Salt solution for colon cleansing

• US 20030202957A1
• Filed: 04/30/2002
• Published: 10/30/2003
• Est. Priority Date: 04/30/2002
• Status: Active Grant

• Current Assignee: Braintree Laboratories Incorporated (Sebela International Limited)
• Original Assignee: Braintree Laboratories Incorporated (Sebela International Limited)
• Inventors: Cleveland, Mark vB.
• Granted Patent: US 6,946,149 B2
• Time in Patent Office: Days
• US Class Current: 424/78.38
• 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 31/765 Polymers containing oxygen
• CPC Class Codes: A61K 31/77 of oxiranes
• 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 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• 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 field of colonic diagnostic and surgical procedures is hampered by the lack of optimal means available to cleanse the colon. A compromise between convenient, distasteful, solid or low volume, hyperosmotic solutions which cause considerable fluid and electrolyte imbalances in patients and large volume, difficult to consume, iso-osmotic solutions has had to be made heretofore. This invention describes a low volume, hyperosmotic solution consisting of sulfate salts with and with out polyethylene glycol. Unlike prior art, this composition is useful for the cleansing of the bowel and, in lower volumes, as a laxative, without producing clinically significant changes in bodily function.

Claims

1. A composition for inducing purgation of the colon of a patient which produces no clinically significant electrolyte shifts, comprising a small volume of an aqueous solution which comprises an effective amount of one or more salts selected from the group consisting of Na₂SO₄, MgSO₄, and K₂SO₄, and an effective amount of PEG.

2. A composition according to claim 1 wherein the solution comprises an effective amount of Na₂SO₄, an effective amount of MgSO₄, an effective amount of K₂SO₄, and an effective amount of PEG.

3. A composition according to claim 2 wherein the solution comprises between about 2 grams and about 40 grams of Na₂SO₄, between about 2 grams and about 20 grams of MgSO₄, between about 1 and about 10 grams of K₂SO₄, and between about 0.1 and about 50 grams of PEG.

4. A composition for inducing purgation of the colon of a patient according to claim 1 wherein the composition comprises about 20 grams of Na₂SO₄, about 20 grams of MgSO₄, about 3 grams of K₂SO₄, and about 34 grams of PEG.

5. A composition for inducing purgation of the colon of a patient according to claim 4 wherein the aqueous solution has a volume of less than 500 ml.

6. A composition for inducing purgation of the colon of a patient comprising an aqueous solution consisting essentially of an effective amount of one or more salts selected from the group consisting of Na₂SO₄, MgSO₄, and K₂SO₄, and an effective amount of PEG.

7. A composition for inducing purgation of the colon of a patient according to claim 6 wherein the composition consists essentially of about 20 grams of Na₂SO₄, about 20 grams of MgSO₄, about 3 grams of K₂SO₄, and about 34 grams of PEG in about 330 ml of water.

8. A method for inducing colonic purgation in a patient comprising the steps of:

(a) preparing a composition for inducing colonic purgation in a patient comprising an aqueous solution comprising an effective amount of one or more salts selected from the group consisting of Na₂SO₄, MgSO₄, and K₂SO₄ and an effective amount of PEG;

(b) orally administering an effective amount of the composition to a patient; and

(c) allowing said orally administered composition to induce colonic purgation.

9. A method for inducing colonic purgation according to claim 8 wherein the composition for inducing colonic purgation consists essentially of about 20 grams of Na₂SO₄, about 20 grams of MgSO₄, about 3 grams of K₂SO₄, and about 34 grams of PEG in about 330 ml of water.

10. A method for inducing colonic purgation in a patient according to claim 8 where, in step (b) the effective amount of the composition is administered in two or more doses within a treatment period.

11. A composition for inducing purgation of the colon of a patient comprising a small volume of an aqueous solution which produces no clinically significant electrolyte shifts and which comprising an effective amount of one or more salts selected from the group consisting of Na₂SO₄, MgSO₄, and K₂SO₄.

12. A composition according to claim 11 wherein the solution comprises an effective amount of Na₂SO₄, an effective amount of MgSO₄, an effective amount of K₂SO₄.

13. A composition according to claim 12 wherein the solution comprises between about 2 grams and about 40 grams of Na₂SO₄, between about 2 grams and about 20 grams of MgSO₄, between about 1 and about 10 grams of K₂SO₄.

14. A composition for inducing purgation of the colon of a patient comprising an aqueous solution consisting essentially of an effective amount of one or more salts selected from the group consisting of Na₂SO₄, MgSO₄, and K₂SO₄.

15. A method for inducing colonic purgation in a patient comprising the steps of:

(a) preparing a composition for inducing colonic purgation in a patient comprising an aqueous solution comprising an effective amount of one or more salts selected from the group consisting of Na₂SO₄, MgSO₄, and K₂SO₄;

(b) orally administering an effective amount of the composition to a patient; and

(c) allowing said orally administered composition to induce colonic purgation.