Patent ID: 9125836
Filing Date: 2015-09-08
Classification: A61K,A61P

Abstract:
1. A rapidly soluble film preparation comprising: an active-ingredient-containing layer consisting of an active ingredient, a water soluble polymer selected from the group consisting of methyl cellulose, hydroxypropyl cellulose and hydroxypropyl methyl cellulose, a disintegrating agent which is a mixture of crystalline cellulose and carboxymethyl cellulose sodium, a plasticizer, one or more substances selected from the group consisting of an emulsifier, a sweetener, a corrective, a masking reagent and an aromatizer; and an active-ingredient-free layer comprising the plasticizer and a component selected from the group consisting of methyl cellulose and hydroxypropyl methyl cellulose, wherein a content of the active ingredient is from 0.1% by mass to 75.0% by mass of a total mass of the film preparation, a total content of the active ingredient and the water soluble polymer in the active-ingredient-containing layer is from 15.0% by mass to 95.0% by mass of a total mass of the active-ingredient-containing layer, and a content of the water soluble polymer in the film preparation is from 5.0 to 35.0% by mass relative to the total mass of the film preparation, wherein the emulsifier is selected from the group consisting of alkylbenzene sulfonate, carrageenan, carboxy vinyl polymers, guar gum, glycerin fatty acid esters, sucrose fatty acid esters, stearic acid, lanolin, egg-yolk lecithin, cetanol, sorbitan fatty acid esters, soybean lecithin, sorbitan trioleate, pectin, polyoxyethylene hydrogenated castor oil, sodium lauryl sulfate and lauromacrogol; wherein the sweetener is selected from the group consisting of acesulfame potassium, aspartame, dipotassium glycyrrhizinate, saccharin, sodium saccharin, thaumatin and stevia; wherein the corrective is selected from the group consisting of adipic acid, ascorbic acid, citric acid, tartaric acid, tannic acid, fumaric acid, malic acid, methyl salicylate and L-menthol; wherein the plasticizer is selected from the group consisting of Triethyl citrate, glycerin, triacetin, propylene glycol, polyoxyethylene (105) polyoxypropylene (5) glycol, polysorbate, macrogol, glyceryl monostearate and mannitol; wherein the masking agent is selected from the group consisting of a cyclodextrin and an ion-exchange resin; wherein the aromatizer is selected from the group consisting of fennel oil, orange oil, chamomile oil, camphor, cinnamon oil, salvia oil, spearmint oil, clove oil, mentha oil, vanillin, peppermint extract, bergamot oil, borneol, eucalyptus oil, lavender oil, lemon oil, rose oil and Roman chamomile oil; wherein a content of the plasticizer in both of the active-ingredient containing layer and the active-ingredient-free layer is from 11.16% by mass to 22.28% by mass of a total mass of the rapidly soluble film preparation; and wherein a content of the disintegrating agent is from 33.29% by mass to 39.85% by mass of a total mass of the rapidly soluble film preparation.