PROBLEM TO BE SOLVED: To provide an orally disintegrating tablet which is excellent in tablet hardness and disintegrating properties.SOLUTION: The invention provides a production method of an orally disintegrating tablet comprising the following steps (1)-(3): (1) obtaining a tablet by tableting a drug, erythritol with a mean particle diameter of 15-90 μm, a powder mixture containing a binder and lubricant, or a granulation mixture containing a drug, erythritol with a mean particle diameter of 15-90 μm, a binder, and a lubricant, wherein the erythritol content of the tablet is 50-98 mass% to the total mass of the tablet, and the tableting is performed with a tableting pressure which gives the following (i) and (ii) to an orally disintegrating tablet obtained in the step (3): (i) a pore volume V1 with a pore size of 0.1-100 μm is 0.15-0.40 ml/g, and (ii) the ratio of the pore volume V2 with a pore size of 0.1-10 μm to the V1 (V2/V1) is 0.50-1.00 (2) allowing the tablet obtained in the step (1) to pass through the inside of a humidification chamber, wherein the dew point of the vapor generated from the humidifier connected to the humidification chamber is set up at the temperature lower by 1-5°C than the temperature in the humidification chamber and (3) obtaining an orally disintegrating tablet by drying the tablet obtained in the step (2).SELECTED DRAWING: NoneCOPYRIGHT: (C)2016,JPO&INPIT【課題】錠剤硬度と崩壊性とに優れた口腔内崩壊錠を提供する。【解決手段】口腔内崩壊錠の製造方法において、下記工程(1)~(3): (1)薬物、平均粒子径が15~90μmのエリスリトール、結合剤及び滑沢剤を含む混合粉末、又は、薬物、平均粒子径が15~90μmのエリスリトール、結合剤及び滑沢剤を含む造粒混合物を打錠して錠剤を得る工程であって、 該錠剤のエリスリトール含量が、該錠剤の総質量に対して50~98質量%であり、 該打錠を、工程(3)で得られた口腔内崩壊錠に下記(i)及び(ii): (i)細孔径0.1~100μmの細孔体積V1が0.15~0.40ml/gである、 (ii)細孔径0.1~10μmの細孔体積V2のV1に対する比(V2/V1)が0.50~1.00であるを与える打錠圧で行う工程、 (2)工程(1)で得られた錠剤を、加湿庫内を通過させる工程であって、 加湿庫に接続された加湿器から発生する水蒸気の露点が、加湿庫内の温度より1~5℃低く設定されている工程、及び (3)工程(2)で得られた錠剤を乾燥させて、口腔内崩壊錠を得る工程を実施する。【選択図】なし
