[Challenge] Intraoral quick disintegrating which has a high formability and sufficient hardness to the extent that despite its content of high active ingredient, problems such as powdering chipping and does not occur in the transportation and manufacturing, with the collapse of a good oral cavity to provide the preparation of orally rapidly disintegrating tablet obtained by compression molding using a formulation conventional equipment, as well as tablets,. [MEANS FOR SOLVING PROBLEMS] Granulated particles containing the active ingredient in these composite particles of sugar (a) (b) of 2 or more, or consisting of (b) inorganic substance (c) disintegrating agent is dispersed homogeneously, (b ) lubricants, (c) disintegration aid, at least one element selected from binders and / or excipients, after mixing the (d) the active ingredient, by compression molding using the formulations conventional equipment Also, by using the (external lubrication method) is applied to the punch surface-die surface pre lubricants, even at high active ingredient content, and has a sufficient hardness excellent moldability, disintegration and good It is possible to provide an orally rapidly disintegrating tablets.【課題】高い活性成分の含有率でありながら、製造や輸送に欠けや粉化といった問題が生じない程度の充分な硬度と高い成形性を有し、良好な口腔内での崩壊性を有する口腔内速崩壊錠、ならびに通常の製剤設備を用いて圧縮成型することによって得られる口腔内速崩壊錠の製法を提供する。【解決手段】(a)(イ)2種以上の糖類の複合粒子中に、(ロ)無機物及び(ハ)崩壊剤が均質に分散してなるか、又はこれらに活性成分を含有する造粒粒子、(b)滑沢剤、(c)崩壊助剤、賦形剤及び/又は結合剤から選ばれる少なくとも1種以上、(d)活性成分を混合したのち、通常の製剤設備を用いて圧縮成型することによって、また、滑沢剤を予め杵表面・臼表面に塗布する方法(外部滑沢法)を用いることによって、高い活性成分含有においても、優れた成形性、良好な崩壊性及び充分な硬度を有する口腔内速崩壊性錠剤を提供することができる。
