Stabilized pharmaceutical composition

Abstract

The pharmaceutical composition of the invention, which comprises a benzimidazole compound of the formula wherein R 1 is hydrogen, alkyl, halogen, cyano, carboxy, carboalkoxy, carboalkoxyalkyl, carbamoyl, carbamoylalkyl, hydroxy, alkoxy, hydroxyalkyl, trifluoromethyl, acyl, carbamoyloxy, nitro, acyloxy, aryl, aryloxy, alkylthio or alkylsulfinyl, R 2 is hydrogen, alkyl, acyl, carboalkoxy, carbamoyl, alkylcarbamoyl, dialkylcarbamoyl, alkylcarbonylmethyl, alkoxycarbonylmethyl or alkylsulfonyl, R 3 and R 5 are the same or different and each is hydrogen, alkyl, alkoxy or alkoxyalkoxy, R 4 is hydrogen, alkyl, alkoxy which may optionally be fluorinated, or alkoxyalkoxy, and m is an integer of 0 through 4, and a basic inorganic salt stabilizing agent, is physically stable. Magnesium and calcium basic inorganic salt stabilizing agents are particularly useful.

1 - 7 . (Cancelled)  
     
     
         8 . A stabilizing agent comprising a basic inorganic salt of at least one selected from the group consisting of magnesium, calcium, potassium, and sodium for a pharmaceutical composition for the inhibition of gastric acid secretion, comprising an effective amount of a 2-[(2-pyridyl)methylsulfinyl]benzimidazole compound or a derivative thereof or a pharmaceutically acceptable salt thereof.  
     
     
         9 . A stabilizing agent of  claim 8 , wherein the 2-[(2-pyridyl)methylsulfinyl]benzimidazole compound is a benzimidazole compound of the formula (I)  
       
         
           
           
               
               
           
         
         wherein R 1  is hydrogen, alkyl, halogen, cyano, carboxy, carboalkoxy, carboalkoxyalkyl, carbamoyl, carbamoylalkyl, hydroxy, alkoxy hydroxyalkyl, trifluoromethyl, acyl carbamoyloxy, nitro, acyloxy, aryl. aryloxy, alkylthio or alkylsulfinyl;  
         R 2  is hydrogen, alkyl, acyl, carboalkoxy, carbamoyl, alkylcarbamoyl, dialkylcarbamoyl, alkylcarbonylmethyl, alkoxycarbonylmethyl or alkylsulfonyl;  
         R 3  and R 5  are the same or different and each is hydrogen, alkyl, alkoxy or alkoxyalkoxy;  
         R 4  is hydrogen, alkyl, alkoxy which may optionally be fluorinated, or alkoxyalkoxy; and  
         m is an integer from 0 to 4, or a derivative thereof or salt thereof having a gastric acid secretion inhibitory property.  
       
     
     
         10 . A stabilizing agent of  claim 8 , wherein the basic inorganic salt is a basic inorganic salt of magnesium or calcium.  
     
     
         11 . A stabilizing agent of  claim 8 , wherein the basic inorganic salt is a basic inorganic salt of sodium.  
     
     
         12 . A stabilizing agent of  claim 8 , wherein the basic inorganic salt is a basic inorganic salt of potassium.