Creams & its evaluation ppt

How creams are evaluated a brief note...

1. 1 A Concise Presentation By Mr. Deepak Sarangi M.Pharm . PREPARATON OF CREAMS AND ITS EVALUTION

2. CONTENTS INTRODUCTION TYPES OF CREAMS METHOD OF PREPARATION FORMULATION EVALUTION CONCLUSION REFERENCES 2

3. Creams are defines as “a semisolid dosage form containing one or more drug substances dissolved or dispersed in a suitable base” semisolid emulsions of either O/W or W/O type. O/W emulsions, microcrystalline dispersions of long-chain fatty acids or alcohols that are water washable. 3 INTRODUCTION

4. USES The provision of a barrier to protect the skin This may be a physical barrier or a chemical barrier as with sunscreens To aid in the retention of moisture (especially W/O creams) Cleansing & Emollient effects As a vehicle for drug substances such as local anaesthetics , anti- inflammatories (NSAIDs or corticosteroids), hormones, antibiotics, antifungals or counter-irritants . 4

5. TYPES Oily creams oil-in-water (O/W) creams which are composed of small droplets of oil dispersed in a continuous phase more comfortable and cosmetically acceptable as they are less greasy and more easily washed off using water. emulsifying agents of natural origins( bees wax, wool alcohols, wool fat) Emollient and creamy, white or translucent and stiff. eg : Fluocinolone Acetonide Cream 5

6. Aqueous cream water-in-oil (W/O) creams which are composed of small droplets of water dispersed in a continuous oily phase. more difficult to handle but many drugs which are incorporated into creams are hydrophobic and will be released more readily from a W/O cream than an O/W cream more moisturizing as they provide an oily barrier which reduces water loss from the stratum corneum , the outermost layer of the skin. accommodate and release better lipophilic API e.g.: Moisturizing & Cold cream 6

7. Cosmetic creams All purpose cream, baby cream, barrier cream, bleaching cream, cleansing cream, cold cream, hair cream, hand cream, vanishing cream. Medicated creams Hydrocortisone cream - treat rashes like poison oak or poison ivy, psoriasis and eczema. Antibiotic creams- abrasions or small wounds to treat minor infections. Antifungal creams- ringworm, Candida Intertrigo or Candida diaper rash. Zinc oxide cream- sunblock activity and for infant diaper rash. 7

8. FORMULATION Hydrophilic ointment (O/W type emulsion base) 25% white petrolatum 25% stearyl alcohol 12% propylene glycol 1%sodium lauryl sulphate 37% water Cold cream (W/O type emulsion base) 12% white wax 12.5% cetyl esters wax 56% mineral oil 0.5% sodium borate 19% water 8

9. MANUFACTURING PROCESS STEPS Preparation of the oil phase : Flake/powder ingredients, sometimes dry blended in advance, are dispersed into mineral oil or silicone oil. Heating may be required to melt some ingredients. Hydration of aqueous phase ingredients : Emulsifiers, thickeners and stabilizers are dispersed into water in a separate vessel. Heating may be required to accelerate hydration Forming the Emulsion : The two phases are blended under vigorous agitation to form the emulsion. Dispersion of the Active Ingredient: The active ingredient often makes up only a small proportion of the formulation; this must be efficiently dispersed to maximize yield and product effectiveness 9

10. MACHINERY REQUIRED Steam jocketed kettle Kettle with stirrer Tube filling machine Numatic tube sealing machine 10

11. QUALITY CONTROL AND STANDARDS The quality of these products are maintained as per the buyers specification. Important quality controlling parameters are as per the FDA norms and BIS specification. The requirements of a cream are as follows: It should liquefy at body temperature. Its viscosity should be low enough to permit easy spreading but high enough to retain in suspension particles of dirt and insoluble foreign matter. It should penetrate the epidermis (via natural openings) and contain enough light oils to permit flushing the pores. It should be an emulsion type with a small percentage of water. 11

12. TEST METHOD VERTICAL DIFFUSION CELL METHOD Simple, reliable, and reproducible, measuring drug release from semisolid dosage forms. Consists of two primary chambers separated by a membrane Test product is applied to the membrane via the top chamber. Bottom chamber contains fluid from which samples are taken. Determines the amount of active that has permeated the membrane at each time point Constant temperature of 37°C 12

13. Case study BETAMETHASONE CREAM Manufacturing Directions : Heat the mixture of cetyl stearyl alcohol, cremophor A6, cremophor A25, liquid paraffin and paraben to approximately 80°C. Also heat water seperately at 80°C. Mix both solutions together with rigourous stirring. Heat propylene glycol and Betamethasone until the active ingredient is dissolved. Mix both the solution and continue to stir. Cool it to room temperature to produce a white Betamethasone cream. 13 Material Name Qty/kg (g) Cetyl stearyl alcohol 70.0 Cremophor A6 15.0 Cremophor A25 15.0 Liquid paraffin 12.0 Paraben (S) 2.0 Water 697.0 Propylene glycol 80.0 Betamethasone 1.0

14. REFERENCE Margarath M., “ Topical and transdermal drug products”, The United States Pharmacopial Convention, indd 12-25. “Vanishing and Cleansing and Cold Cream”, Chemical Division MSME Development Institute, Raagada Nicole Krilla , M. A., Debanjan Das, and John G. Augustian , “Semisolid Formulation Development: The CRO Approach” by SP Formulations, P.No 1-12. David A. Katz “Preparation Of A Skin Cream”, P.No 1-4. Sarfaraz K. Niazi , “ Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Products” V-4, Informa Healthcare, New York, London. 14

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