Transmucosal delivery devices with enhanced uptake
View Patent ↗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.
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.