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 - 73 . (canceled) 
   
   
       74 . A method for cleansing the colon of a human comprising administering orally to the human a preparation comprising, per litre, the following components: a) 30 to 350 g polyethylene glycol; and b) 3 to 20 g of a mixture of ascorbic acid and a salt of ascorbic acid; the volume of composition administered being from 1.5 to 4 litres. 
   
   
       75 . The method as claimed in  claim 74 , wherein the colon is cleansed prior to carrying out a diagnostic, therapeutic or surgical procedure on the colon. 
   
   
       76 . The method as claimed in  claim 74 , wherein the ascorbic acid and the salt of ascorbic acid are present in a weight ratio within the range of from 2:8 to 8:2. 
   
   
       77 . The method as claimed in  claim 74 , wherein the colon is cleansed prior to carrying out a colonoscopy. 
   
   
       78 . The method as claimed in  claim 74 , wherein the preparation comprises 5 to 15 g of a mixture of ascorbic acid and a salt of ascorbic acid. 
   
   
       79 . The method as claimed in  claim 74 , wherein the preparation further comprises one or more electrolytes selected from sodium chloride, potassium chloride, sodium hydrogen carbonate, an alkali metal sulphate, and an alkaline earth metal sulphate. 
   
   
       80 . The method as claimed in  claim 79 , wherein the preparation comprises sodium chloride, potassium chloride, and sodium sulphate. 
   
   
       81 . The method as claimed in  claim 74 , wherein the preparation comprises approximately 100 g of polyethylene glycol per litre. 
   
   
       82 . The method as claimed in  claim 74 , wherein the volume of the preparation administered is approximately two litres. 
   
   
       83 . The method as claimed in  claim 74 , wherein the method comprises administering a first portion of the preparation the evening before a procedure and a second portion of the preparation on the day of the procedure, each portion being approximately one litre. 
   
   
       84 . The method as claimed in  claim 83 , wherein the method further comprises administering 0.3 to 2 litres of clear fluid after administering the first portion of the preparation. 
   
   
       85 . The method as claimed in  claim 84 , wherein the volume of clear fluid is approximately 0.5 litres. 
   
   
       86 . The method as claimed in  claim 84 , wherein the method further comprises administering 0.5 to 1.5 litres of clear fluid after administering the second portion of the preparation. 
   
   
       87 . The method as claimed in  claim 84  in which the clear fluid is a water-based beverage. 
   
   
       88 . The method as claimed in  claim 86  in which the clear fluid is a water-based beverage. 
   
   
       89 . The method as claimed in  claim 87  or  88  in which the water-based beverage is selected from water, lemonade, cola drinks, cordial drinks, clear fruit juices, clear alcohol-containing beverages and beer. 
   
   
       90 . The method as claimed in  claim 83 , wherein each portion of the preparation is administered over an approximately one hour time period. 
   
   
       91 . The method as claimed in  claim 80  wherein the preparation comprises per litre 100 grams of polyethylene glycol 3350, 7.5 grams of sodium sulfate, 2.691 grams of sodium chloride, 1.015 grams of potassium chloride, 4.7 grams of ascorbic acid, 5.9 grams of sodium ascorbate, and further comprises 0.233 g aspartame, 0.117 g acesulfame K and 0.34 g lemon flavor. 
   
   
       92 . A method of cleansing the colon of a human subject, which comprises taking a solution comprising, per litre, the following components: 100 grams of polyethylene glycol 3350, 7.5 grams of sodium sulfate, 2.691 grams of sodium chloride, 1.015 grams of potassium chloride, 4.7 grams of ascorbic acid, and 5.9 grams of sodium ascorbate. 
   
   
       93 . The method as claimed in  claim 92 , wherein the volume of solution taken is 1.5 to 4 litres. 
   
   
       94 . The method as claimed in  claim 92 , wherein the method comprises taking two doses of solution each of one litre, each swallowed within one hour, and each followed by 500 ml of additional clear fluid. 
   
   
       95 . The method as claimed in  claim 94 , wherein a first dose is taken in the afternoon or evening before a colonoscopy, and a second dose is taken in the morning of, and before, a colonoscopy. 
   
   
       96 . The method as claimed in  claim 92 , wherein the method comprises taking two one litre doses of solution, each drunk within one hour, and after the two litres at least 1000 ml of additional clear fluid is taken. 
   
   
       97 . The method as claimed in  claim 96 , wherein the two one litre doses of solution are taken the day before a procedure. 
   
   
       98 . The method as claimed in  claim 92  or  93 , wherein the solution further comprises aspartame, acesulfame K and lemon flavouring. 
   
   
       99 . The method as claimed in  claim 98  in which the subject takes 2 litres of solution and 1 litre of additional clear fluid. 
   
   
       100 . The method as claimed in  claim 98  in which the subject takes 2 litres of solution and 1 additional litre of clear fluid, the treatment being split into two doses, one during the evening before and one the morning of, and before, a colonoscopy. 
   
   
       101 . The method as claimed in  claim 98  in which the subject takes 2 litres of solution and 1 additional litre of clear fluid in the evening prior to a colonoscopy. 
   
   
       102 . The method as claimed in  claim 98  in which the subject takes a first approximately one litre of solution over one hour and then drinks approximately 0.5 litres of clear fluid, the evening before a colonoscopy, and then, on the morning of the colonoscopy, takes a second litre of solution over one hour and then drinks 0.5 litres of clear fluid, at least one hour before the colonoscopy. 
   
   
       103 . The method as claimed in  claim 98  in which the subject takes a first approximately one litre of solution over one hour in the evening before a colonoscopy, and then about 1.5 hours later takes a second litre of solution over one hour, and takes approximately 1 litre of additional clear liquid during the evening.