Semisolid Dosage Forms

(Cream & Oinment)

Ointments
 Semisolid Dosage Forms
• Topical preparations are used for both local
and systemic effects.

• Systemic drug absorption should always be

considered when using topical products if the
patient is pregnant or nursing, because drugs
can enter the fetal blood supply and breast
milk and be transferred to the fetus or nursing
infant.
 Semisolid Dosage Forms
• A topical dermatological product is designed
to deliver drug into the skin in treating dermal
disorders, with the skin as the target organ.

• A transdermal product is designed to deliver

drugs through the skin (percutaneous
absorption) to the general circulation for
systemic effects, with the skin not being the
target organ
 Semisolid Dosage Forms
• Ointments, creams, and gels are semisolid dosage
forms intended for topical application.

• They may be applied to the skin, placed on the surface

of the eye, or used nasally, vaginally, or rectally.

• Most of these preparations are used for the effects of

the therapeutic agents they contain.

• The unmediated ones are used for their physical

effects as protectants or lubricants.
 OINTMENTS
• Ointments are semisolid preparations intended for
external application to the skin or mucous membranes.

• Ointments may be medicated or not.

• Unmedicated ointments are used for the physical

effects they provide as protectants, emollients, or
lubricants.

• Ointment bases, may by used for their physical effects

or as vehicles for medicated ointments.
• OINTMENT BASES:
• Ointment bases are generally classified by the
USP into four groups:
• (a) oleaginous bases,
• (b) absorption bases,
• (c) water-removable bases,
• (d) water-soluble bases.
 SELECTION OF THE APPROPRIATE
BASE
• Selection of the base to use in the formulation of an
ointment depends on careful assessment of a number of
factors, including the following:
• • Desired release rate of the drug substance from the
ointment base
• • Desirability of topical or percutaneous drug absorption
• • Desirability of occlusion of moisture from the skin
• • Stability of the drug in the ointment base
• • Effect, if any, of the drug on the consistency or other
features of the ointment base
• • Desire for a base easily removed by washing with water
• • Characteristics of the surface to which it is applied
• For example, an ointment is generally applied
to dry, scaly skin; a cream is applied to
weeping or oozing surfaces, and a lotion is
applied to intertriginous areas or where
friction may occur, as between the thighs or
under the armpit.
 PREPARATION OF OINTMENTS
• Ointments are prepared by two general
methods:
• (a) incorporation
• (b) fusion,

• Depending primarily on the nature of the

ingredients.
 Incorporation
• The components are mixed until a uniform
preparation is attained.

• On a small scale, as in extemporaneous

compounding, the pharmacist may mix the
components using a mortar and pestle, or a
spatula may be used to rub the ingredients
together on an ointment slab (a large glass or
porcelain plate or pill tile).
• Others will use an ointment mill
• Incorporation of Solids.
• When preparing an ointment by spatulation, the
pharmacist works the ointment with a stainless
steel spatula having a long, broad blade and
periodically removes the accumulation of
ointment on the large spatula with a smaller one.

• If the components of an ointment react with

metal (as does iodine), hard rubber spatulas may
be used.
• Incorporation of Liquids.
• Liquid substances or solutions of drugs, as
described above, are added to an ointment only
after due consideration of an ointment base’s
capacity to accept the volume required.

• For example, only very small amounts of an

aqueous solution may be incorporated into an
oleaginous ointment, whereas hydrophilic
ointment bases readily accept aqueous solutions.
 Fusion
• By the fusion method, all or some of the components
of an ointment are combined by being melted
together and cooled with constant stirring until
congealed.

• Components not melted are added to the congealing

mixture as it is being cooled and stirred.

• Naturally, heat-labile substances and any volatile

components are added last, when the temperature of
the mixture is low enough not to cause decomposition
or volatilization of the components.
 PACKAGING, STORAGE,
AND LABELING
• Ointments and other semisolid preparations are packaged
either in large-mouth ointment jars or in metal or plastic
tubes.

• Semisolid preparations must be stored in well-closed

containers to protect against contamination and in a cool
place to protect against product separation in heat.

• When required, light-sensitive preparations are packaged

in opaque or light-resistant containers.

