Chapter 10: Ointments, Creams and Gels

Semisolid dosage forms intended for

topical application
Used for the effects of the therapeutic
agents they contain.
Unmedicated used for their physical
effects as
Protectants
Lubricants
Topical preparations -> used for both
local and systemic effects
Systemic drug absorption considered
when using topical products if ptx is
pregnant or nursing, drugs cab enter
fetal blood supply and breast milk and
transferred to the fetus or nursing infant.
Topical dermatological product ->
designed to deliver drug into the skin in
treating dermal disorders, with the skin
as the target organ
Transdermal product -> designed to
deliver drugs through the skin
(percutaneous absorption) to general
circulation for systemic effects , with the
skin not being the target organ.

OINTMENTS
-

Semisolid preparations intended for

external application to the skin or
mucous membranes.
Unmedicated ointments -> used for
physical effects they provide as
Protectants
Emollients
Lubricants
Ointment bases -> used for physical
effects or vehicles for medicated
ointments.

OINTMENT BASES
1. Oleaginous base
- Hydrocarbon bases
Uses:
- Emollient effect

Protect against the escape of moisture

Effective as occlusive dressing
Remain on the skin for long periods
without drying
Difficult to wash off
Water and aqueous preparation -> may
be incorporated, only in small amounts
Liquid petrolatum (mineral oil)
levigating agent
Used when powdered substances are
to be incorporated in hydrocarbon
bases

Examples:
a. Petrolatum, USP purified mixture of
semisolid hydrocarbons
- From petroleum
- Unctuous mass, varying in color from
yellowish to light amber
- Melts at 38C 60 C
- Used alone or in combination with other
agents as an ointment base
- Known as:
Yellow petrolatum
Petroleum jelly
Commercial: Vaseline
b. White Petrolatum, USP ->purified
mixture of semisolid hydrocarbons from
petroleum that has been wholly or
nearly decolorized
- Lighter
color,
considered
more
esthetically
pleasing
by
some
pharmacists
- Known as:
White petrolatum jelly
Commercial: white Vaseline
c. Yellow ointment, USP
Yellow wax purified wax obtained the
honeycomb of the bee Apis mellifera
Preparation:

Melting the yellow wax on water bath

Adding petrolatum
Cooling, stirring until congealed

Known as:
Simple ointment has greater
viscosity than plain petrolatum
d. White ointment, USP -> differs from
yellow ointment by substitution of white
wax(bleached and purified yellow wax)
and white petrolatum in the formula.

Commercial:
Aquaphor and Aquabase -> variations of
hydrophilic petrolatum
-

2. Absorption bases
2 types:
a. Those that permit the incorporation of
aqueous solution resulting in the
formation on water-in-oil (W/O)
emulsions (ex: hydrophilic petrolatum)
b. Those that are W/O emulsions
(emulsion bases) that permits the
incorporation of additional quantities of
aqueous soln (ex: lanolin)

a. Hydrophilic petrolatum, USP ->

prepared by melting stearyl alcohol
and white wax on steam bath
Adding cholesterol with stirring
Add white petrolatum
Allow micture to cool while stirring,
congealed

Have the capacity to absorb up to 3

times their weight in water and are
useful to help incorporate a watersoluble
b. Lanolin, USP (anhydrous lanolin)
From the wool of sheep (Ovis aries)
Purified wax like substance that has
been
cleaned,
deodorized,
ad
decolorized.
Contains not more than 0.25% water.
Modified Lanolin USP -> lanolin
processed to reduce contents of free
lanolin alcohols an any detergent and
pesticide residues.

Uses:

Emollient
Do not provide the degree of
occlusion afforded by oleaginous
bases
Not easily removed from the skin by
water washing
External phase of emulsion oleaginous
Used as pharmaceutical adjuncts to
incorporate small volumes of
aqueous soln into hydrocarbon
bases.
Accomplished by incorporating the
aqueous soln into absorption bases and
then incorporating this micture to
hydrocarbon base

3. Water- Removable Bases

Oil-in-water emulsions commonly
called creams
External phase of emulsion aqueous
- Easily washed from the skin and often
called water-washable bases.
- May be diluted with water or aqueous
soln
- Absorb serous discharge
Ex:
a. Hydrophilic Ointment (USP)
- Stearyl alcohol and white petrolatum
melted together at 75C
Sodium lauryl sulfate - emulsifying
agent

With the stearyl alcohol and white

petrolatum constituting the oleaginous
phase of the emulsion and other
ingredients the aqueous phase.
Methylparaben and propylparaben ->
antimicrobial preservatives.

