PROBLEM TO BE SOLVED: To provide production methods of a premix drug substance for producing an acetaminophen formulation.SOLUTION: Provided is a production method of a premix drug substance for supplying to a tableting machine or a granulator, in which A) a dispersant is blended with acetaminophen containing 20% by volume or more of particles with a size of 200 μm or more with respect to 100% by volume of acetaminophen, the dispersant is dispersed and adhered to the surface of the acetaminophen particles by disintegration and granulation once or multiple times, a powder containing 30% by volume or less of particles with a size of 200 μm or more with respect to 100% by volume of the powder of the acetaminophen and dispersant is obtained, further B) other additives are compounded, the additives are dispersed and adhered to the surface of the acetaminophen particles by disintegration and granulation once or more times, in the step of blending the additives.SELECTED DRAWING: NoneCOPYRIGHT: (C)2019,JPO&INPIT【課題】アセトアミノフェン製剤を製造するためのプレミックス原薬の製造方法の提供。【解決手段】A)アセトアミノフェン100体積%に対して、200μm以上の粒子を20体積%以上含有するアセトアミノフェンに分散剤を配合し、1回又は複数回解砕整粒することにより、アセトアミノフェン粒子の表面に分散剤を分散・付着させ、アセトアミノフェン及び分散剤の粉末100体積%に対して、200μm以上の粒子を30体積%以下含有する粉末とし、さらに、B)その他の添加剤を配合し、添加剤を配合する過程において1回又は複数回解砕整粒することにより、アセトアミノフェン粒子の表面に添加剤を分散・付着させる、打錠機又は造粒機に供給するためのプレミックス原薬の製造方法。【選択図】なし
