This document discusses different types of creams and their formulation and preparation methods. It begins with introducing creams as semisolid emulsions for topical application containing one or more drug substances. The main types are oily/oil-in-water creams and aqueous/water-in-oil creams. It then covers the purposes of creams, common ingredients in formulations, quality control testing methods like vertical diffusion cell testing, and provides an example formulation for betamethasone cream. The document aims to provide information on creams for pharmaceutical applications.
2. • 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. 1. protect the skin
2. This may be a physical barrier or a chemical
barrier as with sunscreens
3. To aid in the retention of moisture (especially
W/O creams)
4. Cleansing & Emollient effects
5. As a vehicle for drug substances such as local
anaesthetics, anti-inflammatories (NSAIDs or
corticosteroids), hormones, antibiotics,
antifungals or counter-irritants. 4
5. 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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8. MEDICATED CREAMS
o Hydrocortisone cream - treat rashes like
poison oak or poison ivy, psoriasis and
eczema.
o Antibiotic creams- abrasions or small
wounds to treat minor infections.
o Antifungal creams- ringworm, Candida
Intertrigo or Candida diaper rash.
o Zinc oxide cream- sunblock activity and
for infant diaper rash 8
9. FORMULATION
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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
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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