Abstract: The present invention is directed to an aripiprazole oral soluble film and a preparation method thereof. The aripiprazole oral soluble film comprises 10-60% w/w of aripiprazole in a crystalline state and 30-95% w/w of one or more film-forming materials, wherein 90% of the aripiprazole particles have a size of ?14.3 ?m and are uniformly blended in the film without visible undispersed particles. The aripiprazole oral soluble film has excellent bioavailability, uniformity, stability, and palatability. The oral soluble film preparation is prepared by first grinding aripiprazole particles to have desired small particle sizes, then blending the aripiprazole particles with film forming materials in an aqueous solution to a uniform suspension, defoaming the suspension, and coating the suspension on a substrate and drying it to form a film.

Abstract: The present invention is directed to an aripiprazole oral soluble film and a preparation method thereof. The aripiprazole oral soluble film comprises 10-60% w/w of aripiprazole in a crystalline state and 30-95% w/w of one or more film-forming materials, wherein 90% of the aripiprazole particles have a size of ?14.3 ?m and are uniformly blended in the film without visible undispersed particles. The aripiprazole oral soluble film has excellent bioavailability, uniformity, stability, and palatability. The oral soluble film preparation is prepared by first grinding aripiprazole particles to have desired small particle sizes, then blending the aripiprazole particles with film forming materials in an aqueous solution to a uniform suspension, defoaming the suspension, and coating the suspension on a substrate and drying it to form a film.

Abstract: The present invention provides an oral transmucosal film or patch for delivering doxepin through the buccal mucosa or sublingual mucosa. The film or patch is a bilayer structure containing a mucoadhesive layer with amorphous doxepin and soluble backing layer without doxepin. The film or patch has satisfactory bioavailability and improved palatability. The mucoadhesive layer comprises 0.5-25% (w/w) of doxepin, 50-96% of one or more film-forming agents, 1-30% (w/w) of one or more adhesives, and 0.05-5% (w/v) of one or more stabilizers. The backing layer comprises 80-100% (w/w) of one or more film-forming agents. Preferred adhesives include povidone, carbomer, and polycarbophil. Preferred stabilizers include butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), citric acid, and ascorbic acid.

Abstract: The present invention provides a pharmaceutical composition for delivering palonosetron through the buccal mucosa or sublingual mucosa. The pharmaceutical composition comprises 0.05-35% (w/w) of palonosetron, 40-90% of a film forming agent, 1-10% (w/w) of a plasticizer, 5-25% (w/v) of an adhesive agent, and 0.1-5% of a penetration enhancing agent. A preferred plasticizer is a polysorbate. A preferred adhesive agent is polyvinylpyrrolidone or carboxymethylcellulose. A preferred penetration enhancing agent is peppermint oil or menthol.

Abstract: The present invention provides a pharmaceutical composition for delivering an active agent taxane through transmucosal administration, more particularly through the buccal mucosa or sublingual mucosa. The present invention provides a method for treating cancer by buccal or sublingual administration of the pharmaceutical composition to a subject. The pharmaceutical composition comprises a taxane, a non-ionic surfactant, a viscosity enhancing agent, an adhesive agent, and an alcohol solvent at pH 4-6.