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 . An abuse deterrent mucoadhesive device for use in managing pain or opioid dependence, the device comprising:
 a mucoadhesive layer comprising an effective amount of buprenorphine buffered to a pH of between about 4.0 and about 6.0; and   a backing layer buffered to a pH between about 4.0 and about 4.8.   
     
     
         2 . The device according to  claim 1 , wherein the backing layer comprises an effective amount of naloxone and wherein the w/w ratio of buprenorphine to naloxone present in the device is between 1:1 and 10:1. 
     
     
         3 . The device according to  claim 2 , wherein the w/w ratio of buprenorphine to naloxone present in the device is 6:1. 
     
     
         4 . The device according to  claim 3 , wherein the mucoadhesive layer is buffered to a pH of between about 4.50 and about 5.50 and the wherein the backing layer is buffered to a pH of between about 4.10 and about 4.4. 
     
     
         5 . The device according to  claim 4 , wherein the mucoadhesive layer is buffered to a pH of about 4.75 and the backing layer is buffered to a pH of about 4.25. 
     
     
         6 . The device according to  claim 1  comprising about 0.075-12 mg buprenorphine. 
     
     
         7 . The device according to  claim 2  comprising about 0.0125-2 mg of naloxone. 
     
     
         8 . The device according to  claim 1  wherein the bioavailability of buprenorphine absorbed from the device is greater than 40%.