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Claims for Patent: 6,369,085

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Claims for Patent: 6,369,085

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-ben zimidazole, 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:09/077,719
Patent Claims: 1. The magnesium salt of S-omeprazole trihydrate, wherein the compound is characterized by the following major peaks in its X-ray diffractogram:

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

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

4. A process for the preparation of the magnesium salt of S-omeprazole trihydrate according to any of claims 1, 2 or 3 which comprises treating a magnesium salt of S-omeprazole any other form with water.

5. A process for the preparation of the magnesium salt of S-omeprazole trihydrate according to any of claims 1, 2 or 3 which comprises the following steps:

a) mixing a potassium salt of S-omeprazole with an organic solvent;

b) converting the potassium salt of S-omeprazole into a corresponding magnesium salt of S-omeprazole by treating the potassium salt with a magnesium source;

c) precipitating the magnesium salt of S-omeprazole by addition of a non-solvent;

d) isolating the obtained magnesium salt of S-omeprazole;

e) treating the obtained magnesium salt of S-omeprazole with water, and

f) isolating and drying the obtained magnesium salt of S-omeprazole trihydrate.

6. The process according to claim 5, wherein the organic solvent of step a) is methanol.

7. The process according to claim 5, wherein the non-solvent of step c) is acetone.

8. The process according to claim 5 wherein steps a) to e) are replaced by the following single step: converting the potassium salt of S-omeprazole into a corresponding magnesium salt of S-omeprazole by treating the potassium salt with a magnesium source in water.

9. The process according to claim 5, wherein the magnesium source is magnesium sulfate.

10. The process according to claim 8, wherein the magnesium source is magnesium sulfate.

11. A pharmaceutical composition comprising the magnesium salt of S-omeprazole trihydrate according to any of claims 1, 2 or 3 as active ingredient and a pharmaceutically acceptable carrier.

12. A method of treating a gastric acid related condition which method comprises administering to a subject suffering from said condition a therapeutically effective amount of the magnesium salt of S-omeprazole trihydrate according to any of claims 1, 2 or 3.
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