US 11,806,429 B2
Film formulations containing dexmedetomidine and methods of producing them
Vasukumar Kakumanu, Guntur (IN); David Christian Hanley, Brookfield, CT (US); Frank Yocca, Clinton, CT (US); Chetan Dalpatbhai Lathia, Woodbridge, CT (US); and Scott David Barnhart, Glen Rock, PA (US)
Assigned to BioXcel Therapeutics, Inc., New Haven, CT (US)
Filed by BioXcel Therapeutics, Inc., New Haven, CT (US)
Filed on Jan. 20, 2022, as Appl. No. 17/579,914.
Application 17/579,914 is a continuation of application No. 17/103,013, filed on Nov. 24, 2020, granted, now 11,559,484.
Application 17/103,013 is a continuation of application No. 16/931,630, filed on Jul. 17, 2020, granted, now 11,478,422.
Application 16/931,630 is a continuation of application No. 16/453,679, filed on Jun. 26, 2019, granted, now 10,792,246, issued on Oct. 6, 2020.
Claims priority of provisional application 62/849,747, filed on May 17, 2019.
Claims priority of provisional application 62/798,842, filed on Jan. 30, 2019.
Claims priority of provisional application 62/787,649, filed on Jan. 2, 2019.
Claims priority of provisional application 62/767,422, filed on Nov. 14, 2018.
Claims priority of provisional application 62/693,726, filed on Jul. 3, 2018.
Claims priority of provisional application 62/690,407, filed on Jun. 27, 2018.
Prior Publication US 2022/0142918 A1, May 12, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/00 (2006.01); A61P 25/22 (2006.01); A61K 47/38 (2006.01); A61K 9/70 (2006.01); A61K 31/4174 (2006.01); A61K 47/34 (2017.01)
CPC A61K 9/0056 (2013.01) [A61K 9/7007 (2013.01); A61K 31/4174 (2013.01); A61K 47/34 (2013.01); A61K 47/38 (2013.01); A61P 25/22 (2018.01)] 15 Claims
 
1. A method of treating agitation in a patient comprising administering a film comprising dexmedetomidine or a pharmaceutically acceptable salt thereof, water-soluble hydroxypropyl cellulose polymers having molecular weight of about 40,000 daltons, about 140,000 daltons, and about 370,000 daltons and a water-soluble polyethylene oxide polymer having a molecular weight of about 600,000 daltons, to the oral mucosa of the patient, wherein the method achieves about 70% to about 80% of Cmax within 2 hours of administration, wherein the Cmax is about 78 ng/L to about 200 ng/L, wherein said dexmedetomidine or pharmaceutically acceptable salt thereof is present in the film in an amount of about 40 micrograms.