Claims for Patent: 10,792,306

Summary for Patent: 10,792,306

Title:	Colonoscopy—preparation
Abstract:	The invention provides a colon cleansing solution comprising: a) 300 to 2000 mmol per litre ascorbate anion provided by ascorbic acid, one or more salts of ascorbic acid, or a mixture thereof; and b) 10 to 200 g per litre polyethylene glycol. The invention also provides methods and kits associated with, or making use of the solutions. The invention also provides a method of cleansing the colon of a subject comprising: —administering to the subject an effect amount of a first cleansing solution; and then after a time interval—administering to the subject an effective amount of a second cleansing solution, wherein the two cleansing solutions are as described in the specification.
Inventor(s):	Marc Halphen, Hans-Jurgen Gruss, Ian Cox, Alasdair Cockett, Peter Stein, Alex Ungar
Assignee:	Norgine BV
Application Number:	US16/788,527
Patent Claims:	1. A kit comprising: A) a first component, being a composition for the preparation of a first colon cleansing solution by admixture with 400 to 600 ml water; and B) a second component, being a composition for the preparation of a second colon cleansing solution by admixture with 400 to 600 ml water; the first component comprising a) 90 to 112.5 g polyethylene glycol having an average molecular weight of 2500 to 4500 Da, b) 3.75 to 11.25 g sodium sulphate; the second component comprising a) 50 to 60 g ascorbate anion, wherein the ascorbate anion is provided by sodium ascorbate and ascorbic acid, and wherein the weight ratio of sodium ascorbate to ascorbic acid is from 1:10 to 10:1; and b) 15 to 45 g polyethylene glycol having an average molecular weight of 2500 to 4500 Da. 2. A kit as claimed in claim 1, wherein the first component comprises 100 g polyethylene glycol with an average molecular weight between 3000 to 4000 Da. 3. A kit as claimed in claim 1, wherein the first component comprises 9 g sodium sulphate. 4. A kit as claimed in claim 1, wherein the second component comprises 40g polyethylene glycol with an average molecular weight between 3000 to 4000 Da. 5. A kit as claimed in claim 1, wherein the first component further comprises: a) 0.75 to 3.0 g of sodium chloride; b) 0.375 to 1.125 g of potassium chloride c) one or more sweeteners; and d) optionally one or more flavouring agents. 6. A kit as claimed in claim 5 wherein the sweetener is sucralose. 7. A kit as claimed in claim 1, wherein the second component further comprises: c1) 1.5 to 3.5 g of sodium chloride; c2) 1 to 2.5 g of potassium chloride; d) one or more sweeteners; and e) optionally one or more flavouring agents. 8. A kit as claimed in claim 7 wherein the sweetener is aspartame. 9. A kit as claimed in claim 1 wherein the first component is a composition for the preparation of a first colon cleansing solution by admixture with 500 ml water. 10. A kit as claimed in claim 1 wherein the second component is a composition for the preparation of a second colon cleansing solution by admixture with 500 ml water. 11. A kit as claimed in claim 1 wherein the first solution is substantially free from ascorbic acid and salts thereof. 12. A kit comprising: a first colon cleansing solution, and a second colon cleansing solution, the first colon cleansing solution being a solution in 400 to 600 ml water comprising: a) 100 to 200 g per litre polyethylene glycol having an average molecular weight of 2500 to 4500 Da; and b) 8.0 to 20 g per litre sodium sulphate; the second colon cleansing solution being a solution in 400 to 600 ml water comprising: a) 100 to 120 g per litre ascorbate anion, wherein the ascorbate anion is provided by sodium ascorbate and ascorbic acid, and wherein the weight ratio of sodium ascorbate to ascorbic acid is from 1:10 to 10:1; and b) 30 to 90 g per litre polyethylene glycol having an average molecular weight of 2500 to 4500 Da. 13. A kit as claimed in claim 12, wherein the second colon cleansing solution comprises 80 g per litre polyethylene glycol with an average molecular weight between 3000 to 4000 Da. 14. A kit as claimed in claim 12, wherein the first colon cleansing further comprises: c1) 1.0 to 4.0 g per litre of sodium chloride; c2) 1.0 to 3.0 g per litre of potassium chloride; d) one or more sweeteners; and e) optionally one or more flavouring agents. 