Claims for Patent: 12,239,659

Summary for Patent: 12,239,659

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:	Azurity Pharmaceuticals Inc
Application Number:	US18/743,526
Patent Claims:	1. A method of cleansing a colon of a patient, the method comprising: (a) providing a first container comprising a first portion of 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, 0.5 grams of sodium chloride, lemon-lime flavor, neotame, and advantame; (b) providing a second container comprising a second portion of the first dose of a colon cleansing product comprising malic acid and citric acid; (c) mixing the contents of the first container and the contents of the second container together to form a first mixture and then mixing the first mixture with about 0.5 liters to about 1.0 liters of water, thereby forming the first dose of the colon cleansing product; (d) consuming the first dose; (e) providing a third container comprising a first portion of 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, lemon-lime flavor, neotame, and advantame; (f) providing a fourth container comprising a second portion of the second dose of the colon cleansing product comprising malic acid and citric acid; (g) mixing the contents of the third container and the contents of the fourth container together to form a second mixture and then mixing the second mixture with about 0.5 liters to about 1.0 liters of water, thereby forming the second dose of the colon cleansing product; and (h) consuming the second dose, wherein consumption of the first dose and second dose cleanses the colon of the patient sufficiently for diagnostic and surgical procedures to be performed, 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 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. 7. The method of claim 6, 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. 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.