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Last Updated: October 29, 2020

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Claims for Patent: 10,342,762

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Summary for Patent: 10,342,762
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 (Petaluma, CA), Hamel; Lawrence (Pacific Grove, CA), Poutiatine; Andrew I. (Mill Valley, CA)
Assignee: AcelRx Pharmaceuticals, Inc. (Redwood City, CA)
Application Number:14/296,992
Patent Claims: 1. A dosage form for oral transmucosal administration to a subject, comprising: from about 0.25 micrograms to about 200 micrograms sufentanil, wherein said dosage form is bioadhesive and has a volume of less than 30 microliters or a mass of less than 30 mg wherein after administration of the dosage form to the subject, the dosage form provides a Tmax with a coefficient of variation less than 40%, wherein said Tmax is from about 19.8 minutes to about 60 minutes.

2. The dosage form of claim 1, wherein the dosage form has a volume of less than 10 microliters or a mass of less than 10 mg.

3. The dosage form of claim 1, wherein after administration of the dosage form to the subject, at least 50% of the drug delivery of sufentanil occurs via the oral transmucosal route.

4. The dosage form of claim 3, wherein after administration of the dosage form to the subject, at least 55% of the drug delivery of sufentanil occurs via the oral transmucosal route.

5. The dosage form of claim 3, wherein after administration of the dosage form to the subject, at least 60% of the drug delivery of sufentanil occurs via the oral transmucosal route.

6. The dosage form of claim 1, wherein after administration of the dosage form to the subject results in a dose-normalized Cmax of about 2.72+/-0.84 pg/mL per mcg dosed.

7. The dosage form of claim 1, wherein the oral transmucosal administration is to the sublingual membrane.

8. The dosage form of claim 1, wherein the administration is to the buccal membrane.

9. The dosage form of claim 1, wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 65%.

10. The dosage form of claim 1, wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 75%.

11. The dosage form of claim 1, wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 80%.

12. The dosage form of claim 1, wherein the dosage form comprises one or more hydrogel forming excipients.

13. The dosage form of claim 12, wherein the one or more hydrogel forming excipients is hydroxypropyl methylcellulose.

14. A drug delivery device comprising the dosage form of claim 1.

15. A dosage form for oral transmucosal administration to a subject, comprising: a bioadhesive dosage form of from about 0.25 micrograms to about 200 micrograms sufentanil with a volume of less than 30 microliters or a mass of less than 30 mg wherein the administration of the dosage form to the subject results in a dose-normalized C.sub.max of 2.72+/-0.84 pg/mL per mcg of sufentanil dosed and a T.sub.max with a coefficient of variation less than 40%.

16. The dosage form of claim 15, wherein after administration of the dosage form to the subject, the dosage form provides a T.sub.max of from 19.8 minutes to 60 minutes.

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