Substituted benzimidazole dosage forms and methods of using same
DCFirst Claim
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1. A method of treating a gastric acid related disorder in a subject in need thereof, comprising:
- providing a solid pharmaceutical composition for oral administration to the subject, the composition consisting essentially of;
(a) a therapeutically effective amount of at least one acid labile, substituted benzimidazole H+, K+-ATPase proton pump inhibitor;
(b) at least one buffering agent in an amount of about 0.1 mEq to about 2.5 mEq per mg proton pump inhibitor; and
(c) one or more optional pharmaceutically acceptable excipients; and
orally administering the pharmaceutical composition to the subject, wherein upon oral administration of the pharmaceutical composition to the subject, an initial serum concentration of the proton pump inhibitor greater than about 0.1 μ
g/ml is obtained at any time within about 30 minutes after administration of the composition.
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Abstract
Disclosed herein are methods, kits, combinations, and compositions for treating gastric acid disorders employing pharmaceutical compositions comprising a proton pump inhibiting agent (PPI) and a buffering agent in a pharmaceutically acceptable carrier.
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Citations
50 Claims
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1. A method of treating a gastric acid related disorder in a subject in need thereof, comprising:
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providing a solid pharmaceutical composition for oral administration to the subject, the composition consisting essentially of;
(a) a therapeutically effective amount of at least one acid labile, substituted benzimidazole H+, K+-ATPase proton pump inhibitor;
(b) at least one buffering agent in an amount of about 0.1 mEq to about 2.5 mEq per mg proton pump inhibitor; and
(c) one or more optional pharmaceutically acceptable excipients; and
orally administering the pharmaceutical composition to the subject, wherein upon oral administration of the pharmaceutical composition to the subject, an initial serum concentration of the proton pump inhibitor greater than about 0.1 μ
g/ml is obtained at any time within about 30 minutes after administration of the composition.- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
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26. A method of treating a gastric acid related disorder in a subject in need thereof, comprising:
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orally administering to the subject a single dose of a solution or suspension of a pharmaceutical composition, the composition consisting essentially of;
(a) a therapeutically effective amount of at least one acid labile, substituted benzimidazole H+, K+-ATPase proton pump inhibitor;
(b) at least one buffering agent in an amount of about 0.1 mEq to about 2.5 mEq per mg proton pump inhibitor; and
(c) one or more optional pharmaceutically acceptable excipients wherein an initial serum concentration of the proton pump inhibitor greater than about 0.1 μ
g/ml is obtained at any time within about 30 minutes after administration of the composition, and wherein the administering step does not require further administration of the buffering agent(s) beyond that administered in the single dose.- View Dependent Claims (27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 46, 47, 48, 49, 50)
40.The method of claim 39, wherein the sodium bicarbonate is in an amount from about 250 mg to about 4000 mg. -
40. The method of claim 39, wherein the sodium bicarbonate is in an amount from about 1000 mg to about 2000 mg.
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41. The method of claim 39, wherein the sodium bicarbonate is in an amount of at least about 400 mg.
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42. The method of claim 39, wherein the buffering agent comprises calcium carbonate.
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46. The method of claim 26, wherein the excipient is selected from the group consisting of a pharmaceutically compatible carrier, a binder, a suspending agent, a flavoring agent, a sweetening agent, a disintegrant, a flow aid, a lubricant, an adjuvant, a colorant, a diluent, a moistening agent, a preservative, a parietal cell activator, an anti-foaming agent, an antioxidant, a chelating agent, an antifungal agent, an antibacterial agent, or an isotonic agent, and combinations of any of the foregoing.
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47. The method of claim 26, wherein the subject is an adult human.
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48. The method of claim 26, wherein the disorder is selected from the group consisting of duodenal ulcer disease, gastric ulcer disease, gastroesophageal reflux disease, erosive esophagitis, poorly responsive symptomatic gastroesophageal reflux disease, pathological gastrointestinal hypersecretory disease, Zollinger Ellison Syndrome, heartburn, esophageal disorder, and acid dyspepsia.
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49. The method of claim 26, wherein the excipient is one or more flavoring agents selected from the group consisting of aspartame, thaumatin, sucrose, dextrose, or a chocolate, a cocoa, a cola, a peppermint, a spearmint, a watermelon, an apple, a caramel, a meat, a root beer, a maple, a cherry, a coffee, a mint, a licorice, a nut, a butter, a butterscotch, a butter pecan, or a peanut butter flavoring, and combinations of any of the foregoing.
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50. The method of claim 26, wherein the composition is administered once or twice a day.
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- 43. The method of claim 43, wherein the calcium carbonate is in an amount from about 250 mg to about 4000 mg.
Specification