Bowel cleansing composition

Abstract

The present invention relates to a bowel cleansing preparation comprising, as a first cleansing ingredient, a certain sugar alcohol such as xylitol and sorbitol; as a second cleansing ingredient, ascorbic acid or a mixture of ascorbic acid and a salt of ascorbic acid; and aqueous solvent, wherein the concentration of said first cleansing ingredient is 10 g / L to 500 g / L based on the total preparation, the concentration of said second cleansing ingredient is 15 g / L to 500 g / L based on the total preparation, and the volume of said aqueous solvent is 0.1 L to 1.0 L. The bowel cleansing preparation has excellent cleansing efficacy, improved ease of administration and safety and can thus be used for bowel preparation prior to colonoscopy, therapeutic endoscopy, abdominal surgery and anal surgery for hemorrhoid as well as for the treatment and alleviation of diseases such as chronic and acute constipation.

Description

FIELD OF THE INVENTION[0001]The present invention relates to a bowel cleansing preparation. More particularly, the present invention relates to a novel bowel cleansing preparation comprising high concentrations of a specific sugar alcohol and ascorbic acid so as to improve the ease of administration by reducing the total dosage and yet improve bowel cleansing efficacy while ensuring safety.BACKGROUND OF THE INVENTION[0002]According to the reports from the World Cancer Research Fund International, colon cancer is the third most common cancer worldwide with incidences of colon cancer during the year 2012 estimated to be 1.4 million worldwide and expected to be 2.4 million in the year 2035. For the diagnosis of colon cancer, colonoscopy is essential. Moreover, colonoscopy is very important because colon cancer can be prevented if colon polyps, which are considered to be the source of colon cancer, are detected during colonoscopy and removed.[0003]For accurate colonoscopy examination, b...

AI Technical Summary

Benefits of technology

The present invention aims to provide a new bowel cleansing preparation with improved efficiency, ease of administration, safety, and economical mass production and commercialization. The new preparation has been designed to overcome the problems of the prior art, such as the requirement for a large volume of liquid and the discomfort experienced during the process. The goal is to make bowel cleansing more accessible and tolerable for patients while still providing exceptional results.

Problems solved by technology

If too much residue remains after bowel cleansing, it is difficult to perform an accurate examination, and the poor visualization increases the risk of complications such as perforation, and sometimes the painful bowel preparation has to be repeated, which might result in the patient's refusal or avoidance of the examination.

Secondly, the ease of administration is determined by the volume of the bowel cleansing preparation to be ingested, the taste of the preparation, and the occurrence of discomforts such as nausea, vomiting, and abdominal pain following the ingestion of the preparation.

Even if a bowel cleansing preparation has excellent cleansing power, if its administration is difficult, one cannot successfully complete the intake process in accordance with the dosing regimen, resulting in inadequate bowel cleansing.

In addition, the unpleasant experience with bowel cleansing often leads to the refusal of repeat examination, and rumors about the difficulties of administration may impede the popularization of colonoscopies harming public health.

However, administration of such cleansing preparations was accompanied by a great deal of pain and difficulties.

Bowel cleansing preparations with sorbitol have also been considered to be inappropriate in most advanced countries including the U.S. and Europe due to similar risks.

Such inadequate cleansing by PEG formulations has been demonstrated by a number of published studies.

Problems with PEG formulations that are more serious than the unsatisfactory bowel cleansing efficacy include the very large volume (up to 4 L) of the formulations to be ingested, and the difficulty of ingestion due to the unpleasant taste of the PEG formulations.

Such difficulty of ingestion gave rise to the wide-spread negative perception of bowel preparation, which has lead people to fear or avoid colonoscopies.

Although research has been indicating that phosphate preparations are less difficult to ingest and their cleansing efficacy also compares similarly or favorably to the PEG formulations, persistent concerns regarding the risk of renal injury have been a big obstacle for their utilization.

However, the biggest problem with picosulfate preparations lies in its relatively poor bowel cleansing efficacy.

Partly because of this problem, picosulfate preparations are not widely used in the U.S. and Canada.

However, the preparation has a problem in that the total volume of ingestion amounts to 3.45 L according to its recommended dosing instruction and its cleansing efficacy is relatively poor despite the incorporation of magnesium citrate.

As shown above, known bowel cleansing preparations have serious problems such as excessively large volumes of ingestion, difficulties in administration due to unpalatable taste, risks of substantial adverse effects such as renal disorders, causing the production of combustible colonic gases, and poor cleansing efficacy which is an essential element of a bowel cleansing preparation.

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