Cetostearyl Alcohol

Category

Emollient; Emulsifying Agents; Viscosity-increasing Agents

Grade

Pharmceutical Excipients

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.

UNII

2DMT128M1S

Chemical Name

Cetostearyl alcohol

CAS Number

8005-44-5

Synonyms

Alcohol cetylicus et stearylicus; cetearyl alcohol; cetyl stearyl alcohol; Crodacol CS90; Lanette O; Speziol C16-18 Pharma; Tego Alkanol 1618; Tego Alkanol 6855

Administration route

Oral; topical; vaginal

Dosage Form

Oral tablets; topical emulsions, lotions, ointments; vaginal suppositories

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.

Source and Preparation

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.

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.

Incompatibilities

Incompatible with strong oxidizing agents and metal salts.