Ointments and creams

Contents
Introduction
Types
Advantages and disadvantages
Ointment bases
Medicinal applications
Preparation
Packaging
Labeling
Example
Difference
1) Ointments

Definition
Ointments are semisolid preparations intended for
external application to the skin or mucous membranes.

Introduction
 Absorption
. Not easily absorbed.

 Consistency
Have thicker consistency.

 Greasiness
More greasy.
  Transparency
Clear.

 Concentration of oil
Have a Higher concentration of oil.

 Spreading ability
Low.

 Stability on skin
Stay longer on surface.

 Healing power
Slow
TYPES OF OINTMENTS

The various types of ointments are:

 Unmedicated ointments
Medicated ointments

UNMEDICATED OINTMENTS
These ointments do not contain any drugs. They are
useful as emollients, protectants . Example: Petroleum
jelly.

MEDICATED OINTMENTS
These ointments contain drugs which show local or
systemic effects.

Sub-types These are of several sub-types:

Dermatologic ointments
Opthalmic ointments
Rectal ointments
Vaginal ointments
Nasal ointments

DERMATOLOGIC OINTMENTS :
These ointments are applied topically on the external
skin. The ointment is applied to the affected area as a
thin layer and spread evenly using gentle pressure with
the fingertips. These are of three types:
(1) Epidermic ointments: The drugs present in these
type of ointments exert their action on the epidermis of
the skin. Example: Ketoconazole ointment.
(2) Endodermic ointments: The drugs present in these
types of ointments exert their action on the deeper
layers of cutaneous tissue. Example: Demodex ointment.
(3) Diadermic ointments: The drugs present in these
types of ointments enter into the deeper layers of skin
and finally in the systemic circulation and exert systemic
effects. Example: Nitroglycerine ointment.

OPTHALMIC OINTMENTS:
These are sterile preparations which are applied inside
the lower eye lid. Only anhydrous bases are used in their
preparation. The ointment is applied as a narrow band of
approximately 0.25 - 0.5 inch. Example: Sulfacetamide
sodium ointment.

RECTAL OINTMENTS:
 These are the ointments to be applied to the peri- anal
or within the anal canal. The bases used are
combinations of PEG 300 and PEG 3350, cetyl alcohol and
cetyl esters, wax, liquid paraffin and white paraffin.
Example: Benzocaine ointment.

VAGINAL OINTMENTS :
These ointments are applied to the vulvo-vaginal area or
inside the vagina. As vagina is more susceptible to
infections, the ointment should be free from micro-
organisms, moulds and yeasts. Example: Candicidin
ointment.

NASAL OINTMENTS :
These are used in the topical treatment of nasal mucosa.
Drugs get absorbed into the general circulation through
the rich blood supply of the nasal lining. Example:
Ipratropium bromide

Medicinal application of the Ointment

 Ointments are used topically for several purposes,
e.g., as protectants, antiseptics, emollients,
antipruritics, kerotolytics, and astringents.
  In the case of a protective ointment, it serves to
protect the skin against moisture, air, sun rays and
other external factors.
 It is necessary that the ointment neither
penetrates the human skin barriers nor facilitates
the absorption of substances through this barrier.
 An antiseptic ointment is used to destroy or inhibit
the growth of bacteria. Frequently bacterial
infections are deeply seated; a base which has the
capacity to either penetrate or dissolve and
release the medication effectively is therefore
desired.
 Ointments used for their emollient effect should
be easy to apply, be non-greasy and effectively
penetrate the skin.

