Claims for Patent: 8,202,535

Summary for Patent: 8,202,535

Title:	Small-volume oral transmucosal dosage forms
Abstract:	Small-volume oral transmucosal dosage forms or NanoTabs.RTM. comprising a predetermined amount of a pharmaceutically active drug are provided. Exemplary applications include use of the NanoTabs.RTM. to administer a drug for the treatment of acute, post-operative or breakthrough pain.
Inventor(s):	Palmer; Pamela (San Francisco, CA), Schreck; Thomas (Portola Valley, CA), Tzannis; Stelios (Newark, CA), Hamel; Larry (Mountain View, CA), Poutiatine; Andrew I. (San Anselmo, CA)
Assignee:	Acelrx Pharmaceuticals, Inc. (Redwood City, CA)
Application Number:	11/650,174
Patent Claims:	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.sub.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.sub.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.sub.max that is shorter than the T.sub.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.sub.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.