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.