OINTMENT BASES
Ointment bases may be used for their physical effects or
as vehicles for medicated ointments.Ointment bases are
generally classified into four groups: 1. Oleaginous
bases,2. Absorption bases, 3. Water-removable bases,
and 4. Water-soluble bases.
1 .OLEAGINOUS BASES
 Oleaginous bases are also termed hydrocarbon
bases.
 On application to the skin, they have an emollient
effect, protect against the escape of moisture, are
effective as occlusive dressings, can remain on the
skin for long periods without drying out, and
because of their immiscibility with water are
difficult to wash off.
 Water and aqueous preparations may be
incorporated, but only in small amounts and with
some difficulty.
  When powdered substances are to be
incorporated into hydrocarbon bases, liquid
petrolatum (mineral oil) may be used as the
levigating agent.
Examples of hydrocarbon ointment bases.
Petrolatum, white petrolatum, white ointment, and
yellow ointment are examples of hydrocarbon ointment
bases.
 Petrolatum, USP, is a purified mixture of
semisolid hydrocarbons obtained from petroleum.
It is an unctuous mass, varying in color from
yellowish to light amber. It melts at 38°C to 60°C
and may be used alone or in combination with
other agents as an ointment base. Petrolatum is
also known as yellow petrolatum and petroleum
jelly. A commercial product is Vaseline.
 White Petrolatum, USP, is a purified mixture of
semisolid hydrocarbons from petroleum that has
been wholly or nearly decolorized. It is used for
the same purpose as petrolatum, but because of
its lighter color, it is considered more esthetically
pleasing by some pharmacists and patients. White
 petrolatum is also known as white petroleum jelly.
A commercial product is White Vaseline.
Preparation of yellow ointment USP
Yellow Ointment, USP. This ointment has the
following formula for the preparation of 1000 g:
Yellow wax ------ 50 g
Petrolatum ------ 950 g.
 Yellow wax is the purified wax obtained from the
honeycomb of the bee Apis mellifera. The
ointment is prepared by melting the yellow wax on
a water bath, adding the petrolatum until the
mixture is uniform, then cooling and stirring until
congealed. Also called simple ointment, it has a
slightly greater viscosity than plain petrolatum.
 White Ointment, USP. This ointment differs from
yellow ointment by substitution of white wax
(bleached and purified yellow wax) and white
petrolatum in the formula.

2 .ABSORPTION BASES
Absorption bases are of two types:
  those that permit the incorporation of aqueous
solutions resulting in the formation of water-in-oil
(W/O) emulsions.
Example hydrophilic petrolatum and
 those that are W/O emulsions (syn: emulsion
bases) that permit the incorporation of additional
quantities of aqueous solutions.
Example lanolin.
These bases may be used as emollients,although they do
not provide the degree of occlusion afforded by the
oleaginous bases. Absorption bases are not easily
removed from the skin with water washing, because the
external phase of the emulsion is oleaginous. Absorption
bases are useful as pharmaceutical adjuncts to
incorporate small volumes of aqueous solutions into
hydrocarbon bases. This is accomplished by incorporating
the aqueous solution into the absorption base and then
incorporating this mixture into the hydrocarbon base.
Preparation of Hydrophilic Petrolatum, USP
Hydrophilic Petrolatum, USP, has the following formula
for the preparation of 1000 g:
Stearyl alcohol ---- 30 g
White wax ----- 80 g
Cholesterol ---- 30 g
White petrolatum --- 860 g.
It is prepared by melting the stearyl alcohol and
white wax on a steam bath, adding the cholesterol
with stirring until dissolved, adding the white
petrolatum, and allowing the mixture to cool while
stirring until congealed.
A commercial product, Aquaphor, a variation of
hydrophilic petrolatum, has the capacity to absorb
up to three times its weight in water and useful to
help incorporate a water-soluble drug, e.g.,
tobramycin sulfate, into a oleaginous ointment
