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

Anhydrous Emollient Dry Skin Lotion

Rx
For 100 g Olive oil, light Cocoa butter White petrolatum 20 g 40 g 40 g

METHOD OF PREPARATION
1. Calculate the required quantity of each ingredient for the total amount to be prepared. 2. Accurately weigh and/or measure each ingredient. 3. Melt the cocoa butter and white petrolatum together at a temperature of about 40C. 4. Incorporate the light olive oil, mix well, and cool. 5. Pour into a plastic squeeze bottle that has a dispenser tip. 6. Package and label.

Cocoa butter (Theobroma oil) is a yellowish or white brittle solid that has a slight odor of cocoa. It is derived from natural sources and is composed primarily of the triglycerides of saturated and unsaturated fatty acids. It melts between 31C and 34C, is freely soluble in chloroform and in ether, and is slightly soluble in 95% ethanol. Heating to a temperature greater than 36C lowers the solidification point of cocoa butter because of its polymorphic nature and the formation of a metastable form. Cocoa butter should be stored at temperatures less than 25C. It is used as a suppository base and is also a major ingredient in chocolate. 2 White petrolatum (white petroleum jelly, white soft paraffin) is a white, translucent, soft unctuous mass that is inert, odorless, and tasteless. It is a mixture of semisolid saturated hydrocarbons obtained from petroleum. It is used primarily in the following topical formulations in the concentrations listed: emollient creams (10% to 30%), topical emulsions (4% to 25%), and topical ointments (up to 100%). White petrolatum has a specific gravity of about 0.815 to 0.880 and melts in a temperature range between 38C and 60C. It is practically insoluble in ethanol, in glycerin, and in water but is soluble in chloroform and in most fixed and volatile oils. It is stable, but when exposed to light it may discolor as a result of the oxidation of impurities. That oxidation can be minimized by the addition of a suitable antioxidant such as butylated hydroxyanisole, butylated hydroxytoluene, or -tocopherol. Heating white petrolatum to a temperature above its melting range (about 70C) for extended times should be avoided, but it can be sterilized by dry heat. 3

PACKAGING
Package in a tight, light-resistant container.

LABELING
For external use only. Keep out of the reach of children.

STABILITY
A beyond-use date of 6 months can be used for this preparation.1

USE
This thick lotion has been used to treat very dry skin. It has excellent emollient properties and is often applied at bedtime.

REFERENCES
1. United States Pharmacopeia XXIV/National Formulary 19. Rockville MD:US Pharmacopeial Convention, Inc; 1999:2487, 2698-2702. 2. Reilly WJ Jr. Pharmaceutical necessities. In: Gennaro AR, ed. Remington: The Science and Practice of Pharmacy. 19th ed. Easton PA:Mack Publishing Company; 1995:1400, 1409. 3. Weller PJ. Petrolatum: In: Kibbe AH, ed. Handbook of Pharmaceutical Excipients. 3rd ed. Washington DC:American Pharmaceutical Association; 1994:331-333.

QUALITY CONTROL
Actual yield compared with theoretical yield, physical observation.

DISCUSSION
Dry skin (especially during the winter in a cold climate) is very common. The low relative humidity indoors during the winter in cold climates causes the loss of moisture from the skin, which becomes dry, cracked, painful, and sometimes infected. A good emollient preparation applied at least once daily and allowed to remain in place facilitates dermal hydration by minimizing the evaporation of water from the skin surface. A thicker or thinner preparation can be easily prepared from this formulation. Olive oil is obtained by carefully crushing and pressing recently collected ripe olives in a mill and a press. When that process does not break the putamen, the highest grade oil (virgin oil, sublime oil, first-expressed oil) is obtained. Olive oil is a pale yellow or light greenish-yellow oily liquid that has a slight characteristic odor and taste. It is slightly soluble in alcohol and has a specific gravity between 0.910 and 0.915. Olive oil is used in making ointments, liniments, emulsions, and various other dosage forms. It is also used as an emollient laxative. 1,2

International Journal of Pharmaceutical Compounding 199 Vol. 6 No. 3 May/June 2002