Injectable flowable composition comprising buprenorphine
AssigneeIndivior UK Limited
InventorsRichard L. Norton, Andrew Watkins, Mingxing Zhou
Life of this patent
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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 use disorder in a subject in need thereof, the method comprising injecting in the subject a flowable composition that forms a biodegradable implant in the body of the subject, the composition comprising about 18 wt. % of buprenorphine free base, about 32 wt. % of a 50:50 poly(lactide-co-glycolide) copolymer, and about 50 wt. % of N-methyl-2-pyrrolidone, wherein the implant provides a therapeutically effective level of buprenorphine for at least about 28 days.
A method for treating opioid use disorder in a subject in need thereof, the method comprising injecting in the subject a flowable composition that forms a biodegradable implant in the body of the subject, the composition comprising about 18 wt. % of buprenorphine free base, about 32 wt. % of a 50:50 poly(lactide-co-glycolide) copolymer, and about 50 wt. % of N-methyl-2-pyrrolidone, wherein the implant provides a substantially linear release of buprenorphine after about 24 hours after injecting the subject.
A method for treating opioid use disorder in a subject in need thereof, the method comprising injecting in the subject a flowable composition that forms a biodegradable implant in the body of the subject, the composition comprising about 18 wt. % of buprenorphine free base, about 32 wt. % of a 50:50 poly(lactide-co-glycolide) copolymer, and about 50 wt. % of N-methyl-2-pyrrolidone, wherein the implant provides a substantially linear release of buprenorphine after about 24 hours after injecting the subject and a therapeutically effective level of buprenorphine for at least about 28 days.
A method for treating opioid use disorder in a subject in need thereof, the method comprising injecting in the subject a flowable composition that forms a biodegradable implant in the body of the subject, the composition comprising about 18 wt. % of buprenorphine free base, about 32 wt. % of a 50:50 poly(lactide-co-glycolide) copolymer, and about 50 wt. % of N-methyl-2-pyrrolidone, wherein the implant has a burst release of the buprenorphine within about 24 hours after injecting the subject followed by a substantially linear release of buprenorphine and provides a therapeutically effective level of buprenorphine for at least about 28 days.
A method for treating opioid use disorder in a subject in need thereof, the method comprising injecting in the subject a flowable composition that forms a biodegradable implant in the body of the subject, the composition comprising about 8 wt. % to about 22 wt. % of buprenorphine free base, a biodegradable thermoplastic polymer and a biocompatible polar aprotic organic liquid, wherein the implant provides a therapeutically effective level of buprenorphine for at least about 28 days.
A flowable composition comprising about 18 wt. % of buprenorphine free base, about 32 wt. % of a 50:50 poly(lactide-co-glycolide) copolymer, and about 50 wt. % of N-methyl-2-pyrrolidone.
Dependencies are inferred from the claim text.