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Claims for Patent: 7,745,466

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Claims for Patent: 7,745,466

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:11/853,323
Patent Claims: 1. A pharmaceutical composition comprising a first and second active ingredient and a pharmaceutically acceptable carrier, wherein the first active ingredient is the magnesium salt of S-omeprazole trihydrate, and wherein the second active ingredient is selected from the group consisting of anti-bacterial compounds, non-steroidal anti-inflammatory agents, antacid agents, alginates and prokinetic agents.

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

3. The pharmaceutical composition according to claim 1, wherein the magnesium salt of S-omeprazole trihydrate is characterized by the following major 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 pharmaceutical composition according to claim 1, wherein the magnesium salt of S-omeprazole trihydrate is in a highly crystalline form.

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

6. The pharmaceutical composition according to claim 1, wherein the composition is in unit dose form suitable for peroral or parenteral administration.

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

8. The pharmaceutical composition according to claim 1, wherein the second active ingredient is a non-steroidal anti-inflammatory agent.

9. A pharmaceutical composition comprising a first and second active ingredient and a pharmaceutically acceptable carrier, wherein the first active ingredient is the magnesium salt of S-omeprazole trihydrate and the second active ingredient is a non-steroidal anti-inflammatory agent.

10. The pharmaceutical composition according to claim 9, wherein the magnesium salt of S-omeprazole trihydrate is represented by FIG. 1.

11. The pharmaceutical composition according to claim 9, wherein the magnesium salt of S-omeprazole trihydrate is characterized by the following major peaks in its X-ray diffractogram: TABLE-US-00008 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.

12. The pharmaceutical composition according to claim 9, wherein the magnesium salt of S-omeprazole trihydrate is in a highly crystalline form.

13. The pharmaceutical composition according to claim 9, wherein the magnesium salt of S-omeprazole trihydrate is in a stable form.

14. The pharmaceutical composition according to claim 9, wherein the total daily dose of the magnesium salt of S-omeprazole trihydrate is from 10 mg to 80 mg.

15. The pharmaceutical composition according to claim 9, wherein the composition is in unit dose form suitable for peroral or parenteral administration.

16. A method of treating a gastric acid related condition comprising administering an effective amount of the pharmaceutical composition according to claim 1 or 9 to a patient in need thereof.
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