Pharmaceutical creams

Complete presentation about pharmaceutical creams

1. Pharmaceutical Creams Presented to: Dr. Jamshaid Sheikh Presented by: Awais irshaad…15019 Shahzaib…15015 fatima mustafa…15062 iram amjad…15031

2. 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

3. 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.

4. 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 .

5. 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

6. 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 .

7. 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 .

8. 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.

9. 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.

10. 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.

11. Bases used for creams: BASES ARE CLASSIFIED INTO FOUR GENERAL GROUPS .

12. 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.

13. 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.

14. Examples:

15. 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

16. Properties:

17. Examples:

18. 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

19. Example: VANISHING CREAMS

20. 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.

21. Example: PEG OINTMENT

22. 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

23. Preparation process:

24. General method of preparation: As with other types of emulsion, hygiene is extremely important and all surfaces, spatulas and other equipment must be thoroughly cleaned with IDA. Always make an excess as it is never possible to transfer the entire cream into the final container. Determine which of the ingredients are miscible with the aqueous phase and which with the oily phase. Dissolve the water-soluble ingredients in the aqueous phase. 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.

25. 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.

26. 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 .

27. The incorporation of liquids into a cream base: Non-volatile, miscible liquids: M ay 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 .

28. 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 ).

29. 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.

30. Ideal characteristics of creams:

31. Preservation: AMONG THE ANTIMICROBIAL PRESERVATIVES USED TO INHIBIT MICROBIAL GROWTH IN TOPICAL PREPARATIONS ARE:

32. Containers used for creams: Container that are commonly used are:

33. Filling:

34. 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.

35. 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.

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

37. 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.

38. 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”

39. Refrences: Pharmaceutical Compounding and Dispensing by John F Marriott..2 nd Edition Chapter 9 th ..Page No. 153 ANSEL’S .. PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS. Pharmaceutical Practice_5 th -Edition_ A. J. Winfield.. Ch#36..page 337 Pharmaceutical Compounding and Dispensing by Chris Langley & Dawn Belcher…….. Chapter 5 th ….page no 91…. Pharmaceutics –Dosage Form and Design by David Jones…. Chapter 3 rd …

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