Patent ID: 8580830
Filing Date: 2013-11-12
Classification: A61K,A61P

Abstract:
1. A non-mucoadhesive orally disintegrating film, able to disintegrate upon contact with saliva in the buccal cavity within about sixty seconds, comprising ondansetron or a pharmaceutically acceptable salt thereof in combination with a hydrophilic binder and a water-soluble diluent, wherein: a) said film comprises from about 4 to 24 mg ondansetron or a pharmaceutically acceptable salt thereof; b) said ondansetron or pharmaceutically acceptable salt thereof is present in an amount of from about 0.05% to about 50% (w/w/), based on the total weight of the film; c) said film has a Tmax of from about 1.0 to about 2.5 hours; d) said ondansetron or pharmaceutically acceptable salt thereof has an absolute bioavailability in said film of about 45-75%; and e) wherein the said film further comprises means for retarding absorption of active ingredient through the oral mucosa wherein the means for retarding the absorption of active ingredient through the oral mucosa are selected from the group consisting of: (1) an ion exchange resin that binds ondansetron and prevents its ionization and dissolution upon disintegration of the film, wherein said ion exchange resin is selected from the group consisting of polymers and copolymers of acrylic acid, methacrylic acid, sulfonated styrene, sulfonated divinylbenzene, dextrans, and silica gel modified by the addition of ionic groups; (2) pH adjusting agents; (3) cyclodextrin or acrylate polymers; and (4) ondansetron in base form; wherein said retarding means are able to deliver greater than 60% of said ondansetron to the gastrointestinal tract when the film is placed on the tongue, allowed to disintegrate and subsequently swallowed.