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Claims for Patent: 6,780,882

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Claims for Patent: 6,780,882

Title: Substituted benzimidazole dosage forms and method of using same
Abstract:There is provided a solid pharmaceutical composition having active ingredients that include at least one non-enteric coated proton pump inhibitor and at least one buffering agent. The proton pump inhibitor, for example, omeprazole, lansoprazole, rabeprazole, esomeprazole, pantoprazole, pariprazole, and leminoprazole, or an enantiomer, isomer, derivative, free base, or salt thereof, is present in an amount of approximately 5 mg to approximately 300 mg; and the buffering agent is present in an amount of approximately 0.1 mEq to approximately 2.5 mEq per mg of proton pump inhibitor. The dosage form can be non-enteric coated and can be in the form of a suspension tablet, a chewable tablet, an effervescent powder, or an effervescent tablet. Also provided is a method for treating an acid-related gastrointestinal disorder in a subject in need thereof by administering to the subject a solid pharmaceutical composition of the present invention.
Inventor(s): Phillips; Jeffrey O. (Ashland, MO)
Assignee: The Curators of the University of Missouri (Columbia, MO)
Application Number:10/260,132
Patent Claims: 1. A pharmaceutical composition in a form of a commercially stable powder for suspension useful in treatment of gastric acid related disorders, comprising: (a) a therapeutically effective amount of at least one acid labile, substituted benzimidazol H.sub.+,K.sub.+ -ATPase proton pump inhibitor, (b) one or more buffering agents in an amount of about 0.1 mEq to about 2.5 mEq per mg of the proton pump inhibitor, and (c) at least one thickening agent to reduce settling of the inhibitor after constitution with an aqueous medium.

2. The composition of claim 1, wherein the proton pump inhibitor is selected from the group consisting of omeprazole, lansoprazole, rabeprazole, esomerprazole, pantoprazole, pariprazole, and leminoprazole, or an enantiomer, an alkaline salt of an enantiomer, an isomer, a salt or a neutral form thereof.

3. The composition of claim 2, wherein the proton pump inhibitor is omerprazole, or an enantiomer, an alkaline salt of an enantiomer, an isomer, or a salt thereof.

4. The composition of claim 2, wherein the proton pump inhibitor is omerprazole, or an enantiomer, an alkaline salt of an enantiomer, an isomer, or a salt thereof, in an amount of about 2 mg, about 5 mg, about 10 mg, about 15 mg, about 20 mg, about 25 mg, about 30 mg, about 35 mg, about 40 mg, about 45 mg, about 50 mg, about 55 mg, about 60 mg, about 65 mg, about 70 mg, about 75 mg, about 80 mg, about 85 mg, about 90 mg, about 95 mg, about 100 mg, about 105 mg, about 110 mg, about 115 mg, or about 120 mg.

5. The composition of claim 2, wherein the proton pump inhibitor is lansoprazole, or an enantiomer, an alkaline salt of an enantiomer, an isomer, or a salt thereof.

6. The composition of claim 2, wherein the proton pump inhibitor is lansoprazole, or an enantiomer, an alkaline salt of an enantiomer, an isomer, or a salt thereof, in an amount of about 2 mg, about 5 mg, about 10 mg, about 15 mg, about 20 mg, about 25 mg, about 30 mg, about 35 mg, about 40 mg, about 45 mg, about 50 mg, about 55 mg, about 60 mg, about 65 mg, about 70 mg, about 75 mg, about 80 mg, about 85 mg, about 90 mg, about 95 mg, about 100 mg, about 105 mg, about 110 mg, about 115 mg, or about 120 mg.

7. The composition of claim 1, further comprising at least one of an excipient, an adjuvant, a preservative, an antioxidant, a chelating agent, an antifungal agent, an antibacterial agent, an isotonic agent, a flavoring agent, a sweetening agent, an anti-foaming agent, a colorant, a diluent, a moistening agent, a parietal cell activator, and combinations of any of the foregoing.

