Claims for Patent: 7,169,381

Summary for Patent: 7,169,381

Title:	Colon cleansing compositions and methods
Abstract:	A composition comprising, per liter 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 flavorings, 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.
Inventor(s):	Barras; Norman (Chilton, GB), Cox; Ian David (Bilester, GB)
Assignee:	Norgine Europe BV (Amsterdam, NL)
Application Number:	10/693,328
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,169,381
Patent Claims:	1. A dry composition for admixture with water wherein the dry composition comprises, per liter of aqueous solution to be made, the following components, the components of the composition being selected such that an aqueous solution made up to 1 liter 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 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. 2. The dry composition as claimed in claim 1, wherein an aqueous solution made up in 1 liter of water has an osmolarity of 330 mOsmol/kg or greater. 3. The dry composition as claimed in claim 1, wherein an aqueous solution made up in 1 liter of water has an osmolarity in the range 550 mOsmol/kg or lower. 4. The dry composition as claimed in claim 1, wherein the polyethylene glycol has an average molecular weight of 2000 Daltons or greater. 5. The dry composition as claimed in claim 1, wherein the polyethylene glycol has an average molecular weight of 4500 Daltons or lower. 6. The dry composition as claimed in claim 1, wherein the polyethylene glycol has an average molecular weight of 3350 or 4000 Daltons. 7. The dry composition as claimed in claim 1, comprising from 90 g or more of polyethylene glycol per liter. 8. The dry composition as claimed in claim 1, comprising from 150 g or less of polyethylene glycol per liter. 9. The dry composition as claimed in claim 1, comprising 100 g of polyethylene glycol per liter. 10. The dry composition as claimed in claim 1, comprising 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 liter. 11. The dry composition as claimed in claim 1, comprising 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 liter. 12. The dry composition as claimed in claim 1, comprising 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 liter. 13. The dry composition as claimed in claim 1, wherein the alkali metal or alkaline earth metal is magnesium. 14. The dry composition as claimed in claim 1, wherein the alkali metal or alkaline earth metal is sodium. 15. The dry composition as claimed in claim 1, which comprises sodium chloride. 16. The dry composition as claimed in claim 1, comprising sodium chloride in a quantity of 2 g or more per liter. 17. The dry composition as claimed in claim 1, which comprises potassium chloride. 18. The dry composition as claimed in claim 1, comprising potassium chloride in a quantity of from 0.5 g or more per liter. 19. The dry composition as claimed in claim 1, comprising a mixture of ascorbic acid and a salt thereof in a quantity of 5 g or more per liter. 20. The dry composition as claimed in claim 1, comprising a mixture of ascorbic acid and a salt thereof in a quantity of 10 g or less per liter. 21. The dry composition as claimed in claim 1, comprising ascorbic acid and a salt thereof in a weight ratio within the range of from 1:9 to 9:1. 22. The dry composition as claimed in claim 1, comprising sodium ascorbate. 23. The dry composition as claimed in claim 1, further comprising a flavouring. 24. The dry composition as claimed in claim 1, further comprising lemon flavouring. 25. The dry composition as claimed in claim 1, further comprising a sweetener that is not a metabolic substrate for bacteria in the gut. 26. The dry composition as claimed in claim 1, further comprising a sweetener selected from the group consisting of aspartame, acesulfame K, saccharine and citric acid. 27. The dry composition as claimed in claim 1, in which the ascorbic acid and/or the salt of ascorbic acid is coated. 28. A colon cleansing preparation comprising an aqueous solution of a composition as claimed in claim 1. 29. A colon cleansing preparation sachet comprising the components of a composition as claimed in claim 1. 30. A colon cleansing composition kit comprising the components of a composition as claimed in claim 1, comprising at least two portions in which the ascorbic acid and the salts thereof are packaged in a first portion and the other components are packaged in a second portion. 31. A dry composition for admixture with water wherein the dry composition comprises, per liter of aqueous solution to be made, the following components, the components of the composition being selected such that an aqueous solution made up to 1 liter has an osmolarity within the range of from 300 to 700 mOsmol/kg: a) 30 to 350 g polyethylene glycol; b) 3 to 20 g ascorbic acid and one or more salts of ascorbic acid; and c) optionally one or more electrolytes selected from sodium chloride, potassium chloride, sodium hydrogen carbonate and the alkali metal or alkaline earth metal sulphates. 32. The dry composition as claimed in claim 31, wherein the salt of ascorbic acid is an alkali metal or alkaline earth metal ascorbate. 33. The dry composition as claimed in claim 31, wherein the salt of ascorbic acid is sodium ascorbate. 34. The dry composition as claimed in claim 31, wherein the ascorbic acid and the salt thereof are present in a weight ratio within the range of from 1:9 to 9:1. 35. The dry composition as claimed in claim 31, wherein the ascorbic acid and the salt thereof are present in a weight ratio within the range of from 4:6 to 6:4. 36. The dry composition as claimed in claim 31, wherein the composition comprises a sweetener selected from the group consisting of aspartame, acesulfame K, saccharine and citric acid. 37. The dry composition as claimed in claim 31, wherein the composition comprises sodium sulphate. 38. A colon cleansing preparation comprising an aqueous solution of a composition as claimed in claim 31. 39. A colon cleansing preparation sachet comprising the components of a composition as claimed in claim 31. 40. A colon cleansing composition kit comprising the components of a composition as claimed in claim 31, comprising at least two portions in which the ascorbic acid and the salt thereof are packaged in a first portion and the other components are packaged in a second portion.