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Claims for Patent: 8,835,459

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Claims for Patent: 8,835,459

Title:Sublingual fentanyl spray
Abstract: The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable sale thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Inventor(s): Kottayil; S. George (Long Grove, IL), Goskonda; Venkat R. (Phoenix, AZ), Zhu; Zhongyuan (Vernon Hills, IL), Kattookaran; Linet (Mount Prospect, IL), Parikh; Neha (Chicago, IL)
Assignee: Insys Therapeutics, Inc. (Phoenix, AZ)
Application Number:13/895,111
Patent Claims: 1. A sublingual formulation comprising from about 0.001% to about 15% by weight fentanyl, a free base, or a pharmaceutically acceptable salt thereof, from about 20% to about 60% by weight ethanol, and from about 4% to about 6% by weight propylene glycol, the formulation providing a mean T.sub.max of about 1.28+/-0.60 hours when a dose is administered sublingually to humans.

2. A sublingual formulation comprising from about 0.001% to about 15% by weight fentanyl, a free base, or a pharmaceutically acceptable salt thereof, from about 50% to about 60% by weight ethanol, and from about 4% to about 6% by weight propylene glycol, which provides a plasma concentration after administration to humans selected from the group consisting of: about 60% of the mean C.sub.max in about 10 minutes, about 86% of the mean C.sub.max by about 20 minutes and a combination thereof.

3. The sublingual formulation of claim 1, that when administered to humans provides a plasma concentration that is greater than about 80% of the mean C.sub.max for about 2 hours.

4. A sublingual spray formulation comprising 400 mcg dose of fentanyl, a free base, or a pharmaceutically acceptable salt thereof, which provides one or more mean pharmacokinetic values selected from the group consisting of: AUC.sub.last 4.863+/-1.70821 hr*ng/mL, AUC.sub.inf 5.761+/-1.916 hr*ng/mL, and AUC.sub.extrap 10.26+/-5.66%, when administered to humans.

5. A sublingual spray formulation comprising a dose of fentanyl, a free base, or a pharmaceutically acceptable salt thereof, which provides a substantially dose proportional mean AUC.sub.last based on a mean AUC.sub.last of about 4.863+/-1.70821 hr*ng/mL for a 400 mcg fentanyl dose when administered to humans.

6. A sublingual spray formulation comprising a 400 mcg dose of fentanyl, a free base, or a pharmaceutically acceptable salt thereof, which provides a mean F(AUC.sub.last) of about 0.721+/-0.199 ng/mL when administered to humans.
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