small aluminum or plastic tubes
holding 3.5 g (about 0.125 oz)
Syringes for inj or oral use
o Advantages
Exclusion of air from the system
Accurate quantities applied

Filled from open back end

Oint prep by fusion poured while soft but viscous
to prevent stratification
Small scale, extemporaneous comp
o Manually or small-scale filling machine
o Caulking-gun system
Tubes
Semisolid filled into a chamber
and product delivered into the

Soft and resilient

Good moisture barrier
Superior moisture barriers
Less resilient

preferable to metal tubes

Extrusion
o Cylindrical bodies of tubes
o Joined to shoulder, neck, and tip piece,
which is by molding
Multiple-dose tubes
o Have conventional continuous thread

Filling Ointment Tubes

terephthalate
4. Various plastics
5. Foil
6. And/or plastic laminates
sometimes 10 layers thick
LDPE

HDPE

PET

because of foil content

High durability & product compa
These qualities and flexibility make
plastic and plastic laminate tubes

polyethylene or a blend
2. Polypropylene
3. Polyethylene

Laminates
Excellent moisture barrier

tube
Heat-sealing crimper
Tubes heat-sealed for
nice professional

appearance
Large-scale tube packaging
o Automatic filling
o Closing crimping
o Labeling machines
o Capacity to fill 1,000 to 6,000 per hr
Rotary machines four stations

Tube feeding
Cleaning
Filling
Closing

Filling Syringes
-

Drawing the semisolid into the barrel plunger

Removing plunger and fill through the back eng

DERMATOLOGIC PREPARATIONS

Ointments, creams, gels, pastes, and plasters

Medicated application
o should penetrate though the skin and
o retained in the skin for a while
Drug penetration factors:
1. Physicochemical properties
2. Characteristics of vehicle
3. Condition of skin itself
Passive diffusion
Rate of drug absorption depends on
o Drug conc in the vehicle
o Aq solubility
o Oil-water partition coefficient bet stratum

corneum & vehicle

Subs with both aq and lipid solubility
o Good candidates for diffusion
TDDS
o Drug blood levels may be measured &

equated
Topical nonsystemic dermatologic products
o Therapeutically effective drug conc in

the skin not known

o Tx based on qualitative measures
o Clinical efficacy varies bet pt & products
Factors of the base used and product type
o Diff in emollient and occlusive effect
o Ease of application and removal
1 to 3 mg of oint or cream per cm2 of skin

FEATURES AND USE OF

to be retained within base

Medicinal agents added as soln or finely
micronized powder
Fine milling
o Ointment made uniform & smooth
USP sterility test
o Terminal sterilization
Problematic
Steam sterilization or ethylene

o
o

penetrating base
Dry heat sterilization
Threat to the stability of

the drug
Generally not undertaken
Strict methods of aseptic process
Each comp rendered sterile &
aseptically wt before incorporating final

product
Antimicrobial preservatives
1. Methylparaben (0.05%)
2. Propylparaben (0.01%)
3. PhenylHgAc (0.0008%)
4. Chlorobutanol (0.5%)
5. Benzalkonium chloride (0.008%)
USP test metal particles
o Microscopic examination of heat-melted
o

Simple diffusion via the cornea

Lipophilic drugs
o More capable of penetration than
hydrophilic comp
Ophthalmic ointments and gels

surface of the eye

o Cleared from eye 0.5% per min
Ophth solns
o Lose up to 16% vol per min
Ointment base
o Sould not be irritating to the eye
o Must permit diffusion though secretions
o Should have point close to body temp
for comfort and drug release
o Mixt of white petrolatum & liq petrolatum
Unmedicated ophth oint
o Lubricating
Water-absorbing agent
o Lanolin
May be added
Gel base
o PEG and mineral oil
Permits h2o & h2o-insol drugs

oxide sterilization
Neither is capable of

FEATURES AND USE OF

OPHTHALMIC OINTMENTS CREAMS AND GELS

Provide extended residence time on

o
o

ophth ointment
Calibrated eyepiece micrometer disk
Total no. of particles 50 mm/larger from

