22-01-2015 дата публикации
Номер: US20150025084A1
Provided is a fast dissolving film composition comprising a medically active component as an active ingredient, in which the bitter taste of the active ingredient is masked and the fast dissolving film composition has a high content of 50% or higher. More particularly, provided is a pharmaceutical composition which comprises sildenafil or pharmaceutically acceptable salts thereof as an active ingredient, and which comprises a combination of a specific bitter taste masking agent to achieve masking of a bitter taste. Further, provided is a fast dissolving film composition which comprises a combination of a specific plasticizer to mask a bitter taste, and in which the physical properties of the high-content film are excellent. 1. A fast dissolving film comprising sildenafil or a pharmaceutically acceptable salt thereof , a water soluble hydrocolloid , and a plasticizer wherein the sildenafil or pharmaceutically acceptable salt thereof is present in an amount of at least 100 mg or at least 50% by weight with respect to the total weight of the film.2. The fast dissolving film according to claim 1 , wherein the plasticizer is selected from the group consisting of glycerin fatty acid esters claim 1 , sucrose fatty acid esters claim 1 , lecithin claim 1 , enzyme modified lecithin claim 1 , polysorbates claim 1 , sorbitan fatty acid esters claim 1 , sorbitol claim 1 , maltitol claim 1 , xylitol claim 1 , glycerin claim 1 , polyethylene glycol claim 1 , propylene glycol claim 1 , hydrogenated starch syrup claim 1 , starch syrup claim 1 , glycerin claim 1 , triacetin claim 1 , glycerol oleate claim 1 , and medium chain fatty acids.3. The fast dissolving film according to claim 2 , wherein the plasticizer comprises glycerin or sorbitol.4acacia. The fast dissolving film according to claim 1 , wherein the water soluble hydrocolloid is selected from the group consisting of pullulan claim 1 , gelatin claim 1 , pectin claim 1 , low viscosity pectin claim 1 , hydroxypropylmethyl ...
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