• In addition to the usual labeling requirements for

pharmaceutical products, the USP directs the labeling for
certain ointments and creams include the type of base used
(e.g., water soluble or water insoluble).
Cream
• Creams are defines as “semisolid dosage form
containing one or more drug substances
dissolve or dispersed in a suitable base”
• Creams are semi-solid emulsions of oil and
water
• They are of a softer consistency & lighter body
than true oinment
• Semisolid emulsions of either O/W or W/O
 TYPES
• OIL IN WATER (O/W) CREAM
• WATER IN OIL (W/O) CREAM
 Oil in Water (O/W) Creams
• Oil in water (O/W) creams which are composed of
small droplets of oil disperse in a continuous phase.
• More comfortable and cosmetically acceptable as
they are less greasy and more easily washed off
using water.
• Emulsifying agents of natural origins (bees wax,
wool, alcohols, wool fat).
• Emollient and creamy., whitw or translucent and stiff
• E.g : vanishing cream
 Water in Oil (W/O) Creams
• Water-in-oil (W/O) creams which are composed of
small droplets of water dispersed in a continuous oily
phase.
• More difficult to handle but many drugs which are
incorporated into cerams are hydrophobic and will
be released more readily from W/O cream than an
O/W cream
• More moisturizing as they provide an oily barrier
which reduces water loss from the stratum corneum,
the outermost layer of the skin
• E.g. Cold Cream
Cosmetic creams Medicated creams
• All purpose cream. Baby • medicated crems are
cream, barrier cream, contains active
bleaching cream,cleansing pharmaceutical ingredients.
cream, cold cream, hair • E.g:
cream, hand cream, • cetrimide cream used as
vanishing crean. antiseptic
• Zinc oxide cream used as
astringent
• Hydrocortison cream-treat
rashes like poison oak or
poison ivy
 Manufacturing process
Preparation of the
oil phase
Hydration of
aqueous
ingredients
Forming the
emulsion

Dispersion of the
active ingredient
 Advantages of cream
• They gives prolong contact in their site of application
than any other pharmaceutical semi-solid dosage
forms.
• Injured area can be dried quickly by creams than
other semi-solid preparations.
• Non-irritating when applied to the skin.
• Easily water washable. Easy to wipe away.
• Less greasy compared to ointment.
• Easy to spread on the skin’s surface (i.e. easy to
apply).
 Disadvantage of cream
• Stability is not as good as ointment
• They are less hydrophobic than other
semi-solid preparation, so risk of
contamination is high than the others
 Ideal Characteristics

• It should liquefy at body temperature

• It should penetrate the epidermis (via natural
opening)
• Its viscosity should be low enough to permit
easy spreading
• It should be non-toxic
• It should be non-irritant
• It should be non-inflammatory
 Evaluation test
pH
Viscosity
Rheological behavioral of the cream
Determination of type of emulsion
i. Dilution test
ii. Dye solubility test
 pH of the cream
• The pH of various formulations was
determined by using digital pH meter
• About 1 gram of the cream was weighed and
dissolved in 100 ml of destilled water and
stored for two hours.
• To measurement of pH of each formulation
was done in triplicate and average values
were calculated.
 Viscosity
• Determined by Brookfield viscometer
• At 20 rpm at a temperature 25 C and the
determinations were carried out in triplicate
and the average of three readings was
recorded
 Rheological behavioral of the
cream
• The rheological property was determined to
know the flow behavior of formulation.
• The viscocity at different rpm was measured
using Brookfield viscometer.
• The rheological behavior of the formulation
was studied by taking 100 grm of the cream in
the beaker
• The rate of shear was increased gradually
from minimum to maximum and
corresponding dial reading was noted, then
the rate of share was decreased gradually to
the lowest value and the dial reading was
recorded
• The graph was plotted between percent
torque and viscosity to determine type of flow
 Stability test
Globul size
Phase separation
Moisture absorption studies
Shelf life
Spreadability
 Globul size
• 1 ml of cream was diluted to 10 ml with
glycerin.
• A few drops of this were transferred onto a
glass slide and was focused in a microscope.
• By using eye-piece micrometer, the diameters
of 200 particles were determined randomly.
 Particle size distributions recorded for the creams with low heat treatment (L), medium heat
treatment (M) and high heat treatment (H), using laser light scattering. The creams were dispersed
in water in the presence of sodium dodecyl sulphate (SDS 1%) and EDTA to dissociate the
aggregates of fat globules and casein micelles, respectively. The fat globule size distribution in
  .cream with low heat treatment is presented for comparison
 Phase separation
• The formulated cream was kept intact in a
close container 25-30 °C not exposed to light.
• Phase separation was observed carefully every
24 hrs for 30 days.
• Any change in phase separation was checked
 Moisture absorption studies
• About 50 mg of cream was taken on a watch
glass.
• A beaker was taken with full of water and was
kept in a desiccator without adsorbents.
• Watch glass with crean was
introduced into the desicator.
• It was left for 24 hrs.
 Shelf life
• The formulated product was stored in different
temperature conditions like room temperature, 45°C
and 55 °C to accelerate degradation for 1 month.
• Sample were withdrawn periodically every week and
observed for drug decomposition by taking the
absorbance under UV spectrophotometer.
• From the concentrations, and the temperatures, the
shelf life of the product can be estimated.
 Spreadability
• The spreadability was expressed in terms of
time in seconds
• Take two slides to slip off from the cream,
placed in between the slides
under certain load
• Lesser the time taken
for separation of the two
slides, better the spreadability