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

METHOD OF PREPARATION

1. Calculate the required quantity of each ingredient for the totalamount to be prepared.

2. Accurately weigh/measure each ingredient.Formula 13. 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 23. 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, fluidpreparation.

5. Package and label.Formula 33. 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 di-rected.

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 petro-latum, mineral oil, mineral wax, woolwax alcohol and sorbitansesquioleate. It is a light yellow to yellowish-white ointment witha slight, but characteristic odor.2

Aquaphor is a stable, neutral, odorless, anhydrous ointment basethat is miscible with water or aqueous solutions, forming water-in-oil emulsions. It contains petrolatum, mineral oil, ceresin andlanolin alcohol.3

Lanolin anhydrous, or wool fat, is a pale yellow-colored, unctu-ous, waxy substance that has a faint, characteristic odor. It meltsat about 38 to 44°C and has a density of about 0.94 g/mL. It is prac-tically 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, color-less, odorless, viscous, hygroscopic liquid with a sweet taste abouttwo thirds as sweet as that of sucrose. It has a specific gravity of about1.25 and a melting point of 17.8°C. It is miscible with water,methanol and 95% ethanol; practically insoluble in oils and chlo-roform and slightly soluble in acetone.5

Wheat germ oil is obtained by hydraulic expression or solvent ex-traction of wheat germ, which constitutes about 2% of a wheat grain,the seed of Triticum aestivum Linné. It is a bland yellow oil resemblingcorn oil.6

Cocoa butter (theobroma oil) is a yellowish or white-colored brit-tle solid with a slight odor of cocoa. It is derived from natural sourcesand is composed primarily of triglycerides of saturated and unsat-urated fatty acids. It melts at between 31 and 34°C, is freely solu-ble in chloroform and ether and is slightly soluble in 95% ethanol.7

Olive oil is obtained by carefully crushing and pressing recent-ly collected ripe olives in a mill and a press. It is a pale yellow, orlight-greenish-yellow, oily liquid with a slight characteristic odorand taste. It is slightly soluble in alcohol and has a specific gravi-ty 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 0°C. It is a pale yellowoil with a slightly fishy but not rancid odor. It is slightly soluble inalcohol and freely soluble in ether and chloroform.10

References1. United States Pharmacopeia XXIV/National Formulary 19.

Rockville, MD, U.S. Pharmacopeial Convention, Inc., 1999, pp2118-2122.

2. Product Information. Minneapolis, MN, Paddock Laborato-ries, 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, AmericanPharmaceutical Association, 1994, pp 262-263.

5. Price JC. Glycerin. In Wade A, Weller PJ (eds). Handbook of Phar-maceutical Excipients, ed 2. Washington, DC, American Phar-maceutical 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. InGennaro AR (ed). Remington’s Pharmaceutical Sciences, ed 18. Eas-ton, PA, Mack Publishing Company, 1990, pp 1309-1310.

9. United States Pharmacopeia XXIII/National Formulary 18.Rockville, MD, U.S. Pharmacopeial Convention, Inc., 1995, pp2099, 2274.

10. Reynolds JEF (ed). MARTINDALE. The Extra Pharmacopoeia,ed 30. London, The Pharmaceutical Press, 1993, p 1038.

RxFormula Number1 2 3

Aquabase®/Aquaphor® 55Lanolin 15 25Glycerin 15Wheat germ oil 15 25Cocoa butter 50Olive oil 25Cod liver oil 25White petrolatum 50

Diabetic Foot-Care Ointments

130 International Journal of Pharmaceutical CompoundingVol.4 No.2 March/April 2000