US 12,403,090 B2
Oral film compositions and dosage forms having precise active dissolution profiles
Alexander Mark Schobel, Vero Beach, FL (US); Stephen Wargacki, Pittstown, NJ (US); Vincent J. Buono, Basking Ridge, NJ (US); Susan Shumard, Green Brook, NJ (US); and Christopher James Santee, Portage, IN (US)
Assigned to Aquestive Therapeutics, Inc., Warren, NJ (US)
Filed by Aquestive Therapeutics, Inc., Warren, NJ (US)
Filed on Nov. 17, 2022, as Appl. No. 17/989,307.
Application 17/989,307 is a continuation of application No. 16/561,573, filed on Sep. 5, 2019, granted, now 11,541,002.
Claims priority of provisional application 62/732,720, filed on Sep. 18, 2018.
Claims priority of provisional application 62/728,187, filed on Sep. 7, 2018.
Prior Publication US 2023/0149304 A1, May 18, 2023
Int. Cl. A61K 9/00 (2006.01); A61K 31/5513 (2006.01); A61P 25/08 (2006.01)
CPC A61K 9/006 (2013.01) [A61K 31/5513 (2013.01); A61P 25/08 (2018.01)] 14 Claims
 
1. A self-supporting oral film for delivery of a desired amount of an active in an individual unit dose, said film comprising:
a) a water-soluble polymer matrix, a water swellable polymer matrix, or a water-soluble and water swellable polymer matrix;
b) the active being clobazam and having an average particle size D90 of less than about 160 microns; and
c) an additive selected from the group consisting of a sweetener, a flavor, a flavor enhancer, a filler, a plasticizer, a dye, a pigment, a permeation enhancer, a buffer, a preservative, silicon dioxide, an anti-tacking agent, and any combination thereof;
wherein, upon placing the film in a medium, about 60% or more of the active is dissolved in the medium after about 4 minutes.