Claims for Patent: 10,918,723

Summary for Patent: 10,918,723

Title:	Colon cleansing compositions and methods of use
Abstract:	The invention also provides methods an 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:	US15/605,617
Patent Claims:	1. 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 second colon cleansing solution comprising: a) 350 650 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, whereby the first colon cleansing solution is taken over a time period t(d1) followed by optional additional clear fluid over a time period t(cf1), and then following a time interval t(dose interval), the second colon cleansing solution is taken over a time period t(d2) followed by optional additional clear fluid over a time period t(cf2), whereby the subject undergoes a surgical, therapeutic or diagnostic procedure at a time t2 after the beginning of the colon cleansing method, and whereby the time interval after the completion of the second additional clear fluid and the start of the surgical, therapeutic or diagnostic procedure is t(procedure interval). 2. A method as claimed in claim 1 in which the subject ingests the first and second cleansing solutions on the day of the diagnostic, therapeutic or surgical procedure, and: t(d1) is 15 minutes to 1 hour; t(cf1) is 15 minutes to 1 hour; t(dose interval) is in the range of from 0 minutes to 8 hours; t(d2) is 15 minutes to 1 hour; t(cf2) is 15 minutes to 1 hour; t2 is in the range of from 3 to 14 hours; and t(procedure interval) is from 30 minutes to 10 hours. 3. A method as claimed in claim 2 wherein the subject takes from 250 ml up to 1000 ml of the second cleansing solution. 4. A method as claimed in claim 2 wherein the subject takes from 400 ml up to 1100 ml of the first cleansing solution. 5. A method as claimed in claim 2 wherein first cleansing solution has a volume of 500 ml or 750 ml, and the second cleansing solution has a volume of 500 ml. 6. A method as claimed in claim 2 in which the subject takes additional clear fluid after one or both of the first and second colon cleansing solutions. 7. A method as claimed in claim 6, in which the subject takes 300 ml to 1000 ml of additional clear fluid after each of the first and second colon cleansing solutions. 8. A method as claimed in claim 2 wherein: t(d1) is 30 minutes; t(cf1) is 30 minutes; t(dose interval) is in the range of from one hour to two hours; t(d2) is 30 minutes; t(cf2) is 30 minutes; t2 is in the range of from 4 to 8 hours; and t(procedure interval) is from 1 to 6 hours. 9. A method as claimed in claim 1 in which the subject ingests the first and second cleansing solutions in the evening before the day of the diagnostic, therapeutic or surgical procedure, and: t(d1) is 15 minutes to 1 hour; t(cf1) is 15 minutes to 1 hour; t(dose interval) is in the range of from 0 minutes to 8 hours; t(d2) is 15 minutes to 1 hour; t(cf2) is 15 minutes to 1 hour; t2 is in the range of from 10 to 36 hours; and t(procedure interval) is from 8 to 20 hours. 10. A method as claimed in claim 9 wherein the subject takes from 250 ml up to 1000 ml of the second cleansing solution. 11. A method as claimed in claim 9 wherein the subject takes from 400 ml up to 1100 ml of the first cleansing solution. 12. A method as claimed in claim 9 wherein first cleansing solution has a volume of 500 ml or 750 ml, and the second cleansing solution has a volume of 500 ml. 13. A method as claimed in claim 9 wherein the subject takes additional clear fluid after one or both of the first and second colon cleansing solutions. 14. A method as claimed in claim 13, in which the subject takes 300 ml to 1000 ml of additional clear fluid after each of the first and second colon cleansing solutions. 15. A method as claimed in claim 9 wherein: t(d1) is 30 minutes; t(cf1) is 30 minutes; t(dose interval) is in the range of from one hour to two hours; t(d2) is 30 minutes; t(cf2) is 30 minutes; t2 is in the range of from 10 to 36 hours; and t(procedure interval) is from 8 to 20 hours. 16. A method as claimed in claim 1 in which the subject ingests the first cleansing solution in the evening before the day of the diagnostic, therapeutic or surgical procedure, and the second cleansing solution in the morning of the day of the diagnostic, therapeutic or surgical procedure t(d1) is 15 minutes to 1 hour; t(cf1) is 15 minutes to 1 hour; t(dose interval) is in the range of from 8 to 20 hours; t(d2) is 15 minutes to 1 hour; t(cf2) is 15 minutes to 1 hour; t2 is in the range of from 10 to 36 hours; and t(procedure interval) is from 30 minutes to 10 hours. 17. A method as claimed in claim 16 wherein the subject takes from 250 ml up to 1000 ml of the second cleansing solution. 18. A method as claimed in claim 16 wherein the subject takes from 400 ml up to 1100 ml of the first cleansing solution. 19. A method as claimed in claim 18 wherein first cleansing solution has a volume of 500 ml or 750 ml, and the second cleansing solution has a volume of 500 ml. 20. A method as claimed in claim 16 wherein the subject takes additional clear fluid after one or both of the first and second colon cleansing solutions. 21. A method as claimed in claim 20, in which the subject takes 300 ml to 1000 ml of additional clear fluid after each of the first and second colon cleansing solutions. 22. A method as claimed in claim 16 wherein: t(d1) is 30 minutes; t(cf1) is 30 minutes; t(dose interval) is in the range of from 8 to 20 hours; t(d2) is 30 minutes; t(cf2) is 30 minutes; t2 is in the range of from 10 to 36 hours; and t(procedure interval) is from 1 to 6 hours. 