RU2000100361A

RU2000100361A - SODIUM SALT OMEGRAZOLE

Info

Publication number: RU2000100361A
Application number: RU2000100361/04A
Authority: RU
Inventors: Андерс Густавссон; Кристина КЬЕЛЬБОМ; Ингвар ИМЕН
Original assignee: Астра Актиеболаг
Priority date: 1997-06-27
Filing date: 1998-06-11
Publication date: 2001-11-27

Claims

1. Sodium salt of omeprazole form B, characterized by the fact that it is thermodynamically stable.

2. Sodium salt of omeprazole form B, characterized by the fact that it is essentially non-hygroscopic.

3. The sodium salt of omeprazole form B according to claim 1 or 2, characterized in that it gives a picture of x-ray diffraction on the powder, having essentially the following values of d and intensity:
value

- relative intensity
9.8 - wasps
7.8 - donkey
6.7 - with
6.5 - with
6.2 - donkey
5.9 - Wed
5.8 - donkey
5.4 - cl
5.1 - cl
4.6 - Wed
4,5 - Wed
4.3 - with
4.1 - Wed
3.96 - Wed
3.92 - Wed
3.71 - with
3.60 - cl
3.43 - donkey
3.37 - cl
3.25 - donkey
3.17 - donkey
3.14 - cl
3.12 - Wed
3.05 - cl
2.99 - cl
2.98 - Wed
2.91 - Wed
2.89 - Wed
2.79 - donkey
2.62 - donkey
2.59 - donkey
2.50 - donkey
2.45 - donkey
2.40 - donkey
2.37 - donkey
2.28 - donkey
4. The sodium salt of omeprazole form B according to any one of claims 1 to 3, characterized in that it has a monoclinic unit cell with parameters

5. The method of obtaining the sodium salt of omeprazole form B, as defined in any one of claims 1 to 4, comprising the steps in which: a) omeprazole sodium salt is prepared by adding a water base to omeprazole in a mixture of solvents containing alcohol and water b) allow the solution to crystallize, possibly using the sodium salt of omeprazole form B to initiate crystallization; and c) isolate the sodium salt of omeprazole B thus obtained.

6. The method according to claim 5, where the specified water base used in step (a) is sodium hydroxide.

7. The method according to any of claims 5-6, where the specified alcohol used in step (a) is isopropanol.

8. The method of obtaining the sodium salt of omeprazole form B as defined in any one of claims 1 to 4, including the stages in which: a) dissolve the sodium salt of omeprazole of any form or a mixture of any forms in a mixture of solvents containing alcohol and water, b a) allow the solution to crystallize, possibly using the sodium salt of omeprazole form B to initiate crystallization; and c) isolate the sodium salt of omeprazole B thus obtained.

9. A pharmaceutical preparation containing the sodium salt of omeprazole form B as defined in any one of claims 1 to 4 in a mixture with a pharmaceutically acceptable excipient.

10. Pharmaceutical preparation suitable for intravenous administration, containing the sodium salt of omeprazole form B as defined in any of paragraphs. 1-4 in a mixture with a pharmaceutically acceptable excipient.

11. The use of sodium salt of omeprazole form B as defined in any of paragraphs. 1-4 as an active ingredient in the manufacture of a medicament for use in the treatment of gastrointestinal disorders.

12. The use of sodium salt of omeprazole form B as defined in any of paragraphs.1-4 in the manufacture of a pharmaceutical preparation for intravenous administration.

13. A method of treating gastrointestinal disorders in which a therapeutically effective amount of the sodium salt of omeprazole Form B is administered to a patient suffering from gastrointestinal disorders as defined in any one of claims 1 to 4.