Extemporaneous Dispensing of Creams

EXTEMPORANEOUS
DISPENSING OF:
CREAMS
By:
R.Ph Dr. SABA INAYAT ALI
LECTURER
DCOP
26.03.2018
LEARNING OBJECTIVES
At the end of this topic, students will be able to:
 Define creams
 Discuss aqueous and oily creams
 Discuss the problems associated with diluting creams
CREAMS
 Creams are viscous semi-solid emulsions
for external use.
 They are usually either o/w emulsions, i.e.
aqueous creams or w/o emulsions i.e. oily
cream.
 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 or
pathogenicity.
 The preservative systems used are
usually a compromise between
clinical acceptability , formulation
stability and efficacy and may be
inadequate to cope with heavy
microbial contamination
 Creams should therefore be
prepared under conditions of strict
hygiene or better still using aseptic
technique
 As a minimum, all
apparatus used in the
preparation and the final
containers should be
thoroughly cleaned before
use and rinsed with freshly
boiled and cooled purified
water before drying
CREAMS
 In pharmacy the term ‘cream’ is reserved for
external preparations
 Creams are viscous semi-solid emulsions for
external use
 Medicaments can be dissolved or suspended in
creams
 A cream may be ‘water-in-oil’ or ‘oil-in-water’
Water-in-oil creams (oily creams) as bases
 These are produced by emulsifying agents of

natural origin, e.g. beeswax, wool alcohols or wool
fat.
 These bases have good emollient properties.
 They are creamy, white or translucent and rather
stiff.
Wool alcohol
(lanolin)
Oil-in-water creams (aqueous creams) as bases
 These are produced by

synthetic waxes, e.g. macrogol
and cetomacrogol.
 They are the best bases to use
for rapid absorption and
penetration of drugs.
 They are thin, white and
smooth in consistency.
The preparation of a cream from first principles
1. As with other types of emulsion, hygiene is extremely important

and all surfaces, spatulas and other equipment must be
thoroughly cleaned with industrial denatured alcohol (IDA).
 IDA is better than freshly boiled and cooled purified water as it
will quickly evaporate, leaving no residue.
2. Always make an excess as it is never possible to transfer the

entire cream into the final container.
3. Determine which of the ingredients are soluble in/miscible

with the aqueous phase and which with the oily phase.
Dissolve the water-soluble ingredients in the aqueous phase.
4. Melt the fatty bases in an evaporating dish over a water bath at
the lowest possible temperature.
 Start with the base with the highest melting point.
 These should then be cooled to 60°C (overheating can denature
the emulsifying agent and the stability of the product can be lost).
5. Substances that are soluble/miscible with the oily phase should

then be stirred into the melt.
6. The temperature of the aqueous phase should then be adjusted to

60°C.
7. The disperse phase should then be added to the
continuous phase at the same temperature.
8. Stir the resulting emulsion vigorously without

incorporating air, until the product sets. Do not
hasten cooling as this produces a poor product.
VIDEO
 https://www.youtube.com/watch?v=FxIoQd8NArE
 https://www.youtube.com/watch?v=-Gf6dj6F3k0
 The exact quantity cannot be prepared for a cream
as losses will be encountered on transfer.
 Therefore, a suitable overage must be produced in

order to dispense the required final amount.
DILUTED CREAMS
 The pharmacist may be asked to
prepare extemporaneous dilutions of
proprietary creams.
 Choice of the appropriate diluent is
crucial since dilution may impair the
preservative system in the cream and
significantly affect the bioavailability
of any active ingredients.
 The risk of microbial contamination is
great and the practice should not be
encouraged unless considered by the
prescriber to be essential.
DILUTED CREAMS
 Diluent may impair the preservative system in the
cream.
 May affect the bioavailability of the medicament.
 Incompatible with other ingredients.
 Increases the risk of microbial contamination.
DILUTED CREAMS
 Dilutions should be
made only if the diluent
to be used is stated in
the manufacturer’s
data sheet.
 Diluted creams must be
freshly prepared
without the application
of heat and with strict
hygiene precautions.
SHELF-LIFE OF CREAMS
 Extemporaneously prepared creams should
generally be given a short shelf-life unless freedom
from micro-organisms can be assured.
 Diluted creams should be freshly prepared and

should not be used for more than 2 weeks
after issue.
CONTAINERS FOR CREAMS
 Wide-mouthed squat jars may be used for creams
where the risk of contamination in use is
considered to be minimal, e.g. oily creams.
 The containers must be well closed and prevent
water evaporation.
 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 in
use and most
proprietary products
are packed in tubes.
SPECIAL LABEL AND ADVICE FOR PATIENTS
STORE IN A COOL PLACE
 But do not allow to freeze
 The labels for collapsible tubes should be fixed to

the upper (nozzle) end of the tube.
 Sterilized products should be labeled:
STERILE UNTIL OPENED

