Bowel cleansing composition

Abstract

The invention provides compositions for rapid bowel cleansing comprising a water-soluble mixture of polyethylene glycol and sodium phosphate(s). The compositions are particularly useful for preparing the bowel prior to surgery or diagnostic procedures such as colonoscopies. The invention further comprises methods for cleansing the bowel using these compositions, and bowel cleansing kits comprising these compositions.

Description

[0001] The instant application is a continuation-in-part of co-pending U.S. patent application Ser. No. 10 / 194,251, filed Jul. 15, 2002.[0002] The invention relates to compositions for rapid bowel cleansing which are particularly useful for preparing the bowel prior to surgery or diagnostic procedures such as colonoscopies.[0003] 1. Field of the Invention[0004] Gastrointestinal agents for regulating bowel movement can conveniently be placed into two categories: laxatives and bowel cleansers. Laxatives are formulated for long-term use, with the intention of eliminating constipation and obtaining a regular bowel function. Many laxatives work by stimulating bowel motility (peristalsis) in various ways, as by distending the gut with bulking or osmotic agents, or by directly stimulating the bowel nerves or muscles with stimulant laxatives. Other laxatives function as stool softeners or lubricants. The various types of laxatives are often combined in attempts to maximize efficacy or to re...

AI Technical Summary

Benefits of technology

[0012] The compositions demonstrate significantly improved patient compliance and very good efficacy.

[0018] To formulate a convenient single dosage drink, a dry prep composition containing from about 45 to 130 g PEG and from about 5 to about 45 g phosphate powder, typically from about 45 to 70 grams powdered PEG and 10 to 30 grams phosphate powder, preferably about 55 to 65 grams PEG and 15 to 25 grams phosphate powder, is dissolved or suspended in an aqueous liquid of choice, such as water, tea, or juice. The phosphate powders should be readily soluble in the aqueous drink medium to promote optimum palatability and patient compliance. Reduced-solubility powders such as powders coated with insoluble materials are not recommended. Suitable powders for use in the practice of the present invention comprise the water-soluble free-flowing untreated powders described and exemplified supra as mono- and di-sodium phosphate powders commonly used in this art. In an exemplary drink formulation, a single dose dry prep composition containing from about 58 to 63 grams PEG and from about 15 to 20 grams phosphate powder, for example, 60 grams powdered PEG and 18 grams sodium phosphate powder, preferably disodium phosphate powder, is dissolved in about 1 to 1.5 quarts of water or other aqueous liquid, for oral ingestion. Alternately, the compositions can be dissolved in a smaller portion of water, such as eight fluid ounces, and the remainder of the liquid taken in conjunction with this solution. The amount of water or other aqueous medium in which the dry prep composition is dissolved or which is taken with the dry prep composition is not critical; however, for optimum bowel cleansing, at least about a pint should be used, and preferably at least a quart, depending upon the patient's total liquid intake during the treatment.

Problems solved by technology

While purgatives formulated for patient use as enemas are often prescribed before examinations, they are awkward to handle and are frequently not properly administered, so orally-administered preparations are generally preferred.

However, the orally-administered compositions for rapid bowel cleansing in common use also have disadvantages which discourage patient compliance.

This laxative, when formulated and used as a bowel cleanser, is associated with nausea, vomiting, and symptoms of electrolyte imbalance; the product also has an unpleasant taste.

As a result, patient compliance is difficult to obtain, particularly when the cleanser is supplemented with, for example, another saline agent such as a magnesium salt, or a bowel stimulant such as bisacodyl.

(Braintree Laboratories, Braintree, Mass.) have poor patient compliance.

They have an unpleasant taste, and the amount and frequency of fluid the patent is required to drink, typically 8 fluid ounces every ten minutes over several hours, frequently cause severe bloating and attendant nausea.

Further, although these purgatives normally include electrolytes to counterbalance electrolyte loss during treatment, symptoms of electrolyte imbalance are, notwithstanding, often experienced by the patient.

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