Creams, Ointments, pastes and gels

Rise Desnita, M.Si., Apt.

CREAMS
Overview
Upon completion of this chapter, you should be able
to:
 prepare a cream from first principles

 select an appropriate container in which to package

a cream
 prepare an appropriate label for a cream.
definition
 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. A cream is always miscible
with its continuous phase.
 They are intended to be applied to the skin or certain
mucous membranes for protective, therapeutic or
prophylactic
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
2. 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.
3. Melt the fatty bases in an evaporating dish over a
water bath at the lowest possible temperature
4. Substances that are soluble/miscible with the oily
phase should then be stirred into the melt.
5. The temperature of the aqueous phase should then
be adjusted to 60°C.
6. The disperse phase should then be added to the
continuous phase at the same temperature
7. Stir the resulting emulsion vigorously
example
The preparation of Salicylic Acid and Sulphur Cream
BP
1. Use of the product
Used to treat acne (Martindale 33rd edn, pp 1122
and 1124).
2. Is it safe and suitable for the intended purpose?
This is an offi cial preparation, therefore the
formula is safe and suitable for purpose Creams
3. Calculation of formula for preparation
Prepare 20 g of Salicylic Acid and Sulphur Cream
BP.
4. Method of preparation
 The following method would be used to prepare 30
g of Salicylic Acid and Sulphur Cream BP from the
formula above:
1. Weigh 600 mg Salicylic Acid BP on electronic
balance.
2. Transfer to a glass mortar and grind with a pestle.
3. Weigh 600 mg Precipitated Sulphur BP on
electronic balance.
4. Add to the Salicylic Acid BP in the glass mortar and
continue mixing with a pestle until a smooth well-mixed
powder is formed.
5. Transfer the powder to a glass tile.
6. Weigh 28.8 g Aqueous Cream BP on electronic balance.
7. Transfer the Aqueous Cream BP to the glass tile and
triturate with the powders to produce a smooth product.
8. Weigh 20 g of the product and pack into a collapsible
tube or amber glass jar. Label and dispense.
5. Choice of container
A collapsible tube or plain amber jar would be
most suitable
6. Labelling considerations
7. Advice to patient
The patient would be advised to apply the cream as directed.
In addition, the discard date and the fact that the product is for
external use only would be highlighted to the patient. If further
direction for use is requested, the patient could be advised to
apply the cream once or twice a day. Sulphur BP is usually
applied once or twice a day and, although the concentration of
Salicylic Acid BP is quite low when compared to preparations
used in the treatment of warts and hard skin, it will act as a
keratolytic and so a maximum application frequency of once or
twice a day would be appropriate.
OINTMENTS, PASTES
AND GELS
Overview
Upon completion of this chapter, you should be able
to:
 understand the difference between ointments,

pastes and gels

 prepare an ointment from first principles

 select an appropriate container in which to package

ointments, pastes and gels

 prepare an appropriate label for ointments, pastes

and gels.
Ointments
Ointments are preparations for
external application but differ
from creams in that they have
greasy bases. The base is usually
anhydrous and therefore most
ointments are immiscible with
skin secretions. Ointments usually
contain a medicament or a
mixture of medicaments dissolved
or dispersed in the base.
Pastes
 Pastes are semi-solid preparations for external use.
Pastes contain a high proportion of powdered
ingredients and therefore are normally very stiff
 pastes are so thick they can form an unbroken layer
over the skin which is opaque and can act as a sun
filter. This makes them suitable for use for skiers as
they prevent excessive dehydration of the skin
(wind burn) in addition to sun blocking.
Gels

Pharmaceutical gels are often simple phase,

transparent semi-solid systems that are being
increasingly used as pharmaceutical topical
formulations. The liquid phase of the gel may be
retained within a three-dimensional polymer matrix.
Drugs can be suspended in the matrix or dissolved in
the liquid phase.
 Darsar salep

a. Ds. Senyawa hidrokarbon : vaselin putih, vaselin kuning

(vaselin flavum), malam putih (cera album), malam kuning
(cera flavum) atau campurannya
b. Ds. Serap : lemak bulu domba (adeps lanae), campuran 3
bagian kolesterol, 3 bagian stearil alkohol, 8 bagian malam
putih dan 86 bagian vaselin putih, campuran 30 bagian
malam kuning dan 70 bagian minyak wijen.
c. Ds. yang dapat dicuci dengan air atau ds. Emulsi, misalnya
emulsi minyak dalam air (M/A)
d. Ds. yang dapat larut dalam air, misalnya PEG atau
campurannya
1. Dasar salep berlemak/hydrokarbon

