US2007116667A1PendingUtilityA1

Colon cleansing compositions and methods

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Assignee: BARRAS NORMANPriority: Oct 25, 2002Filed: Dec 15, 2006Published: May 24, 2007
Est. expiryOct 25, 2022(expired)· nominal 20-yr term from priority
A61P 31/00A61P 1/00A61P 1/10A61K 31/765A61K 33/06A61K 47/02A61K 47/22A61K 33/14A61K 33/04A61K 45/06A61K 9/0095A61K 9/009A61K 33/00A61K 9/08A61K 31/375
53
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Claims

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.

Claims

exact text as granted — not AI-modified
1 . A method of cleansing the colon of a mammal, comprising administering orally to the mammal a cleansing fluid comprising, per litre, the following components, the components of the cleansing fluid being selected such that it has an osmolarity within the range of from 300 to 700 mOsmol/kg: 
 a) 80 to 350 g polyethylene glycol;    b) 3 to 20 g of a mixture of ascorbic acid and one or more salts of ascorbic acid;    c) 1 to 15 g of an alkali metal or alkaline earth metal sulphate or a mixture of alkali metal or alkaline earth metal sulphates; and    d) optionally one or more electrolytes selected from sodium chloride, potassium chloride and sodium hydrogen carbonate,    the volume of fluid administered being from 1.5 to 3 litres for an adult human and pro rata for a mammal other than an adult human.    
   
   
       2 . The method as claimed in  claim 1  wherein the cleansing fluid has an osmolarity of 330 mOsmol/kg or greater.  
   
   
       3 . The method as claimed in  claim 1  wherein the cleansing fluid has an osmolarity in the range 550 mOsmol/kg or lower.  
   
   
       4 . The method as claimed in  claim 1  wherein the polyethylene glycol has an average molecular weight of 2000 or greater.  
   
   
       5 . The method as claimed in  claim 1  wherein the polyethylene glycol has an average molecular weight of 4500 or lower.  
   
   
       6 . The method as claimed in  claim 1  wherein the polyethylene glycol has an average molecular weight of 3350 or 4000.  
   
   
       7 . The method as claimed in  claim 1  wherein the cleansing fluid comprises from 90 g or more of polyethylene glycol per litre.  
   
   
       8 . The method as claimed in  claim 1  wherein the cleansing fluid comprises from 150 g or less of polyethylene glycol per litre.  
   
   
       9 . The method as claimed in  claim 1  wherein the cleansing fluid comprises 100 g of polyethylene glycol per litre.  
   
   
       10 . The method as claimed in  claim 1  wherein the cleansing fluid comprises the alkali metal or alkaline earth metal sulphate or the mixture of alkali metal or alkaline earth metal sulphates in a quantity of 3 g or more per litre.  
   
   
       11 . The method as claimed in  claim 1  wherein the cleansing fluid comprises the alkali metal or alkaline earth metal sulphate or the mixture of alkali metal or alkaline earth metal sulphates in a quantity 9 g or less per litre.  
   
   
       12 . The method as claimed in  claim 1  wherein the cleansing fluid comprises the alkali metal or alkaline earth metal sulphate or the mixture of alkali metal or alkaline earth metal sulphates in a quantity of 7.5 g per litre.  
   
   
       13 . The method as claimed in  claim 1  wherein the alkali metal or alkaline earth metal is magnesium.  
   
   
       14 . The method as claimed in  claim 1  wherein the alkali metal or alkaline earth metal is sodium.  
   
   
       15 . The method as claimed in  claim 1  wherein the cleansing fluid comprises sodium chloride.  
   
   
       16 . The method as claimed in  claim 1  wherein the cleansing fluid comprises sodium chloride in a quantity of 2 g or more per litre.  
   
   
       17 . The method as claimed in  claim 1  wherein the cleansing fluid comprises potassium chloride.  
   
   
       18 . The method as claimed in  claim 1  wherein the cleansing fluid comprises potassium chloride in a quantity of from 0.5 g or more per litre.  
   
   
       19 . The method as claimed in  claim 1  wherein the cleansing fluid comprises ascorbic acid or a salt thereof in a quantity of 5 g or more per litre.  
   
   
       20 . The method as claimed in  claim 1  wherein the cleansing fluid comprises ascorbic acid or a salt thereof in a quantity of 15 g or less per litre.  
   
   
       21 . The method as claimed in  claim 1  wherein the cleansing fluid comprises ascorbic acid and a salt thereof.  
   
   
       22 . The method as claimed in  claim 1  wherein the cleansing fluid comprises ascorbic acid and a salt thereof in a weight ratio within the range of from 1:9 to 9:1.  
   
   
       23 . The method as claimed in  claim 1  wherein the cleansing fluid comprises sodium ascorbate.  
   
   
       24 . The method as claimed in  claim 1  wherein the cleansing fluid comprises a flavouring.  
   
   
       25 . The method as claimed in  claim 1 , wherein the cleansing fluid comprises lemon flavouring.  
   
   
       26 . The method as claimed in  claim 1  wherein the cleansing fluid comprises a sweetener that is not a metabolic substrate for bacteria in the gut.  
   
   
       27 . The method as claimed in  claim 26 , wherein the sweetener is selected from the group consisting of aspartame, acesulfame K, saccharine and citric acid.  
   
   
       28 . The method as claimed in  claim 1  in which the ascorbic acid and/or the salt of ascorbic acid is coated.  
   
   
       29 . The method as claimed in  claim 1  wherein the cleansing fluid is administered over 1 to 4 hours.  
   
   
       30 . The method as claimed in  claim 1  wherein the colon is cleansed prior to carrying out a diagnostic, therapeutic or surgical procedure on the colon, rectum or anus or elsewhere in the abdomen.

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