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 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 T max between 0.98 hour and 3.95 hours, a C max 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.
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 T max is between 1 hour and 2 hours.
6 . The method of claim 1 , wherein the T max is between 1 hour and 1.5 hours.
7 . The method of claim 1 , wherein the T max is between 1.45 hours and 2 hours.
8 . The method of claim 1 , wherein the C max is between 93.67 ng/L and 206.42 ng/L.
9 . The method of claim 1 , wherein the C max is between 105.84 ng/L and 186.40 ng/L.
10 . The method of claim 1 , wherein the C max is between 113.35 ng/L and 154.79 ng/L.
11 . The method of claim 1 , wherein the C max is between 127.30 ng/L and 144.27 ng/L.
12 . The method of claim 1 , wherein the AUCINF_obs is between 369.07 hr*ng/L and 1064.08 hr*ng/L.
13 . The method of claim 1 , wherein the AUCINF_obs is between 377.98 hr*ng/L and 877.63 hr*ng/L.
14 . The method of claim 1 , wherein the AUCINF_obs is between 428.64 hr*ng/L and 807.14 hr*ng/L.
15 . The method of claim 1 , wherein the AUCINF_obs is between 537.29 hr*ng/L and 691.00 hr*ng/L.
16 . A pharmaceutical delivery system, comprising:
means for achieving a T max between 0.98 hour and 3.95 hours, a C max 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.
17 . The pharmaceutical delivery system of claim 16 , wherein the T max is between 1 hour and 2 hours.
18 . The pharmaceutical delivery system of claim 16 , wherein the T max is between 1 hour and 1.5 hours.
19 . The pharmaceutical delivery system of claim 16 , wherein the T max is between 1.45 hours and 2 hours.
20 . The pharmaceutical delivery system of claim 16 , wherein the C max is between 93.67 ng/L and 206.42 ng/L.
21 . The pharmaceutical delivery system of claim 16 , wherein the C max is between 105.84 ng/L and 186.40 ng/L.
22 . The pharmaceutical delivery system of claim 16 , wherein the C max is between 113.35 ng/L and 154.79 ng/L.
23 . The pharmaceutical delivery system of claim 16 , wherein the C max is between 127.30 ng/L and 144.27 ng/L.
24 . The pharmaceutical delivery system of claim 16 , wherein the AUCINF_obs is between 369.07 hr*ng/L and 1064.08 hr*ng/L.
25 . The pharmaceutical delivery system of claim 16 , wherein the AUCINF_obs is between 377.98 hr*ng/L and 877.63 hr*ng/L.
26 . The pharmaceutical delivery system of claim 16 , wherein the AUCINF_obs is between 428.64 hr*ng/L and 807.14 hr*ng/L.
27 . The pharmaceutical delivery system of claim 16 , wherein the AUCINF_obs is between 537.29 hr*ng/L and 691.00 hr*ng/L.
28 . A method of treating agitation associated with dementia, schizophrenia, or bipolar I or II disorder in a human subject, comprising administering the pharmaceutical delivery system of claim 16 .
29 . The method of claim 28 , wherein the pharmaceutical delivery system is administered sublingually.
30 . The method of claim 28 , wherein the pharmaceutical delivery system is administered buccally.