ABUSE-RESISTANT MUCOADHESIVE DEVICES FOR DELIVERY OF BUPRENORPHINE
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%.