Injectable flowable composition comprising buprenorphine
AssigneeIndivior UK Limited
InventorsRichard L. Norton, Andrew Watkins, Mingxing Zhou
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Abstract
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.
Claims23
A method for treating opioid dependence in a subject in need thereof, the method comprising administering to the subject by subcutaneous injection a therapeutically effective amount of a pharmaceutical composition comprising:
- (i) 10 wt % to about 50 wt % of buprenorphine in the form of a free base or a pharmaceutically acceptable salt;
- (ii) about 5 wt % to about 70 wt % of a poly(lactide-co-glycolide) copolymer;
- and
- (iii) N-methyl-2-pyrrolidone,
- wherein the method produces (a) buprenorphine plasma concentration levels in the subject from about 1.82 ng/mL to about 12.1 ng/mL for about 28 days;
- (b) buprenorphine plasma concentration levels in the subject from about 2.18 ng/mL to about 3.26 ng/mL from the third day to the twenty-fourth day after the first injection;
- and/or (c) a twenty-four hour buprenorphine burst release in the subject of less than 10%.
Dependencies are inferred from the claim text.