FIELD: chemistry.
SUBSTANCE: invention relates to an amorphous allisartan isoproxil having an XRD (x-ray powder diffraction) spectrum as shown in Fig. 1, and the amorphous allisartan isoproxil has an endothermic peak at 56±3 °C, an exothermic peak at 130±3 °C and an endothermic peak at 157±3 °C in the DSC (differential scanning calorimetry) spectrum, and the amorphous allisartan isoproxil is prepared by a method comprising the following steps: dissolving an allisartan isoproxil crystal in an organic solvent that is dichloromethane; concentrating the resulting solution at a relative pressure of -0.05 MPa and a temperature of 25 or 40 °C; and drying in a vacuum at a relative pressure of -0.09 MPa and a temperature of 40 or 50 °C. Invention also relates to a process for the preparation of amorphous allisartan isoproxil, a pharmaceutical composition and a tablet.
EFFECT: technical result: obtaining amorphous allisartan isoproxil having good flowability, which is suitable for post-treatment, having high bulk density and without noticeable electrostatic phenomena.
9 cl, 5 dwg, 6 ex
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CRYSTALLINE ALLISARTAN ISOPROXIL, METHOD FOR PRODUCTION THEREOF AND PHARMACEUTICAL COMPOSITION |
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