Colonoscopy—preparation

• US 10,792,306 B2
• Filed: 02/12/2020
• Issued: 10/06/2020
• Est. Priority Date: 03/11/2011
• Status: Active Grant

• Current Assignee: Norgine B.V.
• Original Assignee: Norgine B.V.
• Inventors: Halphen, Marc, Gruss, Hans-Jurgen, Cox, Ian, Cockett, Alasdair, Stein, Peter, Ungar, Alex
• Primary Examiner(s): Pryor, Alton N
• Application Number:
  US16/788,527
• Publication Number:
  US 20200179443A1
• Time in Patent Office: 237 Days
• Field of Search: None
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/375 Ascorbic acid, i.e. vitamin C; Salts thereof
• CPC Class Codes: A61K 31/765 Polymers containing oxygen
• CPC Class Codes: A61K 31/77 of oxiranes
• CPC Class Codes: A61K 33/04 Sulfur, selenium or tellurium; Compounds thereof
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/22 Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/10 Laxatives

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.

Claims

1. A kit comprising:

A) a first component, being a composition for the preparation of a first colon cleansing solution by admixture with 400 to 600 ml water; and

B) a second component, being a composition for the preparation of a second colon cleansing solution by admixture with 400 to 600 ml water;

the first component comprising

a) 90 to 112.5 g polyethylene glycol having an average molecular weight of 2500 to 4500 Da,

b) 3.75 to 11.25 g sodium sulphate;

the second component comprising

a) 50 to 60 g ascorbate anion,

wherein the ascorbate anion is provided by sodium ascorbate and ascorbic acid, and

wherein the weight ratio of sodium ascorbate to ascorbic acid is from 1;

10 to 10;

1; and

b) 15 to 45 g polyethylene glycol having an average molecular weight of 2500 to 4500 Da.

2. A kit as claimed in claim 1, wherein the first component comprises 100 g polyethylene glycol with an average molecular weight between 3000 to 4000 Da.

3. A kit as claimed in claim 1, wherein the first component comprises 9 g sodium sulphate.

4. A kit as claimed in claim 1, wherein the second component comprises 40g polyethylene glycol with an average molecular weight between 3000 to 4000 Da.

5. A kit as claimed in claim 1, wherein the first component further comprises:

a) 0.75 to 3.0 g of sodium chloride;

b) 0.375 to 1.125 g of potassium chloride

c) one or more sweeteners; and

d) optionally one or more flavouring agents.

6. A kit as claimed in claim 5 wherein the sweetener is sucralose.

7. A kit as claimed in claim 1, wherein the second component further comprises:

c1) 1.5 to 3.5 g of sodium chloride;

c2) 1 to 2.5 g of potassium chloride;

d) one or more sweeteners; and

e) optionally one or more flavouring agents.

8. A kit as claimed in claim 7 wherein the sweetener is aspartame.

9. A kit as claimed in claim 1 wherein the first component is a composition for the preparation of a first colon cleansing solution by admixture with 500 ml water.

10. A kit as claimed in claim 1 wherein the second component is a composition for the preparation of a second colon cleansing solution by admixture with 500 ml water.

11. A kit as claimed in claim 1 wherein the first solution is substantially free from ascorbic acid and salts thereof.

12. A kit comprising:

a first colon cleansing solution, and

a second colon cleansing solution, the first colon cleansing solution being a solution in 400 to 600 ml water comprising;

a) 100 to 200 g per litre polyethylene glycol having an average molecular weight of 2500 to 4500 Da; and

b) 8.0 to 20 g per litre sodium sulphate;

the second colon cleansing solution being a solution in 400 to 600 ml water comprising;

a) 100 to 120 g per litre ascorbate anion,

wherein the ascorbate anion is provided by sodium ascorbate and ascorbic acid, and

wherein the weight ratio of sodium ascorbate to ascorbic acid is from 1;

10 to 10;

1; and

b) 30 to 90 g per litre polyethylene glycol having an average molecular weight of 2500 to 4500 Da.

13. A kit as claimed in claim 12, wherein the second colon cleansing solution comprises 80 g per litre polyethylene glycol with an average molecular weight between 3000 to 4000 Da.

