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1. (WO2017008773) CRYSTALLINE FORMS OF OBETICHOLIC ACID
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CLAIMS

1. Crystalline Form 1-2 of obeticholic acid, exhibiting the following characteristic reflections in the X-ray powder pattern measured by CuKa radiation: 3.1; 6.2; 9.9; 12.4 and 16.7 ± 0.2° 2-theta.

2. Crystalline Form 1-2 of obeticholic acid according to claim 1, characterized by the following further reflections in the X-ray powder pattern: 4.9; 8.9; 10.9 and 15.8 ± 0.2° 2-theta.

3. Crystalline Form 1-2 of obeticholic acid according to claims 1 to 2, characterized by a differential scanning calorimetry curve with the melting point at 80.9°C.

4. Crystalline Form 1-2 of obeticholic acid according to claims 1 to 3, which is in the monohydrate form.

5. Crystalline Form 1-3 of obeticholic acid, exhibiting the following characteristic reflections in the X-ray powder pattern measured by CuKa radiation: 8.0; 10.6; 16.0 and 17.6 ± 0.2° 2-theta.

6. Crystalline Form 1-3 of obeticholic acid according to claim 5, characterized by the following further reflections in the X-ray powder pattern: 10.0; 13.2 and 15.2 + 0.2° 2- theta.

7. Use of Crystalline Form 1-2 of obeticholic acid according to claims 1 to 4 and/or Crystalline Form 1-3 of obeticholic acid according to claims 5 or 6 for the preparation of an amorphous form of obeticholic acid.

8. A method for preparation of the amorphous form of obeticholic acid, characterized in that it comprises drying of Crystalline Form 1-2 in a vacuum drier at the temperature of 40°C or higher.

9. The method for preparation of the amorphous form of obeticholic acid according to claim 8, characterized in that Crystalline Form 1-2 is dried at a temperature in the range from 40 to 80°C.

10. The method for preparation of the amorphous form of obeticholic acid according to claims 8 and 9, characterized in that Crystalline Form 1-2 is dried at the temperature of 40°C for at least 20 hours.

11. A method for preparation of the amorphous form of obeticholic acid, characterized in that it comprises

a) conversion of Crystalline Form 1-2 of obeticholic acid according to claims 1 to 4 and/or Crystalline Form 1-3 of obeticholic acid according to claims 5 or 6 to the ammonium or sodium salt;

b) adding an acid;

c) isolation of the obtained amorphous form precipitate by filtration.

12. Use of Crystalline Form 1-2 of obeticholic acid according to claims 1 to 4 and/or Crystalline Form 1-3 of obeticholic acid according to claims 5 or 6 for the preparation of obeticholic acid with a chemical purity higher than 99.80% according to HPLC.

13. Use of Crystalline Form 1-2 of obeticholic acid according to claims 1 to 4 and/or Crystalline Form 1-3 of obeticholic acid according to claims 5 or 6 for the preparation of a pharmaceutical composition.

14. A pharmaceutical composition, characterized in that it contains Crystalline Form 1-2 of obeticholic acid according to claims 1 to 4 and/or Crystalline Form 1-3 of obeticholic acid according to claims 5 or 6 and at least one pharmaceutically acceptable excipient.

15. The pharmaceutical composition according to claim 14, characterized in that at least one pharmaceutically acceptable excipient is selected from the group comprising lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate and combinations thereof.

16. The pharmaceutical composition according to claims 14 and 15, characterized in that it has the form of a tablet.