Film formulations containing dexmedetomidine and methods of producing them
AssigneesBioXcel Therapeutics, Inc., ARx, LLC
InventorsVasukumar KAKUMANU, David Christian HANLEY, Frank YOCCA, Chetan Dalpatbhai LATHIA, Scott David BARNHART
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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.
Claims30
A method of treating agitation in a patient comprising administering a film comprising about 60 mcg 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 oral mucosa of the patient, and
- wherein the method achieves a Tmax between 0.98 hour and 3.95 hours, a Cmax between 73.42 ng/L and 253.14 ng/L, and an AUCINF_obs between 293.67 hr*ng/L and 2195.38 hr*ng/L.
A pharmaceutical delivery system, comprising:
- means for achieving a Tmax between 0.98 hour and 3.95 hours, a Cmax between 73.42 ng/L and 253.14 ng/L, and an AUCINF_obs between 293.67 hr*ng/L and 2195.38 hr*ng/L;
- means for adhering the pharmaceutical delivery system to human oral mucosa;
- and
- wherein the pharmaceutical delivery system comprises 60 mcg dexmedetomidine or a pharmaceutically acceptable salt thereof.
Dependencies are inferred from the claim text.