Claims for Patent: 9,597,288

Summary for Patent: 9,597,288

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:	15/198,961
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,597,288
Patent Claims:	1. A method for delivering fentanyl to a human comprising: administering a mucoadhesive biodegradable drug delivery device for transmucosal delivery to the oral mucosa of said human, the device comprising: a biodegradable mucoadhesive layer comprising fentanyl disposed in a polymeric diffusion environment, wherein the polymeric diffusion environment has a pH of between about 6 and about 8.5; and a polymeric barrier environment disposed adjacent to the mucoadhesive layer, wherein a unidirectional diffusion gradient of fentanyl is provided upon application to a buccal surface, wherein the overall bioavailability of fentanyl is at least about 60%; and wherein the fentanyl is delivered in less than about 30 minutes. 2. The method of claim 1, wherein the overall bioavailability of fentanyl is at least about 70%. 3. The method of claim 1, wherein the polymeric diffusion environment comprises at least one film-forming water-erodible adhesive polymer and at least one bioadhesive polymer. 4. The method of claim 1, wherein said polymeric barrier environment comprises at least one film-forming water-erodible polymer. 5. The method of claim 1, wherein the polymeric diffusion environment has a pH of between about 7 to about 7.5. 6. The method of claim 1, wherein the mucoadhesive biodegradable drug delivery device further comprises an opioid antagonist. 7. The method of claim 1, wherein the biodegradable drug delivery device further comprises a third layer or coating. 8. The method of claim 1, wherein the polymeric diffusion environment has a pH buffered to between about 6 and about 8.5. 9. The method of claim 1, wherein the polymeric diffusion environment has a pH buffered to between about 7 to about 7.5. 10. The method of claim 8, wherein the overall bioavailability of fentanyl is at least about 70%. 11. The method of claim 8, wherein the polymeric diffusion environment comprises at least one film-forming water-erodible adhesive polymer and at least one bioadhesive polymer. 12. The method of claim 8, wherein said polymeric barrier environment comprises at least one film-forming water-erodible polymer. 13. The method of claim 8, wherein the mucoadhesive biodegradable drug delivery device further comprises an opioid antagonist. 14. The method of claim 8, wherein the biodegradable drug delivery device further comprises a third layer or coating. 15. A device for delivering fentanyl to a human, the device comprising: a biodegradable mucoadhesive layer comprising fentanyl disposed in a polymeric diffusion environment, wherein the polymeric diffusion environment has a pH of between about 6 and about 8.5; and a polymeric barrier environment disposed adjacent to the mucoadhesive layer, wherein a unidirectional diffusion gradient of fentanyl is provided upon application to a buccal surface of a subject, wherein upon application to a buccal surface, the overall bioavailability of fentanyl is at least about 60%; and wherein the fentanyl is delivered in less than about 30 minutes. 16. The device of claim 15, wherein the overall bioavailability of fentanyl is at least about 70%. 17. The device of claim 15, wherein the polymeric diffusion environment comprises at least one film-forming water-erodible adhesive polymer and at least one bioadhesive polymer. 18. The device of claim 15, wherein said polymeric barrier environment comprises at least one film-forming water-erodible polymer. 19. The device of claim 15, wherein the polymeric diffusion environment has a pH of between about 7 to about 7.5. 20. The device of claim 15, wherein the mucoadhesive biodegradable drug delivery device further comprises an opioid antagonist. 21. The device of claim 15, wherein the biodegradable drug delivery device further comprises a third layer or coating. 22. The device of claim 15, wherein the polymeric diffusion environment has a pH buffered to between about 6 and about 8.5. 23. The device of claim 15, wherein the polymeric diffusion environment has a pH buffered to between about 7 to about 7.5. 24. The device of claim 22, wherein the overall bioavailability of fentanyl is at least about 70%. 25. The device of claim 22, wherein the polymeric diffusion environment comprises at least one film-forming water-erodible adhesive polymer and at least one bioadhesive polymer. 26. The device of claim 22, wherein said polymeric barrier environment comprises at least one film-forming water-erodible polymer. 27. The device of claim 22, wherein the mucoadhesive biodegradable drug delivery device further comprises an opioid antagonist. 28. The device of claim 27, wherein said opioid antagonist is naloxone. 29. The device of claim 22, wherein the biodegradable drug delivery device further comprises a third layer or coating. 30. A method for treating pain, the method comprising: adhering a mucoadhesive biodegradable drug delivery device to a buccal surface of a human, the device comprising: a biodegradable mucoadhesive layer comprising a therapeutically effective amount of fentanyl for treating pain disposed in a polymeric diffusion environment, wherein the polymeric diffusion environment has a pH buffered to between about 6 and about 8.5; and a polymeric barrier environment disposed adjacent to the mucoadhesive layer wherein a unidirectional diffusion gradient of fentanyl is provided upon application to the buccal surface, wherein the transmucosal delivery of fentanyl is at least about 50% by direct buccal absorption, wherein the overall bioavailability of fentanyl is at least about 70%; and wherein the fentanyl is delivered in less than about 30 minutes.