Novel 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, including preparations of s-omeprazole, and at least one buffering agent. Also provided is a pharmaceutical composition 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

1 - 22 . (canceled) 
     
     
         23 . 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 s-omeprazole or a pharmaceutically acceptable salt thereof, wherein the s-omeprazole is non-enteric coated; and   (b) sodium bicarbonate in an amount of about 0.2 mEq to about 5 mEq per 2 mg of the s-omeprazole or a pharmaceutically acceptable salt thereof; 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 s-omeprazole by gastric acid upon administration to the subject.   
     
     
         24 . The method of  claim 23 , 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. 
     
     
         25 . The method of  claim 24 , 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. 
     
     
         26 . The method of  claim 25 , wherein the dosage form further comprises a disintegrant. 
     
     
         27 . The method of  claim 25 , where the dosage form further comprises a lubricant. 
     
     
         28 . The method of  claim 26 , wherein the disintegrant is selected from the group consisting of microcrystalline cellulose and croscarmellose sodium. 
     
     
         29 . The method of  claim 28 , wherein the disintegrant is croscarmellose sodium. 
     
     
         30 . The method of  claim 26 , wherein the solid dosage form is a capsule. 
     
     
         31 . The method of  claim 26 , wherein the solid dosage form is a chewable tablet. 
     
     
         32 . The method of  claim 26 , wherein the solid dosage form is a tablet. 
     
     
         33 . The method of  claim 30 , wherein the s-omeprazole is micronized. 
     
     
         34 . The method of  claim 31 , wherein the s-omeprazole is micronized. 
     
     
         35 . The method of  claim 32 , wherein the s-omeprazole is micronized. 
     
     
         36 . The method of  claim 30 , wherein the solid dosage form is administered to the subject in an amount sufficient to provide the subject with a daily dose of s-omeprazole of about 20 mg to about 40 mg. 
     
     
         37 . The method of  claim 31 , wherein the solid dosage form is administered to the subject in an amount sufficient to provide the subject with a daily dose of s-omeprazole of about 20 mg to about 40 mg. 
     
     
         38 . The method of  claim 32 , wherein the solid dosage form is administered to the subject in an amount sufficient to provide the subject with a daily dose of s-omeprazole of about 20 mg to about 40 mg. 
     
     
         39 . The method of  claim 30 , wherein the solid dosage form is administered to the subject in an amount sufficient to provide the subject with a daily dose of s-omeprazole of about 20 mg. 
     
     
         40 . The method of  claim 30 , wherein the solid dosage form is administered to the subject in an amount sufficient to provide the subject with a daily dose of s-omeprazole of about 40 mg. 
     
     
         41 . The method of  claim 31 , wherein the solid dosage form is administered to the subject in an amount sufficient to provide the subject with a daily dose of s-omeprazole of about 20 mg. 
     
     
         42 . The method of  claim 31 , wherein the solid dosage form is administered to the subject in an amount sufficient to provide the subject with a daily dose of s-omeprazole of about 40 mg. 
     
     
         43 . The method of  claim 32 , wherein the solid dosage form is administered to the subject in an amount sufficient to provide the subject with a daily dose of s-omeprazole of about 20 mg. 
     
     
         44 . The method of  claim 32 , wherein the solid dosage form is administered to the subject in an amount sufficient to provide the subject with a daily dose of s-omeprazole of about 40 mg. 
     
     
         45 . The method of  claim 23 , wherein the composition comprises 10 mg s-omeprazole and about 1 mEq to about 25 mEq sodium bicarbonate. 
     
     
         46 . The method of  claim 23 , wherein the composition comprises 20 mg s-omeprazole and about 2 mEq to about 25 mEq sodium bicarbonate. 
     
     
         47 . The method of  claim 23 , wherein the composition comprises 40 mg s-omeprazole and about 4 mEq to about 25 mEq sodium bicarbonate. 
     
     
         48 . The method of  claim 30 , wherein the sodium bicarbonate is present in an amount of about 1000 mg to about 1680 mgs. 
     
     
         49 . The method of  claim 32 , wherein the sodium bicarbonate is present in an amount of about 1000 mg to about 1680 mgs.