Sustained-release buprenorphine formulations

Abstract

The disclosure is directed to sustained-release buprenorphine formulations that provide long-term, therapeutic levels of buprenorphine for the treatment of pain and the maintenance treatment of opioid use disorders, such as opioid dependence.

1 - 20 . (canceled) 
     
     
         21 . A method of treating opioid use disorder in a human in need thereof, the method comprising subcutaneously administering a pharmaceutical composition to the human once per month for at least two months to treat the opioid use disorder; wherein the pharmaceutical composition comprises:
 (i) about 300 mg of buprenorphine free base;   (ii) about 32 wt % of a poly(DL-lactide-co-glycolide) copolymer; and   (iii) about 50 wt % of N-methyl-2-pyrrolidone.   
     
     
         22 . The method of  claim 21 , wherein the month is 28 days. 
     
     
         23 . The method of  claim 21 , wherein the poly(DL-lactide-co-glycolide) copolymer is a 50:50 poly(DL-lactide-co-glycolide) copolymer. 
     
     
         24 . The method of  claim 21 , wherein the poly(DL-lactide-co-glycolide) copolymer has an average molecular weight of about 5,000 Daltons to about 25,000 Daltons. 
     
     
         25 . A method of treating opioid use disorder in a human in need thereof, the method comprising subcutaneously administering a pharmaceutical composition to the human once per month for at least two months to treat the opioid use disorder; wherein the pharmaceutical composition comprises:
 (i) about 300 mg of buprenorphine free base;   (ii) a poly(DL-lactide-co-glycolide) copolymer; and   (iii) N-methyl-2-pyrrolidone.   
     
     
         26 . The method of  claim 25 , wherein a month is 28 days. 
     
     
         27 . The method of  claim 25 , wherein the pharmaceutical composition comprises: (i) about 300 mg of buprenorphine free base; (ii) about 10 wt % to about 60 wt % of the poly(DL-lactide-co-glycolide) copolymer; and (iii) about 30 wt % to about 70 wt % of N-methyl-2-pyrrolidone. 
     
     
         28 . The method of  claim 25 , wherein the pharmaceutical composition comprises: (i) about 300 mg of buprenorphine free base; (ii) about 22 wt % to about 42 wt % of the poly(DL-lactide-co-glycolide) copolymer; and (iii) about 40 wt % to about 60 wt % of N-methyl-2-pyrrolidone. 
     
     
         29 . The method of  claim 25 , wherein the poly(DL-lactide-co-glycolide) copolymer is a 50:50 to 80:20 poly(DL-lactide-co-glycolide) copolymer. 
     
     
         30 . The method of  claim 25 , wherein the poly(DL-lactide-co-glycolide) copolymer is a 50:50 poly(DL-lactide-co-glycolide) copolymer. 
     
     
         31 . The method of  claim 25 , wherein the poly(DL-lactide-co-glycolide) copolymer has an average molecular weight of about 5,000 Daltons to about 25,000 Daltons. 
     
     
         32 . A method of reducing opioid cravings in a human in need thereof, the method comprising subcutaneously administering a pharmaceutical composition to the human once per month for at least two months to reduce opioid cravings; wherein the pharmaceutical composition comprises:
 (i) about 300 mg of buprenorphine free base;   (ii) a poly(DL-lactide-co-glycolide) copolymer; and   (iii) N-methyl-2-pyrrolidone.   
     
     
         33 . The method of  claim 32 , wherein a month is 28 days. 
     
     
         34 . The method of  claim 32 , wherein the pharmaceutical composition comprises: (i) about 300 mg of buprenorphine free base; (ii) about 10 wt % to about 60 wt % of a poly(DL-lactide-co-glycolide) copolymer; and (iii) about 30 wt % to about 70 wt % of N-methyl-2-pyrrolidone. 
     
     
         35 . The method of  claim 32 , wherein the pharmaceutical composition comprises: (i) about 300 mg of buprenorphine free base; (ii) about 22 wt % to about 42 wt % of the poly(DL-lactide-co-glycolide) copolymer; and (iii) about 40 wt % to about 60 wt % of N-methyl-2-pyrrolidone. 
     
     
         36 . The method of  claim 32 , wherein the poly(DL-lactide-co-glycolide) copolymer is a 50:50 to 80:20 poly(DL-lactide-co-glycolide) copolymer. 
     
     
         37 . The method of  claim 32 , wherein the poly(DL-lactide-co-glycolide) copolymer is a 50:50 poly(DL-lactide-co-glycolide) copolymer. 
     
     
         38 . The method of  claim 32 , wherein the poly(DL-lactide-co-glycolide) copolymer has an average molecular weight of about 5,000 Daltons to about 30,000 Daltons. 
     
     
         39 . The method of  claim 32 , wherein the pharmaceutical composition comprises: (i) about 300 mg of buprenorphine free base; (ii) about 32 wt % of the poly(DL-lactide-co-glycolide) copolymer; and (iii) about 50 wt % of N-methyl-2-pyrrolidone. 
     
     
         40 . The method of  claim 39 , wherein the poly(DL-lactide-co-glycolide) copolymer is a 50:50 poly(DL-lactide-co-glycolide) copolymer.