Low dose colonic cleansing system

#Aqueous solutions of sodium phosphate salts (monobasic and dibasic sodium phosphate), such as FLEET® PHOSPHO-SODA®, are very effective oral cathartics and are extensively used prior to colonoscopy, radiographic procedures, and surgery. For pre-colonoscopy use, a split regimen is preferred that includes one 45 mL dose given the evening before colonoscopy and a second 45 mL dose given at least three hours prior to the procedure on the following morning. Each 45 mL dose contains 21.6 g monobasic sodium phosphate, and 8.1 g dibasic sodium phosphate. Patients are instructed to consume only a clear liquids diet for the meal proceeding the first dose, and to drink large amounts of clear liquids, including water and oral rehydration solutions, for example 3 to 4 liters, after each dose. See, for example, US Published Patent Application publication no. US20040192614 to Vanner et al.

#In a first aspect, the invention is a method of colonic cleansing, comprising administering orally a first dose of a liquid osmotic colonic evacuant composition; and administering orally a second dose of the liquid osmotic colonic evacuant composition. The second dose comprises an amount of the liquid osmotic colonic evacuant composition that is 55% to 95% of the amount of the first dose of the liquid osmotic colonic evacuant composition.

#In a second aspect, the invention is a kit for colonic cleansing, comprising a first dose of an osmotic colonic evacuant composition; and a second dose of the osmotic colonic evacuant composition. The second dose comprises an amount of the osmotic colonic evacuant composition that is 55% to 95% of the amount of the first dose of the osmotic colonic evacuant composition. The osmotic colonic evacuant is not in the form of tablets or capsules.

#FIG. 1 depicts components of the kit for one preferred embodiment of the low-dose colonic cleansing system.

#Because a hypertonic solution of sodium phosphate salts acts as an osmotic colonic evacuant of limited duration, it was previously thought that the administration of two equivalent doses of the salt cathartic solution was necessary to promote effective colonic cleansing. The present invention is drawn to the unexpected and surprising finding of effective phosphate salt-based colonic cleansing systems that employ a second dosage amount smaller than required previously.

#The present invention makes use of the discovery of effective colonic cleansing systems when administered in dosages lower than that required in the past. In particular, the present invention makes use of the unexpected and surprising finding that colonic cleansing can be accomplished that is sufficient for colonoscopy by using a smaller dose colonic cleansing system that includes two doses of an osmotic colonic evacuant, where the second dose is reduced. Thus, the invention described herein achieves effective colonic cleansing using a smaller dose of osmotic colonic evacuant than previous colonic cleansing systems.

#The phrase “osmotic colonic evacuant,” as used herein, refers to any composition that induces water infusion and retention into the intestinal lumen when the composition is administered to a subject. Compositions of an osmotic colonic evacuant include solids, powders, gels, or liquids. A liquid composition of an osmotic colonic evacuant may be constituted from a solid, powder, or gel composition using a physiologically acceptable carrier (e.g., water). A liquid composition of an osmotic colonic evacuant suitable for administration also may be constituted from liquid concentrate form using a physiologically acceptable carrier (e.g., water) as diluent.