4. Water- soluble bases

- Do not contain oleaginous components.
- Water washable and often referred as
greaseless
- Soften greatly with addition of water
- Large amounts of aqueous soln are not
effectively incorporated into these bases
- Used for incorporation of solid
substances
a. Polyethylene glycol, NF, (PEG)
ointment
Prototype example of water-soluble
bases
Polymer of ethylene oxide and
water represented by the formula
H(OCH2CH2)nOH (n-> represents
the number of oxyethylene group)
Numeric designations > average
molecular weight of the polymer
PEG has average MW below 600
> clear, colorless liquids
MW above 1000 > waxlike white
materials
MW that are in between > semisolid
The greater the MW = greater
viscosity
NF lists the viscosity of PEG ranging
from the average MW of 200-8000
PEG 3350(solid) + PEG 400(liquid)
- Very pliable semisolid ointment
Selection of the Appropriate Base
1. Desired release rate of the drug subs
from the ointment base
2. Desirability
of
topical
or
percutaneous drug absorption
3. Desirability of occlusion of moisture
from the skin

4. Stability of the drug in the ointment

base
5. Effect of the drug on the consistency
or other features of the ointment
base
6. Desire for a base easily removed by
washing water
7. Characteristics of the surface to
which it iss applied
Ointment applied to dry, scaly skin
Cream applied to weeping or oozing
surfaces
Lotion applied to intertriginous areas
where friction may occur, between the
thighs or under the armpit

Preparation of Ointments
2 methods:
1. Incorporation
- Components are mixed until a uniform
preparation is attained.
Small
scale

extemporaneous
compounding
- Mix the components using mortar and
pestle or spatula to rub the ingredients
together on an ointment slab large glass
or porcelain plate or pill tile)
- Some use nonabsorbent parchment
paper to cover the working surface
- If using ointment parchment pad, its best
to not allow too long contact of the
ointment with the parchment ( too much
will make it soften or tear)
- Other use ointment mill, electronic
mortar, or
Unguator allows a pharmacist to
place the ingredients in a plastic
ointment jar with a special lid that
allows for a mixing blade to be used
to mix ing.

a. Incorporation of Solids
- Preparing using spatulation -> uses
stainless spatula having a long, broad
blade and periodically removes the

accumulation of ointment on the large

spatula with the smaller one.
Hard rubber or silicone spatulas ->
used if components of ointment
react with metal (like iodine)
Ointment is rubbed and working the
components on the hard surface (until
smooth)
Ointment base is placed one side of the
working surface and the powdered
componnets, previously reduced to fine
powders and blended in a mortar on the
other side.
A small portion of the powder is mixed
with a portion of base until uniform
Geometric dilution continued until all
portions of the powder and base are
combined and thoroughly blended.
Reduce the particle size of powder
before incorporation into the ointment
base is desirable = product will not be
gritty
Levigating -> mixing the solid
material in a vehicle in which it is
insoluble to make a smooth
dispersion
Ex: mineral oil for bases in which oils
are the external phase or glycerin for
bases in which water is the external
phase should be compatible with the
drug and base
Mortar and pestle used
Levigating agent = to the volume of the
solid material
After
levigation,
dispersion
is
incorporated into the ointment base y
spatulation or with mortar and pestle
Mortar and pestle method preferred
when large volumes of liquid are added.

For incorporating gummy material like

camphor
Pulverization by intervention can be
used

Material is dissolved in a solvent and

spread out on the pill tile.
Solvent is allowed to evaporate, leaving
a thin film of the material onto which
the other ingredient.
Material is then worked into the
ingredients by trituration with a spatula
b. Incorporation of Liquids
Added onto the ointment only after due
consideration of an ointment bases
capacity to accept the volume required
When its necessary to add an aqueous
preparation to a hydrophobic base ->
soln may first be incorporated into a
minimum amount of hydrophilic base
and that mixture will be aaded to the
hydrophobic base
Alcoholic soln
Small volume may be added easily to
oleaginous vehicles or emulsion bases.

