Colon cleansing compositions

• US 7,658,914 B2
• Filed: 12/08/2006
• Issued: 02/09/2010
• Est. Priority Date: 10/25/2002
• Status: Expired due to Term

• Current Assignee: Norgine B.V.
• Original Assignee: Norgine B.V.
• Inventors: Ungar, Alex, Cox, Ian David, Halphen, Marc, Barras, Norman
• Primary Examiner(s): WEDDINGTON, KEVIN E
• Application Number:
  US11/636,105
• Publication Number:
  US 20070086978A1
• Time in Patent Office: 1,159 Days
• Field of Search: 424/78.01, 514/474, 514/892
• US Class Current: 424/78.01
• 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 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 33/04 Sulfur, selenium or tellurium; Compounds thereof
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/009 Sachets, pouches characterised by the material or function of the envelope with gastric retention A61K9/0065; sachets which are not administered but function merely as a container are classified according to the content, e.g. sachets comprising powder for reconstitution of a drink A61K9/0095
• 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: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/10 Laxatives
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics

Abstract

A composition comprising, per liter of aqueous solution, from 30 to 350 g polyethylene glycol, from 3 to 20 g of an ascorbic acid component selected form the group consisting of ascorbic acid, a salt of ascorbic acid, or a mixture thereof, an alkali metal or alkaline earth metal sulphate, preferably from 1 to 15 g thereof, and optionally one or more electrolytes selected from sodium chloride, potassium chloride, and sodium hydrogen carbonate, and preferably also comprising flavorings, is effective in cleansing the gut in preparation for a endoscopy, especially colonoscopy. It is safer than conventional sodium phosphate-based gut cleansing compositions, and hence can be used for patients who would be at risk with sodium phosphate-based compositions, and is better tolerated than conventional PEG-based compositions, leading to better patient compliance and enabling effective out-patient use.

Claims

1. A kit comprising:

(a) a first container containing a first dry composition, said first dry composition comprising;

(i) 90 g to 125 g of polyethylene glycol (“

PEG”

);

(ii) 5 g to 10 g of an alkali metal sulfate, an alkaline earth metal sulfate or a mixture thereof;

(iii) 2 g to 4 g of sodium chloride; and

(iv) 0.5 g to 1.3 g of potassium chloride; and

(b) a second container containing a second dry composition comprising 5 g to 15 g of an ascorbate component, said ascorbate component comprising ascorbic acid and a salt thereof in an ascorbic acid;

salt weight ratio in the range of 2;

8 to 8;

2,

wherein the calculated total number of moles of individual dissolved species in a solution made with the contents of the first and second containers made up to one liter with water is within the range of 300 to 700 mmol.

2. The kit of claim 1, wherein the calculated total number of moles of individual dissolved species is within the range of 330 to 550 mmol.

3. The kit of claim 1, wherein the first dry composition comprises one or more flavorings.

4. The kit of claim 1, wherein the first dry composition comprises one or more sweeteners.

5. The kit of claim 3, wherein the first dry composition comprises one or more sweeteners.

6. The kit of claim 1, which comprises two first containers and two second containers.

7. The kit of claim 6, wherein the first and second containers are sachets.

8. The kit of claim 1, wherein the first and second containers are sachets.

9. A kit of any one of claims 1 to 5, wherein said first dry composition comprises 100 g polyethylene glycol (PEG) 3350, 7.5 g sodium sulfate, 2.691 g sodium chloride and 1.015 g potassium chloride, and wherein the second dry composition comprises 4.7 g ascorbic acid and 5.9 g sodium ascorbate.

10. A kit comprising:

(a) a first container containing a first dry composition, said first dry composition comprising;

(i) 100 g polyethylene glycol (PEG) 3350;

(ii) 7.5 g sodium sulfate;

(iii) 2.691 g sodium chloride; and

(iv) 1.015 g potassium chloride; and

(b) a second container containing a second dry composition, said second dry composition comprising 4.7 g ascorbic acid and 5.9 g sodium ascorbate.

