Claims for Patent: 12,433,914

Summary for Patent: 12,433,914

Title:	Methods of administering safe colon cleansing compositions
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.
Inventor(s):	Edmund V. Dennett, Mark Cleveland, Russell W. Pelham, Matthew Walker
Assignee:	Braintree Laboratories Inc
Application Number:	US19/062,757
Patent Claims:	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.