base.
Lanolin, USP (Anhydrous lanolin) obtained from
the wool of sheep (Ovis aries), is a purified
waxlike substance that has been cleaned,
deodorized, and decolorized. It contains not
more than 0.25% water. Additional water may
be incorporated into lanolin by mixing. Modified
 Lanolin, USP, is lanolin processed to reduce the
contents of free lanolin alcohols and any
detergent and pesticide residues.
3 .WATER-REMOVABLE BASES
Water-removable bases are oil-in-water emulsions
resembling creams. Because the external phase of
the emulsion is aqueous, they are easily washed
from skin and are often called water washable bases.
They may be diluted with water or aqueous
solutions. They can absorb serous discharges.
Example
Hydrophilic Ointment, USP, is an example of this type
of base.
Preparation of Hydrophilic Ointment, USP
Hydrophilic Ointment, USP, has the following
formula for the preparation of about 1000 g:
Stearyl alcohol --- 250 g
White petrolatum --- 250 g
Methylparaben --- 0.25 g
Propylparaben --- 0.15 g
Sodium lauryl sulfate --- 10.0 g
Propylene glycol --- 120 g
Purified water --- 370 g
The stearyl alcohol and white petrolatum are melted
together at about 75°C. The other agents, dissolved
in the purified water, are added with stirring until
the mixture congeals. Sodium lauryl sulfate is the
emulsifying agent, with the stearyl alcohol and white
petrolatum constituting the oleaginous phase of the
emulsion and the other ingredients the aqueous
phase. Methylparaben and propylparaben are
antimicrobial preservatives.
4 .WATER-SOLUBLE BASES
Water-soluble bases do not contain oleaginous
components. They are completely water washable
and often referred to as greaseless. Because they
soften greatly with the addition of water, large
amounts of aqueous solutions are not effectively
incorporated into these bases. They mostly are used
for incorporation of solid substances.
Example
Polyethylene glycol (PEG) ointment, NF, is the
prototype example of a water-soluble
base.Polyethylene Glycol Ointment, NF PEG is a
polymer of ethylene oxide and water represented by
the formula H(OCH2CH2)nOH, in which n represents
 the average number of oxyethylene groups. The
numeric designations associated with PEGs refer to
the average molecular weight of the polymer. PEGs
having average molecular weight below 600 are
clear, colorless liquids; those with molecular weight
above 1,000 are wax like white materials; and those
with molecular weight in between are semisolids.
The greater the molecular weight, the greater the
viscosity. The NF lists the viscosity of PEGs ranging
from average molecular weight of 200 to 8,000.
Preparation of PEG ointment
The general formula for preparation of 1,000 g of
PEG ointment is
PEG 3350 --- 400 g
PEG 400 ---- 600 g
Combining PEG 3350, a solid, with PEG 400, a liquid,
results in a very pliable semisolid ointment. If a firmer
ointment is desired, the formula may be altered to
contain up to equal parts of the two ingredients. When
aqueous
solutions are to be incorporated into the base,
substitution of 50 g of PEG 3350 with an equal amount of
stearyl alcohol is advantageous in rendering the final
product firmer.
Selection of the Appropriate Base Based on:
1. Desired release rate.
2. Desirability for enhancement of per-cutaneous
absorption.
3. Advisability of occlusion.
4. Short-term or long-term stability.
5. Influence of drug on consistency or other features of
ointment base.
6. Patient factor - dry or weeping (oozing) skin. Choice of
the O.B.Choice of the O.B.
Among the properties which an Ideal ointment base
should possess are:
1. Does not retard wound healing.
2. Low sensitization index.
3. Pharmaceutical elegance.
4. A low index of irritation.
5. Non dehydrating.
6. Non greasy.
7. Neutral in reaction.
8. Good keeping qualities. Ideal O.B.Ideal O.B.
 9. Compatible with common medicaments.
10. Efficient release of medicament at site of
application.
11. Washable (easily removed with water).
12. Minimum number of ingredients.
13. Ease of compounding.

