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Last Updated: March 29, 2024

Details for Patent: 6,384,059


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Title: Crystalline form of omeprazole
Abstract:The present invention relates to a novel crystalline form of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl-1H-benzi midazole, known under the generic name omeprazole. Further, the present invention also relates to the use of the novel crystalline form of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benz imidazole for the treatment of gastrointestinal disorders, pharmaceutical compositions containing it as well as processes for the preparation of the novel crystalline form of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benz imidazole.
Inventor(s): Lovqvist; Karin (Molndal, SE), Sunden; Gunnel (Goteborg, SE), Noreland; David (Sodertalje, SE), Ymen; Ingvar (Saltsjo-Boo, SE)
Assignee: AstraZeneca AB (Sodertalje, SE)
Filing Date:Aug 15, 2000
Application Number:09/640,097
Claims:1. Omeprazole form A having a content within the range 90% to 99% by weight of an omeprazole substance providing an X-ray powder diffraction exhibiting substantially the following d-values:

2. Omeprazole form A according to claim 1, wherein the omeprazole substance is defined by a triclinic unit cell with parameters

a=10.410(4) .ANG., b=10.468(3) .ANG., c=9.729(4) .ANG., .alpha.=111.51(3).degree., .beta.=116.78(3).degree., .gamma.=90.773(3).degree..

3. Omeprazole form A according to claim 1, wherein the omeprazole substance is thermodynamically stable at room temperature.

4. Omeprazole form A according to claim 1, wherein the omeprazole substance is essentially non-hygroscopic.

5. Omeprazole form A according to claim 1, wherein 95% by weight of the omeprazole substance is present.

6. Omeprazole form A according to claim 1, wherein 98% by weight of the omeprazole substance is present.

7. Omeprazole form A according to claim 1, wherein 99% by weight of the omeprazole substance is present.

8. Omeprazole form A having a content within the range 90% to 99% by weight of an omeprazole substance, wherein, in a Raman spectroscopy, the omeprazole substance is identified by the absence of a band at 1364 cm-1 and by the ratio of the relative intensities 842 cm-1 band/836 cm-1 band of <1.

9. A pharmaceutical formulation comprising a therapeutically effective amount of omeprazole form A according to claim 1 in admixture with a pharmaceutically acceptable excipient.

10. A method for inhibiting gastric acid secretion which comprises administration of a therapeutically effective amount of omeprazole form A according to claim 1 to a patient in need thereof.

11. A method for treating gastrointestinal inflammatory diseases which comprises administration of a therapeutically effective amount of omeprazole form A according to claim 1 to a patient in need thereof.

12. A method for the treatment of Helicobacter infections and diseases which comprises administration of a therapeutically effective amount of omeprazole form A according to claim 1 to a patient in need thereof.

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