15. A kit as claimed in claim 14 wherein the sweetener is sucralose. 16. A kit as claimed in claim 12, wherein the second colon cleansing further comprises: c1) 3 to 7 g per litre of sodium chloride; c2) 2 to 5 g per litre of potassium chloride; d) one or more sweeteners; and e) optionally one or more flavouring agents. 17. A kit as claimed in claim 16 wherein the sweetener is aspartame. 18. A kit as claimed in claim 12 wherein the first colon cleansing solution has a volume of 500 ml. 19. A kit as claimed in claim 12 wherein the second colon cleansing solution has a volume of 500 ml. 20. A method of cleansing the colon of a subject comprising: administering to the subject an effective amount of a first colon cleansing solution, as defined in claim 12; and administering to the subject an effective amount of a second colon cleansing solution, as defined in claim 12. 21. A method as claimed in claim 20 comprising a time interval between taking the first solution and taking the second solution, the time interval being between the evening and the following morning. 22. A kit as claimed in claim 12 comprising: a first colon cleansing solution, and a second colon cleansing solution, the first colon cleansing solution being a solution in 400 to 600 ml water consisting of: a) 100 to 200 g per litre polyethylene glycol; and b) 8.0 to 20 g per litre sodium sulphate; c1) 1.0 to 4.0 g per litre of sodium chloride; c2) 1.0 to 3.0 g per litre of potassium chloride; d) one or more sweeteners; and e) optionally one or more flavouring agents; the second colon cleansing solution being a solution in 400 to 600 ml water consisting of: a) 100 to 120 g per litre ascorbate anion, wherein the ascorbate anion is provided by sodium ascorbate and ascorbic acid, and wherein the weight ratio of sodium ascorbate to ascorbic acid is from 1:10 to 10:1; and b) 30 to 90 g per litre polyethylene glycol. c1) 3 to 7 g per litre of sodium chloride; c2) 2 to 5 g per litre of potassium chloride; d) one or more sweeteners; and e) optionally one or more flavouring agents. 23. A kit as claimed in claim 22 wherein the sweetener in the second colon cleansing solution is aspartame. 24. A kit as claimed in claim 22 wherein the first colon cleansing solution has a volume of 500 ml. 25. A kit as claimed in claim 22 wherein the second colon cleansing solution has a volume of 500 ml. 26. A kit comprising: A) a first component, being a composition for the preparation of a first colon cleansing solution by admixture with 400 to 600 ml water; and B) a second component, being a composition for the preparation of a second colon cleansing solution by admixture with 400 to 600 ml water; the first component consisting of a) 90 to 112.5 g polyethylene glycol having an average molecular weight of 2500 to 4500 Da; b) 3.75 to 11.25 g sodium sulphate; c) 0.75 to 3.0 g of sodium chloride; d) 0.375 to 1.125 g of potassium chloride e) optionally one or more sweeteners; and f) optionally one or more flavouring agents; and g) optionally with a taste enhancer of citric acid; the second component consisting of a) 50 to 60 g ascorbate anion, wherein the ascorbate anion is provided by sodium ascorbate and ascorbic acid, and wherein the weight ratio of sodium ascorbate to ascorbic acid is from 1:10 to 10:1; and b) 15 to 45 g polyethylene glycol having an average molecular weight of 2500 to 4500 Da; c1) 1.5 to 3.5 g of sodium chloride; c2) 1 to 2.5 g of potassium chloride; d) optionally one or more sweeteners; and e) optionally one or more flavouring agents. 27. A kit as claimed in claim 22 wherein the sweetener in the first component is sucralose. 28. A kit as claimed in claim 22 wherein the sweetener in the second component is aspartame. 29. A kit as claimed in claim 22 wherein the first component is a composition for the preparation of a first colon cleansing solution by admixture with 500 ml water. 30. A kit as claimed in claim 22 wherein the second component is a composition for the preparation of a second colon cleansing solution by admixture with 500 ml water.