Omeprazole formulation

Abstract

A stable pharmaceutical composition of omeprazole for oral administration which consists essentially of: (a) a core of Omeprazole or a pharmaceutically equivalent salt, a filler and an alkaline material selected from the group consisting of lysing and arginine; and (b) a single layer of coating on said core which comprises a layer of an enteric coating agent which is applied from an organic solvent based system.

1 . A stable pharmaceutical composition of omeprazole for oral administration which consists essentially of: 
 (a) a core of Omeprazole or a pharmaceutically equivalent salt, a filler and an alkaline material selected from the group consisting of lysine and arginine; and    (b) a single layer of coating on said core which comprises a layer of an enteric coating agent applied from an organic solvent based system.    
     
     
         2 . A pharmaceutical composition of omeprazole as defined in  claim 1  wherein said core is further comprised essentially of a surface active agent, and a binder and said pharmaceutical composition is formed into a compressed tablet.  
     
     
         3 . A pharmaceutical composition as defined in  claim 1  wherein said core is further comprised essentially of a an inert core component, a surface active agent and a binder and said pharmaceutical composition is pelleted.  
     
     
         4 . A pharmaceutical composition of omeprazole as defined in  claim 2  wherein the acid resistant component is selected from the group consisting of cellulose acetate phthalate, hydroxypropylmethyl cellulose phthalate, polyvinyl acetate phthalate, carboxymethylethylcellulose, co-polymerized methacrylic acid/methacrylic acid methyl esters.  
     
     
         5 . A pharmaceutical composition of omeprazole as defined in  claim 3  wherein the acid resistant component is selected from the group consisting of cellulose acetate phthalate, hydroxypropylmethyl cellulose phthalate, polyvinyl acetate phthalate, carboxymethylethylcellulose, co-polymerized methacrylic acid/methacrylic acid methyl esters.  
     
     
         6 . A pharmaceutical composition of omeprazole as defined in  claim 1  wherein the enteric coating agent also includes an inert processing aid.  
     
     
         7 . A pharmaceutical composition of omeprazole as defined in  claim 1  wherein the enteric coating agent around the core includes from 5 to 55wt % by weight of the coating of an inert processing aid.  
     
     
         8 . A pharmaceutical composition of omeprazole as defined in  claim 1  which includes a sodium lauryl sulfate as the surface active agent.  
     
     
         9 . A pharmaceutical dosage formulation which consists essentially of: 
 (a) a tablet core comprising omeprazole, a binder, an alkaline agent selected from the group consisting of arginine or lysine, a filler; and    (b) an enteric coating agent around said core, said enteric coating comprising hydroxypropylmethyl cellulose phthalate and talc.    
     
     
         10 . A pharmaceutical composition as defined in  claim 3   wherein the core contains a non-pariel sugar seed.    
     
     
         11 . A pelleted pharmaceutical dosage formulation which consists essentially of: 
 (a) a core comprising a non-pariel sugar seed coated with drug layer composition comprising omeprazole, a binder, an alkaline agent selected from the list consisting of arginine and -lysine, a filler and a surface active agent; and    (b) an enteric coating agent around said core, said enteric coating comprising hydroxypropylmethyl cellulose phthalate and talc which is applied from an organic solvent based system.