Natural balsam -> Peru Balsam, usually

mixed with an equal portion of castor oil
before incorporation into a base.
- Reduces the surface tension of the
balsam and allows even distribution of
the balsam throughout the base.
Ointment or roller mills -> used to
force coarsely formed ointments
through stainless steel or ceramic
rollers to produce ointments uniform
in composition.
2. Fusion
- Components are combined by being
melted together and cooled with
constant stirring until congealed.
Heat-labile substances or volatile
components -> added last, when temp of
mixture is low enough not to cause
decomposition or volatilization
Small scale -> conducted in porcelain
dish or glass beaker
Large scale -> carried out in a large
steam jacketed kettles

Preparation of ointments having an

emulsion base
method of
manufacture both involve both melting
and emulsification.
Water- immiscible components (oil
and waxes) -> melted together in a
steam bath to about 70C - 75C

2. Minimum Fill
- Determination of net weight or volume
of the contents of filled containers to
ensure proper contents compared wit the
labeled amounts

COMPENDIAL
OINTMENTS

REQUIREMENTS

FO

1. Microbial Content
- Topical prep are not required to be
sterile 9except ophthalmic prep)
- Among the antimicrobial preservatives
used to inhibit microbial growth in
topical prep:
Methylparaben
Propylparaben
Phenols
Benzoic acid
Sorbic acid
Quaternary ammonium salts
Example: Betamethasone Valerate Ointment
(USP) must meet the requirements for the test
for absence of Staphylococcus aureus and
Pseudomonas aeruginosa.

good manugfacturing practices to

minimize both the type and the number
of microorganisms in unsterilized
pharmaceutical products.
Involves testing of raw materials
Use of acceptable water
In processs control
Final product testing
Dermatological products should be
test for P. aeruginos and S. aureus
Rectal, urethral, vaginal test for
yeasts and molds

Medicated ointments and ointment bases

containing compnents like
Beeswax
Paraffin
Stearyl alcohol
High molecular weight PEG
Which do not lend themselves well
to mixture by incorporation
Prepared by FUSION
The materials with high melting
point -> melted with the lowest
temp that will produce a melt.

Microbiological attributes of Nonsterile

Pharmaceutical Products -> USP
chapter, placed on strict adherence to
environmental control and application of

3. Packaging, storage and labeling

Ointments or semisolid prep packaged
in either
Large-mouth ointment jars
Metal/plastic tubes
- Semisolid must be stored in well-closed
containers
to
protect
against
contamination and in a cool place to
protect against product separation in
heat.
Light sensitive prep opaque or light
resistant containers
Labeling includes:
Proper storage conditions
Dosing and administration
4. Additional standards
- Examines the semisolid prep for
viscosity and for in vitro drug release to
ensure
within-lot
and
lot-to-lot
uniformity
In vitro drug release test:
diffusion cell studies
CREAMS

semisolid prep containing one or more

medicinal agents dissolved or dispersed
in either water-in-oil (W/O) emulsion or
an oil-in-water (O/W) emulsion or in
another type of water washable base.
Vanishing cream oil-in-water
emulsion containing large percentages
of water and stearic acid or other
oleaginous components.
After application, the water evaporates
and leaves a thin film of stearic acid.
Cream are easier to spread and remove
than ointment
Creams
have
soft,
spreadable
consistency
Cold cream W/O cream
Hydrophilic ointment O/W cream
Creams are described as:
Nonwashable
Washable
Emulsion with an aqueous external
continuous phase (O/W) is more easily
removed than one with a non-aqueous
external phase ( W/O)
Term cream used water-washable
formulation is generally inferred.

Preparations of Cream
-

Could be formulated from:

Oils
Both minerals a vegetables
Fatty alcohols
Fatty acids
Fatty esters
Emulsifying agents:
Nonionic surfactants
Detergents
Soaps formed from fatty acids in
the oil phase hydrolyzed by a base
dissolved in the aqueous phase.
Preparation involves separation into:
Lipid portion
Contains all water insoluble components
Aqueous
Water-soluble components

Both portions are heated to a temp

above the melting point of the
highest melting point component.
Phases are mixed and mixture is
stirred until reaching ambient temp
or mixture is congealed.
Aqueous phase is added to lipid phase
High- shear homogenization reduce
the particle or droplet size and improve
physical stability of the dosage form
API added to phase which it is
soluble at the beginning of the process
After the cream is prepared by suitable
dispersion process like
Levigation
Milling with roller mill
Creams need preservatives

