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Claims for Patent: 8,835,460

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Claims for Patent: 8,835,460

Title:Sublingual fentanyl spray and methods of treating pain
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. (Phoenix, AZ), Zhu; Zhongyuan (Vernon Hills, IL), Kattookaran; Linet (Mount Prospect, IL), Parikh; Neha (Chicago, IL)
Assignee: Insys Therapeutics, Inc. (Phoenix, AZ)
Application Number:13/895,124
Patent Claims: 1. A sublingual formulation comprising discrete liquid droplets of an effective amount of fentanyl or a fentanyl derivative selected from the group consisting of sufentanil, carfentanil, lofentanil and alfatenil, a free base or a pharmaceutically acceptable salt thereof, in a pharmaceutically acceptable liquid carrier; said droplets having a mean diameter of from about 30 to about 70 microns.

2. A non-propellant sublingual fentanyl formulation comprising discrete liquid droplets of an effective amount of fentanyl a free base, or a pharmaceutically acceptable salt thereof, in a pharmaceutically acceptable liquid carrier, wherein the sublingual fentanyl formulation comprises: from about 0.001% to about 15% by weight fentanyl free base; from about 50% to about 60% by weight of ethanol; and from about 4% to about 6% by weight of propylene glycol; said droplets having a mean diameter of at least about 10 microns.

3. A non-propellant sublingual fentanyl formulation comprising discrete liquid droplets of an effective amount of fentanyl a free base, or a pharmaceutically acceptable salt thereof, in a pharmaceutically acceptable liquid carrier, wherein the sublingual fentanyl formulation consists essentially of: from about 0.001% to about 15% by weight fentanyl free base; from about 50% to about 60% by weight of ethanol; and from about 1% to about 30% by weight of propylene glycol; said droplets having a mean diameter of at least about 10 microns.

4. A multi-dose device for sublingual administration of a drug comprising: a reservoir containing the liquid formulation comprising fentanyl, or a fentanyl derivative selected from the group consisting of sufentanil, carfentanil, lofentanil and alfatenil, a free base or a pharmaceutically acceptable salt thereof, in a pharmaceutically acceptable liquid carrier; and the device having an actuator which when actuated delivers a therapeutically effective dose of the liquid formulation in the form of liquid droplets having a mean diameter of from about 30 to about 70 microns.

5. A method of treating pain comprising sublingually administering an effective amount of the sublingual formulation according to claim 1 to a human patient experiencing pain.
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