PREPARATION OF OINTMENTS
Ointments are prepared by two general
methods,1.Incorporation, and 2.Fusion
methodDepending primarily on the nature of the
ingredients.

1. INCORPORATION
The components are mixed until a uniform preparation is
attained. On a small scale, as in extemporaneous
compounding, the pharmacist may mix the components
using a mortar and pestle, or a spatula may be used to
rub the ingredients together on an ointment slab (a large
glass or porcelain plate or pill tile). Some pharmacists use
nonabsorbent parchment paper to cover the working
surface; being disposable, the paper eliminates cleaning
the ointment slab. If using an ointment parchment pad, it
is best not to allow too long contact of the ointment with
the parchment, as it may soften and tear.

Others will use an ointment mill, an electronic mortar

and pestle, or a device called an “Unguator” which allows
a pharmacist to place the ingredients in a plastic
ointment jar with a special lid that allows for a mixing
blade to be used to mix the ingredients in the dispensing
container. These devices can be controlled manually or
via computer software.Ointment or roller mills can be
used to force coarsely formed ointments through
stainless steel or ceramic rollers to produce ointments
uniform in composition and smooth in texture. Small
ointment mills also find use in product development
laboratories and in small batch manufacture or
compounding.

a. INCORPORATION OF SOLIDS
Solids soluble in a common solvent that will affect
neither the stability of the drug nor the efficacy of the
product may first be dissolved in that solvent (e.g., water
or alcohol) and the solution added to the ointment base
by spatulation or in a mortar and pestle. The ointment
base is placed on one side of the working surface and the
powdered components, previously reduced to fine
powders and thoroughly blended in a mortar. A small
portion of the powder is mixed with a portion of the base
until uniform.Geometric dilution is continued until all
portions of the powder and base are combined and
thoroughly and uniformly blended.It often is desirable to
reduce the particle size of a powder or crystalline
material before incorporation into the ointment base so
the final product will not be gritty. This may be done by
levigating, or mixing the solid material in a vehicle in
which it is insoluble to make a smooth dispersion. The
levigating agent (e.g., mineral oil for bases in which oils
are the external phase, or glycerin for bases in which
water is the external phase) should be physically and
chemically compatible with the drug and base. The
levigating agent should be about equal in volume to the
solid material. A mortar and pestle are used for
levigation. This allows both reduction of particle size and
dispersion of the substance in the vehicle. After
levigation, the dispersion is incorporated into the
ointment base by spatulation or with the mortar and
pestle until the product is uniform.

b. INCORPORATION OF LIQUIDS
Liquid substances or solutions of drugs are added to an
ointment only after due consideration of an ointment
base’s capacity to accept the volume required. For
example only very small amounts of an aqueous solution
may be incorporated into an oleaginous ointment,
whereas hydrophilic ointment bases readily accept
aqueous solutions. When it is necessary to add an
aqueous preparation to a hydrophobic base, the solution
first may be incorporated into a minimum amount of a
hydrophilic base and then that mixture added to the
hydrophobic base. However, all bases, even if
hydrophilic, have their limits to retain liquids, beyond
which they become too soft or semiliquid.

2. FUSION

.
By the fusion method, all or some of the components of
an ointment are combined by being melted together and
cooled with constant stirring until congealed.
Components not melted are added to the congealing
mixture as it is being cooled and stirred Naturally, heat-
labile substances and any volatile components are added
last, when the temperature of the mixture is low enough
not to cause decomposition or volatilization of the
components.
Substances may be added to the congealing mixture as
solutions or as insoluble powders levigated with a
portion of the base. Medicated ointments and ointment
bases containing components such as beeswax, paraffin,
stearyl alcohol, and high-molecular-weight PEGs, which
do not lend themselves well to mixture by incorporation,
are prepared by fusion.
By this general process, the materials with the highest
melting points are heated to the lowest required
temperature to produce a melt. The additional materials
are added with constant stirring during cooling of the
melt until the mixture is congealed. In this way, not all of
the components are subjected to the highest
temperature. Alternative methods entail melting the
component with the lowest melting point first and
adding the remaining components in order of their
melting points OR simply melting all of the components
together under slowly increasing temperature. By these
methods, a lower temperature is usually sufficient to
achieve fusion because of the solvent action exerted by
the first melted components on the others.
In preparation of ointments having an emulsion base, the
method of manufacture often involves both melting and
emulsification. The water-immiscible components such
as the oil and waxes are melted together in a steam bath
to about 70°C to 75°C. Meantime, an aqueous solution of
the heat-stable, water-soluble components is prepared
and heated to the same temperature as the oleaginous
components. Then the aqueous solution is slowly added,
with mechanical stirring, to the melted oleaginous
mixture. The temperature is maintained for 5 to 10
minutes and the mixture is slowly cooled and stirred until
congealed. If the aqueous solution is not at the same
temperature as the oleaginous melt, some of the waxes
will solidify on addition of the colder aqueous solution to
the melted mixture.
On a small scale, fusion may be conducted in a porcelain
dish or glass beaker. On a large scale, it is carried out in
large steam jacketed kettles.Once congealed, the
ointment may be passed through an ointment mill (in
large-scale manufacture) or rubbed with a spatula or in a
mortar to ensure a uniform texture.

PACKAGING, STORAGE, AND LABELING

Ointments and other semisolid preparations are
packaged either in large-mouth ointment jars or in metal
or plastic tubes.
Semisolid preparations must be stored in well-closed
containers to protect against contamination and in a cool
place to protect against product separation in heat.
When required, light-sensitive preparations are packaged
in opaque or light-resistant containers.
LABELING REQUIREMENTS
Do not apply on broken skin.
For otic use only In addition to the usual labeling
requirements, labeling for certain ointments include
the type of base used (e.g., water soluble or water
insoluble).
Example of Ointment
Zinc oxide ointment usp
Prepare 30g methyl salicylate ointment BP
1988
Ingredients Amount Working Formula
Methyl salicylate 500g 15g

White bees wax 250g 7.5g

Hydrous wool fats 250g 7.5g

Formulation
Methyl salicylate is a volatile liquid and should be added
to the base as at low a temperature as possible. Bees
wax helps to stiffen the base which would otherwise be
very soft by the large proportion (50%) of liquid methyl
salicylate.

