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Last Updated: March 28, 2024

Details for Patent: 7,514,560


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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-ben- zimidazole, 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 -benzimidazole 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-ben- zimidazole.
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:May 04, 2006
Application Number:11/418,819
Claims:1. A process for the preparation of omeprazole form A represented by FIG. 1, comprising the steps of: a) dissolving or suspending omeprazole of any form, or a mixture of omeprazole of any form, in a suitable solvent at 15-25.degree. C.; b) allowing the solution to crystallize for at least 2 hours, and c) isolating the omeprazole form A thus obtained.

2. The process according to claim 1, wherein the solvent used in step a) is selected from the group consisting of methanol, ethanol, acetone, ethyl acetate, methyl tert. butyl ether, toluene, and any mixture thereof.

3. The process according to claim 1, wherein omeprazole form A is added to induce crystallization.

4. The process method according to claim 1, wherein the omeprazole form A thus obtained is characterized in providing an X-ray powder diffraction pattern exhibiting substantially the following d-values: TABLE-US-00006 Form A d-value Relative (.ANG.) intensity 9.5 vs 7.9 s 7.4 w 7.2 vs 6.0 m 5.6 s 5.2 s 5.1 s 4.89 w 4.64 m 4.60 m 4.53 w 4.49 m 4.31 m 4.19 w 4.15 w 3.95 w 3.71 s 3.59 m 3.48 m 3.45 s 3.31 w 3.22 s 3.17 m 3.11 w 3.04 w 3.00 w 2.91 w 2.86 w 2.85 w 2.75 w 2.67 w 2.45 w 2.41 w.

5. The process according to claim 1, wherein the omeprazole form A thus obtained is characterized by having 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.-90.77(3).degree..

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