DrugPatentWatch Database Preview
« Back to Dashboard
Summary 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)|
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.
For more information try a trial or see the plans and pricing
Serving hundreds of leading biopharmaceutical companies globally:
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.