IP Library Granted Patent US 12,433,914
Granted Patent B2
US 12,433,914 · App. 19/062,757 · Granted Oct 7, 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)
Assignee: Braintree Laboratories, Inc.
A61K31/765A61K9/08A61K33/04A61K47/02A61K47/26A61P1/10
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Quick Facts
Patent No.
US 12,433,914
App. No.
19/062,757
Granted
Oct 7, 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 (14)

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

(a) administering to the patient 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, about 0.5 grams of sodium chloride, malic acid, and citric acid mixed in about 0.5 liters to about 1.0 liters of water;

(b) administering to the patient 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, malic acid, and citric acid mixed in about 0.5 liters to about 1.0 liters of water; and

wherein consumption of the first dose and second dose cleanses the colon of the patient sufficiently for diagnostic and surgical procedures to be performed, and 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 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 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.

10. The method of claim 9 , wherein the first dose further comprises lemon-lime flavor, neotame, and advantame.

11. The method of claim 10 , wherein the second dose further comprises lemon-lime flavor, neotame, and advantame.

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 →
Continuity (4)
Continuation 18792849 · Aug 2, 2024
Continuation 18743526 · Jun 14, 2024
Provisional Application 63521314 · Jun 15, 2023
Related Publication 20250186484A1 · Jun 12, 2025
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