IP Library Granted Patent US 12,239,659
Granted Patent B2
US 12,239,659 · App. 18/743,526 · Granted Mar 4, 2025

Methods of administering safe colon cleansing compositions

Inventors: Edmund V. Dennett (Walpole, MA); Mark Cleveland (Norwell, MA); Russell W. Pelham (Duxbury, MA); Matthew Walker (Brighton, MA)
A61K31/765A61K9/08A61K33/04A61K47/02A61K47/26A61P1/10
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Quick Facts
Patent No.
US 12,239,659
App. No.
18/743,526
Granted
Mar 4, 2025
Kind
B2
Abstract

Disclosed herein are methods of administering compositions comprising a mixture of salts that induce purgation of the colon and are useful to cleanse the colon. Furthermore, the disclosed methods prevent degradation of PEG and allow for cleansing of the colon without the use of adjunct laxatives, including stimulant laxatives such as bisacodyl. The disclosed methods are superior to the prior art in that they allow for higher tolerability, improved safety, lower volumes, and improved patient compliance.

Claims (17)

1. A method of cleansing a colon of a patient, the method comprising:

(a) providing a first container comprising a first portion of a first dose of a colon cleansing product comprising about 178.7 grams of polyethylene glycol, about 7.3 grams of sodium sulfate, about 1.12 grams of potassium chloride, about 0.9 grams of magnesium sulfate, 0.5 grams of sodium chloride, lemon-lime flavor, neotame, and advantame;

(b) providing a second container comprising a second portion of the first dose of a colon cleansing product comprising malic acid and citric acid;

(c) mixing the contents of the first container and the contents of the second container together to form a first mixture and then mixing the first mixture with about 0.5 liters to about 1.0 liters of water, thereby forming the first dose of the colon cleansing product;

(d) consuming the first dose;

(e) providing a third container comprising a first portion of a second dose of the colon cleansing product comprising about 178.7 grams of polyethylene glycol, about 7.3 grams of sodium sulfate, about 1.12 grams of potassium chloride, about 0.9 grams of magnesium sulfate, about 0.5 grams of sodium chloride, lemon-lime flavor, neotame, and advantame;

(f) providing a fourth container comprising a second portion of the second dose of the colon cleansing product comprising malic acid and citric acid;

(g) mixing the contents of the third container and the contents of the fourth container together to form a second mixture and then mixing the second mixture with about 0.5 liters to about 1.0 liters of water, thereby forming the second dose of the colon cleansing product; and

(h) consuming the second dose, wherein consumption of the first dose and second dose cleanses the colon of the patient sufficiently for diagnostic and surgical procedures to be performed, wherein the combination of the first dose and the second dose does not cause a sodium balance of −50.00 mEq/L or greater in the patient.

2. The method of claim 1 , wherein consuming the first dose and consuming the second dose are performed in volumes of about 150 ml to about 300 ml about every 15 minutes.

3. The method of claim 1 , wherein the second dose is consumed between about 4 hours and about 24 hours after the first dose.

4. The method of claim 1 , wherein the second dose is consumed on the day after consumption of the first dose.

5. The method of claim 1 , wherein consumption of the first dose and the second dose of the colon cleansing product does not cause clinically significant electrolyte shifts in the patient.

6. The method of claim 1 , wherein the second portion of the first dose of the colon cleansing product comprises about 1.43 grams of malic acid and about 1.64 grams of citric acid.

7. The method of claim 6 , wherein the second portion of the second dose of the colon cleansing product comprises about 1.43 grams of malic acid and about 1.64 grams of citric acid.

8. The method of claim 1 , wherein the polyethylene glycol is polyethylene glycol 3350.

9. The method of claim 7 , wherein the polyethylene glycol is polyethylene glycol 3350.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 22, 2025
From: BRAINTREE LABORATORIES, INC.; SEBELA IRELAND LIMITED
To: AZURITY PHARMACEUTICALS, INC.
Reel/Frame 073290/0852 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 4, 2025
From: DENNETT, EDMUND V.; CLEVELAND, MARK; PELHAM, RUSSELL W.; WALKER, MATTHEW
To: BRAINTREE LABORATORIES, INC.
Reel/Frame 070734/0042 →