FIELD: chemistry.
SUBSTANCE: crystalline form of aliskiren hemifumarate is characterized by the picture of X-ray diffraction in powder demonstrating the following main peaks, given at degrees 2 Teta+/- 0.3 degree: 3.8, 6.5, 7.7, 8.0, 15.6 and 17.4. said form is obtained from solution with weight ratio (weight/weight) acetonyl : ethanol, being in the interval from 90:10 to 75:25 (for instance, 80:20) at suitable temperature in the interval from 15 to 40°C, for instance, by cooling from 37°C to 35°C and especially after dimming - by further cooling to 20°C, ensuring aliskiren hemifumarate crystallisation, filtered and dried under vacuum, for instance, at 10 mbar and 40°C. Crystalline form of aliskiren hemifumarate is applied for obtaining pharmaceutical composition, suitable for treating disease in warm-blooded animal, modulated by rennin inhibition.
EFFECT: stable aliskiren form, with long storage term, purity, improved parameters of fluidity.
10 cl, 16 tbl, 12 dwg, 13 ex
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