AQUEOUS CREAM BP
 50 g aqueous cream
Ingredients Master formula For 55 g
Emulsifying ointment 300 g 16.5 g
Phenoxyethanol 10 g 0.55 g
Purified water, freshly 690 g 37.95 g

boiled and cooled
ACTION & USES
 Aqueous cream is an emollient and can be used as
a base for drugs.
Method
 The phenoxyethanol is dissolved in water warmed to
60oC
 Weigh the emulsifying ointment and melt it in an
evaporating basin an a water bath or hot plate
 Ensure that both phases are close to 60oC, then mix
both phases
 Remove from the heat and stir continuously until cold,
taking care not to incorporate too much air
 Weigh 50g and pack in an ointment jar or collapsible
tube
SHELF LIFE AND STORAGE
 The preparation should be stored in a cool place,
but not allowed to freeze
 A shelf life of 2-3 weeks is appropriate because the
preparation has not been made in the cleanest
conditions
OILY CREAM BP
 50g oily cream
Ingredients Master formula For 60 g
Wool alcohols ointment 500 g 30 g
Phenoxyethanol 10 g 0.6 g
Dried magnesium 5g 0.3 g

sulphate
Purified water, freshly 485 g 29.1 g

boiled and cooled
Action & uses
 Oily cream is used as an emollient in treating dry
conditions
Method of preparation
 All equipment should be thoroughly cleaned
before use
 Dissolve the magnesium sulphate and
phenoxyethanol in the water and warm to 60oC on
a water bath or hot plate
 Weigh the wool alcohol ointment, using a piece of
paper, and melt it in an evaporating basin at 60oC
 Check that two temperatures are the same
 Add the water, little by little, to the ointment
stirring constantly until a smooth creamy mixture
is produced, while maintaining the temperature at
60oC
 When all the water is added, remove from the
heat and stir gently until the cream is at room
temperature.
 Pack 50g in an ointment jar or collapsible tube
SHELF LIFE AND STORAGE
 Store in a cool place but do not allowed to freeze.
 If liquid separated on storage, stirring may
reincorporate it.
 An expiry date of 4 weeks is appropriate.
EXAMPLES
 CHAPTER # 13 Pharmaceutical practice, Diana M. Collett
 13.5
 13.6
 13.12
 13.13
 13.14
REFERENCE
 CHAPTER # 13 Pharmaceutical practice, Diana M. Collett
 Page # 116-117
 CHAPTER # 33 Pharmaceutical practice, 4th edition, A.J.
Winfield
 Page # 373-374
 Suggested reading:
 http://
www.preservearticles.com/2011122319146/here-is-y
our-short-essay-on-creams.html

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EXTEMPORANEOUS

 These are produced by emulsifying agents of

 These are produced by

1. As with other types of emulsion, hygiene is extremely important

will quickly evaporate, leaving no residue.

2. Always make an excess as it is never possible to transfer the

3. Determine which of the ingredients are soluble in/miscible

 These should then be cooled to 60°C (overheating can denature

5. Substances that are soluble/miscible with the oily phase should

6. The temperature of the aqueous phase should then be adjusted to

8. Stir the resulting emulsion vigorously without

 Therefore, a suitable overage must be produced in

 Diluted creams should be freshly prepared and

STORE IN A COOL PLACE

 But do not allow to freeze

 The labels for collapsible tubes should be fixed to

STERILE UNTIL OPENED

Ingredients Master formula For 55 g

Emulsifying ointment 300 g 16.5 g

Purified water, freshly 690 g 37.95 g

Wool alcohols ointment 500 g 30 g

Dried magnesium 5g 0.3 g

Purified water, freshly 485 g 29.1 g

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