Dual enhancer composition for topical and transdermal drug delivery

This invention relates generally to the topical and transdermal administration of pharmacologically active agents, and more particularly relates to permeation enhancer compositions for enhancing the permeability of skin or mucosal tissue to topically applied pharmacologically active agents. A permeation enhancer composition is provided for increasing the permeability of skin or mucosal tissue to topically or transdermally administered pharmacologically or cosmeceutically active agents. The composition is comprised of a hydroxide-releasing agent and a lipophilic co-enhancer such as a fatty alcohol, a fatty ether, or a fatty acid ester, including fatty acid esters of polyols such as propylene glycol and glycerol. Also provided are pharmaceutical formulations containing a therapeutically effective amount of an active agent in addition to the aforementioned enhancer composition, methods for administering active agents topically or transdermally with enhanced permeation, and drug delivery systems for application to an individual's skin or mucosal tissue, wherein the systems are formulated so as to contain an active agent to be administered and an effective permeation enhancing amount of an enhancer composition of the invention.