Tetomilast polymorphs

Details Tetomilast polymorphs Tetomilast polymorphs

C - Chemistry, Metallurgy

07

D

C07D 417/04 (2006.01) A61K 31/4439 (2006.01) A61P 11/00 (2006.01)

Patent

CA 2634100

The present invention provides a tetomilast crystal that is industrially easily produced in a large volume, (1) a tetomilast hydrate crystal having a powder X-ray diffraction spectrum that is substantially the same as the powder X-ray diffraction spectrum shown in Fig. 2; (2) an anhydrous tetomilast type A crystal 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 type C crystal having a powder X-ray diffraction spectrum that 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 that 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 type A crystal and an anhydrous tetomilast type B crystal. These crystals are stable towards heat and moisture, and are also excellent in terms of the disintegration property and dissolution property of tablets. Accordingly, these crystals are preferably used as pharmaceutical compositions.

L'invention concerne un cristal de tétomilast facilement produit de manière industrielle en grand volume. L'invention concerne un cristal d'hydrate de tétomilast (1) présentant un spectre de diffraction de rayons X sur poudre sensiblement identique au spectre de diffraction de rayons X sur poudre de la figure 2. L'invention concerne un cristal de type A de tétomilast anhydre (2) présentant un spectre de diffraction de rayons X sur poudre sensiblement identique au spectre de diffraction de rayons X sur poudre de la figure 4. L'invention concerne un cristal de type C de tétomilast anhydre présentant un spectre de diffraction de rayons X sur poudre sensiblement identique au spectre de diffraction de rayons X sur poudre de la figure 8. L'invention concerne un cristal de solvate d'acétonitrile de tétomilast (4) présentant un spectre de diffraction de rayons X sur poudre sensiblement identique au spectre de diffraction de rayons X sur poudre de la figure 10. L'invention concerne également un mélange (5) constitué du cristal de type A de tétomilast anhydre susmentionné et d'un cristal de type B de tétomilast anhydre. Ces cristaux sont stables par rapport à la chaleur et à l'humidité et présentent d'excellentes propriétés de désintégration et de dissolution de comprimés. Ainsi, ces cristaux sont de préférence utilisés en tant que compositions pharmaceutiques.

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