Compounding
Melt the grated bees wax and Hydrous wool fats in an
evaporating dish on a water bath. Remove from the heat
and cool until about to solidify. Add the methyl salicylate
and stir until cool.

Storage and shelf life

Store in a cool place.

Container
Wide -mouthed Amber color jar with greaseproof paper
disc and well fitting closure. Note that methyl salicylate
reacts with plastics.

Advice for patients

The ointments will be massaged well into the skin. It
should not be applied to broken or inflamed skin and
near the eyes or mucus membranes. The container
should be kept tightly closed.

Action and uses

Relief of pain in rheumatic conditions.

Prepare 50 Emulsifying Ointment BP 1988

And Use to Prepare 50 Of Whitefield's
Ointment:
For emulsifying ointment BP 1988

Ingredients Amount Working Formula

Emulsifying wax 300g 15g

White Soft Paraffin 500g 15g

Liquid paraffin 200g 10g

For Compound Benzoic Acid BP 1988

Whitefield's ointment in compound Benzoic Acid ointment BP 1988;

Ingredients Amount Working formula

Benzoic acid in fine powder 60g 3g

Salicylic acid in fine powder 30g 1.5g

Emulsifying ointment 910g 27.3g

Formulation:
Emulsifying ointment BP 1988 is a water-miscible base prepared by fusing.

Salicylic acid and benzoic are incorporated by trituration.

Compounding:
Place ingredients for the base in an evaporating dish on a water-bath and allow to melt.it is
most convenient to weigh the liquid paraffin directly into the dish and to add the other
ingredients. Stir gently and mix the ingredients. When homogeneous, remove from the heat and
stir until cool. If for stock, the molten base could be poured into a warm pot and allowed to cool
slowly and distributing on a non-conducting surface.

Soft the medicaments through separate 180micro sieves (using stainless steel for the
salicylic acid). note that salicylic acid is very irritant to the respiratory tract and precautions
should be observed to avoid inhalation. Weigh the powders after sifting and place on a large
ointment title. levigate the powder (i.e., mix the powder to produce a smooth paste) with two or
three time their weight of base, gradually incorporating more bases until homogeneous.

Storage and shelf life:

Store in a cool place.

Container:
Wide mouthed amber jars with a greaseproof paper disc.

Advice for patients:

The ointment should be applied sprangly to affected area. It should not be applied to
broken or inflammed skin.

Action and uses:

Topical antifungal preparation.

Prepare 50g Simple Ointment BP 1988 and

Use to prepare 50g Sulphur ointment BP
1980
For simple ointment BP 1988

Ingredients Master formula working formula

Wool fat 50g 2.5g
Hard paraffin 50g 2.5g
Cestostearyl alcohol 50g 2.5g
White soft paraffin 850g 42.5g
Or yellow soft paraffin
For Sulphur ointment BP 1980

Ingredients Master formula working Formula

Precipitated Sulphur, finely 100g 5g
Sifted
Simple ointment prepared with
White soft paraffin 900g 45g

Formulation;
Simple ointment is an absorption base prepared by fusion. Sulphur is an insoluble solid in
incorporated by trituration.

Compound:
Grate the hard paraffin and weigh out the ingredients for the base. Place to melt in an
evaporating dish on a water bath. Stir gently to aid meeting and to mix the ingredient. When
homogenous, remove from the heat and stir until cold. If for stock, the molten base could be
poured into a warm pot and allowed to cool slowly and undistributed on a non-conducting
surface.
Weigh the Sulphur after sifting through (180 micro g sieve) and place on a large ointment
tile. Levigate the powder with two three times its weight of base, gradually incorporating more
base until homogeneous.

Storage and shelf life:

Store in cool place.

Container:
Wide mouthed amber jar with a greaseproof paper disc.

Advice for patients:

 The skin would be cleansed prior to application and the ointment applied sparingly to the
affected area.

Actions and uses:

Mild antiseptic.

