Gastric acid secretion inhibiting composition

Abstract

A method for the treatment of at least one symptom of gastro-esophageal reflux disease (GERD) in a human suffering from GERD administers an oral pharmaceutical dosage form into a gastro-intestinal tract of a human suffering from GERD. The oral pharmaceutical dosage form contains an acid susceptible proton pump inhibitor or salt thereof (PPI), an H2 receptor antagonist or salt thereof (H2RA), a pharmaceutically acceptable carrier, and optionally an antacid agent and/or alginate. The PPI is selected from lansoprazole, omeprazole, pantoprazole, rabeprazole, pariprazole, leminoprazole, their pharmaceutically acceptable salts, enantiomers and salts of enantiomers and is in a form that protects the PPI from degradation in a stomach. The H2RA is selected from cimetidine, ranitidine, nizatidine and famotidine, their pharmaceutically acceptable salts, isomers and salts of isomers. The PPI is administered in combination with the H2RA for passage into a small

1 . A method for the treatment of at least one symptom of gastro-esophageal reflux disease (GERD) in a human suffering from GERD consisting essentially of administering an oral pharmaceutical dosage form into a gastro-intestinal tract of a human suffering from GERD, the oral pharmaceutical dosage form consisting essentially of an acid susceptible proton pump inhibitor or salt thereof (PPI), an H2 receptor antagonist or salt thereof (H2RA), a pharmaceutically acceptable carrier, and optionally an antacid agent and/or alginate, wherein the PPI is selected from lansoprazole, omeprazole, pantoprazole, rabeprazole, pariprazole, leminoprazole, their pharmaceutically acceptable salts, enantiomers and salts of enantiomers and is in a form that protects the PPI from degradation in a stomach, wherein the H2RA is selected from cimetidine, ranitidine, nizatidine and famotidine, their pharmaceutically acceptable salts, isomers and salts of isomers, and wherein administering the oral pharmaceutical dosage form orally introduces into the gastro-intestinal tract of the human suffering from GERD the PPI in combination with the H2RA for passage into a small intestine for absorption. 
     
     
         2 . The method of  claim 1 , wherein the oral pharmaceutical dosage form is administered to affect a rise in gastric pH above 3 within about 2 hours from the administration of the first dose, thereby treating the human suffering from GERD promptly, and wherein the administering is repeated, if necessary to treat the human suffering from GERD over a prolonged period until 6 hours from the administration of the last dose. 
     
     
         3 . The method of  claim 1 , wherein the at least one symptom of gastro-esophageal reflux disease is indigestion, heartburn, sour stomach and/or upper abdominal pain and/or discomfort. 
     
     
         4 . The method of  claim 1 , wherein the method is suitable for on demand treatment of at least one symptom of gastro-esophageal reflux disease (GERD) in a human suffering from GERD. 
     
     
         5 . The method of  claim 1 , wherein the PPI is in the amount of from 1 mg to 100 mg and/or the H2RA is in the amount of from 1 mg to 800 mg in combination with the PPI. 
     
     
         6 . The method of  claim 1 , wherein the oral pharmaceutical-dosage form contains the optional antacid agent, and wherein the optional antacid agent s one or several of aluminum hydroxide, calcium carbonate, magnesium carbonate, basic magnesium carbonate, magnesium hydroxide, magnesium oxide, and sodium hydrogen carbonate. 
     
     
         7 . The method of  claim 1 , wherein the oral pharmaceutical dosage form is in the form of two concentric layers optionally separated by one or more separating layer(s), wherein the inner concentric layer is the PPI and the outer concentric layer is the H2RA. 
     
     
         8 . The method of  claim 1 , wherein the oral pharmaceutical dosage form is in the form of a capsule, a divided powder/pellet formulation or a tablet. 
     
     
         9 . The method of  claim 1 , wherein the oral pharmaceutical dosage form is in the form of a core and a layer surrounding the core, wherein the core is the PPI and the layer is the H2RA. 
     
     
         10 . The method of  claim 1 , wherein the oral pharmaceutical dosage form contains the antacid agent or the alginate.