Two-member medicated device for rate-controlled administration of lipophilic pharmaceuticals

摘要

The present specification describes a medicated device adapted for a single and rate-controlled rectal or vaginal administration to a mammal of a systemically active pharmaceutical (SAP). The device accomplishes drug administration at an essentially time-independent rate of dosage. Further, the device advantageously results in the substantial exhaustion of the SAP from the device at the conclusion of the single, acute use. The device comprises three elements: (A) an inert resilient support means contoured for easy vaginal or rectal insertion; (B) a first flexible polymer film layer affixed to the support means and containing the SAP dispersed therethrough, this first polymer film not being rate limiting as to the release of drug from the device; and (C) a second polymer film, laminated onto the first polymer film and providing a release rate therefrom of prostaglandin, which is rate limiting both as to the release of prostaglandin from the device and absorption rate by the rectal or vaginal tissues.