tetomilast hydrate crystal, anhydrous tetomilast crystal, tetomilast acetonitrile solvate crystal, mixture, pharmaceutical composition, and processes for the preparation of a tetomilast hydrate, anhydrous tetomilast crystal, acetonitrile solvate crystal of tetomilast and a mixture

摘要

TETOMILAST HYDRATE CRYSTAL, Anhydrous TETOMILAST CRYSTAL, TETOMILAST ACETONYTHRIL SOLVATE CRYSTAL, MIXTURE, PHARMACEUTICAL COMPOSITION, AND PROCESSES FOR PREPARING A TETOMILAST TONOMYSTAL CRYSTAL CRYSTAL TEST OF TETOMILAST AND A MIX. The present invention provides a tetomilast crystal which is easily produced industrially in a large volume. (1) A tetomilast hydrate crystal, having a powder X-ray diffraction spectrum, which is substantially the same as the powder X-ray diffraction spectrum shown in Fig. 2; (2) an anhydrous tetomilast crystal type A, having a powder X-ray diffraction spectrum that is substantially the same as the powder X-ray diffraction spectrum shown in Fig. 4; (3) an anhydrous tetomilast crystal type C, having a powder X-ray diffraction spectrum, which is substantially the same as the powder X-ray diffraction spectrum shown in Fig. 8; (4) a tetomilast acetonitrile solvate crystal having a powder X-ray diffraction spectrum, which is substantially the same as the powder X-ray diffraction spectrum shown in Fig. 10; and (5) a mixture consisting of the above anhydrous tetomilast crystal type A and an anhydrous type B tetomilast crystal. These crystals are heat and moisture stable and are also excellent in terms of disintegration property and tablet dissolution property. . Accordingly, these crystals are preferably used as pharmaceutical compositions.