Claims for Patent: 11,517,524

Summary for Patent: 11,517,524

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:	US17/560,423
Patent Claims:	1. A composition comprising: (i) dexmedetomidine or a pharmaceutically acceptable salt thereof; (ii) a first water-soluble hydroxypropyl cellulose polymer having a molecular weight of about 40,000 daltons in an amount of about 3% to about 15% w/w of the total composition weight; (iii) a second water-soluble hydroxypropyl cellulose polymer having a molecular weight of about 140,000 daltons in an amount of about 3% to about 8% w/w of the total composition weight; (iv) a third water-soluble hydroxypropyl cellulose polymer having a molecular weight of about 370,000 daltons in an amount of about 10% to about 50% w/w of the total composition weight; and (v) a water-soluble polyethylene oxide polymer having a molecular weight of about 600,000 daltons in an amount of about 40% to about 70% w/w of the total composition weight. 2. The composition according to claim 1 in the form of a self-supporting, dissolvable mucoadhesive film. 3. The composition according to claim 2, wherein the self-supporting, dissolvable mucoadhesive film is suitable for sublingual or buccal administration. 4. A composition comprising: (a) dexmedetomidine hydrochloride; and further comprising (b) a film substrate comprising: (i) hydroxypropyl cellulose having a molecular weight of about 40,000 daltons in an amount of about 3% to about 15% w/w of the total composition weight; (ii) hydroxypropyl cellulose having a molecular weight of about 140,000 daltons in an amount of about 3% to about 8% w/w of the total composition weight; (iii) hydroxypropyl cellulose having a molecular weight of about 370,000 daltons in an amount of about 10% to about 50% w/w of the total composition weight; and (iv) polyethylene oxide having a molecular weight of about 600,000 daltons in an amount of about 40% to about 70% w/w of the total composition weight. 5. The composition according to claim 4, wherein dexmedetomidine hydrochloride is present at about 0,05% to about 3% w/w of the total composition weight. 6. The composition according to claim 4, wherein dexmedetomidine hydrochloride is present at about 0.1% to about 0.2% w/w of the total composition weight, hydroxypropyl cellulose having a molecular weight of about 40,000 daltons is present at about 5% w/w of the total composition weight and hydroxypropyl cellulose having a molecular weight of about 140,000 daltons is present at about 5% w/w of the total composition weight. 7. The composition according to claim 4, wherein the composition comprises one or more colorants. 8. The composition according to claim 2, wherein the film has a thickness of about 20 micrometers to about 200 micrometers. 9. The composition according to claim 2, wherein the film has a thickness of about 20 micrometers to about 200 micrometers and covers an area (width×length) of about 100 mm2 to about 300 mm2. 10. The composition according to claim 2, wherein the film has a disintegration time of about 60 seconds to about 180 seconds. 11. The composition according to claim 2, wherein the film has a mucoadhesion force of about 1000 g to about 200 g. 12. The composition according to claim 4, wherein said dexmedetomidine hydrochloride is present in an amount of about 10 micrograms. 13. The composition according to claim 4, wherein said dexmedetomidine hydrochloride is present in an amount of about 20 micrograms. 14. The composition according to claim 4, wherein said dexmedetomidine hydrochloride is present in an amount of about 30 micrograms. 15. The composition according to claim 4, wherein said dexmedetomidine hydrochloride is present in an amount of about 40 micrograms. 16. The composition according to claim 4, wherein said dexmedetomidine hydrochloride is present in an amount of about 60 micrograms. 17. A method of treating agitation in a subject comprising administering buccally to the agitated subject a composition according to claim 4. 18. The composition according to claim 2, wherein the film is completely dissolvable in oral mucosal fluid in about 1 minute to about 5 minutes. 19. The composition according to claim 4, wherein said dexmedetomidine hydrochloride is present in an amount of about 90 micrograms. 20. The composition according to claim 4, wherein said dexmedetomidine hydrochloride is present in an amount of about 120 micrograms. 21. The composition according to claim 4, wherein said composition is administered in one or more units to provide a total daily dose of dexmedetomidine hydrochloride of about 120 micrograms. 22. The composition according to claim 4, wherein said composition is administered in one or more units to provide a total daily dose of dexmedetomidine hydrochloride of about 180 micrograms. 23. The composition according to claim 3, wherein said film is administered in one or more units to provide a total daily dose of dexmedetomidine or a pharmaceutically acceptable salt thereof of about 120 micrograms. 24. The composition according to claim 3, wherein said film is administered in one or more units to provide a total daily dose of dexmedetomidine or a pharmaceutically acceptable salt thereof of about 180 micrograms.