How creams are evaluated a brief note...

1. 1
A Concise Presentation
By
Mr. Deepak Sarangi M.Pharm.

2. CONTENTS
 INTRODUCTION
 TYPES OF CREAMS
 METHOD OF PREPARATION
 FORMULATION
 EVALUTION
 CONCLUSION
 REFERENCES
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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.
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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.
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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
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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
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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.
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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
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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
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10. MACHINERY REQUIRED
 Steam jocketed kettle
 Kettle with stirrer
 Tube filling machine
 Numatic tube sealing machine
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11. QUALITY CONTROLAND 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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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
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13. 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.
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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.
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