Prepare 50g of oily cream (Hydrous ointment

BP 1988)
Ingredients Master formula Working formula

Wool alcohol ointment 500g 25g

Phenoxyethanol 10g 0.5g
Dried magnesium Sulphate 5g 0.25g
Purified water, freshly boiled. 485g 24.25g
And cooled 50g

Formulation:
Wool alcohol ointments contains wool alcohol, liquid paraffin, hard paraffin and yellow or
white soft paraffin. If the oil cream is to be used for the products with pale ingredients then the
ointment made with white paraffin is to be preferred. The wool alcohol act as a W/O emulgent. The
addition of magnesium sulphate enhances the stability and appearance of the product. Phenoxy ethanol
is preservative. It is a liquid at room and is best dissolved by shaking in a hot water.

Compounding:
Melt the wool alcohols ointment and allowed to cool to about 60 degree C . Boil the purified water,
dissolve the phenoxy ethanol and magnesium sulphate and cool to 60 degree C. Gradually add the water
to ointment with constant stirring until a smooth cream is formed. It is important to maintain the
temperature at 60 degree C until the cream has formed to avoid the higher melting point constituents of
the ointment solidifying out.

Storage and shelf life:

The preparation should be stored cool but not allowed to freeze. If on the storage some aqueous liquid
separates it may be re incorporate by stirring.
Ingredients master formula working formula
Wool alcohol 60g 6g
Hard paraffin 240g 24g
White/yellow soft paraffin 100g 10g
Liquid paraffin 600g 60g

Container:
Collapsible metal tube or wide mouthed jar.

Advice for the patients when dispensed:

Not applicable.

Action and uses:

Emollient cream base.

2) Creams
Definition
BP DEFINES:
“Creams are formulated to provide preparation that are
essentially miscible with skin secretion. they are intended
to be applied to the skin or certain mucous membranes
for protective ,therapeutic, or prophylactic purposes
especially when occlusive effect is not necessary.”
IN USPXVIII , CREAMS ARE DEFINED AS;
“Semisolid emulsions of either oil in water or water in oil
type.”
OR
“Semisolid emulsions usually medicated, intended for
external application.”

Introduction
 Pharmaceutical creams are semisolid preparations
containing one or more medicinal agents dissolved
or dispersed in either a W/O emulsion or an O/W
emulsion or in another type of water-washable
base.
 The so-called vanishing creams are oil-in-water
emulsions containing large percentages of water
and stearic acid or other oleaginous components.
After application of the cream, the water
evaporates, leaving behind a thin residue film of
the stearic acid or other oleaginous component.
 Creams find primary application in topical skin
products and in products used rectally and
vaginally.
 Many patients and physicians prefer creams to
ointments because they are easier to spread and
remove.
 Many of the hand and body lotions used to treat
dry skin are o/w emulsions.
 A number of topical emulsions or lotions are used
therapeutically to deliver a drug systemically.
 Corticosteroid-containing emulsions include
Lotrimin AF (clotrimazole, Schering-Plough) and
Diprolene (augmented betamethasone
dipropionate, Schering).
Examples
Aqueous cream: cetrimide cream, cetomacrogol
cream.
Oily cream: oily cream/ hydrous ointment.Cosmetic
creams: All-purpose cream, baby cream, barrier
cream, bleaching cream, cleansing cream cold
cream, hair cream, hand cream, vanishing cream.
Medicated creams: Creams are reserved for external
preparations. A cream may be w/o or o/w
depending on the emulsifying agent used.They are
soft, easy to apply, cooling to skin and easily water
removable.
w/o cream: oily creams
Contains: emulsifying agents of natural origins(bees
wax, wool alcohols, wool fat).
Properties: Emollient.
Creamy, white or translucent and stiff.
o/w creams: aqueous creams
Contains: synthetic waxes e.g., cetomacrogols &
macrogols.
Properties:Causes rapid absorption & penetration.
Thin, white & smooth in consistency.
ADVANTAGES AND DISADVANTAGES
TYPES Of Creams:

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.

