Substantially sodium free diclofenac potassium oral solutions

Abstract

Provided are orally formulations of diclofenac potassium with improved stability in response to cold conditions, and excellent taste and palatability.

1 . A liquid pharmaceutical composition for oral use comprising:
 a) diclofenac potassium salt in an amount from 3.5 to 20% (w/v) with respect to the volume of the composition; and   b) potassium bicarbonate in an amount from 2.0 to 10.0% (w/v) with respect to the volume of the composition;   wherein sodium ions are absent or present in said composition in an amount of up to 0.05% (w/v) with respect to the volume of the composition.   
     
     
         2 . The composition of  claim 1 , wherein said diclofenac potassium salt is present in an amount of about 5% (w/v) with respect to the volume of the composition. 
     
     
         3 . The composition of  claim 1 , wherein said potassium bicarbonate is present in an amount from 2.0 to 5.0% (w/v) with respect to the volume of the composition. 
     
     
         4 . The composition of  claim 1 , wherein said composition has a density from 1.0 to 1.1 g/ml. 
     
     
         5 . The composition of  claim 1 , wherein said composition has a concentration of sodium ions of less than 0.02% (w/v) with respect to the volume of the composition. 
     
     
         6 . The composition of  claim 1 , further comprising at least one sweetening substance substantially free of sodium ions. 
     
     
         7 . The composition of  claim 6 , further comprising from 0.3 to 2.0% (w/v) of a sweetening substance substantially free of sodium ions with respect to the volume of the composition. 
     
     
         8 . The composition of  claim 7 , wherein said sweetening substance is selected from the group consisting of sucralose, aspartame, thaumatin, isomalt, maltitol, lactitol, and xylitol. 
     
     
         9 . The composition of  claim 8 , further comprising glycerol. 
     
     
         10 . The composition of  claim 9 , wherein said glycerol is present in an amount from 10 to 50% (w/v) with respect to the volume of the composition. 
     
     
         11 . A liquid oral pharmaceutical composition comprising:
 a) about 5 weight parts diclofenac potassium,   b) about 30 weight parts ethyl alcohol,   c) about 20 weight parts glycerol,   d) about 2.5 weight parts potassium hydrogen carbonate,   e) about 0.5 weight parts sucralose; and   f) about 42.9 weight parts water.   
     
     
         12 . The composition of  claim 11 , wherein said composition has a density of between 1.0 and 1.1 g/ml. 
     
     
         13 . The composition of  claim 11 , wherein said composition contains from about 10 to about 100 mg of said diclofenac potassium. 
     
     
         14 . A kit for the administration of an oral drug solution comprising:
 a) a defined amount of the composition of  claim 11 ; and   b) a dropper apparatus or graduated pipette.   
     
     
         15 . (canceled) 
     
     
         16 . (canceled) 
     
     
         17 . (canceled) 
     
     
         18 . (canceled) 
     
     
         19 . (canceled) 
     
     
         20 . The composition of  claim 3 , wherein potassium bicarbonate is present in said composition in an amount from 2.5 to 3.0% (w/v) with respect to the volume of the composition. 
     
     
         21 . The composition of  claim 4 , wherein the composition has a density of from 1.0 to 1.05 g/ml.