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Claims for Patent: 7,399,772

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Claims for Patent: 7,399,772

Title:Substituted benzimidazole dosage forms and method of using same
Abstract:The present invention relates to pharmaceutical preparations comprising substituted benzimidazole proton pump inhibitors. There is provided a liquid or solid pharmaceutical composition consisting of a proton pump inhibitor and at least one buffering agent. Also provided is a pharmaceutical composition further comprising a parietal cell activator, an anti-foaming agent, a flavoring agent and combinations thereof; a method for treating acid-related gastrointestinal disorders by administering a solid pharmaceutical composition; and, a kit for the preparation of a liquid oral pharmaceutical composition. Dosage forms include: liquid, powder, tablet, capsule, effervescent powder, effervescent tablet, pellets, and granules.
Inventor(s): Phillips; Jeffrey Owen (Ashland, MO)
Assignee: Curators of the University of Missouri (Columbia, MO)
Application Number:10/641,732
Patent Claims: 1. A method for treating an acid-caused gastrointestinal disorder comprising the step of administering to a subject suffering from said disorder a solid pharmaceutical composition comprising: (a) about 10 mg to about 40 mg of non-enteric coated omeprazole; and (b) sodium bicarbonate in an amount of 0.2 mEq to 5 mEq per 2 mg omeprazole; wherein the composition contains no sucralfate, the acid-caused gastrointestinal disorder is selected from the group consisting of duodenal ulcer, gastric ulcer, gastroesophageal reflux disease, and erosive esophagitis, and the sodium bicarbonate is present in the composition in an amount sufficient to substantially prevent or inhibit acid degradation of at least some of the omeprazole by gastric acid upon administration to the subject.

2. The method of claim 1 wherein the composition is a solid dosage form selected from the group consisting of a tablet, a chewable tablet, a capsule, a troche, and a lozenge.

3. The method of claim 2 wherein the solid dosage form further comprises a pharmaceutically acceptable excipient selected from the group consisting of a binder, a flavoring agent, a sweetening agent, a disintegrant, a flow aid, a lubricant, an adjuvant, a colorant, a diluent, a moistening agent, or combinations thereof.

4. The method of claim 3 wherein the dosage form further comprises a disintegrant.

5. The method of claim 3 where the dosage form further comprises a lubricant.

6. The method of claim 4 wherein the disintegrant is selected from the group consisting of microcrystalline cellulose and croscarmellose sodium.

7. The method of claim 6 wherein the disintegrant is croscarmellose sodium.

8. The method of claim 4 wherein the solid dosage form is a capsule.

9. The method of claim 4 wherein the solid dosage form is a chewable tablet.

10. The method of claim 8 wherein the omeprazole is micronized.

11. The method of claim 9 wherein the omeprazole is micronized.

12. The method of claim 8 wherein the solid dosage form is administered to the subject in an amount sufficient to provide the subject with a daily dose of omeprazole of 20 to 40 mg.

13. The method of claim 9 wherein the solid dosage form is administered to the subject in an amount sufficient to provide the subject with a daily dose of omeprazole of 20 mg to 40 mg.

14. The method of claim 12 wherein the solid dosage form is administered to the subject in an amount sufficient to provide the subject with a daily dose of omeprazole of 20 mg.

15. The method of claim 12 wherein the solid dosage form is administered to the subject in an amount sufficient to provide the subject with a daily dose of omeprazole of 40 mg.

16. The method of claim 13 wherein the solid dosage form is administered to the subject in an amount sufficient to provide the subject with a daily dose of omeprazole of 20 mg.

17. The method of claim 13 wherein the solid dosage form is administered to the subject in an amount sufficient to provide the subject with a daily dose of omeprazole of 40 mg.

18. The method of claim 1 wherein the composition further comprises magnesium silicate, calcium hydroxide, calcium acetate or calcium lactate.

19. The method of claim 1 wherein the composition comprises 10 mg omeprazole and 1 to 25 mEq sodium bicarbonate.

20. The method of claim 1 wherein the composition comprises 20 mg omeprazole and 2 to 25 mEq sodium bicarbonate.

21. The method of claim 1 wherein the composition comprises 40 mg omeprazole and 4 to 25 mEq sodium bicarbonate.
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