Abuse-resistant mucoadhesive devices for delivery of buprenorphine

Abstract

The present invention provides abuse deterrent mucoadhesive devices for delivery of buprenorphine. Each device comprises a mucoadhesive layer and a backing layer, and the pH in each layer is selected, such that absorption of buprenorphine is maximized.

1 . A mucoadhesive device for use in managing pain, the device comprising:
 a mucoadhesive layer comprising between about 0.075 mg to about 12 mg of buprenorphine having a pH in a range between about 4 and about 6; and   a backing layer having a pH lower than said mucoadhesive layer and in a range of up to about half a pH unit below said pH range of said mucoadhesive layer.   
     
     
         2 . The mucoadhesive device of  claim 1 , wherein the mucoadhesive layer and the backing layer comprise different combinations of polymers. 
     
     
         3 . The mucoadhesive device of  claim 1 , wherein the mucoadhesive layer is buffered to a pH of between about 4 to about 6 and the a backing layer is buffered to a pH lower than said mucoadhesive layer and in a range of up to about half a pH unit below said pH range of said mucoadhesive layer. 
     
     
         4 . A mucoadhesive device for use in managing pain, the device comprising:
 a mucoadhesive layer comprising 0.075 mg, 0.15 mg, 0.45 mg, 0.6 mg or 0.75 mg of buprenorphine having a pH in a range of between about 4 and about 6; and   a backing layer having a pH lower than said mucoadhesive layer and in a range of up to about half a pH unit below said pH range of said mucoadhesive layer.   
     
     
         5 . The mucoadhesive device of  claim 4 , wherein the mucoadhesive layer and the backing layer comprise different combinations of polymers. 
     
     
         6 . The mucoadhesive device of  claim 4 , where the mucoadhesive layer is buffered to a pH of between about 4 and about 6 and the backing layer having a pH lower than said mucoadhesive layer and in a range of up to about half a pH unit below said pH range of said mucoadhesive layer. 
     
     
         7 . A mucoadhesive device for use in managing pain, the device comprising:
 a mucoadhesive layer comprising 0.9 mg of buprenorphine having a pH in a range of between about 4 and about 6; and   a backing layer having a pH lower than said mucoadhesive layer and in a range of up to about half a pH unit below said pH range of said mucoadhesive layer.   
     
     
         8 . The mucoadhesive device of  claim 7 , wherein the mucoadhesive layer and the backing layer comprise different combinations of polymers. 
     
     
         9 . The mucoadhesive device of  claim 7 , where the mucoadhesive layer is buffered to a pH of between about 4 and about 6 and the backing layer having a pH lower than said mucoadhesive layer and in a range of up to about half a pH unit below said pH range of said mucoadhesive layer. 
     
     
         10 . A method of managing pain by administering to a subject in need thereof a device for direct transmucosal delivery of buprenorphine to a buccal surface, the device comprising:
 a mucoadhesive layer comprising between about 0.075 mg to about 12 mg of buprenorphine having a pH range between about 4 and about 6; and   a backing layer having a pH lower than said mucoadhesive layer and in a range of up to about half a pH unit below said pH range of said mucoadhesive layer.   
     
     
         11 . The method of  claim 10 , wherein the mucoadhesive layer and the backing layer of said device comprise different combinations of polymers. 
     
     
         12 . The mucoadhesive device of  claim 10 , wherein the mucoadhesive layer is buffered to a pH of between about 4 to about 6 and the a backing is buffered to a pH lower than said mucoadhesive layer and in a range of up to about half a pH unit below said pH range of said mucoadhesive layer.