Drug Compounding Lab

Compounding Pharmaceutical Creams

Objectives:
1. To practice compounding of absorption base (cold cream)

2. To practice compounding of water removable base (vanishing cream)

Introduction:
The United States Pharmacopeia (USP) recognizes four types of semisolids under
classification of ointments:
1. Hydrocarbon bases
2. Absorption bases
3. Water-removable bases
4. Water-soluble bases.
Hydrocarbon bases:
1. Petrolatum
2. White ointment, which is petrolatum with 5% beeswax
Those are typical of this class of lipophilic vehicles.
Hydrocarbon bases are difficult to wash off the skin and may be used as
occlusive coverings to inhibit the normal evaporation of moisture from
the skin.
A thin film of petrolatum produces a sensation of warmth on the skin
because the insensible moisture does not evaporate.
Absorption bases:
Formed by the addition of substances miscible with hydrocarbons and possessing
polar groupings.
These substances are added to make the hydrocarbon bases hydrophilic.
Such hydrophilic mixtures are known as “absorption bases”.
The absorption bases are of two types:
1. The anhydrous form, hydrophilic petrolatum is an example.
2. The emulsion form, cold cream is an example (W/O).
Water-removable bases:
They are oil-in-water emulsions (O/W).
The vanishing cream bases fall into this category.
Removal of these bases from skin is facilitated by the oil-in-water emulsifiers they
contain.
Water-soluble bases:
These vehicles are prepared from mixtures of high and low-molecular-weight
polyethylene glycols (PEG).
They are water-soluble because of the presence of many polar groups and ether
linkages.
Pharmaceutical creams:
Pharmaceutical creams (W/O or O/W) may
contain one or more medicaments incorporated in
one or both of the phases.
Finely powdered insoluble medicament may also
be dispensed in a cream base.
Minimizing microbial contamination:
• The possibility of microbial contamination of creams during preparation must be
minimized since they provide suitable substrates for the growth of micro-
organisms which may cause spoilage.
• The preservative systems used are usually a compromise between clinical
acceptability, formulation stability and efficacy and might be inadequate to cope
with heavy microbial contamination.
• Creams should be prepared under conditions of strict hygiene or better still using
aseptic techniques.
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• As a minimum, all the apparatus used in the preparation and the final
container (pot or jar) should be thoroughly cleaned before use and
rinsed with freshly boiled and cooled purified water before drying.
• Swabbing working surfaces, spatulas and other equipment with 70%
ethanol will reduce the possibility of microbial contamination.
• The aqueous component should always be prepared with freshly
boiled and cooled purified water.
General compounding procedure for creams:
• Preparation of creams usually involves separating the formula components into
two portions: lipid and aqueous.
• The lipid portion contains all water-insoluble components, and the aqueous
portion contains all the water-soluble components.
• Both phases are heated to a temperature above the melting point of the highest
melting component.
• The phases are then mixed, and the mixture is stirred until reaching ambient
temperature or the mixture has congealed.
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• Mixing generally is continued during the cooling process to promote
uniformity.
• Traditionally, the aqueous phase is added to the lipid phase, but
comparable results have been obtained with the reverse procedure.
• Creams usually require the addition of a preservative(s) unless they
are compounded immediately prior to use and intended to be
consumed in a relatively short period of time.
Shelf-life of creams:
Extemporaneously prepared creams should be
given short shelf-life unless freedom from micro-
organisms can be assured.
What is cold cream?
Cold cream is an emulsion in which the proportion of fatty and oily material
predominates.
When it is applied to the skin a cooling effect is produced due to the slow
evaporation of the water contained in the W/O emulsion.
Generally cold cream contains mineral oil (liquid paraffin),
beeswax, borax and water.
What are the uses of cold cream?
1. Medicated cold cream is mainly used as a topical pharmaceutical dosage form for
the treatment of skin.
2. Helps to maintain the skin’s moisture balance and avoid rough skin conditions.
3. As cleansing preparation to remove make-up.
What is vanishing cream?
https://www.youtube.com/watch?v=Bn785oOIDI4
Stearate skin creams were more commonly called vanishing creams because they
seemed to disappear when spread on the skin.
The name may have been coined by the Pond’s Extract Company, who began
making a stearate cream called Pond’s Vanishing Cream.
What are the uses of vanishing cream?
1. Vanishing creams were advertised as beauty creams and skin protectants. They
reduce loss of moisture from dry skin and keep the skin soft.
2. For many women, the most important function was to act as a base for face
powder.
Early loose powders did not adhere well, but this was improved if the skin was
coated with a surface cream. A cold cream could have been used but it had a greasy
feel so was unsuitable for most women unless their skin was very low in oil.
Vanishing creams had a non-oily feel so were generally considered to be a better
solution.
 Formulation and
preparation of cold Dispense 25 g of cold cream!

