|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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.