Functional Category
Stiffening agent.
Applications in Pharmaceutical Formulation
Stearyl alcohol is used in cosmetics(1,2) and topical pharmaceutical creams and ointments as a stiffening agent. By increasing the viscosity of an emulsion, stearyl alcohol increases its stability. Stearyl alcohol also has some emollient and weak emulsifying properties, and is used to increase the water-holding capacity of ointments, e.g. petrolatum. In addition, stearyl alcohol has been used in controlled-release tablets,(3,4) suppositories,(5,6) and microspheres.(7,8) It has also been investigated for use as a transdermal penetration enhancer.(9)
Description
Stearyl alcohol occurs as hard, white, waxy pieces, flakes, or granules with a slight characteristic odor and bland taste.
Stability and Storage Conditions
Stearyl alcohol is stable to acids and alkalis and does not usually become rancid. It should be stored in a well-closed container in a cool, dry place.
Incompatibilities
Incompatible with strong oxidizing agents and strong acids.
Safety
Stearyl alcohol is generally considered to be an innocuous, nontoxic material. However, adverse reactions to stearyl alcohol present in topical preparations have been reported. These include contact urticaria and hypersensitivity reactions, which are possibly due to impurities contained in stearyl alcohol rather than stearyl alcohol itself.(11–15) The probable lethal oral human dose is greater than 15 g/kg. LD50 (rat, oral): 20 g/kg(16)