11. The kit of claim 10, wherein the first dry composition comprises one or more flavorings.

12. The kit of claim 10, wherein the first dry composition comprises one or more sweeteners.

13. The kit of claim 10, which comprises two first containers and two second containers.

14. The kit of claim 13, wherein the first and second containers are sachets.

15. The kit of claim 10, wherein the first and second containers are sachets.

16. The kit of claim 10, wherein the first dry composition further comprises:

(v) 0.233 g aspartame;

(vi) 0.117 g acesulfame K; and

(vii) 0.340 g lemon flavor.

17. A kit comprising:

(a) a first container containing a first dry composition, said first dry composition consisting of;

(i) 100 g polyethylene glycol (PEG) 3350;

(ii) 7.5 g sodium sulfate;

(iii) 2.691 g sodium chloride;

(iv) 1.015 g potassium chloride;

(v) 0.233 g aspartame;

(vi) 0.117 g acesulfame K; and

(vii) 0.340 g lemon flavor; and

(b) a second container containing a second dry composition, said second dry composition consisting of 4.7 g ascorbic acid and 5.9 g sodium ascorbate.

18. The kit of claim 17, which comprises two first containers and two second containers.

19. The kit of claim 18, wherein the first and second containers are sachets.

20. The kit of claim 17, wherein the first and second containers are sachets.

21. An aqueous solution comprising water and:

(a) 90 g/l to 125 g/l of polyethylene glycol (PEG);

(b) 5 g/l to 10 g/l of an alkali metal sulfate, an alkaline earth metal sulfate or a mixture thereof;

(c) 5 g/l to 15 g/l of an ascorbate component, said ascorbate component comprising ascorbic acid and a salt thereof in an ascorbic acid;

salt weight ratio in the range of 2;

8 to 8;

2;

(d) 2 g/l to 4 g/l of sodium chloride; and

(e) 0.5 g/l to 1.3 g/l of potassium chloride,

wherein the calculated total number of moles of individual dissolved species per liter of said solution is within the range of 300 to 700 mmol.

22. The aqueous solution of claim 21, wherein the total calculated number of moles of individual dissolved species is within the range of 330 to 550 nm iol.

23. The aqueous solution of claim 21, which comprises one or more flavorings.

24. The aqueous solution of claim 23, which comprises one or more sweeteners.

25. The aqueous solution of claim 21, which comprises one or more sweeteners.

26. The aqueous solution of any one of claims 21 to 25 comprising:

(a) 100 g/l polyethylene glycol (PEG) 3350;

(b) 7.5 g/l sodium sulfate;

(c) 4.7 g/l ascorbic acid and 5.9 g sodium ascorbate;

(d) 2.691 g/l sodium chloride; and

(e) 1.015 g/l potassium chloride.

27. An aqueous solution comprising water and:

(a) 100 g/l polyethylene glycol (PEG) 3350;

(b) 7.5 g/l sodium sulfate;

(c) 4.7 g/l ascorbic acid;

(d) 5.9 g/l sodium ascorbate;

(e) 2.691 g/l sodium chloride; and

(f) 1.015 g/l potassium chloride.

28. The aqueous solution of claim 27, which comprises one or more flavorings.

29. The aqueous solution of claim 27, which comprises one or more sweeteners.

31. The aqueous solution of claim 27, wherein the aqueous solution further comprises:

(g) 0.233 g/l aspartame;

(h) 0.117 g/l acesulfame K; and

(i) 0.340 g/l lemon flavor.

30. An aqueous solution consisting of water and:

(a) 100 g/l polyethylene glycol (PEG) 3350;

(b) 7.5 g/l sodium sulfate;

(c) 4.7 g/l ascorbic acid

(d) 5.9 g/l sodium ascorbate;

(e) 2.691 g/l sodium chloride;

(f) 1.015 g/l potassium chloride;

(g) 0.233 g/l aspartame;

(h) 0.117 g/l acesulfame K; and

(i) 0.340 g/l lemon flavor.