Taste-masked docusate compositions

Abstract

A taste-masked liquid composition of docusate includes a docusate salt, povidone, a polyether, and water. Additional ingredients in the composition may include thickeners, sweeteners, flavorants, polyols, preservatives, chelating agents and pH adjusters. Such compositions may be used as taste-masked oral compositions of docusate, and may provide therapeutic effects such as stool-softening.

1 . A taste-masked liquid composition, comprising:
 from 0.2 w/w % to 2 w/w % of a docusate salt;   from 0.5 w/w % to 20 w/w % povidone;   from 0.5% to 20% of a polyether; and   water.   
     
     
         2 . The composition of  claim 1 , where the docusate salt is selected from the group consisting of lithium docusate, sodium docusate, potassium docusate, magnesium docusate, calcium docusate, and mixtures thereof. 
     
     
         3 . The composition of  claim 1 , where the docusate salt comprises sodium docusate. 
     
     
         4 . The composition of  claim 1 , where the polyether is selected from the group consisting of polyethylene glycol, polypropylene glycol, poloxamers, and mixtures thereof. 
     
     
         5 . The composition of  claim 1 , where the polyether comprises polyethylene glycol. 
     
     
         6 . The composition of  claim 1 , further comprising from 0.005 w/w % to 2 w/w % of a thickener. 
     
     
         7 . The composition of  claim 6 , where the thickener is selected from the group consisting of xanthan gum, gum arabica, sodium alginate, methylcellulose, carboxymethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxyethylmethylcellulose, hydroxypropylmethylcellulose, carrageenan, guar gum, tragacanth, pectin, and mixtures thereof. 
     
     
         8 . The composition of  claim 1 , further comprising from 0.05 w/w % to 75 w/w % of a sweetener. 
     
     
         9 . The composition of  claim 8 , where the sweetener accounts for 5 w/w % to 75 w/w % of the composition, and the sweetener comprises a sugar selected from the group consisting of xylose, ribose, sucrose, lactose, maltose, mannose, galactose, glucose, fructose, and mixtures thereof. 
     
     
         10 . The composition of  claim 8 , where the sweetener accounts for 5 w/w % to 75 w/w % of the composition, and the sweetener comprises a sugar alcohol selected from the group consisting, erythritol, arabitol, xylitol, mannitol, sorbitol, isomalt, maltitol, lactitol, and mixtures thereof. 
     
     
         11 . The composition of  claim 8 , where the sweetener accounts for 0.05 w/w % to 2 w/w % of the composition, and the sweetener comprises an artificial sweetener selected from the group consisting of saccharin, saccharine sodium salt, aspartame, sucralose, neotame, acesulfame potassium, and mixtures thereof. 
     
     
         12 . The composition of  claim 1 , further comprising from 0.1 w/w % to 4 w/w % of a flavorant. 
     
     
         13 . The composition of  claim 12 , where the flavorant is selected from the group consisting of natural flavors, natural fruit flavors, artificial flavors, artificial fruit flavors, and mixtures thereof. 
     
     
         14 . The composition of  claim 12 , where the flavorant is selected from the group consisting of fruit punch, mint, grape, cherry, strawberry, menthol, bubble gum, and mixtures thereof. 
     
     
         15 . The composition of  claim 1 , further comprising from 2 w/w % to 60 w/w % of a polyol. 
     
     
         16 . The composition of  claim 15 , where the polyol is selected from the group consisting of propylene glycol, glycerin, and mixtures thereof. 
     
     
         17 . The composition of  claim 1 , further comprising 0.1 w/w % to 4 w/w % of a preservative. 
     
     
         18 . The composition of  claim 1 , further comprising a chelating agent. 
     
     
         19 . The composition of  claim 1 , further comprising a pH adjuster. 
     
     
         20 . (canceled) 
     
     
         21 . A taste-masked liquid composition, comprising:
 from 0.2 w/w % to 2 w/w % of a docusate salt;   from 0.5 w/w % to 20 w/w % povidone;   from 0.5 w/w % to 20 w/w % of a polyether;   from 2 w/w % to 40 w/w % of a polyol;   from 0.005 w/w % to 2 w/w % of a thickener;   from 0.05 w/w % to 75 w/w % of a sweetener;   from 0.1 w/w % to 4 w/w % of a flavorant; and   water.   
     
     
         22 .- 31 . (canceled) 
     
     
         32 . A method of making the composition of  claim 1 , comprising:
 combining ingredients comprising the docusate salt, the povidone, the polyether and the water.   
     
     
         33 . The method of  claim 32 , where the combining ingredients is performed without heating. 
     
     
         34 . The method of  claim 32 , where the combining ingredients comprises:
 combining the polyether and the water to form a first mixture,   combining the first mixture and the povidone to form a second mixture, and   combining the second mixture and the docusate salt.   
     
     
         35 . The method of  claim 32 , where
 the ingredients further comprise a thickener, and   the combining ingredients comprises
 forming a first mixture comprising the thickener; 
 forming a second mixture that includes the docusate salt, the povidone, the polyether and the water; and 
 combining the first and second mixtures. 
   
     
     
         36 . The composition of  claim 1 , where the sole pharmaceutically active agent is the docusate salt.