14. A kit as claimed in claim 12, wherein the first colon cleansing further comprises:

c1) 1.0 to 4.0 g per litre of sodium chloride;

c2) 1.0 to 3.0 g per litre of potassium chloride;

d) one or more sweeteners; and

e) optionally one or more flavouring agents.

15. A kit as claimed in claim 14 wherein the sweetener is sucralose.

16. A kit as claimed in claim 12, wherein the second colon cleansing further comprises:

c1) 3 to 7 g per litre of sodium chloride;

c2) 2 to 5 g per litre of potassium chloride;

d) one or more sweeteners; and

e) optionally one or more flavouring agents.

17. A kit as claimed in claim 16 wherein the sweetener is aspartame.

18. A kit as claimed in claim 12 wherein the first colon cleansing solution has a volume of 500 ml.

19. A kit as claimed in claim 12 wherein the second colon cleansing solution has a volume of 500 ml.

20. A method of cleansing the colon of a subject comprising:

administering to the subject an effective amount of a first colon cleansing solution, as defined in claim 12; and

administering to the subject an effective amount of a second colon cleansing solution, as defined in claim 12.

21. A method as claimed in claim 20 comprising a time interval between taking the first solution and taking the second solution, the time interval being between the evening and the following morning.

22. A kit as claimed in claim 12 comprising:

a first colon cleansing solution, and

a second colon cleansing solution,

the first colon cleansing solution being a solution in 400 to 600 ml water consisting of;

a) 100 to 200 g per litre polyethylene glycol; and

b) 8.0 to 20 g per litre sodium sulphate;

c1) 1.0 to 4.0 g per litre of sodium chloride;

c2) 1.0 to 3.0 g per litre of potassium chloride;

d) one or more sweeteners; and

e) optionally one or more flavouring agents;

the second colon cleansing solution being a solution in 400 to 600 ml water consisting of;

a) 100 to 120 g per litre ascorbate anion,

wherein the ascorbate anion is provided by sodium ascorbate and ascorbic acid, and

wherein the weight ratio of sodium ascorbate to ascorbic acid is from 1;

10 to 10;

1; and

b) 30 to 90 g per litre polyethylene glycol.

c1) 3 to 7 g per litre of sodium chloride;

c2) 2 to 5 g per litre of potassium chloride;

d) one or more sweeteners; and

e) optionally one or more flavouring agents.

23. A kit as claimed in claim 22 wherein the sweetener in the second colon cleansing solution is aspartame.

24. A kit as claimed in claim 22 wherein the first colon cleansing solution has a volume of 500 ml.

25. A kit as claimed in claim 22 wherein the second colon cleansing solution has a volume of 500 ml.

27. A kit as claimed in claim 22 wherein the sweetener in the first component is sucralose.

28. A kit as claimed in claim 22 wherein the sweetener in the second component is aspartame.

29. A kit as claimed in claim 22 wherein the first component is a composition for the preparation of a first colon cleansing solution by admixture with 500 ml water.

30. A kit as claimed in claim 22 wherein the second component is a composition for the preparation of a second colon cleansing solution by admixture with 500 ml water.

26. A kit comprising:

A) a first component, being a composition for the preparation of a first colon cleansing solution by admixture with 400 to 600 ml water; and

B) a second component, being a composition for the preparation of a second colon cleansing solution by admixture with 400 to 600 ml water;

the first component consisting of

a) 90 to 112.5 g polyethylene glycol having an average molecular weight of 2500 to 4500 Da;

b) 3.75 to 11.25 g sodium sulphate;

c) 0.75 to 3.0 g of sodium chloride;

d) 0.375 to 1.125 g of potassium chloride

e) optionally one or more sweeteners; and

f) optionally one or more flavouring agents; and

g) optionally with a taste enhancer of citric acid;

the second component consisting of

a) 50 to 60 g ascorbate anion,

wherein the ascorbate anion is provided by sodium ascorbate and ascorbic acid, and

wherein the weight ratio of sodium ascorbate to ascorbic acid is from 1;

10 to 10;

1; and

b) 15 to 45 g polyethylene glycol having an average molecular weight of 2500 to 4500 Da;

c1) 1.5 to 3.5 g of sodium chloride;

c2) 1 to 2.5 g of potassium chloride;

d) optionally one or more sweeteners; and

e) optionally one or more flavouring agents.