Colonoscopy—preparation

• US 9,592,252 B2
• Filed: 03/09/2012
• Issued: 03/14/2017
• Est. Priority Date: 03/11/2011
• Status: Active Grant

• Current Assignee: Norgine B.V.
• Original Assignee: Norgine B.V.
• Inventors: Stein, Peter, Halphen, Marc, Gruss, Hans-Jurgen, Cox, Ian, Cockett, Alasdair, Ungar, Alex
• Primary Examiner(s): Liu, Sue
• Assistant Examiner(s): NIELSEN, THOR B
• Application Number:
  US14/004,604
• Publication Number:
  US 20140010895A1
• Time in Patent Office: 1,831 Days
• Field of Search: None
• US Class Current: 1/1
• 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 liter ascorbate anion provided by ascorbic acid, one or more salts of ascorbic acid, or a mixture thereof; and b) 10 to 200 g per liter 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 effective amount of a first cleansing solution; and then after a time interval —administering to the subject an effective amount of a second cleansing solution, where in the two cleansing solutions are as described in the specification.

Claims

1. A colon cleansing solution comprising:

a) 300 to 2000 mmol per liter ascorbate anion provided by ascorbic acid, one or more salts of ascorbic acid, or a mixture thereof;

b) 10 to 200 g per liter polyethylene glycol; and

c) sodium chloride and potassium chloride.

2. A colon cleansing solution as claimed in claim 1 wherein the ascorbate anion is provided by ascorbic acid, one or more salts of ascorbic acid selected from sodium ascorbate, potassium ascorbate, magnesium ascorbate and calcium ascorbate, or a mixture thereof.

3. A colon cleansing solution as claimed in claim 1 comprising:

a) 300 to 2000 mmol per liter ascorbate anion;

b) 10 to 200 g per liter PEG having an average molecular weight of 3000 to 4000 Dalton (Da);

c) sodium chloride and potassium chloride;

d) optionally one or more flavouring agents; and

e) optionally one or more sweeteners.

8. A colon cleansing solution as claimed in claim 1 comprising the ascorbate component at 80 to 120 g per liter.

9. A colon cleansing solution as claimed in claim 1 comprising PEG at 30 to 90 g per liter.

10. A method of cleansing the colon of a subject comprising administering to the subject an effective amount of a colon cleansing solution as defined in claim 1.

4. A kit comprising:

a first colon cleansing solution, and

a second colon cleansing solution,

the second colon cleansing solution being a solution in water of;

a) 300 to 2000 mmol per liter ascorbate anion provided by ascorbic acid, one or more salts of ascorbic acid, or a mixture thereof;

b) 10 to 200 g per liter polyethylene glycol; and

c) sodium chloride and potassium chloride.

5. A kit as claimed in claim 4 wherein the first colon cleansing solution comprises:

(i) 70 to 250 g per liter PEG having an average molecular weight of 2500 to 4500 Da;

(ii) 2.0 to 20 g per liter 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; and

(v) optionally one or more sweeteners.

6. A kit comprising:

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

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

and optional instructions for use,

the second colon cleansing solution being a second colon cleansing solution as defined in claim 4.

7. A kit as claimed in claim 6 comprising:

A) a first component, being a composition for the preparation of a first colon cleansing solution comprising;

(i) 70 to 250 g per liter PEG having an average molecular weight of 2500 to 4500 Da;

(ii) 2 to 20 g per liter 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, comprising;

a) 300 to 2000 mmol per liter ascorbate anion;

b) 10 to 200 g per liter polyethylene glycol; and

c1) sodium chloride and potassium chloride;

the first solution being different from the second.

11. 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) 300 to 2000 mmol per liter ascorbate anion provided by ascorbic acid, one or more salts of ascorbic acid, or a mixture thereof;

b) 10 to 200 g per liter polyethylene glycol; and

c) sodium chloride and potassium chloride.