Claims for Patent: 8,226,978

Summary for Patent: 8,226,978

Title:	Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Abstract:	Compositions, methods and systems for administration of small volume sufentanil-containing drug dosage forms to the oral mucosa of a subject are disclosed.
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), Rampersaud; Charles (San Francisco, CA), Edwards; Bruce (Menlo Park, CA)
Assignee:	AcelRx Pharmaceuticals, Inc. (Redwood City, CA)
Application Number:	12/521,949
Patent Claims:	1. A dosage form for oral transmucosal administration to a subject, comprising: from about 5 to about 100 micrograms (mcg) of sufentanil and a bioadhesive material, wherein; (i) said bioadhesive material provides for adherence of the dosage form to the oral mucosa of said subject during the period of drug delivery; (ii) said dosage form has a volume of less than 30 microliters or a mass of less than 30 mg; and (iii) after administration of said dosage form to said subject, said dosage form provides a minimal saliva response and minimal swallowing of sufentanil; at least 55% of drug delivery of sufentanil occurs via the oral transmucosal route; said dosage form provides a dose-normalized mean C.sub.max of 1.59-2.75 pg/mL per mcg dosed; and said dosage form provides a T.sub.max with a coefficient of variation of less than 40%. 2. The drug dosage form according to claim 1, wherein said dosage form comprises a dose of sufentanil selected from the group consisting of 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, 40 mcg, 50 mcg, 60 mcg, 70 mcg, 80 mcg and 100 mcg. 3. The dosage form according to claim 1, wherein said dosage form has a mass of less than 10 mg or a volume of less than 10 .mu.l. 4. The dosage form according to claim 1, wherein said oral transmucosal administration is sublingual or buccal administration. 5. The dosage form according to claim 1, wherein the erosion time of said dosage form is from 30 seconds up to a time selected from the group consisting of 5 minutes, 10 minutes, 15 minutes and 30 minutes. 6. The drug dosage form according to claim 4, wherein said dosage form delivers at least 60% of the total amount of sufentanil in said dosage form via the sublingual route. 7. The drug dosage form according to claim 4, wherein a single sublingual administration of said dosage form to a subject results in a bioavailability of greater than 50%. 8. The dosage form according to claim 4, wherein a single sublingual administration of said dosage form to a subject results in a bioavailability of greater than 60%. 9. The dosage form according to claim 4, wherein a single sublingual administration of said dosage form to a subject results in a bioavailability of greater than 70%. 10. The drug dosage form according to claim 4, wherein following repeated sublingual administrations of said dosage form to a subject, the bioavailability is greater than the bioavailability following a single sublingual administration to said subject. 11. The drug dosage form according to claim 4, wherein the difference between the T.sub.max following repeated sublingual administrations and the time of the previous sublingual administration is shorter than the T.sub.max following a single sublingual administration to said subject. 12. The formulation according to claim 1, wherein said dosage form is selected from the group consisting of a lozenge, a pill, a tablet, a membrane and a strip. 13. The dosage form according to claim 12, wherein said dosage form is a tablet. 14. A single dose applicator (SDA), comprising a dosage form according to claim 1. 15. A method of treating pain, comprising administering the dosage form of claim 1 to a patient in need thereof using a single dose applicator (SDA). 16. The method according to claim 15, wherein said pain is acute pain, breakthrough pain or post-operative pain. 17. The method according to claim 16, wherein said pain is acute inpatient pain. 18. The method according to claim 16, wherein said pain is post-operative pain.