FIELD: pharmaceuticals.
SUBSTANCE: invention relates to stable crystalline form II of apremilast that does not contain solvates, method for its preparation, pharmaceutical composition, and pharmaceutical use. At an angle of reflection of 2θ±0.2, the powder X-ray diffraction curve of the crystalline form II of an apremilast has the following characteristic absorption peaks: 11.2, 13.2, 13.5, 13.8, 14.7, 16.2, 17.9, 18.7, 20.2, 20.7, 27.0; differential scanning calorimetry (DSC) thermogram shows one absorption peak at a temperature of 150±3 ºC.
EFFECT: activity of crystalline form II is not lower than that of crystalline form B, and the thermodynamic stability of crystalline form II exceeds thermodynamic stability of crystalline form B.
7 cl, 23 dwg, 4 tbl, 10 ex
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