CETEARYL ALCOHOL

Chemical properties

Cetostearyl alcohol occurs as white or cream-colored unctuous masses, flakes, pellets or granules. It has a faint, characteristic sweet odor. On heating, cetostearyl alcohol melts to a clear, colorless or pale yellow-colored liquid free of suspended matter.

Production Methods

Cetostearyl alcohol is prepared by the reduction of the appropriate fatty acids from vegetable and animal sources. Cetostearyl alcohol can also be prepared directly from hydrocarbon sources.

Pharmaceutical Applications

Cetostearyl alcohol is used in cosmetics and topical pharmaceutical preparations. In topical pharmaceutical formulations, cetostearyl alcohol will increase the viscosity and act as an emulsifier in both water-in-oil and oil-in-water emulsions. Cetostearyl alcohol will stablize an emulsion and also act as a co-emulsifier, thus decreasing the total amount of surfactant required to form a stable emulsion. Cetostearyl alcohol is also used in the preparation of nonaqueous creams and sticks, and in nonlathering shaving creams. Research articles have been published in which cetostearyl alcohol has been used to control or slow the dissolution rate of tablets or microspheres containing water-soluble drugs, or poorly watersoluble drugs, as well as to stabilize amorphous systems. In combination with other surfactants, cetostearyl alcohol forms emulsions with very complex microstructures. These microstructures can include liquid crystals, lamellar structures, and gel phases.

Safety

Cetostearyl alcohol is mainly used in topical pharmaceutical formulations and topical cosmetic formulations.
Cetostearyl alcohol is generally regarded as a nontoxic material. Although it is essentially nonirritating, sensitization reactions to cetostearyl, cetyl, and stearyl alcohols have been reported.
Gamma radiation has been shown to be feasible for sterilization of petrolatum containing cetostearyl alcohol resulting in low levels of radiolysis products, which are of low toxicity.

Storage

Cetostearyl alcohol is stable under normal storage conditions. Cetostearyl alcohol should be stored in a well-closed container in a cool, dry place.

Incompatibilities

Incompatible with strong oxidizing agents and metal salts.

Regulatory Status

Accepted as an indirect food additive and as an adhesive and a component of packaging coatings in the USA. Included in the FDA Inactive Ingredients Database (oral tablets; topical emulsions, lotions, ointments; vaginal suppositories). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.