PROBLEM TO BE SOLVED: To provide enteric-coated sustained release-pharmaceutical compositions which have a simple constitution and are capable of simultaneously having intragastric release inhibition and sigmoid type zero-order release over a long time in the intestinal tract.SOLUTION: Provided is an enteric-coated sustained release formulation for oral administration comprising an uncoated tablet containing a drug and a water absorption swelling gelling agent, and a film coating film which contains ethyl cellulose and/or acetyl cellulose and an enteric coating agent and which coats an uncoated tablet. In a film, the relationship between the weight ratio of the content of ethyl cellulose and/or acetyl cellulose as well as the enteric coating agent with respect to the amount of the film per 1.5 cm2 of the surface area of an uncoated tablet is in the area surrounded by the points a to n shown in FIG. 1.SELECTED DRAWING: Figure 1COPYRIGHT: (C)2019,JPO&INPIT【課題】簡単な構成で、胃内での放出抑制と、腸管内での長時間に亘るシグモイド型0次放出とを両立することが可能な腸溶性徐放性医薬組成物を提供する。【解決の手段】経口投与用の腸溶性徐放性製剤は、薬物と吸水膨潤性ゲル化剤とを含有する素錠と、エチルセルロースおよび/またはアセチルセルロースと腸溶性皮膜剤とを含み素錠を被覆するフィルムコーティング皮膜とを備える。皮膜において、エチルセルロースおよび/またはアセチルセルロースと腸溶性皮膜剤との含有量の重量比と、素錠の表面積1.5cm2当たりの皮膜の量との関係は、図1に示す点a~nで囲まれる領域内である。【選択図】図1
