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Claims for Patent: 8,147,866

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Claims for Patent: 8,147,866

Title:Transmucosal delivery devices with enhanced uptake
Abstract: The present invention provides methods for enhancing transmucosal uptake of a medicament, e.g., fentanyl or buprenorphine, to a subject and related devices. The method includes administering to a subject a transmucosal drug delivery device comprising the medicament. Also provided are devices suitable for transmucosal administration of a medicament to a subject and methods of their administration and use. The devices include a medicament disposed in a mucoadhesive polymeric diffusion environment and a barrier environment.
Inventor(s): Finn; Andrew (Raleigh, NC), Vasisht; Niraj (Cary, NC)
Assignee: BioDelivery Sciences International, Inc. (Raleigh, NC)
Application Number:13/184,306
Patent Claims: 1. A method for providing enhanced uptake of buprenorphine to a subject by direct transmucosal delivery of buprenorphine, the method comprising: administering buprenorphine to a subject by application of a mucoadhesive bioerodable drug delivery device to an oral mucosal surface of the subject, the device comprising: a bioerodable mucoadhesive layer comprising an effective amount of buprenorphine disposed in a polymeric diffusion environment, wherein the polymeric diffusion environment is a buffered environment having a pH of between about 4 and about 6; and a barrier layer comprising a polymeric barrier environment disposed adjacent to the mucoadhesive layer to provide a unidirectional gradient upon application to a mucosal surface for the rapid and efficient delivery of buprenorphine, wherein the unidirectional gradient delivers buprenorphine across the buffered polymeric diffusion environment upon application to the mucosal surface.

2. The method of claim 1, wherein the pH of the polymeric diffusion environment is between about 4.5 and about 5.5.

3. The method of claim 1, wherein the pH of the polymeric diffusion environment is between about 4.5 and about 5.

4. The method of claim 1, wherein a first quantifiable plasma concentration of buprenorphine is observed at about 45 minutes.

5. The method of claim 1, wherein an effective plasma concentration of buprenorphine is maintained for at least 4 hours.

6. The method of claim 1, wherein the device further comprises an opioid antagonist selected from the group consisting of naloxone, naltrexone, nalmefene, nalide, nalmexone, nalorphine, nalbuphine, cyclazocine, levallorphan and combinations thereof.

7. The method of claim 6, wherein the opioid antagonist is naloxone.

8. A mucoadhesive bioerodable drug delivery device suitable for direct transmucosal administration of buprenorphine to a subject, the mucoadhesive bioerodable drug delivery device comprising: a bioerodable mucoadhesive layer comprising an effective amount of buprenorphine disposed in a polymeric diffusion environment, wherein the polymeric diffusion environment is a buffered environment having a pH between about 4 and about 6; and a barrier layer comprising a polymeric barrier environment disposed adjacent to the mucoadhesive layer to provide a unidirectional gradient upon application to a mucosal surface for the rapid and efficient delivery of buprenorphine, wherein the unidirectional gradient delivers buprenorphine across the buffered polymeric diffusion environment.

9. The device of claim 8, wherein the pH of the polymeric diffusion environment is between about 4.5 and about 5.5.

10. The device of claim 8, wherein the pH of the polymeric diffusion environment is between about 4.5 and about 5.

11. The device of claim 8, wherein the device further comprises an opioid antagonist selected from the group consisting of naloxone, naltrexone, nalmefene, nalide, nalmexone, nalorphine, nalbuphine, cyclazocine, levallorphan and combinations thereof.

12. The device of claim 11, wherein the opioid antagonist is naloxone.
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