GELS
-

Called jellies
Semisolid systems containing of
dispersions of small or large molecules
in an aqueous liquid vehicle rendered
jellylike by the addition of a gelling
agent like:
Synthetic macromolecules
Carbomer 934
Cellulose derivatives
Carboxymethylcellulose
Hydroxypropyl methylcellulose
Natural guums
Tragacanth
Carbomers high molecular weight
water-soluble polymers of acrylic
acidcross linked with allyl ethers of
sucrose and/or pentaerythritol.
Viscosity depends on polymeric
composition.
NF contains monographs 6 polymers:
Carbomers 910
934
934P
940
941
1342

Used as gelling agents at

concentrations of 0.5%- 2.0 % in
water.
Carbomer 940 highest viscosity,
between 40,000 and 60,000 centipoises
as 0.5% aqueous dispersion.

1. Single phase gels macromolecules

are uniformly distributed throughout a
liquid with no apparent boundaries
between the dispersed macromolecules
and the liquid
2. Two phase system gel mass
consisting of flocules of small distinct
particles
Referred as magma
Milk of magnesia (magnesia
magma) consists of a gelatinous
precipitate of magnesium hydroxide.
- Gels may thicken in standing
- Forms thixotrope
- Must be shaken to liquefy ad enable
pouring
Gels may be formulated to contain drug
Substance , solvents such as
Alcohol
Propylene glycol
Antimicrobial preservatives
Methylparaben
Propylparaben
Chlorhexidine gluconate
Stabilizers

Edetate disodium
Medicated gels administered through
skin, eye, nose, vagina, rectum

Androgel 1.62%

Topical uses, clear, colorless gel

containing testosterone
Contains Carbopol 980, ethyl
alcohol,
isopropyl
myristate,
purified
water,
and
sodium
hydroxide
Androgen indicated for replacement
therapy in adult males for deficiency
or
absence
of
endogenous
testosterone.
Delivers
about
20 mg
of
testosterone per pump actuation
applied topically once a day in the
morning in shoulders and upper
arms.
Gels can be administered by topical oromucosal
routes
Antibiotic-containing
gels

administered by teat infusion in

veterinary medicine to treat mastitis.
Preparation of Gels
- Gels formed with large organic
molecules may be formed by dispersing
the molecule in the continuous phase
(by heating starch)
- Cross linking the dispersed moleccules
by changing the pH( as for carbomers) ,
or by reducing the continuous phase ( as
for jellies formed with sucrose)
Packaging and Storage
- Should be stored in tight containers to
prevent water loss. Avoid freezing gels
TRANSDERMAL PREPARATIONS
Penetration enhancers include:
Dimethyl sulfoxide
Ethanol
Propylene glycol
Glycerin
PEG
Urea
Dimetylacetamide
Sodium lauryl sulfate
Poloxamers
Spans
Tweens
Lecithins
Terpenes

Transdermal
prep
commonly
compounded is Pluronic lecithin
organogel consists of Pluronic
( poloxamer) F127 gel (20%-30%
concentration)
Mixed at a ratio of 1:5 with mixture
of equal parts of isopropyl almitate
and lecithin
Aids in rapid penetration of manu
active drug through the skin.

MISCELLANEOUS SEMISOLID
PREPARATIONS: PASTES, PLASTERS,
AND GLYCEROGELATINS
PASTES
- Semisolid prep intended for applications
to the skin.
- Contain larger portion of solid material (
25%) than ointments and therefore are
stiffer
- Prepared by direct mixing or heating
prior to the incorporation of of solids.
- When levigating is used to smoothen the
component, portion of the base id used
rather than liquid, which soften the paste
- Pastes remain in place after application
because of the stiffness of pastes.
- Not suitable to hairy parts of body
because of stiffness and impenetrability
Example:
Zinc oxide paste (Lassars Plain
Zinc Paste) prepared by mixing
25% each of zinc oxide and starch
with white petrolatum
- Product is very firm and better protect
the skin and absorb secretions than in
zinc oxide ointment.
PLASTERS
- Solid or semisolid adhesive masses
spread on a backing of paper, fabric,
moleskin or plastic
Adhesive material
Rubber base
Synthetic resin
- Applied to the skin to provide prolonged
contact at site.

