Solutions comprising polyethylene glycol and electrolytes

Abstract

The invention provides a solution in water comprising the following components at the following concentrations: (a) N×(70 to 130) g/L polyethylene glycol (PEG) having an average molecular weight of 2500 to 4500; (b) N×(1.6 to 4.0) g/L sodium chloride; (c) N×(0.2 to 0.6) g/L potassium chloride; (d) N×(0.6 to 2.2) g/L sodium bicarbonate; (e) N×an amount of preservative; (f) optionally N×an amount of flavouring; and (g) optionally N×an amount of sweetener where N is in the range of 2 to 8. The solution is a concentrate for dilution. In use it is diluted N-fold with water to provide a solution for administration to a subject for the treatment of constipation or faecal impaction. Also provided are solutions, kits, unit doses and methods that comprise or use the solutions.

1 . A solution in water comprising the following components at the following concentrations:
 (a) N×(70 to 130) g/L polyethylene glycol (PEG) having an average molecular weight of 2500 to 4500;   (b) N×(1.6 to 4.0) g/L sodium chloride;   (c) N×(0.2 to 0.6) g/L potassium chloride;   (d) N×(0.6 to 2.2) g/L sodium bicarbonate;   (e) N×an amount of preservative;   (f) optionally N×an amount of flavouring; and   (g) optionally N×an amount of sweetener   
       where N is in the range of 2 to 8. 
     
     
         2 . A solution as claimed in  claim 1 , wherein the solution comprises N×(0.3 to 1.4) g/L of preservative. 
     
     
         3 . A solution as claimed in  claim 1 , wherein the preservative comprises methyl paraben, ethyl paraben or benzyl alcohol, or a mixture of two or more of them. 
     
     
         4 . A solution as claimed in  claim 1  comprising N×(0.02 to 0.2) g/L of sweetener, for example comprising one or both of acesulfame K and sucralose, and/or the solution comprises N×(0.2 to 2) g/L of flavouring, for example Orange Juice or Tropical Fruit flavour. 
     
     
         5 . A solution as claimed in  claim 1  comprising the following components at the following concentrations:
 (a) 350 to 600 g/L polyethylene glycol (PEG) having an average molecular weight of 2500 to 4500; 
 (b) 8.0 to 20 g/L sodium chloride; 
 (c) 1.0 to 3.0 g/L potassium chloride; 
 (d) 3.0 to 11 g/L sodium bicarbonate; 
 (e) preservative; 
 (f) optional flavouring; and 
 (g) optional sweetener. 
 
     
     
         6 . A solution as claimed in  claim 5 , wherein the solution comprises 1.5 to 7.0 g/L of preservative. 
     
     
         7 . A solution as claimed in  claim 5 , wherein the preservative comprises methyl paraben, ethyl paraben or benzyl alcohol, or a mixture of two or more of them. 
     
     
         8 . A solution as claimed in  claim 5  comprising 0.1 to 1.0 g/L of sweetener, for example comprising one or both of acesulfame K and sucralose, and/or the solution comprises 1.0 to 10 g/L of flavouring, for example Orange Juice or Tropical Fruit flavour. 
     
     
         9 . A solution as claimed in  claim 1  comprising the following components at the following concentrations:
 (a) 525 g/L polyethylene glycol (PEG) having an average molecular weight of 2500 to 4500; 
 (b) 14.028 g/L sodium chloride; 
 (c) 1.864 g/L potassium chloride; 
 (d) 7.140 g/L sodium bicarbonate; 
 (e) preservative; 
 (f) optional flavouring; and 
 (g) optional sweetener. 
 
     
     
         10 . A solution as claimed in  claim 9  comprising:
 (e) 2.5 or 3.5 g/L preservative; 
 (f) 3.2 g/L flavouring; and 
 (g) 0.52 g/L sweetener. 
 
     
     
         11 . A solution as claimed in  claim 1  that is substantially free from any sulphate component. 
     
     
         12 . A container containing a solution as claimed in  claim 1 , for example containing 25 ml, 100 ml, 150 ml, 250 ml or 500 ml of solution. 
     
     
         13 . A container as claimed in  claim 12  containing:
 (a) x×262.50 g polyethylene glycol (PEG) 3350; 
 (b) x×7.014 g sodium chloride; 
 (c) x×0.932 g potassium chloride; 
 (d) x×3.570 g sodium bicarbonate; 
 (e) x×an amount of preservative; 
 (f) optionally x×an amount of flavouring; 
 (g) optionally x×an amount of sweetener; and 
 (h) water to x×500 ml; 
 Wherein x is 0.5 to 2, for example x is 0.5 or 1. 
 
     
     
         14 . A kit comprising a container as claimed in  claim 12  together with instructions for use, for example instructing the user to dilute a stated volume of the solution with a stated volume of water. 
     
     
         15 . A kit comprising a container as claimed in  claim 12  together with a measuring accessory for measuring out a defined volume of the solution. 
     
     
         16 . A method of preparing a concentrate solution as claimed in  claim 1  comprising combining the components (a) to (g) with water. 
     
     
         17 . A method of preparing a solution for the treatment of constipation or faecal impaction, which method comprises combining a solution as claimed in  claim 1  with water. 
     
     
         18 . A solution that has been prepared by combining a solution as claimed in  claim 1  with water. 
     
     
         19 - 20 . (canceled) 
     
     
         21 . A method of treating constipation or faecal impaction, which method comprises administering orally to the subject a solution as claimed in  claim 18 . 
     
     
         22 . A solution as claimed in  claim 5  that is substantially free from any sulphate component.