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Claims for Patent: 8,466,175

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Claims for Patent: 8,466,175

Title:Form of S-omeprazole
Abstract: The present invention relates to a novel form of the (-)-enantiomer of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1H-be- nzimidazole, i.e. S-omeprazole. More specifically, it relates to a novel form of the magnesium salt of the S-enantiomer of omeprazole trihydrate. The present invention also relates to processes for preparing such a form of the magnesium salt of S-omeprazole and pharmaceutical compositions containing it. Furthermore, the present invention also relates to new intermediates used in the process.
Inventor(s): Cotton; Hanna (Sodertalje, SE), Kronstrom; Anders (Sodertalje, SE), Mattson; Anders (Sodertalje, SE), Moller; Eva (Sodertalje, SE)
Assignee: AstraZeneca AB (Sodertalje, SE)
Application Number:13/298,373
Patent Claims: 1. A method of treating Helicobacter infections comprising the administration of an effective amount of the magnesium salt of S-omeprazole trihydrate and an antibacterial compound to a patient in need thereof.

2. The method according to claim 1, wherein the magnesium salt of S-omeprazole trihydrate is represented by FIG. 1.

3. The method according to claim 1, wherein the magnesium salt of S-omeprazole trihydrate is characterized by the following peaks in its X-ray diffractogram: TABLE-US-00007 d-value/.ANG. Relative Intensity 2.67 m 2.79 m 3.27 m 3.52 s 3.82 s 3.96 vs 4.14 m 5.2 m 5.6 m 6.7 vs 6.9 s 8.3 w 16.6 vs.

4. The method according to claim 1, wherein the magnesium salt of S-omeprazole trihydrate is in a highly crystalline form.

5. The method according to claim 1, wherein the magnesium salt of S-omeprazole trihydrate is in a stable form.

6. The method according to claim 1, wherein the magnesium salt of S-omeprazole trihydrate is suitable for oral administration.

7. The method according to claim 6, wherein the antibacterial compound is suitable for oral administration.

8. The method according to claim 6, wherein the antibacterial compound is suitable for parenteral administration.

9. The method according to claim 1, wherein the magnesium salt of S-omeprazole trihydrate is suitable for parenteral administration.

10. The method according to claim 9 wherein the antibacterial compound is suitable for oral administration.

11. The method according to claim 9, wherein the antibacterial compound is suitable for parenteral administration.

12. The method according to claim 1, wherein the antibacterial compound is suitable for oral administration.

13. The method according to claim 1, wherein the antibacterial compound is suitable for parenteral administration.

14. The method according to claim 1, wherein the total daily dose of the magnesium salt of S-omeprazole trihydrate is from 10 mg to 80 mg.
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