23. A method as claimed in claim 1 in which the second colon cleansing solution comprises: a) (i) 14 to 16 g per litre ascorbic acid and (ii) 92 to 100 g per litre 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 litre PEG having an average molecular weight of 3000 to 4000 Da; c) 3 to 8 g per litre sodium chloride and 1 to 7 g per litre potassium chloride; d) one or more flavouring agents; and e) one or more sweeteners. 24. A method as claimed in claim 1 in which the first colon cleansing solution comprises: (i) 90 to 200 g per litre PEG having an average molecular weight of 2500 to 4500 Da. (ii) 2.0 to 15 g per litre of one or more alkali metal sulphates, alkaline earth metal sulphates or a mixture thereof (iii) 0.5 to 5.0 g per litre sodium chloride, and 0.05 to 5.0 g per litre potassium chloride; (iv) one or more flavouring agents; and (v) one or more sweeteners. 25. A method as claimed in claim 2 wherein the method is carried out on the day of a colonoscopy of a subject, and At approximately 05:00H, the subject takes solution S2 in 500 mL of water over 30 minutes at a rate of approximately 250 mL every 15 minutes; The subject drinks 500 mL of additional water over the next 30 minutes at the rate of 250 mL every 15 minutes until complete; Then a 1 hour liquid-free break is observed; At approximately 07.00H, the subject takes solution T1 in 500 mL of water over 30 minutes at a rate of 250 mL every 15 minutes; The subject drinks 500 mL of additional water; and Colonoscopy is carried out at least one hour after the last of the additional water is consumed, the first cleaning solution S2 being a solution comprising 100.00 g PEG 3350, 9.00 g Na2SO4 (anhyd), 2.00 g NaCl, 1.00 g KCl, 0.40 g sucralose, 0.500 g Fruit Punch Flavouring and 0.75 g Citric Acid in water to a volume of 500 ml, and the second cleaning solution T1 being a solution comprising 40.00 g PEG 3350, 3.20 g NaCl, 1.20 g KCl, 1.93 g Aspartame, 0.60 g Orange Flavouring, 48.11 g Sodium Ascorbate and 7.54 g Ascorbic Acid in water to a volume of 500 ml. 26. A method as claimed in claim 9 wherein the method is carried out on the day before a colonoscopy of a subject, and At approximately 18:00 H, the subject takes solution S2 in 500 mL of water over 30 minutes at a rate of approximately 250 mL every 15 minutes until complete; The subject drinks 500 mL of additional water; After an interval of 1-2 hours, the subject takes solution T1 in 500 mL of water over 30 minutes at the rate of 250 mL every 15 minutes until complete; The subject drinks 500 mL of additional water; and Colonoscopy is carried out the following day, the first cleaning solution S2 being a solution comprising 100.00 g PEG 3350, 9.00g Na2SO4 (anhyd), 2.00 g NaCl, 1.00 g KCl, 0.40 g sucralose, 0.500 g Fruit Punch Flavouring and 0.75 g Citric Acid in water to a volume of 500 ml, and the second cleaning solution T1 being a solution comprising 40.00 g PEG 3350, 3.20 g NaCl, 1.20 g KCl, 1.93 g Aspartame 0.60 g Orange Flavouring, 48.11 g Sodium Ascorbate and 7.54 g Ascorbic Acid in water to a volume of 500 ml. 27. A method as claimed in claim 16 wherein on the day before the colonoscopy: At approximately 18:00 H, the subject takes Formulation S2 in 16 fl oz (500 mL) of water; The subject drinks 16 fl oz (500 mL) of mandatory additional water; and, on the day of the colonoscopy: At approximately 06:00 H, the subject takes Formulation T1 in 16 fl oz (500 mL) of water over 30 minutes at the rate of 250 mL every 15 minutes until complete; The subject drinks 500 mL of additional water; and Colonoscopy is carried out at least one hour after the last of the additional water is consumed, the first cleaning solution S2 being a solution comprising 100.00 g PEG 3350, 9.00 g Na2SO4 (anhyd), 2.00 g NaCl, 1.00 g KCl, 0.40 g sucralose, 0.500 g Fruit Punch Flavouring and 0.75 g Citric Acid in water to a volume of 500 ml, and the second cleaning solution T1 being a solution comprising 40.00 g PEG 3350, 3.20 g NaCl, 1.20 g KCl, 1.93 g Aspartame, 0.60 g Orange Flavouring, 48.11 g Sodium Ascorbate and 7.54 g Ascorbic Acid in water to a volume of 500 ml. 28. A method as claimed in claim 1 in which the subject is advised not to eat heavy meals before starting the colon cleansing treatment, or the subject is advised to fast for 12 hours before starting the colon cleansing treatment, or the subject is advised to follow a “white diet” for a day before, or the day of the start of the colon cleansing procedure, or the subject is advised to consume only a light meal, during that period; “white diet” being food intake restricted to white and cream-coloured foods. 29. A method as claimed in claim 1 in which the second colon cleansing solution comprises: a) (i) 15.08 g per litre ascorbic acid and (ii) 96.22 g per litre sodium ascorbate b) 80 g per litre PEG having an average molecular weight of 3000 to 4000 Da; c) 6.4 g per litre sodium chloride and 2.4 g per litre potassium chloride; d) one or more flavouring agents; and e) one or more sweeteners. 30. A method as claimed in claim 1 in which the first colon cleansing solution comprises: (i) 200 g per litre PEG having an average molecular weight of 2500 to 4500 Da; (ii) 18 g per litre of one or more alkali metal sulphates, alkaline earth metal sulphates or a mixture thereof; (iii) 4 g per litre sodium chloride, and 2 g per litre potassium chloride; (iv) one or more flavouring agents; and (v) one or more sweeteners.