HME TRANSDERMAL COMPOSITIONS CONTAINING TESTOSTERONE

摘要

A bioadhesive laminate comprising testosterone and methods for its preparation are provided. The laminate comprises a hot-melt extruded (HME) drug reservoir layer comprising testosterone and an inert backing layer. The drug reservoir layer comprises a thermoplastic bioadhesive composition containing testosterone and the inert backing layer. The laminate is adapted for transdermal administration. When administered buccally to a subject, the laminate provides therapeutically effective plasma levels of testosterone such that the Cmax of testosterone is less than about 1000 ng/dL and the Tmax falls within the period of about two to fifteen hours. In a particular embodiment, the laminate provides therapeutic plasma levels of testosterone in the range of about 300 to 1000 ng/dL throughout a period of about one to twenty four hours after buccal administration to a subject. The laminate provides an in vitro controlled release of testosterone for a period of about four to thirty hours after exposure to an aqueous assay medium.