Claims for Patent: 8,975,270

Summary for Patent: 8,975,270

Title:	Injectable flowable composition comprising buprenorphine
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.
Inventor(s):	Norton; Richard L. (Fort Collins, CO), Watkins; Andrew (Fort Collins, CO), Zhou; Mingxing (Fort Collins, CO)
Assignee:	RB Pharmaceuticals Limited (Berkshire, GB)
Application Number:	13/836,134
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,975,270
Patent Claims:	1. An injectable flowable composition comprising: (i) 8 wt% to about 30 wt% of buprenorphine in the form of a 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; wherein the composition is transformed in situ into a solid implant by contact with water, body fluid, or other aqueous medium. 2. The composition of claim 1, wherein the composition comprises from about 3 milligrams to about 300 milligrams of buprenorphine in the form of the free base or the pharmaceutically acceptable salt. 3. The composition of claim 1, wherein the polymer is a 50/50 poly (DL-lactide-co-glycolide) copolymer. 4. The composition of claim 1, wherein the poly(DL-lactide-co-glycolide) copolymer has an average molecular weight from about 5,000 Daltons to about 40,000 Daltons. 5. An injectable flowable composition consisting of: (i) 8 wt% to about 30 wt% of buprenorphine in the form of a 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; wherein the composition is transformed in situ into a solid implant by contact with water, body fluid, or other aqueous medium. 6. The composition of claim 5, wherein the poly(DL-lactide-co-glycolide) copolymer is a 50/50 poly(DL-lactide-co-glycolide) copolymer. 7. The composition of claim 5, wherein the poly(DL-lactide-co-glycolide) copolymer has an average molecular weight from about 5,000 Daltons to about 40,000 Daltons. 8. The composition of claim 5, wherein the flowable composition comprises from about 3 milligrams to about 300 milligrams of buprenorphine in the form of a free base or pharmaceutically acceptable salt. 9. The composition of claim 5, wherein poly(DL-lactide-co-glycolide) copolymer is a 50/50, 55/45, 60/40, 65/35, 70/30, 75/25, 80/20, 85/15, 90/10, or 95/5 poly(DL-lactide-co-glycolide) copolymer. 10. An injectable flowable composition comprising: (i) 8 wt% to about 30 wt% of buprenorphine in the form of a 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. 11. A method for treating a patient having an opioid dependency comprising parenterally administering to the patient a therapeutically effective amount of the composition of claim 1 once per month to treat the opioid dependency. 12. A method for treating a patient having an opioid dependency comprising parenterally administering to the patient a therapeutically effective amount of the composition of claim 5 once per month to treat the opioid dependency. 13. A method for treating a patient having an opioid dependency comprising parenterally administering to the patient a therapeutically effective amount of the composition of claim 10 once per month to treat the opioid dependency. 14. An injectable flowable composition consisting of: (i) 8 wt% to about 30 wt% of buprenorphine in the form of a 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. 15. A method for treating a patient having an opioid dependency comprising parenterally administering to the patient a therapeutically effective amount of the composition of claim 14 once per month to treat the opioid dependency.