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|Title:||Sublingual fentanyl spray|
|Abstract:||The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt 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. (Gurnee, IL), Zhu; Zhongyuan (Vernon Hills, IL), Parikh; Neha (Chicago, IL), Kattookaran; Linet (Mount Prospect, IL)|
|Assignee:||Insys Therapeutics, Inc. (Phoenix, AZ)|
1. A unit dose of a non-propellant sublingual fentanyl formulation comprising discrete liquid droplets of an effective amount of fentanyl and a pharmaceutically acceptable
liquid carrier, wherein the sublingual fentanyl formulation comprises: from about 0.1% to about 0.8% by weight of fentanyl or a pharmaceutically acceptable salt thereof; from about 20% to about 60% by weight of ethanol; and from about 4% to about 6% by
weight of propylene glycol; wherein after sublingual administration to a human, said sublingual fentanyl formulation provides a mean time to maximum plasma concentration (T.sub.max) of fentanyl of from about 5 to about 120 minutes.
2. The unit dose of claim 1, wherein said discrete liquid droplets have a size distribution of from about 10 .mu.m to about 200 .mu.m.
3. The unit dose of claim 1 wherein after sublingual administration to a human, the sublingual fentanyl formulation provides a mean time to maximum plasma concentration (T.sub.max) of fentanyl of from about 10 to about 60 minutes.
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