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A Concise Presentation

By

Mr. Deepak Sarangi M.Pharm.

PREPARATON OF CREAMS AND ITS EVALUTION

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CONTENTSINTRODUCTIONTYPES OF CREAMSMETHOD OF PREPARATIONFORMULATIONEVALUTIONCONCLUSIONREFERENCES

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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.

INTRODUCTION

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USES

The provision of a barrier to protect the skinThis may be a physical barrier or a chemical barrier

as with sunscreensTo aid in the retention of moisture (especially W/O

creams)Cleansing & Emollient effectsAs a vehicle for drug substances such as local

anaesthetics, anti-inflammatories (NSAIDs or corticosteroids), hormones, antibiotics, antifungals or counter-irritants.

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TYPESOily creamsoil-in-water (O/W) creams which are composed of small

droplets of oil dispersed in a continuous phasemore 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

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Aqueous creamwater-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

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Cosmetic creamsAll purpose cream, baby cream, barrier cream, bleaching

cream, cleansing cream, cold cream, hair cream, hand cream, vanishing cream.

Medicated creamsHydrocortisone 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.

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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 wax12.5% cetyl esters wax56% mineral oil0.5% sodium borate19% water

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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

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MACHINERY REQUIREDSteam jocketed kettleKettle with stirrerTube filling machineNumatic tube sealing

machine

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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.

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TEST METHODVERTICAL DIFFUSION

CELL METHODSimple, 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

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Case study

BETAMETHASONE CREAM

Manufacturing Directions:1. 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.

2. Mix both solutions together with rigourous stirring.

3. Heat propylene glycol and Betamethasone until the active ingredient is dissolved.

4. Mix both the solution and continue to stir.

5. Cool it to room temperature to produce a white Betamethasone cream.

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

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REFERENCEMargarath 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.

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