Unmedicated plasters provide

protection or mechanical support at the
site of application.
Adhesive tape used to be official
under the title adhesive plaster
Medicated plasters among used
plasters is
Salicylic acid plaster used on the
toes for the removal of corns.
Horny layers of skin are removed by
keratolytic action of salicylic acid.
Concentration ranges 10%-40%

GLYCEROGELATINS
- Plastic masses containing gelatin (15%),
glycerin (40%) water (35%) and and
added medicinal substance (10%) such
as zinc oxide.
- Prepared by softening the gelatin in
water (10 mins), heating on steam bath,
adding the medicinal subs mixed with
glycerin, allowing mixture to cool with
stirring until congealed.
- Applied to skin for long term
- Melted before application
- Applied tto affected area with fine brush
- The glycol hardens after application,
covered with bandage

Zinc gelatin most recent official

glycerogelatin, used in the treatment of
varicose ulcers
Known as Zinc Gelatin Boot
Ability to form a pressure bandage.
Packaging Semisolid Preparations
Topical dermatologic products packaged
in:
Jars
Tubes
Syringes
Opthalmic, nasal, vaginal and rectal
semisolid products:
tubes
syringes

ointment jar made of clear or opaque

glass or plastic.
Either green, amber, blue

Opaque jars for light sensitive

products
porcelain white
dark green
amber
ointment jars 0.5 to 1 lb in size.
Jars and tubes tested for
compatibility and stability
Stability testing of filled containers
a room temperature( 20C)
Accelerated
stability
testing
conditions (40-50C)
Tubes for Topical Pharmaceutical
Products:
Light in weight
Relatively inexpensive
Convenient for use
Compatible with most formulative
components
Greater protection against external
contamination
Ointment Tubes made up of:
Aluminum
Plastic
Ophthalmic, rectal, vaginal, aural or
nasal ointment packaged with special
applicator tips
Tubes of aluminum coated with:
Epoxy resin
Vinyl
Lacquer
To eliminate any interactions between
content and the tube.
Plastic tubes are made of:
High-or-low density polyethylene
(HDPE or LDPE) or blend of each
Polypropylene (PP)\
Polyethylene terephthalate (PET)
Plastic, foil, laminates
LDPE soft and resilient; good
moisture barrier
HDPE superior moisture barrier; less
resilient
PP high level of heat resistance
PET transparency and high degree of
product chemical compatibility

Laminates excellent moisture barrier

(foil content, high durability, product
compatibility)
Plastic tubes are preferable than metal
tubes.
Molding
Cylindrical bodies of plastic tubes made
by extrusion, joined to shoulder, neck,
and tip piece.
Multiple dose tubes have continuous
thread closures.
Single dose tubes with a tearaway tip
Ointment, creams, gels packaged in
5-, 15-, 30 g tubes
Ophthalmic ointments - packaged in
small aluminum or collapsible plastic
tubes (3.5 g)

Filling Ointment Jars

Small scale transferring the weighed
amount of ointment into the jar with a
spatula.
Ointment is packed on the bottom
and along the sides of the jar,
avoiding entrapment of air.
Ointments prepared by Fusion
poured directly into the ointment jar to
congeal in it.
Large scale pressure fillers force the
specified amount of ointment into the
jars.
Filling Ointment Tubes
- Filled from the open back end of the
tube, opposite from the cap end.
Prepared by Fusion poured while still
hot but viscous directly into the tubes
with the caution to prevent stratification
of components.
Prepared Small scale filled manually
or small-scale filling machine
Caulking- gun system semisolid is
filled into the chamber and the product
id delivered into to the tube.
Heat-sealed or heat-sealing crimper
for professional appearance

Large scale
Automatic filling, closing, crimping
and labeling machines are used.
Machines have the capacity 1,000
6,000 tubes per hour
Rotary machines have 4 stations for
Tube feeding
Cleaning
Filling
Closing
Plastic and laminate tubes sealed by
heat and crimping
Metal tubes sealed by folding, and
crimping with or without a vinyl, latex,
lacquer sealant.
Electronic mortars and pestles used
to prepare an ointment, cream, gel in
dispensing container

