Implantable polymeric device for sustained release of buprenorphine

Abstract

The present invention provides compositions, methods, and kits for treatment of opiate addiction and pain. The invention provides a biocompatible nonerodible polymeric device which releases buprenorphine continuously with generally linear release kinetics for extended periods of time. Buprenorphine is released through pores that open to the surface of the polymeric matrix in which it is encapsulated. The device may be administered subcutaneously to an individual in need of continuous treatment with buprenorphine.

1 . An implantable device for treating opiate addiction, comprising buprenorphine and a biocompatible, nonerodible polymeric matrix,
 wherein said buprenorphine is encapsulated within said matrix, and   wherein when said implantable device is implanted subcutaneously in a mammal, said buprenorphine is continuously released in vivo over a sustained period of time through pores that open to the surface of said matrix at a rate that results in a steady state plasma buprenorphine level of at least about 0.1 ng/ml.   
     
     
         2 . The implantable device according to  claim 1 , wherein the polymeric matrix comprises ethylene vinyl acetate copolymer (EVA). 
     
     
         3 . The implantable device according to  claim 2 , wherein said EVA comprises about 33% vinyl acetate. 
     
     
         4 . The implantable device according to  claim 3 , comprising about 10 to about 85% buprenorphine. 
     
     
         5 - 6 . (canceled) 
     
     
         7 . The implantable device according to  claim 3 , wherein the implantable device is produced by an extrusion process. 
     
     
         8 . The implantable device according to  claim 7 , comprising dimensions of about 2 to about 3 mm in diameter and about 2 to about 3 cm in length. 
     
     
         9 . (canceled) 
     
     
         10 . The implantable device according to  claim 9 , wherein said implantable device releases about 1 mg buprenorphine per day in vitro. 
     
     
         11 . The implantable device according to  claim 1 , wherein the sustained period of time is at least about 3 months. 
     
     
         12 . An implantable device for treating pain, comprising buprenorphine and a biocompatible, nonerodible polymeric matrix,
 wherein said buprenorphine is encapsulated within said matrix, and   wherein when said implantable device is subcutaneously implanted in a mammal, said buprenorphine is continuously released in vivo over a sustained period of time through pores that open to the surface of said matrix at a steady state rate of at least about 0.1 mg per day.   
     
     
         13 . The implantable device according to  claim 12 , wherein the polymeric matrix comprises EVA. 
     
     
         14 . The implantable device according to  claim 13 , wherein said EVA comprises 33% vinyl acetate. 
     
     
         15 . The implantable device according to  claim 14 , comprising about 10 to about 85% buprenorphine. 
     
     
         16 - 17 . (canceled) 
     
     
         18 . The implantable device according to  claim 14 , wherein the implantable device is produced by an extrusion process. 
     
     
         19 . The implantable device according to  claim 18 , comprising dimensions of about 2 to about 3 mm in diameter and about 2 to about 3 cm in length. 
     
     
         20 . (canceled) 
     
     
         21 . The implantable device according to  claim 19 , wherein said implantable device releases about 1 mg buprenorphine per day in vitro. 
     
     
         22 . The implantable device according to  claim 12 , wherein the sustained period of time is at least about 3 months. 
     
     
         23 . A method for treatment of opiate addiction, comprising administering at least one implantable device according to  claim 1  subcutaneously,
 wherein said at least one implantable device releases buprenorphine in vivo over a sustained period of time through pores that open to the surface of said matrix at a rate that results in a steady state plasma buprenorphine level of about 1 to about 10 ng/ml. 
 
     
     
         24 - 28 . (canceled) 
     
     
         29 . A method for treatment of pain, comprising administering at least one implantable device according to  claim 12  subcutaneously,
 wherein said at least one implantable devices continuously releases buprenorphine in vivo over a sustained period of time through pores that open to the surface of said matrix at a steady state rate of about 0.1 to about 5 mg per day. 
 
     
     
         30 - 34 . (canceled) 
     
     
         35 . A kit for use in treatment of opiate addiction, comprising at least one implantable device according to  claim 1 , and instructions for use. 
     
     
         36 . A kit for use in treatment of pain, comprising at least one implantable device according to  claim 12 , and instructions for use.