PROBLEM TO BE SOLVED: To provide a high productivity film coating composition which uses PVA with a saponification degree of 85.0 mol% to 89.0 mol% and hardly causes the adhesion between the tablets during film coating, and to provide an oral solid preparation using the composition and a method for producing the composition.SOLUTION: A film coating composition for an oral solid preparation comprises PVA with an average saponification degree of 85.0 mol% to 89.0 mol% satisfying the following requirement (A) or requirement (B) and a plasticizer. Requirement (A): The solution is obtained by adding 130.0 ml of 1-propanol to 100.0 g of a 5.0 mass% aqueous solution of PVA and stirring them. The transparency of the solution at 20°C is 50.0% or less. Requirement (B): The solution is obtained by adding 230.0 ml of 1-propanol to 100.0 g of a 5.0 mass% aqueous solution of PVA and stirring them. The concentration of the supernatant obtained by leaving the stirred solution to stand at 20°C for 24 hours is 0.75 mass% or more.SELECTED DRAWING: NoneCOPYRIGHT: (C)2017,JPO&INPIT【課題】けん化度が85.0モル%~89.0モル%のPVAを使用し、フィルムコーティング中の錠剤同士の付着が発生しにくく、生産性の高いフィルムコーティング組成物、それを用いた経口固形製剤及びその製造方法を提供することを目的とする。【解決手段】下記要件(A)又は要件(B)を満たす、平均けん化度が85.0モル%~89.0モル%のPVAと可塑剤とを含む経口固形製剤用フィルムコーティング組成物。要件(A):PVAの5.0質量%水溶液100.0gに対して、1-プロパノールを130.0ml加え、撹拌して得られる液の20℃における液の透明度が50.0%以下である。要件(B):PVAの5.0質量%水溶液100.0gに対して、1-プロパノールを230.0ml加え、撹拌した液を、20℃で24時間静置して得られる上澄み液の濃度が0.75質量%以上である。【選択図】なし
