F O R M U L A T I O N S

Diabetic Foot-Care Ointments

Rx
Aquabase/Aquaphor Lanolin Glycerin Wheat germ oil Cocoa butter Olive oil Cod liver oil White petrolatum Formula Number 1 2 55 15 15 15 25 50 25 3 25

25 50

METHOD OF PREPARATION
1. Calculate the required quantity of each ingredient for the total amount to be prepared. 2. Accurately weigh/measure each ingredient.

Formula 1
3. Blend the wheat germ oil and glycerin with the lanolin. 4. Incorporate the mixture into the Aquabase/Aquaphor and mix well. 5. Package and label.

Formula 2
3. Blend the wheat germ oil with the olive oil and mix well. 4. Incorporate the mixture into the cocoa butter using very mild heat, if necessary, and mix well. This will yield a thick, fluid preparation. 5. Package and label.

Lanolin anhydrous, or wool fat, is a pale yellow-colored, unctuous, waxy substance that has a faint, characteristic odor. It melts at about 38 to 44C and has a density of about 0.94 g/mL. It is practically insoluble in water and sparingly soluble in cold ethanol (95%). It is freely soluble in chloroform and ether.4 Glycerin (glycerol, 1,2,3-propane triol) occurs as a clear, colorless, odorless, viscous, hygroscopic liquid with a sweet taste about two thirds as sweet as that of sucrose. It has a specic gravity of about 1.25 and a melting point of 17.8C. It is miscible with water, methanol and 95% ethanol; practically insoluble in oils and chloroform and slightly soluble in acetone.5 Wheat germ oil is obtained by hydraulic expression or solvent extraction of wheat germ, which constitutes about 2% of a wheat grain, the seed of Triticum aestivum Linn. It is a bland yellow oil resembling corn oil.6 Cocoa butter (theobroma oil) is a yellowish or white-colored brittle solid with a slight odor of cocoa. It is derived from natural sources and is composed primarily of triglycerides of saturated and unsaturated fatty acids. It melts at between 31 and 34C, is freely soluble in chloroform and ether and is slightly soluble in 95% ethanol.7 Olive oil is obtained by carefully crushing and pressing recently collected ripe olives in a mill and a press. It is a pale yellow, or light-greenish-yellow, oily liquid with a slight characteristic odor and taste. It is slightly soluble in alcohol and has a specific gravity between 0.910 and 0.915.8,9 Cod liver oil is the oil obtained from the fresh liver of the cod, refined, and clarified by filtration at about 0C. It is a pale yellow oil with a slightly fishy but not rancid odor. It is slightly soluble in alcohol and freely soluble in ether and chloroform.10

References
1. United States Pharmacopeia XXIV/National Formulary 19. Rockville, MD, U.S. Pharmacopeial Convention, Inc., 1999, pp 2118-2122. 2. Product Information. Minneapolis, MN, Paddock Laboratories, Inc. 3. Product Information. S. Norwalk, CT, Beiersdorf, Inc. 4. Winfield AJ. Lanolin. In Wade A, Weller PJ (eds). Handbook of Pharmaceutical Excipients, ed 2. Washington, DC, American Pharmaceutical Association, 1994, pp 262-263. 5. Price JC. Glycerin. In Wade A, Weller PJ (eds). Handbook of Pharmaceutical Excipients, ed 2. Washington, DC, American Pharmaceutical Association, 1994, pp 204-206. 6. Budavari S. The Merck Index, ed 10. Rahway, NJ, Merck & Co., Inc., 1983, p 1441. 7. Meyer MC, Pagliocca B. Suppository bases. In Wade A, Weller PJ (eds). Handbook of Pharmaceutical Excipients, ed 2. Washington, DC, American Pharmaceutical Association, 1994, pp 512-518. 8. Swinyard EA, Lowenthal W. Pharmaceutical necessities. In Gennaro AR (ed). Remingtons Pharmaceutical Sciences, ed 18. Easton, PA, Mack Publishing Company, 1990, pp 1309-1310. 9. United States Pharmacopeia XXIII/National Formulary 18. Rockville, MD, U.S. Pharmacopeial Convention, Inc., 1995, pp 2099, 2274. 10. Reynolds JEF (ed). MARTINDALE. The Extra Pharmacopoeia, ed 30. London, The Pharmaceutical Press, 1993, p 1038.

Formula 3
3. Blend the cod liver oil with the lanolin. 4. Incorporate the white petrolatum and mix well. 5. Package and label.

PACKAGING
Package in tight, light-resistant containers.

LABELING
For external use only. Keep out of reach of children. Use as directed.

STABILITY
These preparations should be stable for six months.1

DISCUSSION
Aquabase ointment is a stable, unscented, preservative-free, dye-free anhydrous hydrophilic ointment base. It contains petrolatum, mineral oil, mineral wax, woolwax alcohol and sorbitan sesquioleate. It is a light yellow to yellowish-white ointment with a slight, but characteristic odor.2 Aquaphor is a stable, neutral, odorless, anhydrous ointment base that is miscible with water or aqueous solutions, forming water-inoil emulsions. It contains petrolatum, mineral oil, ceresin and lanolin alcohol.3

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International Journal of Pharmaceutical Compounding Vol.4 No.2 March/April 2000