Filling Syringes
-

Filled either by drawing the semi-solid

into the barrel using the plunger
By removing the plunger and filling
through the back end of the syringe.
Accomplished by placing a straightened
paper clip down the inside othe barrel
and inserting the barrel.
Paper clip allows the escape of air
until the plunger contacts the
ointment

Skin Histology and their drug penetration:

FEATURES AND USE OF THE

DERMATOLOGIC PREARATIONS

Topical treatments used:

Ointments
Creams
Gels
Pastes
Plasters
Oral therapy treatment of poison ivy
with prednisone
In treating skin diseases:

The drug should penetrate and be

retained in the skin for a while\
Drug penetration:
Physicochemical properties of
medicinal subs.
Characteristics of pharmaceutical
vehicle
Condition of skin
Normal unbroken skin natural
barrier, limiting rate and degree of drug
penetration.

Stratum corneum outter layer

Leaving epidermis
Dermis collectively a laminate of
barriers protecting against external
agents and loss of water.
Blood capillaries and nerve fibers
rise from subcutaneous fat into the
dermis up to epidermis
The stratuum corneum offers little
resistance to drug penetration;
semipermeable; drug absorption through
passive diffusion
Rate of drug movement depends on:
Drug concentration in vehicle
Its aqueous solubility
Oil-water partition coefficient
between the stratum corneum
Subs with both aqueous and lipid
solubility good candidates for
diffusion
Drug reached the vascularized
dermal layer available for
absorption
Hair follicles and gland ducts provide
entry for drug molecules
Drug blood levels achieved by
transdermal delivery systems
measured and equated against desired
therapeutic effects, same is not true for

topical nonsystemic dermatologic

products.
Topical products therapeutically
effective drug concentration is not
known, treatment is based on qualitative
measures, with clinical efficacy often
varying between patients and products
Differences in emollient, occlusive
effects and ease of application and
removal between products
Factors of the base used and product
type
Oleaginous bases provide greater
occlusion and emollient effects than
hydrophilic or water washable bases
Pastes greater occlusion and more
effective than ointments at absorbing
serous discharge
Creams oil in water emulsions,
spread more easily than ointments and
are easier to remove.
Water soluble bases nongreasy and
are easily removed

FEATURES AND USE OF OPTHALMIC

OINTMENTS AND GELS

Ointments and gels

Used in the topical treatment of eye
diseases
Systemic therapy use of diuretics in
adjunctive treatment of glaucoma.
Cornea major route by which drugs
enter the eye by simple diffusion
Conjunctiva and sclera provide
alternate route for drugs that are poorly
absorbed cornea.
Drug penetration depends
Drugs ability to traverse these
layers
Lipophilic drugs more capable of
penetration than hydrophilic compounds
Ophthalmic drug penetration
Limited by short residence time on the
surface of the eye because of rapid

removal by tearing and other natural

mechanisms, small surface area of the
cornea for drug absorption, and the
corneas natural resistance to drug
penetration.
Ophthalmic ointments and gels
provide extended residence time on the
surface of the eye, increasing the
duration of their surface effects and
bioavailability for absorption into ocular
tissues.
Cleared from the eye as slowly as 0.5%
Solutions can lose up to 16% of
their volume per minute
Ointment bases
Have softening point close to body
temp,for comfort and drug release.
Mixtures of white petrolatum and
liquid petrolatum (mineral oil)
used as he base in medicated and
unmedicated (lubricating) ihalmic
ointments
Lanolin water absorbing agent is
added
PEG and mineral oil gel base is
used; this form permits water and
water insoluble drugs to be retained
within the base.
Medicinal agents added as:
Solution
Finely micronized powder
Fine milling = uniform and smooth
ointment

Ophthalmic ointments must meet:

USP sterility tests
Test for metal particles in
ophthalmic ointments

Terminal sterilization of finished

ointment by standard methods may
be problematic
Steam sterilization or ethylene oxide
methods are ineffective because

neither are capable of penetrating the

ointment base
Dry heat sterilization can penetrate
the ointment base
High heat required may pose a
threat to the stability and separating
ointment base form the components.
Strict methods of aseptic processing
being employed
Preservatives used:
Methylparaben
Propylparaben
Combined
Phenylmercuric acetate
Chlorobtanol
Benzalkonium chloride
Microscopic examination of a heatmelted ophthalmic ointment
USP test for meal particles
Calibrated eyepiece micrometer disk
counts detected metal particles

