PROBLEM TO BE SOLVED: To improve stability of a formulation by combining a suitable additive agent with a fluidizer to solve the problem of the fluidizer of promoting degradation of a drug frequently, the fluidizer being combined in order to improve fluidity at the time of granulation because sugar alcohol or saccharide or the like, which is frequently used as a main excipient of a formulation, is inferior in fluidity.SOLUTION: The invention provides an oral formulation of olanzapine including an orally disintegrable tablet, which can inhibit the increase in related substances by heat, humidity, and light irradiation, can be produced by a common method, and is also excellent in stability or physical quality, by containing an alkaline additive agent into a formulation composition of olanzapine which is destabilized by a fluidizer.COPYRIGHT: (C)2015,JPO&INPIT【課題】製剤の主たる賦形剤として繁用される糖アルコール又は糖類等は流動性が劣る為、造粒時の流動性を改善する目的で流動化剤が配合されるが、流動化剤にはしばしば薬物の分解を促進する課題があり、これに適切な添加剤を配合することによる製剤の安定性の改善。【解決手段】流動化剤により不安定化するオランザピンの製剤組成物にアルカリ性添加剤を配合することで、熱、湿度及び光照射による類縁物質の増加を抑制することができ、一般的な方法で製造可能で、安定性や物理的品質にも優れた口腔内崩壊錠をはじめとするオランザピンの経口製剤。【選択図】なし
