Colon cleansing compositions and methods

Abstract

A composition comprising, per litre of aqueous solution, from 30 to 350 g polyethylene glycol, from 3 to 20 g of an ascorbic acid component selected form the group consisting of ascorbic acid, a salt of ascorbic acid, or a mixture thereof, an alkali metal or alkaline earth metal sulphate, preferably from 1 to 15 g thereof, and optionally one or more electrolytes selected from sodium chloride, potassium chloride, and sodium hydrogen carbonate, and preferably also comprising flavourings, is effective in cleansing the gut in preparation for a endoscopy, especially colonoscopy. It is safer than conventional sodium phosphate-based gut cleansing compositions, and hence can be used for patients who would be at risk with sodium phosphate-based compositions, and is better tolerated than conventional PEG-based compositions, leading to better patient compliance and enabling effective out-patient use.

1 . A dry composition provided in two or more component form, comprising:
 (i) 90 to 125 g of polyethylene glycol (PEG)   (ii) 5 to 10 g of an alkali metal sulfate, an alkaline earth metal sulfate or a mixture thereof;   (iii) 2 to 4 g of sodium chloride;   (iv) 0.5 to 1.3 g of potassium chloride; and   (v) 5 to 15 g of an ascorbate component, said ascorbate component comprising ascorbic acid and a salt thereof in an ascorbic acid:salt weight ratio in the range of 2:8 to 8:2,   
     wherein the calculated total number of moles of individual dissolved species in a solution made with the composition made up to one liter with water is within the range of 300 to 700 mmol. 
   
   
       2 . The dry composition of  claim 1 , wherein the calculated total number of moles of individual species is within the range of 330 to 550 mmol. 
   
   
       3 . The dry composition of  claim 1 , wherein the dry composition comprises one or more flavourings. 
   
   
       4 . The dry composition of  claim 1 , wherein the dry composition comprises one or more sweeteners. 
   
   
       5 . The dry composition of  claim 4 , wherein the dry composition comprises one or more flavourings. 
   
   
       6 . A 2 liter aqueous solution comprising water and:
 (a) 90 g/l to 125 g/l of polyethylene glycol (PEG);   (b) 5 g/l to 10 g/l of an alkali metal sulfate, an alkaline earth metal sulfate or a mixture thereof;   (c) 5 g/l to 15 g/l of an ascorbate component, said ascorbate component comprising ascorbic acid and a salt thereof in an ascorbic acid:salt weight ratio in the range of 2:8 to 8:2;   (d) 2 g/l to 4 g/l of sodium chloride; and   (e) 0.5 g/l to 1.3 g/l of potassium chloride,   
     wherein the calculated total number of moles of individual dissolved species per liter of said solution is within the range of 300 to 700 mmol. 
   
   
       7 . The solution of  claim 6 , wherein the calculated total number of moles of individual species is within the range of 330 to 550 mmol. 
   
   
       8 . The solution of  claim 6 , wherein the solution comprises one or more flavourings. 
   
   
       9 . The solution of  claim 6 , wherein the solution comprises one or more sweeteners. 
   
   
       10 . The solution of  claim 9 , wherein the solution comprises one or more flavourings. 
   
   
       11 . A kit comprising dry components for the preparation of a solution as claimed in any one of  claims 6  to  10 .