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|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 Pharma, Inc. (Chandler, AZ)|
1. A sublingual spray formulation comprising a dose of fentanyl which provides one or more mean pharmacokinetic values selected from the group consisting of: AUClast
4.863+/-1.70821 hr*ng/mL, AUCinf 5.761+/-1.916 hr*ng/milliliter, and AUCextrap 10.26+/-5.66%, when administered to humans.
2. 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 AUClast based on a mean AUClast of about 4.863+/-1.70821 hr*ng/milliliter when administered to humans.
3. A sublingual spray formulation comprising a dose of fentanyl, a free base or a pharmaceutically acceptable salt thereof, which provides a mean F(AUClast) of about 0.721+/-0.199 ng/milliliter when administered to humans.
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