DISPENSING PHARMACY

Lecture 09-- Creams

Dr. Aneela Amin
Pharm. D., M. Phil.
Lecturer
Shifa Tameer-e-Millat University, Islamabad

Ref: Pharmaceutical compounding and dispensing By Chris Langley,

Dawn Belcher
Learning objectives
General Definitions
Terminologies Used
Methods for incorporating solids and liquids in base
General Principle of formulating a cream
Packaging
Discard Dates
Labelling
Work examples
 Creams
British Pharmacopoeia (BP) definition
Creams are formulated to provide preparations that are
essentially miscible with the skin secretion. They are
intended to be applied to the skin or certain mucous
membranes for protective, therapeutic or prophylactic
purposes, especially where an occlusive effect is not
necessary.
 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’ depending
on the emulsifying agent used.
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.

 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.

 General principles of cream preparation
As with other types of emulsion, hygiene is extremely
important and all surfaces, spatulas and other equipment
must be thoroughly cleaned with industrial methylated
spirits (IMS).
Always make an excess as it is never possible to transfer
the entire cream into the final container.
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.
 General principles of cream preparation
Melt the fatty bases in an evaporating dish over a water
bath at the lowest possible temperature . Start with the
base having the highest melting point. These should then
be cooled to 60C (overheating can denature the
emulsifying agent)
Substances that are soluble/miscible with the oily
phase should then be stirred into the melt.
The temperature of the aqueous phase should then be
adjusted to 60C
 General principles of cream preparation
The disperse phase should then be added to the
continuous phase at the same temperature. Hence :
– for an oil-in-water (o/w) product , add oil to water
– for a water-in-oil (w/o) product add , water to oil.

Stir the resulting emulsion without incorporating air,

until the product sets. Do not hasten cooling as this
produces a poor product.
Example:
 Terminology used in the preparation of
creams, ointments, pastes and gels
Two common terms used in the extemporaneous
preparation of creams are trituration and levigation.
A. Trituration
This is the term applied to the incorporation, of finely
divided insoluble powders or liquids , in to the base.
The powders are placed on the tile and the base is
incorporated using the ‘doubling-up’ technique.
Liquids are usually incorporated by placing a small amount
of base on a tile and making a ‘well’ in the centre. Small
quantities of liquid are then added and mixed in.
 Terminology used in the preparation of
creams, ointments, pastes and gels
A. Trituration (Contd…)
It is important to take care not to form air pockets that
contain liquid, which if squeezed when using an
inappropriate mixing action, will spray fluid on the
compounder and surrounding area.
Trituration can be successfully achieved using a mortar but
this method is usually reserved for large quantities.
 Terminology used in the preparation of
creams, ointments, pastes and gels
B. Levigation
This is the term applied to the incorporation of insoluble
coarse powders in to the base .
 It is often termed ‘wet grinding’.
It is the process where the powder is rubbed down, with
either the molten base or a semisolid base. A considerable
shearing force is applied to avoid a gritty product.
Methods for incorporating solids and
liquids into cream and ointment bases
 Incorporation of ingredients into a cream
base
In addition to the preparation of a cream from first
principles, it is common to incorporate either liquid or
solid ingredients , into a cream base.
a. Incorporation of solids into a cream base
If the cream base has been prepared from first principles,
the solid can be incorporated into the cream as it cools.
Soluble solids: should be added to the molten cream at
the lowest possible temperature and the mixture is stirred
until cold.
 Incorporation of ingredients into a cream base (Solids)
Insoluble solids: should be incorporated using an ointment
tile and spatula. If there is more than one powder to be added
these should be triturated together in a mortar using the
‘doubling-up’ technique prior to transfer to an ointment tile
Coarse powders: a minimum quantity of cream should be
placed in the centre of the tile and used to levigate the powders.
A considerable shearing force should be applied to avoid a gritty
product.
Fine powders may be triturated into the finished cream on an
ointment tile. Small amounts of powder should be added to an
equal amount of cream (i.e. using the ‘doubling up’ technique).
These should be well triturated.
 Incorporation of ingredients into a cream base
b) Incorporation of Liquids into a cream base.
Non-volatile, miscible liquids may be mixed with the
molten cream in the evaporating basin.
Volatile or immiscible liquids(e.g. coal tar solutions)
should be triturated with the cream on the ointment tile.
A very small amount of the cream should be placed on the
tile and a ‘well’ made in the centre.
 Traditionally, small quantities of liquid should be gently
folded in to avoid splashing.
 Incorporation of ingredients into a cream base(liquids)

Then add small quantities of the liquid and fold into the
base gently.

 If using coal tar or other volatile ingredients, these should

not be weighed until immediately before use and the
beaker in which it has been weighed should be covered
with a watch glass to prevent evaporation.
 Example:

Product formula (i.e. the diluent to use) must be decided by the

compounder. Refer to a diluent directory,
 Sources of information
NPA (national pharmacists association)Diluent
Directory (UK)
Product data sheet (Summary of Product
Characteristics – SPC)
Reports in the pharmaceutical literature
Personal contact with product manufacturer.
 Packaging
As all pharmaceutical creams are intended for external
use, a suitable container would be either an amber wide-
necked ointment jar or a metal collapsible tube.
Pharmaceutical ointment jars come in a variety of
different sizes and it is important to choose a suitably
sized container to match the volume of preparation to be
dispensed. This is best done by eye.
Obviously it is important not to use a size of container
that is too large for the volume of preparation to be
dispensed, for both cost and appearance reasons.
 Packaging
Do not be fooled by the size marked on the bottom of the jar:
the value refers to the weight of water that the container will
hold. As ointments are less dense than water, 100 g of
ointment will not fit in a 100 g ointment jar.
Amber glass jars are preferable to clear glass jars as they
protect the preparation from degradation by light.
More recently, plastic ointment jars have become available
and, although cheaper than glass jars, are less preferable
because of an increased likelihood of the products reacting
with the container .
When packaging a cream into an ointment jar , ensure that
the cream is packed well and that no air pockets are visible.
This will produce a product with a professional appearance.
Discard Dates
The creams are given a four-week discard date.
This is significantly shorter than the suggested discard
date for extemporaneously prepared ointments (which
is three months)because of the susceptibility of
creams to microbial contamination
Diluted creams would normally be given a two-week
discard date.
 Labelling
In addition to the standard requirements for the labelling
of extemporaneous preparations, the following points
need to be taken into consideration:
‘For external use only’ – This warning must be added to
the label of all extemporaneously prepared creams as all
creams are for external use only.
All directions on labels should use active rather than
passive verbs,
for example ‘Take two’(not ‘Two to be taken’), ‘Use one’
(not ‘One to be used’), ‘Insert one’ (not ‘One to be
inserted’), etc.
How many grams of Betnovate Cream are contained
in 200 g of a 1 in 20
dilution of Betnovate Cream in Aqueous Cream BP?

How many grams of Eumovate Cream are contained

in 200 g of a 1 in 4
dilution of Eumovate Cream in Aqueous Cream BP?

How many grams of Betnovate Cream are contained

in 300 g of a 1 in 5 dilution
of Betnovate Cream in Cetomacrogol A Cream BPC?