Production is possible in tablet production facility typically also have a sufficient hardness for practical use, the present invention, (a delay of rapidly disintegrating time in the oral cavity and the hardness decreased tablet) the change in characteristics due to factors such as humidity to provide an orally rapidly disintegrating tablet that has the features that it is difficult to produce. An oral cavity rapidly disintegrating tablet disintegration time in the oral cavity is 60 seconds or less in hardness 40N above, the present invention, (a) the active ingredient good excipient wettability to water (b) which is characterized by being obtained by compression molding a mixture of the (d) disintegrating agents, water-insoluble polymer does not substantially reduce the wettability to water in the excipient (c) moldability good related to the oral cavity rapidly disintegrating tablets.本発明は、通常の錠剤製造設備で製造が可能で、実用上充分な硬度を有し、また、湿度等の要因による特性の変化(錠剤の硬度低下及び口腔内での速崩時間の遅延)を生じ難いという特長を有する口腔内速崩壊性錠を提供する。本発明は、硬度40N以上で口腔内での崩壊時間が60秒以内である口腔内速崩壊性錠であって、(a)活性成分;(b)水への濡れ性が良好な賦形剤;(c)成形性が良好で前記賦形剤の水への濡れ性を実質的に低下させない水不溶性高分子;及び(d)崩壊剤の混合物を圧縮成形して得られることを特徴とする当該口腔内速崩壊性錠に関する。