OTHER TYPES:
Cosmetic creams:
All purpose cream, baby cream, barrier cream,
bleaching cream, cleansing cream, cold cream, hair
cream, hand cream, vanishing cream.
Cold cream
It is an emulsion of water and certain fats usually
including beeswax and various scent agents,
designed to smooth skin and remove makeup.The
emulsion is of Water in Oil type.The name Cold
Cream is derived from the cool feeling that the
creams leave on the skin.
 Medicated creams: Medicated creams are
contains active pharmaceutical ingredients.
Example
 Cetrimide cream used as antiseptic.

 Zinc oxide cream used as Sunblock.

 Hydrocortisone cream - treat rashes.

PREPARATION PROCESS:
Preparation of oil phase.
Hydration of aqueous phase ingredients.
Forming the emulsion.
Dispersion of active ingredient.
GENERAL METHOD OF PREPARATION:
 1) As with other types of emulsion, hygiene is extremely
important and all surfaces, spatulas and other equipment
must be thoroughly cleaned with IDA.
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 miscible with
the aqueous phase and which with the oily phase.
4) Dissolve the water-soluble ingredients in the aqueous
phase.
5) 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.
6) Substances that are miscible with the oily phase
should then be stirred into the melt.
7) The temperature of the aqueous phase should then
be adjusted to 60°C.
8) The disperse phase should then be added to the
continuous phase at the same temperature.
9) Incorpuration of Solid ingredients to the prepared
emulsion.

THE INCORPORATION OF INGREDIENTS INTO A

CREAM BASE
The incorporation of solids into a cream base:
If the cream base has been prepared from first
principle the solid can be incorporated into the
cream as it cools.
Alternatively, if using a pre-prepared base, soluble
and insoluble solids may be incorporated using the
method employed for insoluble solids.
Soluble solids: should be added to the molten cream
at the lowest possible temperature and the mixture
stirred until cold.
Insoluble solids: should be incorporated using a
glass 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 a glass tile.
Coarse powders. A minimum quantity of cream
should be placed in the centre of the glass tile and
used to levigate the powders.
THE INCORPORATION OF LIQUIDS INTO A
CREAM BASE
Non-volatile, miscible liquids: May be mixed with
the molten cream in the evaporating basin.
Alternatively, if a pre-prepared base is used, then
incorporate as for volatile or immiscible liquids.
Volatile or immiscible liquids Coal tar solutions,
should be triturated with the cream on the glass tile.
IDEAL CHARACTERISTICS OF CREAMS:
It should liquefy at body temperature. It should
penetrate the epidermis (via natural opening). Its
viscosity should be low enough to permit easy spreading.
It should be non-toxic. It should be non-irritant. It should
be non-inflammatory.

PRESERVATION:

CONTAINERS USED FOR CREAMS:

Wide mouthed jars. Collapsible Metal. Flexible Plastic
tubes. Aluminium tubes. Container that are commonly
used are:
FILLING: FILLING IS DONE BY TWO WAYS:
HAND FILLING
MECHANICAL FILLING
HAND FILLING:
WEIGHTED AMOUNT OF CREAM IS PLACED IN A JAR
WITH THE HELP OF FLEXIBLE SPATULA.
CREAM IS FORCED DOWN TO BOTTOM AND ALONG
WALLS OF JAR TO AVOID AIR ENTRAPMENT.
WE CAN ALSO FILL A TUBE BY HANDE.
MECHANICAL FILLING:
IN THIS METHOD CREAMS CAN BE FILLED IN TIN JARS
AND POLYETHYLENE TUBES.
FILLING IS DONE BY PRESSURE FILLER WHICH
CONSIST OF NOZEL AND PISTON FROM WHICH
OOZES OUT ON APPLYINGPRESSURE ON PISTON.
TUBES ARE FILLED FROM BACK SIDE AND THEN ARE
SEALED.
Example of cream
cetrimide

