IP Library Granted Patent US 11,033,498
Granted Patent B2
US 11,033,498 · App. 16/207,800 · Granted Jun 15, 2021

Solid oral sulfate salt formulations for cleaning 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 11,033,498
App. No.
16/207,800
Granted
Jun 15, 2021
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 (17)

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

a) administering a first dose of a colon cleansing composition consisting essentially of an oral dosage form that comprises 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 liquid within two hours of the first dose;

c) administering a second dose of the colon cleansing composition consisting essentially of the oral dosage form that comprises about 17.75 grams of sodium sulfate, about 2.7 grams of magnesium sulfate, and about 2.25 grams of potassium chloride; and

d) administering a second volume of a liquid within two hours of the second dose, wherein the colon cleansing composition cleanses the colon.

2. The method of claim 1 , wherein the oral dosage form is a tablet.

3. The method of claim 2 , wherein at least 6 tablets are administered in the first dose and at least 6 tablets are administered in the second dose.

4. The method of claim 3 , wherein 12 tablets are administered in the first dose and 12 tablets are administered in the second dose.

5. The method of claim 1 , wherein the oral dosage form comprises sodium caprylate.

6. The method of claim 1 , wherein the oral dosage form comprises polyethylene glycol.

7. The method of claim 1 , wherein the oral dosage form comprises sodium caprylate and polyethylene glycol.

8. The method of claim 7 , wherein the oral dosage form comprises from about 0.1 grams to about 1.0 grams of sodium caprylate and from about 1.6 grams to about 2.1 grams of polyethylene glycol.

9. The method of claim 1 , wherein the liquid is water.

10. The method of claim 1 , wherein the first volume is at least about 16 ounces.

11. The method of claim 1 , wherein the second volume is at least about 16 ounces.

12. The method of claim 1 , wherein the first volume of liquid and the second volume of liquid are each consumed within 60 minutes.

13. The method of claim 1 , wherein the administration of the colon cleansing composition does not cause clinically significant electrolyte shifts.

Assignments (11)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 2, 2026
From: SEBELA BT HOLDINGS, INC.
To: SEBELA INTERNATIONAL DEVELOPMENT LIMITED
Reel/Frame 073662/0070 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 29, 2026
From: CLEVELAND, MARK VB.; DENNETT, EDMUND V., JR.; PELHAM, RUSSELL W.
To: BRAINTREE LABORATORIES, INC.
Reel/Frame 073632/0311 →
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: SEBELA US INC.
To: SEBELA BT HOLDINGS, INC.
Reel/Frame 063755/0122 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 24, 2023
From: SEBELA BT HOLDINGS, INC.
To: BRAINTREE LABORATORIES, INC.
Reel/Frame 063755/0194 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 24, 2023
From: SEBELA INTERNATIONAL BERMUDA LIMITED
To: SEBELA US INC.
Reel/Frame 063754/0885 →
RELEASE OF SECURITY INTEREST Recorded Jul 13, 2021
From: BIOPHARMA CREDIT PLC
To: BRAINTREE LABORATORIES, INC
Reel/Frame 056838/0248 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2020
From: SEBELA INTERNATIONAL DEVELOPMENT LIMITED
To: SEBELA INTERNATIONAL BERMUDA LIMITED
Reel/Frame 054609/0141 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2020
From: SEBELA INTERNATIONAL BERMUDA LIMITED
To: SEBELA US INC.
Reel/Frame 054609/0311 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2020
From: SEBELA US INC.
To: SEBELA BT HOLDINGS
Reel/Frame 054609/0415 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2020
From: SEBELA BT HOLDINGS
To: CHAVOUS, DAVID
Reel/Frame 054609/0450 →
Continuity (2)
Continuation 15669749 · Aug 4, 2017
Related Publication 20190099375A1 · Apr 4, 2019