Functional Category
Antifoaming agent; dissolution enhancer; emollient; emulsifying agent; skin penetrant; sustained-release agent.
Applications in Pharmaceutical Formulation
Oleyl alcohol is mainly used in topical pharmaceutical formulations and has been used in transdermal delivery formulations.(1–7) It has been utilized in the development of biodegradable injectable thermoplastic oligomers,(8) and in aerosol formulations of insulin(9) and albuterol.(10)
Description
Oleyl alcohol occurs as a pale yellow oily liquid that gives off acrid fumes when heated.
Stability and Storage Conditions
The bulk material should be stored in a well-closed container in a cool, dry, place
Safety
Oleyl alcohol is mainly used in topical pharmaceutical formulations and is generally regarded as a nontoxic and nonirritant material at the levels employed as an excipient. However, contact dermatitis due to oleyl alcohol has been reported.(12–14) The results of acute oral toxicity and percutaneous studies in animals with products containing 8% oleyl alcohol indicate a very low toxicity.(15) Formulations containing 8% or 20% oleyl alcohol administered by gastric intubation, at doses up to 10 g/kg bodyweight, caused no deaths and no toxic effects in rats.(15)