Liquid pharmaceutical composition

Abstract

This invention relates to new pharmaceutical compositions and methods for their preparation, and in particular it relates to taste-masked liquid compositions comprising a solution of a histamine H 2 -antagonist complexed with an alginate and also containing a humectant. The solution is buffered to a pH of between about 6 to 7. The inventive solution may be flavored and sweetened and preserved.

1 . A liquid pharmaceutical composition for the oral administration of a therapeutically effective amount of nizatidine, said composition comprising a solution of nizatidine or a pharmaceutically acceptable salt thereof and a taste-masking agent capable of forming a complex with the nizatidine wherein said taste-masking agent comprises alginate and wherein said composition exhibits a non-bitter taste.  
     
     
         2 . The pharmaceutical composition according to  claim 1 , wherein the alginate taste-masking agent comprises sodium alginate.  
     
     
         3 . The pharmaceutical composition according to  claim 1 , wherein the nizatidine is in the form of a pharmaceutically acceptable salt.  
     
     
         4 . The pharmaceutical composition according to  claim 1 , wherein the nizatidine is in the form of a free base.  
     
     
         5 . The pharmaceutical composition according to  claim 1 , wherein the ratio of nizatidine to alginate taste-masking agent is from 1:0.1 to 1:0.6 weight:weight.  
     
     
         6 . The pharmaceutical composition according to  claim 1 , wherein the ratio of nizatidine to alginate is about 1:0.2 to about 1:0.4 weight:weight.  
     
     
         7 . The pharmaceutical composition according to  claim 1  further comprising a flavoring agent selected from the groups consisting of natural and artificial flavors and mints.  
     
     
         8 . The pharmaceutical composition according to  claim 1  further comprising a sweetening agent selected from the group consisting of water-soluble sweetening agents, water-soluble artificial sweetening agents and mixtures thereof.  
     
     
         9 . The pharmaceutical composition according to  claim 8 , wherein said water-soluble natural sweetening agent is selected from the group consisting of: xylose, ribose, glucose, mannose, galactose, fructose, dextrose, sucrose, sugar, maltose, partially hydrolyzed starch, corn syrup solids, sorbitol, xylitol, mannitol and mixtures thereof.  
     
     
         10 . The pharmaceutical composition according to  claim 8 , wherein said artificial sweetening agent is L-aspartylphenylalanine methyl ester.  
     
     
         11 . The pharmaceutical composition according to  claim 8 , wherein said water-soluble artificial sweetening agent is selected from the group consisting of: sodium or calcium saccharin salts, cyclamate salts, acesulfam-K, ammonium glycyrrhizinate, dipotassium glycyrrhizinate, and the free acid form of saccharin.  
     
     
         12 . The pharmaceutical composition according to  claim 7 , wherein said flavoring agent is present in from about 0.01% to about 1% by weight/volume of the final composition.  
     
     
         13 . The pharmaceutical composition according to  claim 7 , wherein said flavoring agent is one or more members selected from the group consisting of: peppermint, menthol, artificial vanilla, cinnamon, lemon, lime, orange, menthol, strawberry, bubblegum, and mixtures thereof.  
     
     
         14 . The pharmaceutical composition according to  claim 1 , further comprising a humectant.  
     
     
         15 . The pharmaceutical composition according to  claim 14 , wherein the humectant is present in an amount from 8 to 15 percent w/v of the final composition.  
     
     
         16 . The pharmaceutical composition according to  claim 14 , wherein the humectant is selected from the group consisting of glycerol, propylene glycol and mixtures thereof.  
     
     
         17 . The pharmaceutical composition according to  claim 1 , wherein the liquid is adjusted to a pH of 6.0 to 7.0.  
     
     
         18 . The pharmaceutical composition according to  claim 1 , wherein the liquid is adjusted to a pH of 6.0 to 6.9.  
     
     
         19 . The pharmaceutical composition according to  claim 1 , wherein the liquid is adjusted to a pH of 6.25 to 6.75.  
     
     
         20 . The pharmaceutical composition according to  claim 1 , further comprising an artificial sweetness enhancer in from about 0.05 to about 1.5 percent w/v of the final composition.  
     
     
         21 . The pharmaceutical composition according to  claim 1 , further comprising EDTA in an amount from about 0.05% w/v to about 0.1% w/v.