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. |