FILM FORMULATIONS CONTAINING DEXMEDETOMIDINE AND METHODS OF PRODUCING THEM
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.
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 a C max of about 73 ng/L to about 253 ng/L, wherein said dexmedetomidine or pharmaceutically acceptable salt thereof is present in the film in an amount of about 60 micrograms.
2 . The method of claim 1 , wherein the patient is a human.
3 . The method of claim 1 , wherein the administration to the oral mucosa of the patient is sublingual administration.
4 . The method of claim 1 , wherein the administration to the oral mucosa of the patient is buccal administration.
5 . The method of claim 1 , wherein the C max is about 73 ng/L.
6 . The method of claim 1 , wherein the C max is about 253 ng/L.
7 . The method of claim 1 , wherein the C max is about 132 ng/L.
8 . The method of claim 1 , wherein the method achieves T max at about 1 to about 4 hours.
9 . The method of claim 1 , wherein the method achieves T max at about 1 hour.
10 . The method of claim 1 , wherein the method achieves T max at about 1.5 hours.
11 . The method of claim 1 , wherein the method achieves T max at about 2 hours.
12 . The method of claim 1 , wherein the method achieves T max at about 4 hours.
13 . A film comprising dexmedetomidine or a pharmaceutically acceptable salt thereof, wherein the film achieves a C max of about 73 ng/L to about 253 ng/L, wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is present in an amount of about 60 micrograms, and wherein the film further comprises 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.
14 . The film of claim 13 , wherein the C max is about 73 ng/L.
15 . The film of claim 13 , wherein the C max is about 253 ng/L.
16 . The film of claim 13 , wherein the C max is about 132 ng/L.
17 . The film of claim 13 , wherein the method achieves T max at about 1 to about 4 hours.
18 . The film of claim 13 , wherein the method achieves T max at about 1 hour.
19 . The film of claim 13 , wherein the method achieves T max at about 1.5 hours.
20 . The film of claim 13 , wherein the method achieves T max at about 2 hours.
21 . The film of claim 13 , wherein the method achieves T max at about 4 hours.
22 . The film of claim 13 , wherein the film has a thickness of about 20 micrometers to about 200 micrometers.
23 . The film of claim 13 , wherein the film has a thickness of about 20 micrometers to about 200 micrometers and covers an area (width×length) of about 100 mm 2 to about 300 mm 2 .
24 . The film of claim 13 , wherein the film has a disintegration time of about 60 seconds to about 180 seconds.
25 . The film of claim 13 , wherein the film is completely dissolvable in oral mucosal fluid in about 1 minute to about 5 minutes.