Claims for Patent: 9,655,843

Summary for Patent: 9,655,843

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:	15/212,912
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,655,843
Patent Claims:	1. A method for delivering buprenorphine to a human comprising: administering a mucoadhesive biodegradable drug delivery device for transmucosal delivery, the device comprising: a bioerodible mucoadhesive layer comprising buprenorphine disposed in a polymeric diffusion environment, wherein the polymeric diffusion environment has a pH of between about 4 and about 7.5, and a polymeric barrier environment disposed adjacent to the mucoadhesive layer, and wherein a unidirectional diffusion gradient of buprenorphine is provided upon application to a buccal surface. 2. 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. 3. The method of claim 1, wherein said polymeric barrier environment comprises at least one film-forming water-erodible polymer. 4. The method of claim 1, wherein the polymeric diffusion environment has a pH of between about 4 to about 6. 5. The method of claim 1, wherein the polymeric barrier environment further comprises an opioid antagonist. 6. The method of claim 1, wherein the biodegradable drug delivery device further comprises a third layer or coating. 7. The method of claim 1, wherein the polymeric diffusion environment has a pH buffered to between about 4 and about 7.5. 8. The method of claim 1, wherein the polymeric diffusion environment has a pH buffered to between about 4 to about 6. 9. The method of claim 7, wherein the polymeric diffusion environment comprises at least one film-forming water-erodible adhesive polymer and at least one bioadhesive polymer. 10. The method of claim 7, wherein said polymeric barrier environment comprises at least one film-forming water-erodible polymer. 11. The method of claim 7, wherein the polymeric barrier environment further comprises an opioid antagonist. 12. The method of claim 7, wherein the biodegradable drug delivery device further comprises a third layer or coating. 13. A device for delivering buprenorphine to a human, the device comprising: a bioerodible mucoadhesive layer comprising buprenorphine disposed in a polymeric diffusion environment, wherein the polymeric diffusion environment has a pH of between about 4 and about 7.5; and a polymeric barrier environment disposed adjacent to the mucoadhesive layer, and wherein a unidirectional diffusion gradient of buprenorphine is provided upon application to a buccal surface of a human. 14. The device of claim 13, wherein the polymeric diffusion environment comprises at least one film-forming water-erodible adhesive polymer and at least one bioadhesive polymer. 15. The device of claim 13, wherein said polymeric barrier environment comprises at least one film-forming water-erodible polymer. 16. The device of claim 13, wherein the polymeric diffusion environment has a pH of between about 4 and about 6. 17. The device of claim 13, wherein the polymeric barrier environment further comprises an opioid antagonist. 18. The device of claim 13, wherein the biodegradable drug delivery device further comprises a third layer or coating. 19. The device of claim 13, wherein the polymeric diffusion environment has a pH buffered to between about 4 and about 7.5. 20. The device of claim 13, wherein the polymeric diffusion environment has a pH buffered to between about 4 to about 6. 21. The device of claim 19, wherein the polymeric diffusion environment comprises at least one film-forming water-erodible adhesive polymer and at least one bioadhesive polymer. 22. The device of claim 19, wherein said polymeric barrier environment comprises at least one film-forming water-erodible polymer. 23. The device of claim 19, wherein the polymeric barrier environment further comprises an opioid antagonist. 24. The device of claim 19, wherein the biodegradable drug delivery device further comprises a third layer or coating. 25. 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 bioerodible mucoadhesive layer comprising a therapeutically effective amount of buprenorphine for treating pain disposed in a polymeric diffusion environment, wherein the polymeric diffusion environment has a pH buffered to between about 4 and about 7.5; and a polymeric barrier environment disposed adjacent to the mucoadhesive layer wherein a unidirectional diffusion gradient of buprenorphine is provided upon application to the buccal surface.