Claims for Patent: 9,707,297

Summary for Patent: 9,707,297

Title:	Compositions
Abstract:	The invention provides a colon cleansing solution comprising: a) 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. 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:	15/141,054
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,707,297
Patent Claims:	1. A kit comprising: A) a first component, being a composition optionally presented in two or more parts for the preparation of a first colon cleansing solution comprising: (I) 52.5 to 187.5 g PEG having an average molecular weight of 2500 to 4500 Da (II) 1.5 to 15 g 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 B) a second component, being a composition optionally presented in two or more parts for the preparation of a second colon cleansing solution, comprising a) 150 to 400 mmol 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) 5 to 100 g polyethylene glycol having an average molecular weight of 2500 to 4500 Da, the first solution being different from the second. 2. A kit as claimed in claim 1 wherein the first component comprises 90 to 112.5 g PEG. 3. A kit as claimed in claim 1 wherein the first component comprises 6.0 to 15 g sodium sulphate. 4. A kit as claimed in claim 1 wherein the first component comprises 1.5 to 2.25 g sodium chloride. 5. A kit as claimed in claim 1 wherein the first component comprises 0.375 to 1.125 g potassium chloride. 6. A kit as claimed in claim 1 wherein the first component comprises: (I) 100 g PEG having an average molecular weight of 3000 to 4000 Da; (II) 9 g sodium sulphate; (III) 2.0 g sodium chloride and 1.0 g potassium chloride; (IV) one or more flavouring agents; and (V) one or more sweeteners. 7. A kit as claimed in claim 6 wherein the flavouring agent is mango, and the sweetener is sucralose. 8. A kit as claimed in claim 7 wherein the first component further comprises citric acid as a taste enhancer. 9. A kit as claimed in claim 1 wherein the first component is in dry powder form. 10. A kit as claimed in claim 1 wherein in the second component B) the ascorbate component a) is packaged separately from the PEG component b). 11. A kit as claimed in claim 1 wherein the second component comprises 6.0 to 10 g ascorbic acid and 40 to 60 g sodium ascorbate. 12. A kit as claimed in claim 1 wherein the second component comprises 30 to 50 g PEG. 13. A kit as claimed in claim 1 wherein the second component comprises 2.0 to 3.5 g sodium chloride. 14. A kit as claimed in claim 1 wherein the second component comprises 0.75 to 1.5 g potassium chloride. 15. A kit as claimed in claim 1 wherein the second component comprises a) ascorbate anion provided by a mixture of: (i) 7.54 g ascorbic acid and (ii) 48.11 g sodium ascorbate b) 40 g PEG having an average molecular weight of 3000 to 4000 Da; c) 3.20 g sodium chloride and 1.20 g potassium chloride; d) one or more flavouring agents; and e) one or more sweeteners; wherein component a) is packaged in a first compartment and components b), c), d), and e) are packaged in a second compartment. 16. A kit as claimed in claim 15 wherein the sweetener is aspartame and the flavouring is selected from lemon, kiwi, strawberry, grapefruit, orange, fruit punch and mango. 17. A kit as claimed in claim 1 wherein the second component is in dry powder form. 18. A kit comprising: A) a first component, being a composition optionally presented in two or more parts for the preparation of a first colon cleansing solution comprising: (I) 100 g PEG having an average molecular weight of 3000 to 4000 Da (II) 9.0 g sodium sulphate (III) 2.0 g sodium chloride and 1.0 g potassium chloride; (IV) one or more flavouring agents; and (V) one or more sweeteners, and B) a second component for the preparation of a second colon cleansing solution, comprising a) ascorbate anion provided by a mixture of: (i) 7.54 g ascorbic acid and (ii) 48.11 g sodium ascorbate b) 40 g PEG having an average molecular weight of 3000 to 4000 Da; c) 3.20 g sodium chloride and 1.20 g potassium chloride; d) one or more flavouring agents; and e) one or more sweeteners; whereby component a) is packaged in a first compartment and components b), c), d), and e) are packaged in a second compartment. 19. A kit as claimed in claim 18 wherein the first component comprises mango flavouring, sucralose and citric acid; and the second component comprises aspartame and a flavouring selected from lemon, kiwi, strawberry, grapefruit, orange, fruit punch and mango. 20. A kit as claimed in claim 18 wherein the first and second components are dry powders. 21. A kit comprising: a first colon cleansing agent, the first colon cleansing agent solution comprising: (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 a second colon cleansing agent, the second colon agent solution being a solution in water of: a) 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. 22. A kit as claimed in claim 21 wherein the first colon cleansing solution comprises: (i) 175 to 220 g per liter PEG having an average molecular weight of 2500 to 4500 Da (ii) 15 to 20 g per liter of one or more alkali metal sulphates, alkaline earth metal sulphates or a mixture thereof (iii) 3.0 to 5.0 g per liter sodium chloride, and 1.5 to 2.5 g per liter potassium chloride; (iv) optionally one or more flavouring agents; and (v) optionally one or more sweeteners. 23. A kit as claimed in claim 21 wherein the second colon cleansing solution comprises: a) ascorbate anion provided by a mixture of: (i) 12 to 20 g per liter ascorbic acid and (ii) 80 to 120 g per liter sodium ascorbate the components (i) and (ii) being present in a weight ratio of from 1:5063 to 1:7.875; b) 60 to 100 g per liter PEG having an average molecular weight of 3000 to 4000 Da; c) 3 to 8 g per liter sodium chloride and 1 to 7 g per liter potassium chloride; d) one or more flavouring agents; and e) one or more sweeteners. 24. A kit as claimed in claim 21 comprising: a first colon cleansing agent, the first colon cleansing agent solution comprising: (i) 200 g per liter PEG having an average molecular weight of 3350 Da (ii) 18 g per liter sodium sulphate (iii) 4.0 g per liter sodium chloride, and 2.0 g per liter potassium chloride (iv) one or more flavouring agents; and (v) one or more sweeteners, and a second colon cleansing agent, the second colon agent solution being a solution consisting essentially of: a) ascorbate anion provided by a mixture of: 15.08 g per liter ascorbic acid and 96.22 g per liter sodium ascorbate b) 80 g per liter PEG having an average molecular weight of 3000 to 4000 Da; c) 6.4 g per liter sodium chloride and 2.4 g per liter potassium chloride; d) one or more flavouring agents; and e) one or more sweeteners.