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Summary for Patent: 8,921,387
|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 (Slough, Berkshire, GB)|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for patent 8,921,387|
1. An injectable flowable composition comprising: (i) 8 wt % to about 22 wt % of buprenorphine free base; (ii) about 25 wt % to about 50 wt % of a
poly(DL-lactide-co-glycolide) biodegradable thermoplastic polymer; wherein the polymer has an average molecular weight of about 5,000 Daltons to about 40,000 Daltons; and (iii) about 30 wt % to about 70 wt % of N-methyl-2-pyrrolidone.
2. The composition of claim 1, wherein the composition is transformed in situ into a solid implant by contact with water or a bodily fluid.
3. The composition of claim 1, wherein the polymer is a 50/50 poly(DL-lactide-co-glycolide) biodegradable thermoplastic polymer.
4. The composition of claim 1, wherein the polymer has an average molecular weight of about 9,000 Daltons to about 20,000 Daltons.
5. The composition of claim 1, wherein the polymer has a carboxy terminal group.
6. The composition of claim 1, wherein the weight ratio of buprenorphine to polymer is between 0.01:1 and 2:1.
7. 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.
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