Opthalmic ointments
Packaged in collapsible ointment
tubes
Have elongated narrow tips to
facilitate application of narrow band
of ointment to the eye
Ointment when applied makes your
eye blurry for minutes
ointments should be applied before
bedtime

FEATURES AND USE OF NASAL

OINTMENTS AND GELS

treatment for nasal mucosa

ointments or gels
nose respiratory organs
mucous contains:
lysozyme
glycoproteins
imuunoglobulins
act against bacteria and protect
against their entry into lungs

ciliary action and sneeze reflex

further defense against entry
drugs introduced on nasal passage
for local effects on mucous
membranes and underlying tissues
nasal route of administration
used for systemic absorption of
number of drugs, including:
butorphanol tartrate (Stadol ND,
Bristol Myers Squibb)
analgesic
cyanocobalamin (Nascobal Gel,
Schwarts)
hematopoietic
nafarelin acetate (Synarel, Searle)
treatment of endometrioses
nicotine (Nicotrol NS, McNeil)
adjunct in smoking cessation
nasal routes hold great promise:
insulin
vaccines
number of polypeptides and proteins
cyanocobalamin (Nascobal Gel)
intranasal administration is used in
the treatment vit. B12 deficiency and
pernicious anemia
self administered as nasal gel
0.1 mL gel containing 500 mg
cyanocobalamin = administered
intranasally once weekly
FEATURES AND USE OF RECTAL
PREPARATIONS

Treatment of anorectal conditions

Ointments
Gels
Creams
Creamlike aerosol
Solutions enema or irrigation
Suppositories

Perianal area and anal canal

Ointments, creams and gels

used to treat:

 Anorectal pruritus
Inflammation
Pain associated with hemorrhoids

Rectal ointments and creams

Drug includes:

Astringent (zinc oxide)

Protectants and lubricants (cocoa
butter, lanolin)
Local anesthetic ( pramoxine HCL)
Antipruritics and ani-inflammatory
agents (hydrocortisone)
Antiepileptics (diazepam)
Perianal are
Skin surrounding the anus
Anal canal and rectum
Mucosal lining
Subs applied rectally
Absorbed by diffusion into general
circulation via the network of 3
hemorrhoidal arteries and anal
canal.
Rectal route
Used for systemic absorption

Packed with special perforated

plastic tips to be administered to
anus
Rectal tip should be cleaned
Lubricated with mineral oil and
lubricating jelly

Rectal aerosol foam products

Accompanied by applicators to
facilitate administration.
Applicator attached to the aerosol
container.
FEATURES AND USE OF VAGINAL
PREPARATIONS

Treatment of vulvovaginal area

Ointments
Creams
Creamlike foams
Gels

Other dosage forms include:

The bases used in anorectal oinments are
combinations of:
Combined PEG 300 and 3350
Emulsion cream bases using cetyl
alcohol and cetyl esters wax
White petrolatum and mineral oil
Antimicrobial preservatives:

Methylparaben
Propylparaben
Benzyl alcohol
Butylated hydroxyanisole
Products with water washable base
Easier to spread and remove after
application and tend to satin
clothing less than having an
oleaginous base.

Vaginal inserts
Transdermal drug delivery systems
Oral forms
Topical products are used to treat:

vulvovaginal infections
vaginitis
endometrial atrophy
contraception with spermatocidal
agents

Usual pathogenic organisms of vulvovaginal

infections and vaginitis:
trichonomas vaginalis
candida ( Monilia) albicans
haemophilus vaginalis
anti-infective agents:

nystatin
clotrimazole
miconazole
clindamycin
sulfonamides
endometrial atrophy
treated locally with hormones
dienestrol and progesterone
used to restore vaginal mucosa to its
normal state

contraceptive prep with spermicidal agents like:

nonoxynol9
octoxynol
used alone or in combination with
cervical diaphragm.
Gels
Subject to bacterial growth
Must be free from microorganisms,
yeasts and molds.
Oinments are packaged:

Tubes and vaginal foams in aerosol

canisters
In treating external squeeze small amount in
fingers
In treating internal uses plastic applicator.