Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
|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.
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.