PRACTICAL 11 MODEL ANSWER

Aim: To determine the incompatibility effects of APIs on creams containing cationic, anionic
and non-ionic emulsifiers.

Formula
Emulsifying Wax

Ingredient Original Working

Sodium lauryl sulphate 10 9.6g
Cetostearyl alcohol 90 86.5g
Water 4 3.8g

The cetostearyl alcohol was melted over a hot water bath in an evaporating dish. The
Sodium lauryl sulphate was mixed with hot water and added to the evaporating dish. The
mixture was removed from the hot water bath and allowed to cool with stirring.
The resulting product was a white wax similar to candle wax.

Cetomacrogol Emulsifying Wax BP

Cetostearyl alcohol 80% 8g

Cetomacrogol 20% 2g

The cetostearyl alcohol was weighed out and melted over a hot water bath in an evaporating
dish. The cetomacrogol was then added to the evaporating dish and the mixture stirred until
the mixture was all liquid. The evaporating dish was then removed from the water bath and
allowed to cool, with stirring until the wax had set.

Cetrimide Emulsifying Wax

Cetostearyl alcohol 90% 9g

Cetrimide 10% 1g

The cetostearyl alcohol was weighed out and melted over a hot water bath in an evaporating
dish. The cetrimide was then added to the evaporating dish and the mixture stirred until the
mixture was all liquid. The evaporating dish was then removed from the water bath and
allowed to cool, with stirring until the wax had set.
Aqueous Cream

API %m/m
Salicylic acid 5% 1.5g
Cetrimide 1% 0.3g

Emulsifying Wax 7% m/m

Emulsifying Wax BP 2.1g
Cetomacrogol Emulsifying Wax 2.1g
Cetrimide Emulsifying Wax 2.1g

White soft paraffin 10% m/m 3g

Liquid paraffin 35% m/m 10.5g/12.7ml

Preservative x% m/m
Chlorocresol 0.1% 0.03g
Phenoxyethanol 0.1% 0.03g
Parabens 0.1% 0.03g

Water ad 30g 30g

1. 2.1g of emulsifying wax was weighed out and melted over a hot water bath in an
evaporating dish.
2. 3g of white soft paraffin was weighed out and added to the evaporating dish for
melting.
3. Liquid paraffin was added to the mixture above.
4. Aliquots of the preservative were prepared by weighing 0.3g of preservative powder
and dissolving it in 10ml of warm water. Each 1ml aliquot contained 0.03g.
5. The preservative aliquot was added to the evaporating dish.
6. The remaining amount of warm water was added to the evaporating dish and the
mixture stirred.
7. The API was added to the mixture in the evaporating dish in small amounts with
continual stirring of the mixture.
8. The evaporating dish was removed from the water bath and the mixture stirred till it
had cooled down and the cream had set.
9. The creams were transferred into appropriately labelled jars.

Results

Cream Preservative
Chlorocresol Phenoxyethanol Parabens
1 White, smooth and White, very viscous, White, smooth and
viscous. Easily smooth and oily to the viscous. Easily
spreadable touch. Easily spreadable
spreadable
2 White, smooth and White, very viscous, White, not very smooth
viscous. Easily smooth and easily and slightly viscous. Not
spreadable spreadable easily spreadable
 3 White, viscous, smooth White, very viscous, White, not very smooth
to the touch but also smooth texture and oily. and slightly viscous. Not
oily and sticky. Easily Easily spreadable easily spreadable
spreadable
4 White, viscous, smooth White, very viscous and White, not very smooth
and oily to the touch. smooth feel and texture and slightly viscous. Not
Easily spreadable Easily spreadable easily spreadable
5 White, viscous, oily but White, very viscous, White, smooth and
also gritty to the touch. and oily to the touch. viscous. Easily
Easily spreadable Not easily spreadable spreadable
6 White, viscous, oily but White, highly viscous White, smooth and
gritty to the touch. Not and very smooth. slightly viscous. Easily
easily spreadable Spreadable on the skin. spreadable
7 White, viscous, smooth White, slightly viscous, White, smooth and
to the touch. Easily but not smooth to the viscous. Easily
spreadable touch. Easily spreadable
spreadable
8 White, viscous, lumpy White, smooth, oily and White, smooth to the
and not easily easily spreadable touch and viscous.
spreadable Easily spreadable
9 White, not very viscous, White, slightly viscous, White, smooth to the
smooth and oily to the gritty to the touch and. touch and viscous.
touch. Easily easily spreadable Easily spreadable
spreadable

One Week later

Cream Preservative
Chlorocresol Phenoxyethanol Parabens
1 Still white, smooth and White, very viscous, White, smooth and
viscous. Easily smooth cool and oily to viscous. Spreadable on
spreadable. No the touch. Easily the skin. No cracking
cracking spreadable. No
cracking
2 White, smooth and White, very viscous, White, not very smooth
viscous. Easily smooth and easily and slightly viscous.
spreadable. No spreadable. Fluid Easily spreadable. No
cracking looking. cracking but creaming
visible.
3 White, viscous, smooth White, very viscous, White, smooth and
to the touch but also smooth texture and oily. viscous. Easily
oily and sticky. Easily 2 separate (fluid and spreadable. No
spreadable. No solid) layers visible. cracking
cracking
4 White, viscous, smooth White, very viscous and White, not very smooth
and oily to the touch. smooth feel and texture and viscous.
Easily spreadable. No Easily spreadable. No Spreadable with some
cracking but slight cracking vigorous rubbing on the
creaming skin. No cracking
5 White, viscous, oily but White, viscous, smooth White, smooth and
also gritty to the touch. and oily to the touch. viscous. Spreadable
Easily spreadable. No Not easily spreadable. with vigorous rubbing
cracking No cracking on the skin. No cracking
 6 White, viscous, oily but White, highly viscous White, smooth oily and
gritty to the touch. Not and very smooth. viscous. Requires
easily spreadable. No Spreadable on the skin vigorous rubbing in on
cracking with vigorous rubbing. the skin. No cracking
No cracking
7 White, viscous, smooth White, slightly viscous, White, smooth oily and
to the touch. Easily smooth to the touch. viscous. Easily
spreadable. No Easily spreadable. No spreadable. No
cracking cracking cracking
8 White, viscous, lumpy White, smooth, oily and White, smooth and oily
and not easily viscous. Easily to the touch and
spreadable. No spreadable. No viscous. Requires
cracking cracking vigorous rubbing in on
the skin. No cracking
9 White, not very viscous, White, very viscous and White, smooth to the
smooth and oily to the oily, smooth to the touch and viscous.
touch. Easily touch. Easily Easily spreadable. No
spreadable. No spreadable leaving a cracking
cracking transparent layer on the
skin. No cracking

Discussion
Cream 3 with phenoxyethanol as a preservative showed signs of instability after one week.
The cream had cracked and separated into two distinct layers. The cracking could have
been due to the charge interactions between the different excipients which may not have
been compatible with the API. Generally the creams were of good quality as they were
smooth to the touch and spreadable.