IP Library › Granted Patent US 12,594,298
Granted Patent B2
US 12,594,298 · App. 19/172,077 · Granted Apr 7, 2026

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: Azurity Pharmaceuticals, Inc.
A61K31/765A61K9/08A61K33/04A61K47/02A61K47/26A61P1/10
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Quick Facts
Patent No.
US 12,594,298
App. No.
19/172,077
Granted
Apr 7, 2026
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 (8)

1 . A colon cleansing product comprising:

(a) a first container comprising a first portion of a first dose of a colon cleansing product comprising about 178.7 grams of polyethylene glycol 3350, 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;

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

(c) a third container comprising a first portion of a second dose of the colon cleansing product comprising about 178.7 grams of polyethylene glycol 3350, 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; and

(d) a fourth container comprising a second portion of the second dose of the colon cleansing product comprising malic acid and citric acid,

wherein the colon cleansing product is formulated so that the combination of the first dose and second dose cleanse a colon of a subject without causing a sodium balance of −50.00 mEq/L or greater in the subject.

2 . The colon cleansing product 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.

3 . The colon cleansing product of claim 2 , 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.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 22, 2025
From: DENNETT, EDMUND V.; CLEVELAND, MARK; PELHAM, RUSSELL W.; WALKER, MATTHEW
To: BRAINTREE LABORATORIES, INC.
Reel/Frame 073290/0508 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 22, 2025
From: BRAINTREE LABORATORIES, INC.; SEBELA IRELAND LIMITED
To: AZURITY PHARMACEUTICALS, INC.
Reel/Frame 073290/0852 →
Continuity (4)
Continuation 18792849 · Aug 2, 2024
Continuation 18743526 · Jun 14, 2024
Provisional Application 63521314 · Jun 15, 2023
Related Publication 20250228888A1 · Jul 17, 2025
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