Compositions

Abstract

The invention provides a colon cleansing solution comprising: a) 300 to 800 mmol per litre ascorbate anion provided by a mixture of: (i) ascorbic acid and (ii) one or more salts of ascorbic acid the components (i) and (ii) being present in a molar ratio of from 1:4.5 to 1:7.0; and b) 10 to 200 g per litre polyethylene glycol. The invention also provides methods an kits associated with, or making use of the solutions, and compositions for the preparation of the solutions.

1 . A colon cleansing solution comprising:
 a) 300 to 800 mmol per litre ascorbate anion provided by a mixture of:
 (i) ascorbic acid and 
 (ii) one or more salts of ascorbic acid 
 the components (i) and (ii) being present in a molar ratio of from 1:4.5 to 1:7.0; and 
   b) 10 to 200 g per litre polyethylene glycol.   
     
     
         2 . A colon cleansing solution as claimed in  claim 1  wherein the one or more salts of ascorbic acid are selected from sodium ascorbate, potassium ascorbate, magnesium ascorbate and calcium ascorbate, or a mixture thereof. 
     
     
         3 . A colon cleansing solution as claimed in  claim 1  comprising ascorbate anion in a concentration of: 300-700 mmol per litre, for example 350-650 mmol per litre, for example 450-600 mmol per litre. 
     
     
         4 . A colon cleansing solution as claimed in  claim 1  wherein the molar ratio of the components (i) and (ii) is from 1:4.75 to 1:6.75; more preferably from 1:5.0 to 1:6.0; for example from 1:5.40 to 1:5.80; for example 15:85. 
     
     
         5 . A colon cleansing solution as claimed in  claim 1  wherein the solution comprises 60 to 140 g/litre of ascorbate component, for example 80 to 130 g/litre, for example 80 to 120 g/litre, for example 100 to 120 g/litre. 
     
     
         6 . A colon cleansing solution as claimed in  claim 1  which comprises 12 to 20 g/litre of ascorbic acid and 80 to 120 g/litre of sodium ascorbate. 
     
     
         7 . A colon cleansing solution as claimed in  claim 1  in which the polyethylene glycol has an average molecular weight of 2000 to 8000, for example 2500 to 4500 Da, for example 2680 to 4020 Da, for example 3000 to 4000 Da. 
     
     
         8 . A colon cleansing solution as claimed in  claim 1  wherein the solution comprises 20 to 160 g per litre of PEG, for example 40 to 120 g per litre, for example 60 to 100 g per litre, for example 80 g per litre. 
     
     
         9 . A colon cleansing solution as claimed in  claim 1  which comprises sodium chloride at a concentration of 3 to 8 g per litre, for example 4 to 7 g per litre; for example 5.6 g per litre or 6.4 g per litre. 
     
     
         10 . A colon cleansing solution as claimed in  claim 1  which comprises potassium chloride at a concentration of 1 to 10 g per litre, for example a concentration of 1 to 7 g per litre, for example 1.5 to 5 g per litre, for example 1.5 to 3 g per litre, for example 2.0 to 2.8 g per litre; for example 2.4 g per litre or 2.6 g per litre. 
     
     
         11 . A colon cleansing solution as claimed in  claim 1  which comprises sodium sulphate, potassium sulphate or magnesium sulphate, at a concentration of 2 to 20 g per litre, for example 5 to 15 g per litre, for example 8 to 15 g per litre, for example 10 to 14 g per litre, for example 12 g per litre. 
     
     
         12 . A colon cleansing solution as claimed in  claim 1  which is essentially free from alkali metal sulphates and alkaline earth metal sulphates. 
     
     
         13 . A colon cleansing solution as claimed in  claim 1  which comprises a flavouring agent. 
     
     
         14 . A colon cleansing solution as claimed in  claim 1  which comprises a sweetener. 
     
     
         15 . A colon cleansing solution as claimed in  claim 14  comprising aspartame and orange flavouring. 
     
