Claims for Patent: 10,646,512

Summary for Patent: 10,646,512

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:	US15/407,080
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,646,512
Patent Claims:	1. A composition for admixture with 300 ml to 800 ml water, wherein the composition is optionally presented in two or more parts, and comprises: a) 50 to 60 g of an ascorbate component, the ascorbate component being ascorbic acid, one or more salts of ascorbic acid, or a mixture of ascorbic acid and one or more salts of ascorbic acid; b) 10 to 50 g polyethylene glycol; and c) sodium chloride and potassium chloride; wherein the ascorbate component and polyethylene glycol are in a weight ratio of 1.0 to 4.0:1 ascorbate to polyethylene glycol. 2. The composition as claimed in claim 1 comprising: a) 50 to 60 g of ascorbate component; b) 10 to 50 g PEG having an average molecular weight of 3000 to 4000 Da; c) sodium chloride and potassium chloride; d) optionally one or more flavouring agents; and e) optionally one or more sweeteners. 3. The composition as claimed in claim 1 comprising 1.5 to 3.5 g of sodium chloride. 4. The composition as claimed in claim 1 comprising 1.0 to 2.5 g of potassium chloride. 5. The composition as claimed in claim 1 comprising 40 g of PEG. 6. The composition of claim 1, wherein the solution has a volume of 400 ml to 700 ml. 7. A composition comprising the following components in the following weight ratios: a) ascorbate anion provided by ascorbic acid, one or more salts of ascorbic acid, or a mixture thereof: 1.0 to 4.0 parts; b) polyethylene glycol: 1.0 part; c1) sodium chloride: 0.05 to 0.3 parts; and c2) potassium chloride: 0.02 to 0.08 parts. 8. The composition as claimed in claim 7 comprising the following components in the following weight ratios: a) ascorbate anion: 1.0 to 4.0 parts; b) polyethylene glycol: 1.0 part; c1) sodium chloride: 0.06 to 0.2 parts; and c2) potassium chloride: 0.03 to 0.07 parts. 9. The composition as claimed in claim 7 which is a dry powder composition. 10. The composition as claimed in claim 7 which is substantially free from any bicarbonate. 11. The composition as claimed in claim 7 comprising the following components in the following weight ratios: a) ascorbate anion: 1.0 to 4.0 parts; b) PEG having an average molecular weight of 3000 to 4000 Da: 1.0 part; c1) sodium chloride: 0.05 to 0.3 parts; c2) potassium chloride: 0.02 to 0.08 parts; d) optionally one or more flavouring agents; and e) optionally one or more sweeteners. 12. The composition as claimed in claim 7, wherein the composition comprises: a) 50 to 60 g ascorbate component, the ascorbate component being ascorbic acid, one or more salts of ascorbic acid, or a mixture of ascorbic acid and one or more salts of ascorbic acid b) 10 to 50 g polyethylene glycol; and c) sodium chloride and potassium chloride. 13. The composition as claimed in claim 7 comprising: a) 50 to 60 g ascorbate component, the ascorbate component being ascorbic acid, one or more salts of ascorbic acid, or a mixture of ascorbic acid and one or more salts of ascorbic acid; b) 10 to 50 g PEG having an average molecular weight of 3000 to 4000 Da; c) sodium chloride and potassium chloride; d) optionally one or more flavouring agents; e) optionally one or more sweeteners. 14. A kit comprising: A) a first sachet comprising a first composition for the preparation of a first colon cleansing solution; B1) a second sachet; and B2) a third sachet, wherein the second and third sachets together provide the composition as claimed in claim 1 for the preparation of a second colon cleansing solution. 15. A kit comprising: A) a first component being a composition for the preparation of a first colon cleansing solution, the first component 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; (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 having a volume of 300 ml to 800 ml, the second component comprising: a) 50 to 60 g of an ascorbate component, the ascorbate component being ascorbic acid, one or more salts of ascorbic acid, or a mixture of ascorbic acid and one or more salts of ascorbic acid; b) 10 to 50 g polyethylene glycol; and c) sodium chloride and potassium chloride wherein the ascorbate component and the polyethylene glycol are in a weight ratio of 1.0 to 4.0:1 ascorbate to polyethylene glycol in the second composition. 16. The kit as claimed in claim 15 wherein: A) a first sachet comprises: (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; (v) optionally one or more sweeteners, B1) a second sachet comprises: (i) 10 to 50 g PEG having an average molecular weight of 2500 to 4500 Da; (ii) sodium chloride and potassium chloride and/or one or more salts of ascorbic acid; and B2) a third sachet comprises ascorbic acid, wherein the optional one or more salts of ascorbic acid in the second sachet (B1) and the ascorbic acid in the third sachet (B2) together providing 50 to 60 g ascorbate component.