Abstract: The present invention provides an oral patch for localized treatment of mouth ulcers containing combination of tetracaine and triamcinolone as active drugs. The patch is a bilayer structure containing a drug layer with amorphous tetracaine hydrochloride and amorphous triamcinolone acetonide and a water-soluble backing layer without a drug. The oral patch with combination of drugs has improved efficacy over each individual drug. The drug layer comprises 3-20% by weight of amorphous tetracaine hydrochloride, or a pharmaceutical acceptable salt thereof, 0.1-2.0% by weight of amorphous triamcinolone acetonide or a pharmaceutical acceptable salt thereof, 20-95% by weight of a first film-forming material, 1-12% by weight of an adhesive, 1-20% by weight of one or more cooling agent, and optionally 1-12% by weight of a plasticizer. The backing layer comprises 70-95% by weight of one or more film-forming agents, 2-10% by weight of a plasticizer and optionally 1-8% by weight of a flavoring agent.

Abstract: The present invention provides an oral transmucosal film for delivering agomelatine through the buccal mucosa or sublingual mucosa. The film is a bilayer structure containing a mucoadhesive layer with amorphous agomelatine and a water-soluble backing layer without agomelatine. The film has improved bioavailability and improved palatability. The mucoadhesive layer comprises comprising 0.1%-40% by weight of amorphous agomelatine, or a pharmaceutical acceptable salt thereof, 50-98% by weight of a first film-forming material, 0.5-20% by weight of an oil phase excipient, and 0.5-17% by weight of a surfactant. The backing layer comprises 60-100% (w/w) of one or more film-forming agents.

Abstract: The present invention provides an oral transmucosal film for delivering tadalafil through the buccal mucosa or sublingual mucosa. The film is a single layer structure containing amorphous tadalafil, one or more solubilizers, one or more penetration enhancers, and one or more adhesives to deliver the drug through a transmucosal route. Comparing with an oral tadalafil tablet, the present oral transmucosal film provides improved absorption rate and Tmax. The oral transmucosal film comprises 5%-60% by weight of amorphous tadalafil, 25-96% by weight of a film-forming material, 1-20% by weight of a solubilizer, 0.5-10% by weight of a penetration enhancer, and 1-15% by weight of an adhesive.

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.