This document provides an overview of pharmaceutical creams, including their definition, preparation methods, ingredients, and packaging. Creams are viscous emulsions for external use that can dissolve or suspend medicaments. They are classified as water-in-oil or oil-in-water depending on the emulsifying agent. Proper bases must be selected based on the intended use and stability of active ingredients. Creams are prepared through emulsification and incorporation processes and packaged in containers like jars or tubes with a typical discard date of 4 weeks.

2. PHARMACEUTICAL CREAMS
PRESENTED TO:
DR. JAMSHAID SHEIKH
PRESENTED BY:
AWAIS IRSHAAD…15019
SHAHZAIB…15015
FATIMA MUSTAFA…15062
IRAM AMJAD…15031

3. CONTENTS:
 Introduction & overview of creams
 Official Definition
 General method of preparation
 Terminology used in the preparation of creams
 Bases used for Creams.
 The incorporation of ingredients into a cream base.
 Filling.
 Preservation.
 Packagaing & labeling

4. INTRODUCTION & OVERVIEW
 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.

5. OFFICIAL DEFINITION
 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.

6. DIFFERENCE BITWEEN CREAM AND OINTMENT:
Ointments Creams
Contain more than 50% hydrocarbans & less than 20
% water.
Contain less than 50% hydrocarbans & more than 20
% water.
Thicker consistency,greasy,difficult to spread over
large surface.
Light in consistency,easy to spread over large
surface.
W/o or O/w emulsions.
Stay longer on the surface of skin Skin dry up faster
Prefered for dry skin Prefered for oily skin

7. TYPES:
 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.

8.  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.

9. OTHER TYPES:
 Cosmetic creams:
 All purpose cream, baby cream, barrier cream,
bleaching cream, cleansing cream, cold cream, hair cream, hand cream, vanishing cream.
 MEDICATED CREAMS:
Medicated creams are contains active pharmaceutical ingredients.
 Cetrimide cream used as antiseptic.
 Zinc oxide cream used as Sunblock.
 Hydrocortisone cream - treat rashes.

10. TRITURATION:
 This is the term applied to the incorporation
of finely divided insoluble powders or liquids
into 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 ointment base on a tile and
making a ‘well’ in the centre. Small quantities
of liquid are then added and mixed in.
 Trituration can be successfully achieved using
a mortar but this method is usually reserved
for large quantities.

11. LAVIGATION:
 This is the term applied to the incorporation of
insoluble coarse powders into the base.
 It is often termed ‘wet grinding’.
 It is the process where the powder is rubbed down
with either the molten base or semi-solid base.
 A considerable shearing force is applied to avoid a
gritty product.

13. BASES USED FOR CREAMS:
 BASES ARE CLASSIFIED INTO
FOUR GENERAL GROUPS.
OLEAGINOUS BASES.
ABSORPTION BASES.
WATER-REMOVABLE BASES.
WATER-SOLUBLE BASES.

14. OLEAGINOUS BASES
(HYDROCARBON BASES)
 ON APPLICATION TO SKIN THEY HAVE AN EMOLLIENT EFFECT.
 PROTECT AGAINST ESCAPE OF MOISTURE.
 THEY ARE EFFECTIVE AS OCCLUSIVE DRESSINGS.
 IMMISCIBLE WITH WATER AND DIFFICULT TO WASH OFF.

15. CONTI…
 THEY CAN REMAIN ON SKIN FOR LONGER PERIODS WITHOUT DRYING OUT.
 WATER AND AQUEOUS SOLUTIONS IN SMALL AMOUNTS CAN BE
INCORPORATED WITH SMALL DIFFICULTY.
 WHEN POWDERED SUBSTANCES ARE TO BE INCORRPORATED LIQUID
PETROLATUM IS USED AS LEVIGATING AGENT.

16. EXAMPLES:
PETROLATUM
WHITE
PETROLATUM
YELLOW
OINTMENT
WHITE
OINTMENT

17. ABSORPTION BASES:
 TWO TYPES:
 THOSE THAT PERMIT INCORPORATION OF AQUEOUS SOLUTIONS
RESULTING IN FORMATION OF W/O EMULSIONS
 THOSE THAT ARE ALREADY W/O EMULSIONS AND PERMIT INCORPORATION
OF ADDITIONAL QUANTITY OF AQUEOUS SOLUTION

18. PROPERTIES:
THESE BASES MAY BE USED AS EMOLLIENT
DIFFICULT TO WATER WASHING
THESE BASES ARE NOT EASY TO REMOVE FROM SKIN SINCE THE EXTERNAL PHASE OF EMULSION IS OLEAGINOUS
THEY DO NOT PROVIDE DEGREE OF OCCLUSION
THEY FORM A GREASY FILM ON SKINSURFACE