10 products does not exceed 50

o Nmt one tube contains >8 such particles
Collapsible ointment tubes

0.25 to 0.5 in ribbon of oint along the inside of

the lower lid

FEATURES AND USE OF

NASAL

OINTMENTS AND GELS

-

Mucus contains
o Lysozyme
o Glycoproteins
o Immunoglobulins
Act against bacteria & entry to

and accompanying veins in the anal canal

Systemic absorption
o Prochlorperazine supp
Bases
1. PEG 300
2. PEG 3350
3. Cetyl alcohols
4. Cetyl esters wax
5. White petrolatum
6. Mineal oil

lungs
Primarily for local effects on the mucous
membranes and underlying tissues
(nasal decongestants)
Systemic absorption
o Butorphanol tartrate
(Stadol NS, Bristol-Myers Squibb)
Analgesic
o Cyanocobalamin
(Nascobal Gel, Scwartz)
Hematopoietic
o Nafarelin acetate
(Synarel, Searle)
Tx of endometriosis
o Nicotine
(Nicotrol NS, McNeil)
Adjunct in smoking cessation

Antimicrobial preservatives
1. Methylparaben
2. Propylparaben
3. Benzyl acohol
4. Butylated hydroxyanisole
Water-washable base
o Easier to spread and remove
o Tend to stain clothing less than
oleaginous base
Rectal oint and creams
o With special perforated plastic tips
Pain and inflamm associated

Great promise for the admin of insulin, vaccines,

and a number of polypeptides and proteins
Cyanocobalamin (Nascobal Gel)
o Intranasal administration
o Tx of vit. B12 def, inc pernicious anemia
o 0.1 mL containing 500 mg once weekly

Oint, gels, creams, and creamlike aerosols

Topical application perianal area
Insertion anal canal 3cm long
Anorectal pruritus, inflammation, hemorrhoids
Astringents
o ZnO
Protectants and lubricants
o Cocoa butter
o Lanolin
Local anesthetics
o Pramoxine HCL
Antipruritics, anti-inflammatory agents
o Hydrocortisone
Antiepileptics
o Diazepam
Diffusion

with hemorrhoids
Lubricated with mineral oil or

lubricating jelly
Rectal aerosol products
o (Proctofoam-HC, Schwarz)
o Also accompanied with applicators
Filled with measured dose of

FEATURES AND USE OF RECTAL PREPARATIONS

-

Via the network of 3 hemorrhoidal arteries

product
Product delivered by pushing
the plunger of the applicator

FEATURES AND USE OF VAGINAL PREPATIONS

-

Ointment, creams, creamlike foams, and gels

Vulvovaginal area
Vulvovaginal infections, vaginitis,
endometrial atrophy, contraception with
spermatocidal agents
Trichomonas vaginalis
Candida (Monilia) albicans
Haemophilus vaginalis
Endometrial atrophy
o Dienestrol and progesterone
Restore vaginal mucosa to
normal state

Contraceptive prep
o Spermicidal agents
1. Nonoxynol-9
2. Octoxynol
Alone or in combination
w/ a cervical diaphragm
Tested to be free of offending microorganisms,
yeasts, and molds
Gels
o Especially subject to bacterial growth
Ointments, creams, and gels
o Tubes
Vaginal foams
o Aerosol canisters
Mycelex-7 Vaginal Cream, Ortho-McNeal
o Applied externally to the vulva
Most intended to be delivered by applicator tips

DRUGS RELEASED FROM

SEMISOLID DOSAGE FORMS
-

Must be capable of being released from the

vehicle in a reproducible way

It is critical that the rate of release be
reproducibly determined
o For uniformity from batch to batch as

Vaginal foams
o O/W emulsions resembling light creams
o Water miscible and nongreasy
Once a day best done at bedtime
o Medication retention
o Avoidance of daytime leakage
o Lessened soiling of clothing
Creams with water-washable bases
o Preferred to oleaginous ointments
Unmedicated lubricant jellies
o Rectal, urethral, and vaginal exam
Tightly closed
Gels and jellies
o Prone to fry out if left unsealed

well as for release of drug for absorption

In vitro release testing
o Recommended by FDA
o Measure of product sameness
during scale-up & postapproval changes
Semisolid dosage forms
o Produce distinct difficulties in the
development of in vitro models
Physicochemical properties
Physiological environments
Release test
o Must be reproducible and reliable
o Not a measure of bioavailability
Must be capable of detecting
changes in drug-release
o

characteristics
Changes may alter biological

performace
Formerly, semisolid dosage form was placed in
direct contact with a receptor fluid
Franz diffusion cell
o Semisolid is placed on membrane
situated on top of a receptor chamber
o

containing receptor soln

Receptor soln where it is sampled &

analyzed
Results plotted as cocn of drug in
receptor fluid vs time