Bowel cleansing composition

Abstract

A bowel cleansing composition includes as a first cleansing ingredient, a specific sugar alcohol such as xylitol, sorbitol, etc., as a second cleansing ingredient glycerol, erythritol, threitol, arabitol, ribitol, mannitol, galactitol, fucitol, iditol, inositol, volemitol, isomalt, maltitol, lactitol, maltotriitol, maltotetraitol, and polyglycitol, as a second cleansing ingredient ascorbic acid or a mixture of ascorbic acid and a salt of ascorbic acid, as a third cleansing ingredient picosulfate, and an aqueous solvent, wherein the concentration of the first cleansing ingredient is 10 g / L to 500 g / L based on the total composition, the concentration of the second cleansing ingredient is 15 g / L to 500 g / L based on the total composition, the concentration of the third cleansing ingredient is 1 mg / L to 100 mg / L based on the total composition, and the volume of the aqueous solvent is 0.1 L to 1.0 L.

Description

FIELD OF THE INVENTION[0001]The present invention relates to a bowel cleansing composition. More specifically, the present invention relates to a novel bowel cleansing composition comprising high concentrations of a specific sugar alcohol and ascorbic acid in addition to picosulfate that is a laxative agent 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 precursor of colon cancer, are detected during colonoscopy an...

AI Technical Summary

Benefits of technology

[0018]In order to solve the problems in the prior art described above, the present invention has the objective of providing a novel bowel cleansing composition that is equipped not only with excellent cleansing efficacy to greatly improve the proportion of adequate bowel preparation that is still at about 70% at most but also with ease of administration owing to the improved taste as well as safety for the human body.

[0019]The present invention has another objective of providing a novel bowel cleansing composition which allows for economical mass production and commercialization.

Problems solved by technology

Firstly, high cleansing power is an essential requirement for an accurate colonoscopy procedure.

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 procedure 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 agent to be ingested, the taste of the agent, and the occurrence of discomforts such as nausea, vomiting, and abdominal pain following the ingestion of the agent.

Even if a bowel cleansing agent 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.

The most serious problems with PEG preparations were their very large volume amounting to 4 L and difficulties of ingestion due to their disgusting taste.

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

In addition to such difficulties of ingestion, PEG preparations have not achieved satisfactory bowel cleansing power.

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

For that reason, picosulfate preparations are most commonly used in Europe, but their relatively poor bowel cleansing power is the biggest problem with these preparations.

The recommended regimen for Ferring's Prepopik® (sodium picosulfate, magenisum oxide, and anhydrous citric acid) approved by the U.S. FDA indicates the total volume of ingestion amounting to 2.22 L, and according to actual use of this preparation it has been found to be problematic due to its relatively poor cleansing power compared to PEG solutions.

Moreover, picosulfate-containing bowel cleansing agents do not contain electrolytes and thus they rarely cause hyponatremia or hypopotassemia due to overdose, but severe side effects such as spasm, etc., have been reported.

Due to the incorporation of magnesium into this preparation, hypermagenesemia may occur, and thus patients with renal disorders are banned from using the preparation.

Thus, picosulfate-containing bowel cleansing agents developed for solving the ingestion difficulties with PEG preparations have improved compliance but show poor bowel cleansing efficacy.

Consequently, patients still have to ingest large amounts ranging from 2.3 L to 3.5 L, and there exist problems of electrolyte abnormalities and hypermagenesemia.

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