19. EXAMPLES:
COLD CREAM
LANOLIN
ANHYDROUS LANOLIN

20. WATER REMOVABLE BASES
(EMULSIFYING BASES)
 THEY ARE OIL IN WATER EMULSIONS HAVING AN EMULSIFIER WHICH
MAKES THEM READILY MISCIBLE WITH WATER.
 THEY MAY BE DILUTED WITH WATER OR AQUEOUS SOLUTIONS.
 BECAUSE OF THEIR SURFACE ACTIVE PROPERTY THEY FACILITATE CONTACT
b/w SKIN AND MEDICAMENT

21. EXAMPLE:
 VANISHING CREAMS

22. WATER SOLUBLE BASES:
(GREASELESS BASES)
 UNLIKE OTHER BASES THEY CONTAIN ONLY WATER SOLUBLE COMPONENTS.
 THEY ARE COMPLETELY WATER WASHABLE.
 AQUEOUS SOLUTIONS CAN NOT BE INCORPORATED EFFICIENTLY
BECAUSTHEY SOFTEN GREATLY WITH WATER ADDITION.
 THEY MOSTLY ARE USED FOR INCORPORATIONOF SOLID SUBSTANCES.

23. EXAMPLE:
 PEG OINTMENT

24. SELECTION OF APPROPRIATE BASE:
 DEPENDS UPON PURPOSE FOR WHICH CREAM IS GOING TO BE APPLIED:
 DESIRED RELEASE OF DRUG SUBSTANCE FROM BASE.
 DESIRABILITY OF TOPICAL ABSORPTION.
 DESRABILITY OF OCCLUSION OF MOISTURE FROM SKIN.
 STABILITY OF DRUG IN BASE.
 DESIRABILITY OF SURFACE TO WHICH IT IS TO BE APPLIED.
 SHOULD HAVE A SUITABLE PH.
 NO DEHYDRATING EFFECT
 NON IRRITANT AND NON SENSITISING.
 COMPATIBLE WITH A LARGE NUMBER OF DRUGS.
 MISCIBLE WITH SKIN SECRETIONS e.g SEBUM ,SWEAT etc

25. PREPARATION PROCESS:
Preparation of oil phase.
Hydration of aqueous phase ingredients.
Forming the emulsion.
Dispersion of active ingredient.

26. 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.

27. 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.

28. 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.

29. 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.

30. ADVANTAGES:
 They gives prolong contact in their site of application than any other
pharmaceutical semisolid dosage forms.
 Injured area can be dried quickly by creams than other semi-solid
preparations.
 Non-irritating when applied to the skin.
 Easily water washable. Easy to wipe away.
 Less greasy compared to ointment.
 Easy to spread on the skin's surface (i.e. easy to apply).

31. DISADVANTAGES:
 Stability is not as good as ointment.
 They are less hydrophobic than other semisolid preparation, so risk of
contamination is high than the others.

32. 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.

33. PRESERVATION:
METHYLPARABEN PROPYLPARABEN PHENOLS BENZOIC ACID SORBIC ACID
AMONG THE ANTIMICROBIAL PRESERVATIVES USED TO
INHIBIT MICROBIAL GROWTH IN TOPICAL PREPARATIONS
ARE:

34. CONTAINERS USED FOR CREAMS:
Wide mouthed jars.
Collapsible Metal.
Flexible Plastic tubes.
Aluminium tubes.
Container that are commonly used are:

35. FILLING:
FILLING IS DONE
BY TWO WAYS:
HAND FILLING
MECHANICAL
FILLING

36. 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.

37. 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.

38.  VACCUM FILLERS ARE ALSO AVAILABLE IN WHICH NOZEL IS ATTACHED TO
VACCUM PUMP.

40. DISCARD DATE:
 Some official texts suggested that creams are given a four-week discard date.
 This is significantly shorter than the 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.
 Instead of ‘Expiry date” apply the term ‘Discard after’ or ‘Do not use after’
followed by a definite date and/or time.

41. STORAGE, AND LABELING
 In large-mouth ointment jars or in metal or plastic tubes.
 In well-closed containers to protect against contamination
and in a cool place to protect against product separation
due to heat.
 When required light sensitive preparations are packaged in
light resistant containers.
 In addition to the usual labeling requirements for
pharmaceutical products, the USP directs that the labeling
for certain ointments and creams include the type of base
used (e.g., water-soluble or waterinsoluble).
“FOR EXTERNAL USE ONLY”

43. REFRENCES:
 Pharmaceutical Compounding and Dispensing by
John F Marriott..2nd Edition
Chapter 9th ..Page No. 153
 ANSEL’S.. PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS.
 Pharmaceutical Practice_5th-Edition_ A. J. Winfield.. Ch#36..page 337
 Pharmaceutical Compounding and Dispensing by
Chris Langley & Dawn Belcher……..
Chapter 5th….page no 91….
 Pharmaceutics –Dosage Form and Design by
David Jones….
Chapter 3rd …