Functional Category
Emollient; emulsifying agent; viscosity-increasing agent.
Applications in Pharmaceutical Formulation
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.(1) 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,(2–5) or poorly watersoluble drugs,(6–8) as well as to stabilize amorphous systems.(9) In combination with other surfactants, cetostearyl alcohol forms emulsions with very complex microstructures. These microstructures can include liquid crystals, lamellar structures, and gel phases.(10–21)
Description
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.
Stability and Storage Conditions
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.
Safety
Cetostearyl alcohol is mainly used in topical pharmaceutical formulations and topical cosmetic formulations. 3.0 1215 1392 1730 1764 2012 1779 1749 2297 2325 2340 2364 2442 2352 2312 0.0 1000 −5.0 × [2nd deriv. log(1/R)] 1100 1300 1500 1700 1900 2100 2300 2500 Wavelength/nm −0.2 0.7 log(1/R) Figure 1: Near-infrared spectrum of cetostearyl alcohol measured by reflectance. C 150 Cetostearyl alcohol is generally regarded as a nontoxic material.(22) Although it is essentially nonirritating, sensitization reactions to cetostearyl, cetyl, and stearyl alcohols(23–28) 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.(29