Colon lavage system

• US 8,778,306 B2
• Filed: 04/20/2010
• Issued: 07/15/2014
• Est. Priority Date: 04/21/2009
• Status: Active Grant

• Current Assignee: Dark Canyon Laboratories, LLC
• Original Assignee: Dark Canyon Laboratories, LLC
• Inventors: Bachwich, Dale R.
• Primary Examiner(s): Hartley, Michael G
• Assistant Examiner(s): EBRAHIM, NABILA G
• Application Number:
  US12/763,821
• Publication Number:
  US 20110189091A1
• Time in Patent Office: 1,547 Days
• Field of Search: None
• US Class Current: 424/9.1
• CPC Class Codes: A23L 27/88 Taste or flavour enhancing agents
• 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 31/194 having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
• CPC Class Codes: A61K 31/375 Ascorbic acid, i.e. vitamin C; Salts thereof
• 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 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 9/0095 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: A61K 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61K 9/4808 characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084
• CPC Class Codes: A61K 9/50 Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals A61K9/2081 takes precedence; particles with a single coating comprising drug A61K9/167
• CPC Class Codes: A61P 1/10 Laxatives
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals

Abstract

The present invention provides compositions, systems, kits, and methods for preparation prior to a colonoscopy or other gastrointestinal procedure. In particular, the present invention provides a colon lavage system comprising an aqueous portion and a solid portion.

Claims

1. A method for preparing a subject for a colon-related procedure comprising:

a) providing a plurality of individually packaged osmotic agent doses and a plurality of individually packaged electrolyte doses;

b) dissolving one or more of said plurality of osmotic agent doses in water;

c) administering one or more of said plurality of osmotic agent doses dissolved in water to said subject;

d) administering one or more of said plurality of electrolyte doses in solid form to said subject; and

e) repeating steps (b)-(d) until all of said plurality of osmotic agent doses and all of said plurality of electrolyte doses have been ingested by said subject.

2. The method of claim 1, further comprising the step of passing stool from the colon of said subject.

3. The method of claim 2, further comprising the step of analyzing said stool.

4. The method of claim 1, further comprising the step of performing a diagnostic or surgical procedure on said subject.

5. The method of claim 1, wherein step b) further comprises dissolving a flavorant in said water.

6. The method of claim 1, wherein the osmotic agent is PEG having average molecular weight between 2000 and 8000.

7. The method of claim 1, wherein the osmotic agent is PEG 3350.

8. The method of claim 1, wherein the electrolytes are independently selected from the group consisting of sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride, magnesium sulfate, magnesium citrate, ascorbic acid, and sodium ascorbate.

9. The method of claim 1, wherein the electrolytes are independently selected from the group consisting of sodium bicarbonate, sodium chloride, and potassium chloride.

10. The method of claim 1, wherein the electrolyte dose comprises:

from 0.2 g to 20 g sodium chloride;

from 0.1 g to 5 g potassium chloride; and

from 0.1 g to 10 g sodium bicarbonate.

11. The method of claim 10, further comprising from 0.1 g to 40 g sodium sulfate.

12. The method of claim 10, wherein the electrolyte doses are in a pill, tablet, gel-cap, micro-encapsulated granules, or capsule form and the electrolyte dose comprises from 0.5 g to 1 g sodium chloride;

from 0.2 g to 0.5 g potassium chloride;

from 0.7 g to 1 g sodium bicarbonate; and

from 0.1 g to 4 g sodium sulfate.

13. The method of claim 10, wherein the electrolyte dose comprises from 1 g to 2 g sodium chloride;

from 0.1 g to 0.3 g KCl; and

from 0.5 g to 1 g sodium bicarbonate.

14. The method of claim 7, wherein the electrolyte doses are in a pill, tablet, capsule, gel-cap, micro-encapsulated granules, or liquid form and wherein a unit dose of PEG is from 20 g to 175 g of PEG 3350.

15. The method of claim 14, wherein a unit dose of PEG is from 25 g to 100 g.

16. The method of claim 14, wherein the unit dose of PEG is from 25 g to 35 g.

17. The method of claim 14, wherein the unit dose of PEG is from 50 g to 60 g.

18. A method for preparing a subject for a colon-related procedure comprising:

a) in a first time period;

i) administering to the subject a solution comprising;

PEG, water, and a flavorant; and

ii) administering to the subject a plurality of capsules comprising electrolytes; and

b) in a second time period;

i) administering to the subject a solution comprising;

PEG, water, and a flavorant; and

ii) administering to the subject a plurality of capsules comprising electrolytes.