Small-volume oral transmucosal dosage forms

1. A method of treating pain in a subject, comprising administering a small volume substantially homogeneous solid tablet by adhering said tablet to the oral mucosa of said subject, wherein: a) said tablet has a volume of from about 3 microliters (mcl) to about 15 mcl; b) said tablet comprises from about 2 to about 200 micrograms (mcg) of sufentanil and a bioadhesive material; c) said bioadhesive material provides for adherence of said tablet to the oral mucosa substantially throughout during the period of drug delivery; d) said tablet generates a minimal saliva response and minimal swallowing of drug; e) at least 50% of drug delivery occurs via the oral transmucosal route; and f) administration of said tablet to said subject results in a T max of from about 19.8 minutes to about 60 minutes.

2. The method according to claim 1 , wherein said oral mucosal membrane is a sublingual membrane.

3. The method according to claim 1 , wherein said oral mucosal membrane is a buccal membrane.

4. The method according to claim 1 , wherein said tablet has a volume of less than 10 mcl.

5. The method according to claim 1 , wherein said tablet comprises a dose of sufentanil selected from the group consisting of 5 mcg, 10 mcg, 15 mcg, 20 mcg, 40 mcg, 60 mcg, and 80 mcg, and 100 mcg.

6. The method according to claim 1 , wherein oral transmucosal administration of said tablet to said subject results in a bioavailability of greater than 65%.

7. The method according to claim 1 , wherein oral transmucosal administration of said tablet to said subject results in a bioavailability of greater than 75%.

8. The method according to claim 1 , wherein oral transmucosal administration of said tablet to said subject results in a bioavailability of greater than 85%.

9. The method according to claim 1 , wherein oral transmucosal administration of said drug tablet to said subject results in a T max with a coefficient of variation of less than 40%.

10. The method according to claim 1 , wherein repeated oral transmucosal administration of said tablet to said subject, results in a T max that is shorter than the T max following a single oral transmucosal administration to said subject.

11. The method according to claim 1 , wherein oral transmucosal administration of said tablet results in a therapeutic time ratio of from about 0.5 to about 2.0.

12. The method according to claim 1 , wherein an amount of drug selected from the group consisting of at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, at least 98% and at least 99% of the total amount of drug in said tablet is absorbed via the oral transmucosal route.

13. The method according to claim 12 , wherein at least 60% of the total amount of drug in said tablet is absorbed via the oral transmucosal route.

14. The method according to claim 1 , wherein said tablet is administered using a device.

15. The method according to claim 1 , wherein said tablet is self-administered.

16. The method according to claim 14 , wherein said tablet is administered using a single-does applicator.

17. The method of treating pain according to claim 1 , wherein following said administering, pain relief is evident in said subject.

18. The method of claim 1 , wherein said pain is acute pain, breakthrough pain or post-operative pain.

19. The method according to claim 18 , wherein said pain is acute pain.

20. The method according to claim 19 , wherein said subject is treated by a paramedic or military medic.

21. The method according to claim 19 , wherein said subject is treated in the field.

22. The method according to claim 19 , wherein said subject is treated under non-sterile conditions.

23. The method according to claim 5 , wherein said tablet comprises 20 mcg of sufentanil.

24. The method according to claim 1 , wherein said tablet comprises 30 mcg of sufentanil.

25. The method according to claim 1 , wherein a single oral mucosal administration of said subject results in an average T max of 40.8±13.2 minutes.

26. The method of claim 1 , wherein repeated administrations result in an area under the curve (AUC) with a coefficient of variation of less than 30%.

27. The method according to claim 1 , wherein complete erosion of said tablet is evident by visual examination after a time selected from the group consisting of about 5 minutes, about 10 minutes and about 15 minutes following administration.