Claims for Patent: 9,326,969

Summary for Patent: 9,326,969

Title:	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 and kits associated with, or making use of the solutions, and compositions for the preparation of the solutions.
Inventor(s):	Clayton; Lucy (Uxbridge, GB), Cockett; Alasdair (Uxbridge, GB), Christodoulou; Mark (Uxbridge, GB), Davidson; Ian (Uxbridge, GB), Farrag; Lynn (Uxbridge, GB), Halphen; Marc (London, GB), Jones; Leighton (Uxbridge, GB), Petrossian; Vanik (Woburn, MA), Stein; Peter (Amsterdam Zuid-Oost, NL), Tisi; David (Woburn, MA), Ungar; Alex (Wigton, GB), Worthington; Jeffrey (Woburn, MA)
Assignee:	NORGINE BV (Amsterdam Zuid Oost, NL)
Application Number:	14/657,495
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,326,969
Patent Claims:	1. A method of cleansing the colon or bowel wherein the subject takes a colon cleansing solution comprising: a) an ascorbate component comprising 300 to 800 mmol per liter 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 liter polyethylene glycol. 2. A method as claimed in claim 1 wherein the colon cleansing solution comprises 60 to 140 g/liter of ascorbate component. 3. A method as claimed in claim 1 wherein the colon cleansing solution comprises 12 to 20 g/liter of ascorbic acid and 80 to 120 g/liter of sodium ascorbate. 4. A method as claimed in claim 1 wherein the polyethylene glycol has an average molecular weight 2500 to 4500 Da. 5. A method as claimed in claim 1 wherein the colon cleansing solution comprises 20 to 160 g per liter of PEG. 6. A method as claimed in claim 1 wherein the colon cleansing solution comprises sodium chloride at a concentration of 3 to 8 g per liter. 7. A method as claimed in claim 1 wherein the colon cleansing solution comprises potassium chloride at a concentration of 1 to 10 g per liter. 8. A method as claimed in claim 1 wherein the colon cleansing solution comprises a flavouring agent and/or a sweetener. 9. A method as claimed in claim 1 wherein the colon cleansing solution consists essentially of: a) (iii) 14 to 16 g per liter ascorbic acid and (iv) 92 to 100 g per liter sodium ascorbate b) 75 to 85 g per liter PEG having an average molecular weight of 3000 to 4000 Da; c) 6.0 to 6.8 g per liter sodium chloride and 2.0 to 2.8 g per liter potassium chloride; e) one or more flavouring agents; and f) one or more sweeteners. 10. A method as claimed in claim 1 wherein the subject takes the cleansing solution in a single dose. 11. A method as claimed in claim 10 wherein the dose is of a volume of 700 ml to 1500 ml, and the subject optionally ingests some additional clear fluid after ingesting the solution. 12. A method as claimed in claim 1 wherein the subject takes the cleansing solution in a split dose, two doses being separated by a time interval. 13. A method as claimed in claim 12 wherein two doses are taken separated by an overnight interval, or wherein two doses are taken on the same day. 14. A method as claimed in claim 13 wherein each dose is of a volume of 300 ml to 1000 ml, and the subject optionally ingests some additional clear fluid after ingesting each or either dose of the solution. 15. 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 first colon cleansing solution or the second colon cleansing solution being a solution comprising: a) an ascorbate component comprising 300 to 800 mmol per liter 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 liter polyethylene glycol. 16. A method as claimed in claim 15 wherein the first colon cleansing solution comprises: (i) 70 to 250 g per liter PEG having an average molecular weight of 2500 to 4500 Da; (ii) 2.0 to 20 g per liter 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. and the second colon cleansing solution comprises: a) an ascorbate component comprising 300 to 800 mmol per liter 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 liter polyethylene glycol. 17. A method as claimed in claim 15 wherein first cleansing solution has a volume of 200 ml to 1000 ml, and the second cleansing solution has a volume of 200 ml to 1000 ml. 18. A method as claimed in claim 17 wherein first cleansing solution has a volume of 500 ml or 750 ml, and the second cleansing solution has a volume of 500 ml. 19. A method as claimed in claim 15 in which the subject takes additional clear fluid after one or both of the first and second colon cleansing solutions. 20. A method as claimed in claim 19, in which the subject takes 300 ml to 1000 ml of additional clear fluid after each of the first and second colon cleansing solutions.