Racecadotril liquid compositions

Abstract

A liquid composition comprising racecadotril and cyclodextrin.

What is claimed: 
     
         1 . A liquid composition comprising racecadotril and cyclodextrin, wherein the cyclodextrin is a sulfobutyl ether derivative of β-cyclodextrin. 
     
     
         2 . The composition of  claim 1 , wherein the racecadotril is an RS racemic form or R form. 
     
     
         3 . The composition of  claim 1 , wherein the racecadotril is present in an amount of from about 0.10 grams to about 0.30 grams per 100 ml of the liquid composition 
     
     
         4 . (canceled) 
     
     
         5 . The composition of  claim 1 , wherein the cyclodextrin is present in an amount of from about 6 grams to about 8 grams per 100 ml of the liquid composition. 
     
     
         6 . The composition of  claim 1 , further comprising an optional ingredient selected from the group consisting of buffers, preservatives, sweeteners, viscosity modifiers, colors, aromas, flavors, and mixtures thereof. 
     
     
         7 . The composition of  claim 6 , wherein the buffer is a citrate, an acetate, a phosphate, or mixtures thereof. 
     
     
         8 . The composition of  claim 6 , wherein the sweetener is sorbitol, high fructose corn syrup, sucralose, aspartame, saccharine, sucrose, or mixtures thereof. 
     
     
         9 . The composition of  claim 6 , wherein the preservative is sodium benzoate, potassium benzoate, propyl paraben, methyl paraben, butyl paraben, or mixtures thereof. 
     
     
         10 . A liquid composition comprising:
 about 0.1 wt. % to about 0.3 wt. % racecadotril;   about 6 wt. % to about 8 wt. % cyclodextrin, wherein the cyclodextrin is a sulfobutyl ether derivative of β-cyclodextrin;   about 16 wt. % to about 19 wt. % sorbitol;   about 45 wt. % to about 55 wt. % high fructose corn syrup;   about 0.1 wt. % to about 0.4 wt. % sodium chloride;   about 0.1 wt. % to about 0.8 wt. % polyethylene glycol;   about 15 wt. % to about 30 wt. % water; and   about 0 wt. % to about 0.5 wt. % flavor,   wherein each wt. % is based upon 100 ml of the composition.   
     
     
         11 . The liquid composition of  claim 1  comprising racecadotril, wherein the liquid composition has a pH of from about 3 to about 5 at 25° C. 
     
     
         12 . A soft shell solid dosage form comprising the composition of  claim 1 . 
     
     
         13 . A hard shell solid dosage form comprising the composition of  claim 1 . 
     
     
         14 . The composition of  claim 1 , wherein the composition is delivered orally. 
     
     
         15 . The composition of  claim 1 , wherein the composition is a liquid oral dosage form. 
     
     
         16 . A tablet dosage form comprising the composition of  claim 1 . 
     
     
         17 . A method for treating a subject experiencing diarrhea comprising the step of orally administering to the subject a composition comprising racecadotril and cyclodextrin, wherein the cyclodextrin is a sulfobutyl ether derivative of β-cyclodextrin.