Claims for Patent: 12,083,179

Summary for Patent: 12,083,179

Title:	Colon cleansing compositions and method of use
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 acidthe components (i) and (ii) being present in a molar ratio of from 1:4.5 to 1:7.0; andb) 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):	Lucy Clayton, Alasdair Cockett, Mark Christodoulou, Ian Davidson, Lynn Farrag, Marc Halphen, Leighton Jones, Vanik Petrossian, Peter Stein, David Tisi, Alex Ungar, Jeffrey Worthington
Assignee:	Norgine BV
Application Number:	US17/384,227
Patent Claims:	1. A colon cleansing solution comprising: (i) 175 to 220 g per litre PEG having an average molecular weight of 2500 to 4500 Da; (ii) 15 to 20 g per litre of one or more alkali metal sulphates, alkaline earth metal sulphates or a mixture thereof; (iii) 3.0 to 5.0 g per litre sodium chloride, and 1.5 to 2.5 g per litre potassium chloride; (iv) optionally one or more flavouring agents; and (v) optionally one or more sweeteners, wherein the solution has a volume of 400-600 ml. 2. The colon cleansing solution as claimed in claim 1, wherein the solution is substantially free of an ascorbate component. 3. The solution as claimed in claim 1, wherein the alkali metal sulphates, alkaline earth metal sulphates or a mixture thereof are selected from sodium sulphate, potassium sulphate and magnesium sulphate. 4. The colon cleansing solution as claimed in claim 1, comprising a sweetener and further comprising a souring agent. 5. The colon cleansing solution as claimed in claim 4, wherein the souring agent is citric acid or encapsulated citric acid. 6. The colon cleansing solution as claimed in claim 1, wherein the sweetener is sucralose. 7. The colon cleansing solution as claimed in claim 1, wherein the solution comprises 200 g per litre PEG. 8. The colon cleansing solution as claimed in claim 1, wherein the solution comprises 17 to 19 g per litre of one or more alkali metal sulphates, alkaline earth metal sulphates or a mixture thereof. 9. The colon cleansing solution as claimed in claim 1 comprising: (i) 200 g per litre PEG having an average molecular weight of 2500 to 4500 Da.; (ii) 18 g per litre of sodium sulphate; (iii) 4.0 g per litre sodium chloride, and 2.0 g per litre potassium chloride; (iv) optionally one or more flavouring agents; and (v) optionally one or more sweeteners; wherein the solution is substantially free of an ascorbate component. 10. A kit comprising: a first colon cleansing solution, and a second colon cleansing solution, wherein the first colon cleansing solution is as claimed in claim 2. 11. The kit as claimed in claim 10, wherein the second colon cleansing solution comprises: 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; b) 10 to 200 g per litre polyethylene glycol; c) optionally one or more electrolytes; d) optionally one or more alkali metal or alkaline earth metal sulphates; e) optionally one or more flavouring agents; and f) optionally one or more sweeteners. 12. The kit as claimed in claim 10, wherein the second cleansing solution comprises one or more of the following: (a) the one or more salts of ascorbic acid are selected from sodium ascorbate, potassium ascorbate, magnesium ascorbate and calcium ascorbate, or a mixture thereof; (b) the ascorbate anion in a concentration of 300-700 mmol per litre; (c) the molar ratio of the components (i) and (ii) is from 1:4.75 to 1:6.75; (d) the solution comprises 60 to 140 g/litre of ascorbate component, and/or (e) 12 to 20 g/litre of ascorbic acid and 80 to 120 g/litre of sodium ascorbate. 13. The kit as claimed in claim 10, wherein the second cleansing solution comprises one or more of the following: (a) essentially free from alkali metal sulphates and alkaline earth metal sulphates; (b) a flavouring agent; (c) a sweetener; (d) aspartame and orange flavouring; and/or (e) aspartame at 0.5 to 4 g per litre and orange flavouring at 0.2 to 1.8 g per litre. 14. A kit comprising compositions used for admixture with water, wherein the compositions are used to make the first solution as claimed in claim 1 and second solution as claimed in claim 11. 15. The kit as claimed in claim 14, wherein the composition used to make the first solution comprises: (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) optionally one or more flavouring agents; and (v) optionally one or more sweeteners; wherein the composition is substantially free of an ascorbate component. 16. The kit as claimed in claim 14, wherein the composition used to make the second solution comprises: a) (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. 17. The kit as claimed in claim 14, wherein the composition used to make the first solution comprises: (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) optionally one or more flavouring agents; and (v) optionally one or more sweeteners; wherein the composition is substantially free of an ascorbate component; and the composition used to make the second composition comprises: a) (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. 18. The kit as claimed in claim 17, wherein each composition is provided to be made up in 400-600 ml water. 19. A method of cleansing the colon of a subject comprising administering to the subject an effective amount of a colon cleansing solution as claimed in claim 1. 20. A method of cleansing the colon of a subject comprising administering to the subject an effective amount of a colon cleansing solution as claimed in claim 9.