     
         16 . A colon cleansing solution as claimed in  claim 15  comprising aspartame at 0.5 to 4 g per litre, for example 2.5 to 4.0 g per litre, for example 3.0 g per litre, for example 3.86 g per litre; and orange flavouring at 0.2 to 1.8 g per litre. 
     
     
         17 . A colon cleansing solution comprising:
 a) 300 to 800 mmol per litre ascorbate anion provided by a mixture of
 (i) ascorbic acid and 
 (ii) one or more salts of ascorbic acid 
 the components (i) and (ii) being present in a molar ratio of from 1:4.5 to 1:7.0; 
   b) 10 to 200 g per litre PEG having an average molecular weight of 3000 to 4000 Da;   c) sodium chloride and potassium chloride;   e) one or more flavouring agents; and   f) one or more sweeteners.   
     
     
         18 . A colon cleansing solution as claimed in  claim 1  wherein some or all of components other than the ascorbate component and the PEG are provided separately from the solution, for example in a tablet or capsule. 
     
     
         19 . A composition for admixture with water which comprises:
 a) 150 to 400 mmol ascorbate anion provided by a mixture of:
 (i) ascorbic acid and 
 (ii) one or more salts of ascorbic acid 
   the components (i) and (ii) being present in a molar ratio of from 1:4.5 to 1:7.0; and   b) 5 to 100 g polyethylene glycol having an average molecular weight of 3000 to 4000 Da;   
     
     
         20 . A composition comprising the following components in the following weight ratios:
 a) ascorbate anion 0.82 to 4.0 parts provided by a mixture of:
 (i) ascorbic acid and 
 (ii) one or more salts of ascorbic acid 
   the components (i) and (ii) being present in a molar ratio of from 1:4.5 to 1:7.0; and   b) polyethylene glycol 1.0 part.   
     
     
         21 . A solution as claimed in  claim 1 , for use as a single dose colon cleansing treatment in a volume of 700 to 1500 ml. 
     
     
         22 . A solution as claimed in  claim 1 , for use as a split dose colon cleansing treatment wherein one or both of the doses has a volume of 200 to 1000 ml. 
     
     
         23 . A kit comprising:
 a first colon cleansing solution, and   a second colon cleansing solution,   
       the second colon cleansing solution being a solution as claimed in  claim 1 . 
     
     
         24 . A kit as claimed in  claim 23  wherein the first colon cleansing solution comprises:
 (i) 70 to 250 g per litre PEG having an average molecular weight of 2500 to 4500 Da; 
 (ii) 2.0 to 20 g per litre of one or more alkali metal sulphates, alkaline earth metal sulphates or a mixture thereof; 
 (iii) optionally one or more electrolytes; 
 (iv) optionally one or more flavouring agents; and 
 (v) optionally one or more sweeteners. 
 
     
     
         25 . A method of cleansing the colon of a subject comprising:
 administering to the subject an effective amount of a first colon cleansing solution;   administering to the subject an effective amount of a second colon cleansing solution,   
       the second colon cleansing solution being a solution as claimed in  claim 1 . 
     
     
         26 . A kit comprising compositions for admixture with water, wherein the compositions are for making the first and second solutions set out in  claim 23 . 
     
     
         27 . A method as claimed in  claim 25  wherein the subject takes from 250 ml up to 1000 ml of the second cleansing solution. 
     
     
         28 . A method as claimed in  claim 25  wherein first cleansing solution has a volume of 500 ml or 750 ml, and the second cleansing solution has a volume of 500 ml. 
     
     
         29 . A method as claimed in  claim 25  in which the subject takes additional clear fluid after one or both of the first and second colon cleansing solutions. 
     
     
         30 . A method as claimed in  claim 29 , in which the subject takes 300 ml to 1000 ml of additional clear fluid after each of the first and second colon cleansing solutions.