IP Library Granted Patent US 11,382,864
Granted Patent B2
US 11,382,864 · App. 17/347,469 · Granted Jul 12, 2022

Solid oral sulfate salt formulations for cleansing a colon and methods of using same

Inventors: Mark vB Cleveland (Norwell, MA); Edmund V. Dennett, Jr. (Walpole, MA); Russell W Pelham (Duxbury, MA)
Assignee: Braintree Laboratories, Inc.
A61K9/20A61K9/2853A61K33/04A61K33/14
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Quick Facts
Patent No.
US 11,382,864
App. No.
17/347,469
Granted
Jul 12, 2022
Kind
B2
Abstract

Disclosed herein are solid oral dosage formulations comprising sodium sulfate, magnesium sulfate, and potassium chloride for inducing purgation of the colon of a subject. Furthermore, the disclosed compositions and formulations are useful to cleanse the colon when administered in sufficient quantities. Methods for inducing purgation of the colon and for cleansing the colon are also disclosed.

Claims (19)

1. A method of cleansing a colon of a subject, the method comprising

a. administering a first dose of a composition consisting essentially of about 17.75 grams of sodium sulfate, about 2.7 grams of magnesium sulfate, and about 2.25 grams of potassium chloride;

b. administering a first volume of water while administering the first dose of the composition;

c. administering a second volume of water after the first dose and prior to a second dose;

d. administering a third volume of water after the first dose and prior to the second dose;

e. administering the second dose of the composition consisting essentially of about 17.75 grams of sodium sulfate, about 2.7 grams of magnesium sulfate, and about 2.25 grams of potassium chloride;

f. administering a fourth volume of water while administering the second dose of the composition;

g. administering a fifth volume of water after the second dose; and

h. administering a sixth volume of water after the second dose, wherein the first and second doses cleanse the colon of the subject.

2. The method of claim 1 , wherein the composition further comprises polyethylene glycol.

3. The method of claim 1 , wherein the composition further comprises one or more water-soluble excipients.

4. The method of claim 3 , wherein the one or more water-soluble excipients comprises sodium caprylate.

5. The method of claim 2 , wherein the polyethylene glycol is PEG-8000.

6. The method of claim 1 , the amount of the first volume of water and the second volume of water are individually 16 ounces.

7. The method of claim 1 , wherein the composition comprises a solid oral dosage form.

8. The method of claim 1 , wherein the first and the second doses are administered as tablets.

9. The method of claim 8 , wherein the total number of tablets administered in the first dose is 12 tablets.

10. The method of claim 8 , wherein the total number of tablets administered in the second dose is 12 tablets.

11. The method of claim 1 , wherein the first dose is administered on a day prior to a diagnostic procedure and the second dose is administered on the day of the diagnostic procedure.

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 May 24, 2023
From: CLEVELAND, MARK VB; DENNETT, EDMUND V, JR; PELHAM, RUSSELL W
To: BRAINTREE LABORATORIES, INC.
Reel/Frame 063754/0111 →