Claims for Patent: 11,478,422

Summary for Patent: 11,478,422

Title:	Film formulations containing dexmedetomidine and methods of producing them
Abstract:	Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
Inventor(s):	Vasukumar KAKUMANU, David Christian HANLEY, Frank Yocca, Chetan Dalpatbhai LATHIA, Scott David Barnhart
Assignee:	EZ Bioxcel Solutions Pvt Ltd , Bioxcel Therapeutics Inc
Application Number:	US16/931,630
Patent Claims:	1. A self-supporting, dissolvable, film, comprising: (i) dexmedetomidine or a pharmaceutically acceptable salt thereof; (ii) one or more first water-soluble hydroxypropyl cellulose polymers having a molecular weight of about 40,000 daltons; (iii) one or more second water-soluble hydroxypropyl cellulose polymers having a molecular weight of about 140,000 daltons; (iv) one or more third water-soluble hydroxypropyl cellulose polymers having a molecular weight of about 370,000 daltons; and (v) one or more pharmaceutically acceptable carriers; wherein the first water-soluble hydroxypropyl cellulose polymer having a molecular weight of about 40,000 daltons is present at about 3% to about 8% w/w of the total film weight wherein the second water-soluble hydroxypropyl cellulose polymer having a molecular weight of about 140,000 daltons is present at about 3% to about 8% w/w of the total film weight wherein the third water-soluble hydroxypropyl cellulose polymer having a molecular weight of about 370,000 daltons is present at about 20% to about 40% w/w of the total film weight wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is present at about 0.05% to about 3% weight/weight (w/w) of the total film weight, and wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is substantially uniformly distributed throughout the film. 2. The film of claim 1, wherein the pharmaceutically acceptable carriers are selected from the group consisting of: liquid carriers, flavors, sweeteners, refreshing agents, pH adjusting agents, permeation enhancers, plasticizers, bulking agents, surfactants, anti-foaming agents, and colorants. 3. The film of claim 1, wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is present in a dose of about 0.5 micrograms to about 200 micrograms. 4. The film of claim 1, wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is present in a dose of about 120 micrograms. 5. The film of claim 1, further comprising a water-soluble polyethylene oxide polymer having a molecular weight of about 600,000 daltons, wherein said water-soluble polyethylene oxide polymer having a molecular weight of about 600,000 daltons is present at about 50% to about 60% w/w of the total film weight. 6. The film of claim 1, wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is present in a dose of about 30 micrograms. 7. The film of claim 1, wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is present in a dose of about 60 micrograms. 8. The film of claim 1, wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is present in a dose of about 90 micrograms.