Pharmaceutical preparation and method for producing the same

A pharmaceutical preparation in the form of granules comprising nuclear particles and a coating layer coating the nuclear particles, wherein

• the nuclear particles comprise a drug, a first nuclear-particle component, a second nuclear-particle component and a nonionic surfactant,
• the drug is an aniline derivative represented by the following general formula (I):
• wherein W represents S or O,
• or a pharmaceutically acceptable salt thereof, or a hydrate thereof,
• the first nuclear-particle component is at least one crystalline cellulose having a shape selected from a needle-shape and a substantially columnar shape, and
• the second nuclear-particle component is at least one pharmaceutically acceptable additive having a substantially spherical shape,
• the nuclear particles are agglomerated particles formed from the first nuclear-particle component and the second nuclear-particle component, the nuclear particles have many voids formed between the first nuclear particle component and the second nuclear particle component, and a large amount of the drug and the surfactant are retained in the voids, wherein the surfactant is present as a liquid component, and
• at least one of the following conditions is satisfied:
• (i) a mass ratio of the first nuclear-particle component and the second nuclear-particle component is 1:1 to 1:10, (ii) an average aspect ratio of the first nuclear-particle component is 1.8 or more and an average aspect ratio of the second nuclear-particle component is 1.0 to 1.7, or (iii) the ratio of the needle-shape and/or a substantially columnar shape in the first nuclear particle component being 60 to 100%;
• wherein the pharmaceutical preparation is made by a method comprising:
• (a) mixing the first nuclear-particle component and the second nuclear-particle component to obtain a nuclear particle mixture,
• (b) dissolving or suspending the drug in a mixture of the nonionic surfactant and a solvent to obtain a mixed solution,
• (c) contacting the nuclear particle mixture obtained in (a) with the mixed solution obtained in (b) in a fluidized bed granulator to obtain the nuclear particles containing the first nuclear-particle component, the second nuclear-particle component, the drug and the surfactant, wherein voids are formed between the first nuclear-particle component and the second nuclear-particle component, and the drug and the nonionic surfactant are incorporated into and retained within the voids, the surfactant being present as a liquid component, and
• (d) coating the nuclear particles obtained in (c) to obtain the pharmaceutical preparation.