cream:

Name of raw material Quantity (%) Function

Cetyl ester wax (spermaceti) 4.0 % Stiffening agent and emollient
Bees wax 15.0 % Stiffening agent
Liquid paraffin ( = 0.85 g/ml) 55.0 % Emollient, solvent and vehicle of an oil phase
Sodium borate (borax) 0.9 % Emulsifying agent
Sodium benzoate 0.1 % Preservative
Purified water q.s. (ad. or up to) 100.0 % Solvent and vehicle of an aqueous phase
Method of preparation:
1. Weigh the solid ingredients.
2. If necessary, reduce the cetyl ester wax and the white wax to small pieces.
3. Melt the cetyl ester wax and the bees wax in a beaker (or crucible) using a water bath.
4. Add the liquid paraffin and continue heating the mixture until it reaches 70 oC.
5. Dissolve sodium borate and sodium benzoate in purified water, which has been
warmed in a second beaker, to 70 oC.
6. Add the warm aqueous mixture gradually to the melted oleaginous mixture.
7. Remove the resulting mixture from the heat, stir rapidly and continuously until the
mixture has congealed.
8. Package and label.
Labeling notes:

•The color of print is red.

•The most important auxiliary label is "for external use".
•Storage condition is "store in cool place".
Formulation and preparation of vanishing
cream:
•Chemically vanishing creams are O/W emulsions consisting of stearic acid, an
alkali, a polyol and water.
•The alkali reacts with some of the stearic acid to form a soap which then functions
as the emulsifier.
•The polyol (e.g. glycerin) helped to soften and protect the skin. Glycerin also acted
as a humectant which helped prevent the vanishing cream from drying out while it
sat on the shelf.
•The selection of the alkali also affected the consistency of the cream. Sodium
hydroxide produced harder creams while potassium hydroxide produced softer
creams with a good consistency and sheen.
 Dispense 20 g of vanishing cream!

Name of raw material Quantity (% Function

by weight)
Bees wax 1.0 % Stiffening agent
Cetyl alcohol 15.0 % Emulsifying agent, thickener, emollient
Benzoic acid 0.1% Preservative
Propylene glycol 10.0 % Humectant, softens and protects the skin
Sodium lauryl sulfate 2.0 % Surfactant
Purified water q.s. (ad.) 100.0% Solvent and vehicle for aqueous phase
Method of preparation:
1. Weigh the solid ingredients.
2. Melt the bees wax and cetyl alcohol in a beaker (or crucible) using a water bath (70
o
C).
3. Dissolve benzoic acid and sodium lauryl sulfate in purified water, which has been
warmed in a second beaker, to 70 oC, then add propylene glycol to the aqueous phase.
4. Add the warm aqueous mixture gradually to the melted oleaginous mixture with
steady agitation and continue stirring until emulsification has taken place.
5. Remove the resulting mixture from the heat, stir rapidly and continuously until the
mixture has congealed.
6. Package and label.
Labeling notes:

•The color of print is red.

•The most important auxiliary label is "for external use".
•Storage condition is "store in cool place" and "dry place".
Thank You