Apparatus
Two beakers ,Glass rod ,Thermometer ,container
Procedure
 Step 1: measured ingredients in a top loading
balance.
 Step 2: heated distilled water in water bath at (60°c
-70°c)
 Step 3: took one beaker, prepared oil phase.
Cetosteryl Alcohol was dissolved in liquid paraffin
with the help of hot distilled water.
 Step 4: took another beaker, prepared water phase.
Cetrimide was dissolved in purified water in the
same temperature. Then, dissolved the warm oily
phase into aqueous phase. Stirred continuously until
emulsion is formed & cool.
 Used a glass rod to transfer the mixture to a
container or tube.Finally, it was ready for labeling
and packaging.
 Labeling: All written, printed or graphic material
passing various information of the product stocked
to the container of the product is known as label.
Precaution
 All the ingredients are weighed with great care.
 The final volume of the preparation was taken into
the container with care.
  The container was closed tightly.
Composition: Each 5 gm contains 1.5 mg of cetrimide
Indication: wounds, cuts, insect’s bite etc.
Side effects: No severe side effects Caution:
For external use only.
Uses of cetrimide Generally used as a cream for topical
use.
Also used for : Prevent infection in – cuts
 Smaller wounds
 Wound cleansing
 Nappy rash
 Seborrhoeic dermatitis
 Minor burns
 Insect’s bites
 Sterilizing surgical instruments etc.
Prepare 30g of Aqueous cream BP 1988
Ingredients Master formula Working formula
Emulsifying ointment 300g 9g

Phenoxyethanol 10g 0.3g

purified water, freshly boiled 690g 20.7g

And cooled

Formulation
This is cream made of anionic emulsifying wax. Phenoxyethanol is water soluble liquid and act
as preservatives.

Compounding

Dissolve the Phenoxyethanol in hot purified water and adjust the solution to weight. maintain
the solution at 60C°.

Melt emulsifying wax and warm at 60C°.

Check the temperature of both the phases is 60C° then add to the aqueous phase to the melted
ointment and stir until cool.

Storage and shelf life

It should be stored in cool but not allowed to freeze.

Container

Collapsible metal tube.

Advice for the patients

Not applicable. Used as diluents or cream base.

Action and uses

Emollients cream base.

Prepare 25g of salicylic acid and sulfur cream BP 1980

Ingredients Master formula Working formula

salicylic acid, finally stiffed 20g 0.5g

Precipitated sulfur 20g 0.5g

Aqueous cream sufficient to produce 1000g 25g

Formulation

Aqueous cream is used as base for dispersion of solid ingredient.

Compounding

The salicylic acid should be stifed before weighing using 180micrometers stainless steel sieve.
The powder is very irritant to the respiratory tract and precautions should be observed to avoid
inhalation.

The preparation should be made under conditions of strict hygiene.

Working surfaces,balances,tiles,spatulas and all equipment should be spotlessly clean and
swabbed with 70% ethanol before using minimizing microbial contamination. The powder
should be mixed tightly to a large flexible spatula and the bases incorporated. The product
should remain uncovered as little as possible and container should be filled as hygienically as
possible.

Storage and shelf life

The cream should be store cool and not allowed to freeze.

Container

Collapsible metal tube.

Advice for patients when dispensed

The cream should not be applied to broken or inflamed skin, contact with the eyes should be
avoided.

Detailed advice for use in scalps and skin disorders is given in pharmaceutical codex.

Actions and uses

Keratolytic with bacteriostatic and fungicidal properties.

Preparation of cold cream

Ingredients Master formula Working formula

White bees wax 10g 10g

Liquid paraffin 30g 30g

Borax 0.5%g 0.5%g

Perfume 0.2ml 0.2ml

Water 9.3ml 9.3ml

50g 50g

Procedure

Grate the bees wax. Melt the bees wax with liquid paraffin and raise the temperature upto
70C°, gradually added the solution of borax and water to the melted mixture, preferably
mechanically until cream has site. Stirring the cream , care must be taken to avoid excessive
aeration. Add perfume , when temperature reaches to 43-40C° with continuous stirring. Pack in
a suitable container and closed tightly to prevent dehydration.
Container

Open mouth plastics or glass jar.

Dose

Applied to the skin as required.

Uses

It is used to prevent dryness of skin.

Preparation of shaving cream

Ingredients Master formula Working formula

Stearic acid 20-40% 30%

Coconut oil 6-10% 8%

glycerol 5-15% 10%

Potassium hydroxide 2-6% 4%

Vegetable or mineral oil 1-5% 2.5%

Water quantity sufficient quantity sufficient

Sodium hydroxide 1-3% 2%

Procedure

First of all melt the Stearic acid with coconut oil at temperature 80C°/F. After this added sodium
hydroxide and potassium hydroxide to it. This is followed by addition of melted excess of super fatty acid
or oil. Then heat water and glycerol are added at once, avoid aeration, cool the batch to maximum
agitation.

Uses

It is used to produce smooth foam for easily removal of hairs from the skin.