8. The composition of claim 1, wherein the buffering agent is selected from the group of a bicarbonate salt of a Group IA metal, an alkali earth metal buffering agent, a calcium buffering agent, a magnesium buffering agent, an aluminum buffering agent, sodium bicarbonate, potassium bicarbonate, magnesium hydroxide, magnesium lactate, magnesium gluconate, magnesium oxide, magnesium aluminate, magnesium carbonate, magnesium silicate, magnesium citrate, aluminum hydroxide, aluminum hydroxide/magnesium carbonate, aluminum hydroxide/sodium bicarbonate coprecipitate, aluminum glycinate, aluminum magnesium hydroxide, aluminum phosphate, sodium citrate, calcium citrate, sodium tartrate, sodium acetate, sodium carbonate, sodium polyphosphate, sodium dihydrogen phosphate, potassium polyphosphate, sodium polyphosphate, potassium pyrophosphate, disodium hydrogenphosphate, dipotassium hydrogenphosphate, trisodium phosphate, tripotassium phosphate, potassium carbonate, potassium metaphosphate, calcium acetate, calcium glycerophosphate, calcium chloride, calcium hydroxide, calcium lactate, calcium carbonate, calcium gluconate, calcium bicarbonate, sodium phosphate, potassium phosphate, calcium phosphate, magnesium phosphate, potassium citrate, trihydroxymethylaminomethane, an amino acid, an acid salt of an amino acid, and an alkali salt of an amino acid, or combinations of an of the foregoing.

9. The composition of claim 1, wherein the amount of the buffering agent present in the composition is about 0.5 mEq to about 150 mEq.

10. The composition of claim 1, wherein the amount of the buffering agent present in the composition is about 5 mEq to about 30 mEq.

11. The composition of claim 1, wherein the amount of the buffering agent present in the composition is about 15 mEq to about 30 mEq.

12. The composition of claim 1, wherein the buffering agent is sodium bicarbonate.

13. The composition of claim 12, wherein the amount of the sodium bicarbonate present in the composition is about 2 mEq to about 70 mEq.

14. The composition of claim 12, wherein the amount of the sodium bicarbonate present in the composition is about 10 mEq to about 55 mEq.

15. The composition of claim 12, wherein the amount of the sodium bicarbonate present in the composition is about 12.5 mEq to about 30 mEq.

16. The composition of claim 12, wherein the amount of the sodium bicarbonate present in the composition is about 0.2 mEq, 1 mEq, 2 mEq, 3 mEq, 5 mEq, 10 mEq, 12.5 mEq, 15 mEq, 20 mEq, 25 mEq, 30 mEq, 50 mEq, 70 mEq, or 150 mEq.

17. The composition of claim 1, wherein the buffering agent is calcium carbonate.

18. The composition of claim 17, wherein the amount of the calcium carbonate present in the composition is about 2 mEq to about 70 mEq.

19. The composition of claim 17, wherein the amount of the calcium carbonate present in the composition is about 10 mEq to about 55 mEq.

20. The composition of claim 17, wherein the amount of the calcium carbonate present in the composition is about 12.5 mEq to about 30 mEq.

21. The composition of claim 1, wherein the amount of the calcium carbonate present in the composition is about 0.2 mEq, 1 mEq, 2 mEq, 3 mEq, 5 mEq, 10 mEq, 12.5 mEq, 15 mEq, 20 mEq, 25 mEq, 30 mEq, 50 mEq, 70 mEq, or 150 mEq.

22. The composition of claim 1, wherein the buffering agent is a mixture of sodium bicarbonate and calcium carbonate.

23. The composition of claim 22, wherein the amount of sodium bicarbonate and calcium carbonate totals about 2 mEq to about 70 mEq.

24. The composition of claim 22, wherein the amount of sodium bicarbonate and calcium carbonate totals about 10 mEq to about 55 mEq.

25. The composition of claim 22, wherein the amount of sodium bicarbonate and calcium carbonate totals about 12.5 mEq to about 30 mEq.

26. The composition of claim 22, wherein the amount of the sodium bicarbonate and calcium carbonate totals about 0.2 mEq, 1 mEq, 2 mEq, 3 mEq, 5 mEq, 10 mEq, 12.5 mEq, 15 mEq, 20 mEq, 25 mEq, 30 mEq, 50 mEq, 70 mEq, or 150 mEq.

27. The composition of claim 1, wherein at least some of the proton pump inhibitor is micronized.

28. The composition of claim 1, wherein at least some of the buffering agent is micronized.

29. The composition of claim 1, wherein the thickening agent is selected from the group consisting of methylcellulose, carboxymethylcellulose, microcrystalline cellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, alginate, carageenan, xanthan gum, acacia, tragacanth, locust bean gum, guar gum, carboxypolymethylene, polyvinyl pyrrolidone, polyvinyl alcohol, poloxamer, magnesium aluminum silicate (veegum), bentonite, hectorite, povidone, and maltol, or combination thereof.
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