Tidak suka
Tidak berair
air

Tidak bisa
Tidak larut
dicuci
dalam air
dengan air
2. Dasar salep serap

Tidak bisa
larutdicuci
dalam
Suka air
air
dengan air
 3. Dasar salep emulsi

Berair

Suka air

Tidak larut dalam air

Mudah dicuci dengan air

Merupakan emulsi o/w

4. Dasar salep larut dalam air

Tidak berair Suka air

Dapat dicuci Dapat larut

dengan air dalam air
Example
The preparation of Zinc Ointment BP
1. Use of the product
For nappy and urinary rash and eczematous condition
(British National Formulary 51st edn, p 571).
2. Is it safe and suitable for the intended purpose?
This is an official preparation, therefore the formula is safe and
suitable for purpose. External products which do not
contain potent ingredients are normally applied liberally when
required. Therefore, an application frequency of four times a
day would be suitable for the treatment of nappy rash.
3. Calculation of formula for preparation
Prepare 20 g of Zinc Ointment BP.
4. Method of preparation
The following method would be used to prepare 30 g
of Zinc Ointment BP from the formula above:
1. Weigh 4.5 g Zinc Oxide BP on electronic balance.
2. Transfer to a porcelain mortar and stir with a
pestle.
3. Transfer the Zinc Oxide BP to a glass tile.
4. Weigh 25.5 g Simple Ointment BP on electronic
balance.
5. Transfer the Simple Ointment BP to the glass tile.
6. Triturate the Zinc Oxide BP with the Simple
Ointment BP until a smooth product is formed.
7. Weigh 20 g of the product and pack into a
collapsible tube or amber glass jar. Label and
dispense
5. Choice of container
A collapsible tube or plain amber jar would be
most suitable
6. Labelling considerations
7. Advice to patient
The parent/guardian would be advised to apply the
ointment to the affected areas four times a day. In
addition, the discard date and the fact that the product
is for external use only would be highlighted to the
parent/guardian.
The preparation of Compound Zinc Paste BP
1. Use of the product
Mild astringent (Martindale 33rd edn, p 1128).
2. Is it safe and suitable for the intended purpose?
This is an offi cial preparation, therefore the formula
is safe and suitable for purpose.
3. Calculation of formula for preparation
Prepare 20 g Compound Zinc Paste BP.
4. Method of preparation
 The following method would be used to prepare 30
g of Compound Zinc Paste BP from the formula
above: Noting the melting point of the base:
White/Yellow Soft Paraffi n BP 38–56°C (British
Pharmacopoeia 1988, p 416)
1. Weigh 7.5 g Zinc Oxide BP on electronic balance.
2. Weigh 7.5 g Starch BP on electronic balance.
3. Weigh 15 g White Soft Paraffi n BP on electronic
balance.
4. Transfer the Zinc Oxide BP to a porcelain mortar.
5. Add the Starch BP to the mortar and triturate with
the pestle to form an evenly mixed powder.
6. Transfer the powder to a glass tile.
7. Transfer the White Soft Paraffi n BP to the glass
tile.
8. Mix the powders with the White Soft Paraffin BP
using a metal spatula and remembering the
principle of ‘doubling up’when mixing
9. Triturate until a smooth product is formed.
10.Weigh 20 g and pack into a collapsible tube or
amber glass jar. Label and dispense.
5. Choice of container
A collapsible tube or plain amber jar would be most
suitable.
6. Labelling considerations
7. Advice to patient
The patient would be advised to apply the ointment to
the affected areas three times a day. In addition, the
discard date and the fact that the product is for
external use only would be highlighted to the patient.
latihan
1. You are asked to prepare 15 g of an ointment containing 25% Salicylic Acid
BP in White Soft Paraffin BP. What quantity of powder is required (the 15 g
includes an overage)?
a. 2.5 g
b. 2.75 g
c. 3.75 g
d. 5.75 g

2. How much White Soft Paraffi n BP would be used when making the ointment
outlined in question 1?
a. 9.35 g
b. 11.25 g
c. 12.25 g
d. 12.5 g
3. You are asked to prepare 50 g of an ointment containing 0.75% Salicylic Acid
BP in White Soft Paraffi n BP. What quantity of powder is required (the 50 g
includes an overage)?
a. 75 mg
b. 375 mg
c. 3.75 g
d. 7.5 g

4. You are presented with the following prescription: Hydrocortisone BP 2.5 g White
Soft Paraffi n BP ad 50 g. What is the percentage w/w of Hydrocortisone BP?
a. 1%
b. 2.5%
c. 4.75%
d. 5%