Injectable flowable composition buprenorphine

摘要

The present invention is directed to a buprenorphine sustained release delivery system capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 14 days to about 3 months. The buprenorphine sustained release delivery system includes a flowable composition and a solid implant for the sustained release of buprenorphine, a metabolite, or a prodrug thereof. The implant is produced from the flowable composition. The buprenorphine sustained release delivery system provides in situ 1-month and 3-month release profiles characterized by an exceptionally high bioavailability and minimal risk of permanent tissue damage and typically no risk of muscle necrosis.

主权项

1. A method for treating opioid addiction in a human in need thereof comprising administering a therapeutically effective amount of a pharmaceutical composition to the human to treat the opioid addiction; wherein the pharmaceutical composition comprises:
(i) 8 wt % to about 30 wt % of buprenorphine in the form of the free base or a pharmaceutically acceptable salt; (ii) about 20 wt % to about 70 wt % of a poly(DL-lactide-co-glycolide) copolymer; and (iii) about 30 wt % to about 70 wt % of N-methyl-2-pyrrolidone.