Session 9: Compounding of Creams
CcoHAS – DODOMA
Metal
Learning Tasks
By the end of this session students are expected to be
able to:
Define creams
Describe procedures for preparing creams
Prepare creams
Label prepared cream
Dispense prepared cream into suitable containers and
closure
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Creams are semi-solid emulsions intended for application
to the skin or mucous membrane, they are viscous
semisolid emulsion system with opaque appearance
Usually they are of two types, namely:
A. Aqueous creams, i.e. oil-in-water emulsions (O/W).
This creams contain oil-in-water emulsifying agent
B. Oily creams, i.e. water-in-oil emulsions (W/O).
This cream contain water-in-oil emulsifying agent.
Aqueous creams are relatively non-greasy and are most
useful as water-washable bases whereas oily creams are
emollient and cleansing.
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Patients often prefer a w/o cream to an ointment
because the cream spreads more readily, is less greasy
and the evaporating water soothes the inflamed tissue
O/w creams (‘vanishing’ creams) rub into the skin;
the continuous phase evaporates and increases the
concentration of a water-soluble drug in the adhering
film.
Consistency and rheological characters depend on
weather the cream is w/o or o/w.
Creams intended for application to large open
wounds should be sterile
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Procedures for Preparing Creams
i. Emulsified creams are prepared by heating the
components of the oily phase including the
emulgent until molten and then cooling to 60°C.
ii. The components of the aqueous phase are mixed in
a separate vessel and also heated at 60°C.
iii. The aqueous phase is then added to the oily phase at
the same temperature, this is very important and the
thermometer should be used.
iv. The resulting emulsion should be stirred until cool
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v. Rapid cooling may result in separation of high melting point
components and excessive aeration caused by vigorous stirring
may also lead to a granular product.
vi. If necessary the product may be homogenized after cooling.
vii. Dilution of creams
Should be done under hygienic conditions
Stability and bacteriocidal properties of original cream should
NOT be reduced on dilution
The diluent should be compatible with ingredients and the whole
original preparation
Dilution may alter extent of release of medicament from creams
Information on suitability of diluent should be available,
otherwise DO NOT DILUTE
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viii. Preservation & hygiene during preparation
Creams can support growth of micro-organisms,
hence most need preservatives
Accidental contamination will almost certainly occur
during bench scale manufacture, but good technique
can keep this to a minimum
All apparatus and final containers should be
thoroughly cleansed before use and purified water
should be used in the preparation of products
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Preparing of Creams
Official formula given for aqueous calamine cream
PCx
Calamine……………………………… 4.0g
Zinc oxide……………………………… 3.0.0g
Emulsifying wax…………………… 6.0g
Arachis oil (0.86g/mL)………… 30.0g
Purified water, freshly boiled and
cooled ............................. 57.0g
Mitte: 50.0g for Amos Juma
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Thus,
o Amount of official formula = 100g
o Total amount required = 50g
o Amount of each ingredient (x) =?
FACTOR= Required amount
Official amount
= 50gm
100gm
= 0.5
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Method of preparation
Melt oily phase (heat up to 75oC, and cool to 60oC)
Prepare aqueous phase and heat to 60oC
Add aqueous phase to oily phase with slow but constant
agitation until cold
Incorporate insoluble medicinal ingredient
Then transferred to suitable container, label and ready
for dispensing to a patient.
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Labeling of Prepared Creams
i. The preparation should be labelled “For External Use Only”
in red ink and bear the instructions that it should be stored in
a cool place.
ii. The strength of active ingredients must be stated as
percentage by weight or by volume.
iii. For diluted creams, the label should state that the product
should not be used after two weeks from the date it was
dispensed unless otherwise stated.
iv. The date of dispensing (preparation date)
v. Instruction for use.
vi. The expiry date, where applicable and/ or manufacturing date
vii. Storage condition
viii. The name of the dispenser (initial)
ix. The name and address of the dispensing institution.
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Dispensing of Prepared Creams into Suitable
Containers and Closure.
Creams should be dispensed in well-closed containers to
prevent evaporation of the aqueous phase.
Wide-mouthed squat jars may be used for creams where
the risk of contamination may be minimal but the mouth of
the jar should be covered with a disc of greaseproof paper.
Collapsible metal or flexible plastic tubes are to be
preferred since these reduce the risk of contamination
during use, most creams are packed in tubes.
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Key Points
Creams are semi-solid emulsions intended for application
to the skin or mucous membrane, they are viscous
semisolid emulsion system with opaque appearance
Usually they are of two types, namely: aqueous creams,
i.e. oil-in-water emulsions this creams contain oil-in-
water emulsifying agent and oily creams, i.e. water-in-oil
emulsions, this creams contain water-in-oil emulsifying
agent.
Suitable containers and closure for creams are: Flexible
plastic tubes or collapsible metal tubes and wide-mouth
glass or plastic jars with plastic screw caps with
impermeable liners or close fitting slip-on lids
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