Combination of Itriglumide and Proton Pump Inhibitors in the Treatment of Gastrointestinal and Related Disorders

Abstract

The invention relates to the combination of the cholecystokinin-2 (CCK-2) receptor antagonist Itriglumide and proton pump inhibitors (PPIs) for the treatment of patients suffering from gastrointestinal and related disorders.

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         6 . A pharmaceutical composition useful for relieving or alleviating symptoms of gastroesophageal reflux disease, said composition comprising (i) itriglumide or its racemate and (ii) an ATP-ase proton pump inhibitor selected from the group consisting of omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, and pharmaceutically acceptable salts thereof and with or without a pharmaceutically acceptable carrier. 
     
     
         7 . A pharmaceutical composition useful for the treatment of gastrointestinal disorders comprising (i) itriglumide or its racemate, (ii) a proton pump inhibitor selected from the group consisting of omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, and pharmaceutically acceptable salts thereof and (iii) a pharmaceutically acceptable carrier or excipient, wherein itriglumide is present at a therapeutically effective dosage. 
     
     
         8 . The pharmaceutical composition of  claim 7 , which is a solid dosage form for oral administration. 
     
     
         9 . The pharmaceutical composition of  claim 7 , wherein the proton pump inhibitor or a salt thereof is acid susceptible and said composition further comprises an enteric coating. 
     
     
         10 . A pharmaceutical composition according to  claim 8  further comprising (a) an outer layer comprising (i) an acid susceptible proton pump inhibitor or a salt thereof, and (ii) an enteric coating, and (b) an inner layer comprising itriglumide or its racemate or a salt thereof. 
     
     
         11 . The pharmaceutical composition of  claim 10 , wherein said inner layer further comprises a disintegrant. 
     
     
         12 . A pharmaceutical product useful for relieving or alleviating symptoms of gastroesophageal reflux disease, said composition comprising (i) itriglumide or its racemate and (ii) a proton pump inhibitor selected from the group consisting of omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, and pharmaceutically acceptable salts thereof.