FIELD: pharmacology.
SUBSTANCE: invention relates to a new crystalline modification of 3-(4-amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)-piperidine-2,6-dione (lenalidomide is an international non-proprietary name) - β-modification, characterized by the following set of interplanar distances (d, Å) and corresponding intensities (Irel., %): 12.358 - 8.39%; 11.893 - 29.79%; 11.551 - 100.00%; 8.606 - 8.39%; 7.641 - 4.62%; 7.024 - 8.05%; 5.927 - 8.05%; 5.811 - 19.86%; 5.262 - 28.42%; 5.117 - 9.42%; 4.850 - 5.99%; 4.595 - 5.99%; 4.215 - 10.45%; 4.011 - 6.68%; 3.948 - 11.47%; 3.877 - 51.88%; 3.843 - 39.73%; 3.698 - 16.44%; 3.426 - 6.51%; 3.316 - 4.97%; 3.201 - 5.14%; 3.103 - 4.45%; 3.025 - 3.42%; 2.989 - 2.91%; 2.905 - 9.93%; 2.846 - 5.99%; 2.826-5.65%; 2.702 - 10.27%; 2.640 - 7.88%; 2.555 - 10.27%; 2.478 - 7.19%; 2.339 - 6.51%; 2.647 - 23.12%; 2.282 - 11.82%; 2.243 - 9.93%; 2.168 - 5.82%; 2.107 - 9.08%; 2.081 - 7.36%; 2.066 - 10.96%; 2.027 - 9.76%; 1.943 - 5.65%; 1.912 - 24.83%; 1.795 - 4.45%; 1.719 - 4.62%; 1.694 - 5.72%; 1.659 - 7.19%; 1.634 - 3.94% and DSC curve with two thermal effects: exothermic effect at temperature (174.9±0.5)°C and endothermic effect at a temperature of (267.7±0.5)°C. As well as to a method for its preparation and use in the pharmaceutical industry and medicine as a representative of a new class of immunomodulators possessing both immunomodulatory and anti-angiogenic properties for multiple myeloma treatment.
EFFECT: increased efficiency of composition application.
4 cl, 4 tbl, 6 dwg, 4 ex
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Year |
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