PROBLEM TO BE SOLVED: To provide a producing method of a tablet disintegrating in oral cavity and the tablet disintegrating in oral cavity, in which bitterness in clopidogrel sulfate is masked and stability as original drug is improved during production of the tablet disintegrating in oral cavity and after production of the tablet disintegrating in oral cavity.SOLUTION: There is provided a producing method for a tablet disintegrating in oral cavity comprising: a granule producing step for producing granules containing clopidogrel sulfate and excipient and having an average particle size of 50 μm to 600 μm, in which the granule producing step comprises a step of charging original drag powder containing clopidogrel sulfate having an average particle size of 5 μm to 20 μm and excipient into a stirring granulator and a step of controlling moisture in the stirring granulator so that the granule obtained by the stirring granulation has water content of 1 mass% or more to 12 mass% and a step of forming a layer dissolvable in stomach in which the obtained granule is covered with a macromolecule compound dissolvable in stomach by stirring granulation or flowing granulation to provide a layer dissolvable in stomach onto the granule.COPYRIGHT: (C)2015,JPO&INPIT【課題】クロピドグレル硫酸塩の苦みがマスキングされ、口腔内崩壊錠製造時及び製造後の原薬安定性を向上させうる口腔内崩壊錠の製造方法、及び口腔内崩壊錠を提供する。【解決手段】平均粒子径5μm~20μmのクロピドグレル硫酸塩を含む原薬粉末と賦形剤とを撹拌造粒機に投入する工程と、撹拌造粒機内の水分量を制御して、撹拌造粒によって得られる造粒物の含水率を1質量%以上12質量%未満とする工程と、を含む、クロピドグレル硫酸塩と賦形剤とを含有し、平均粒子径50μm~600μmの造粒物を作製する造粒物作製工程、及び、得られた造粒物を、撹拌造粒又は流動層造粒によって、胃で溶解する高分子化合物を用いて被覆し、造粒物上に胃溶層を作製する胃溶層形成工程、を含む口腔内崩壊錠の製造方法。【選択図】なし
