Oral film compositions and dosage forms having precise active dissolution profiles
AssigneeAquestive Therapeutics, Inc.
InventorsAlexander Mark Schobel, Stephen Wargacki, Vincent J. Buono, Susan Shumard, Christopher James Santee
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Abstract
An oral film in an individual unit dose for delivery of one or more actives is disclosed herein, the film having a precisely calculated and controlled active dissolution profile. A wide variety of actives may be used, including, for example, clobazam, diazepam, or riluzole. Also disclosed are methods of treating a variety of diseases and conditions, for example, epilepsy and seizures, by administering the oral film disclosed herein.
Claims14
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 30% or more of the active is dissolved in the medium after about 3 minutes.
Dependencies are inferred from the claim text.