Functional Category:
Emollient; emulsifying agent
Applications in Pharmaceutical Formulation
Cholesterol is used in cosmetics and topical pharmaceutical formulations at concentrations of 0.3–5.0% w/w as an emulsifying agent. It imparts water-absorbing power to an ointment and has emollient activity. Cholesterol also has a physiological role. It is the major sterol of the higher animals, and it is found in all body tissues, especially in the brain and spinal cord. It is also the main constituent of gallstones.
Description
Cholesterol occurs as white or faintly yellow, almost odorless, pearly leaflets, needles, powder, or granules. On prolonged exposure to light and air, cholesterol acquires a yellow to tan color
Stability and Storage Conditions
Cholesterol is stable and should be stored in a well-closed container, protected from light.
Incompatibilities
Cholesterol is precipitated by digitonin
Safety
Cholesterol is generally regarded as an essentially nontoxic and nonirritant material at the levels employed as an excipient.(3) It has, however, exhibited experimental teratogenic and reproductive effects, and mutation data have been reported.(5) Cholesterol is often derived from animal sources and this must be done in accordance with the regulations for human consumption. The risk of bovine spongiform encephalopathy (BSE) contamination has caused some concern over the use of animalderived cholesterol in pharmaceutical products.(6) However, synthetic methods of cholesterol manufacture have been developed.(4)