Bowel cleansing composition

a technology of bowel cleansing and composition, applied in the direction of drug compositions, antibacterial agents, aerosol delivery, etc., can solve the problems of patient's refusal or avoiding examination, inadequate bowel cleansing, refusal of repeat examination, etc., to achieve superior cleansing effect, enhance administration and compliance, and reduce volume

Inactive Publication Date: 2015-12-03
KANG YOON SIK +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0022]By combining specific concentrations of a sugar alcohol and ascorbic acid, the bowel cleansing preparation of the present invention displays superior cleansing efficacy despite a greatly reduced volume being consumed compared with existing bowel cleansing preparations. The bowel cleansing preparation of the present invention also greatly enhances the ease of administration and compliance by significantly reducing the volume of ingestion. In addition, the bowel cleansing preparation of the present invention improves patient discomfort by causing no or minimal discomforts such as nausea, abdominal pain and vomiting during its consumption, and is safe in that it does not cause severe adverse effects such as chronic disorders or electrolyte abnormalities.
[0023]In addition, by combining specific concentrations of a sugar alcohol and ascorbic acid, the present invention achieves superior cleansing efficacy and antibacterial effect relative to the volume of the consumed fluid, eliminating the risk of production of combustible gases in the colon after bowel cleansing preparation ensuring safety in the human body.
[0024]The most stressful part ab

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 se

Method used

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  • Bowel cleansing composition
  • Bowel cleansing composition
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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0086]In 100 mL of carbonated water as solvent, 46 g of ascorbic acid, 2 g of calcium ascorbate, 40 g of sorbitol, 10 mg of bisacodyl, 1.5 g of citric acid, 33.5 mg of docusate sodium, 20 mg of caffeine, 100 mg of pectin, 30 mg of zinc oxide, 300 mg of simethicone, 1.5 g of sodium bicarbonate, 2 g of potassium bicarbonate, and 35 mg of sucralose were mixed to form 150 ml of a highly concentrated solution, and 350 ml of carbonated water was used as a separate vehicle to prepare a two-part bowel cleansing preparation.

[0087]Mixing was conducted by mixing all the ingredients in powder form at the same time and then pouring carbonated water to dissolve them. Caution is needed because a large amount of carbon dioxide (CO2) gas generated by the neutralization reaction between the acidic ascorbic acid and citric acid and basic bicarbonate salt causes extensive foaming Preparing a 1:10 diluted solution of Gasocol® containing the anti-foaming agent simethicone beforehand and adding it suitabl...

example 2

[0089]In 100 mL of bottled water as solvent, 30 g of ascorbic acid, 60 g of xylitol, 10 mg of bisacodyl, 1.5 g of citric acid, 300 mg of simethicone, 5 g of potassium bicarbonate, and 35 mg of sucralose were mixed to form 150 ml of a highly concentrated solution, and 350 ml of bottled water was used as a separate vehicle to prepare a two-part bowel cleansing preparation. Mixing of the ingredients was conducted in the same manner as in Example 1.

reference examples 1 to 6

[0090]For in vitro tests to assess the safety of sugar alcohols used as a first cleansing ingredient in the present invention, Reference Examples 1 to 6 were prepared for comparison with the solution of Example 1.

[0091]Reference Examples 1 to 6 refer to a COLYTE solution, a PICOLIGHT solution, a CoolPrep solution, a sorbitol (100 g / L) solution, a mannitol (100 g / L) solution, and a 12% xylitol (120 g / L) solution, respectively, with the COLYTE solution, PICOLIGHT solution, CoolPrep solution prepared by diluting the respective active ingredients in bottled water according to the manufacturer's instructions such that the concentration of each active ingredient is the same as its concentration used in the bowel preparation.

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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...

Claims

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Application Information

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IPC IPC(8): A61K31/4402A23L2/52A61K31/047A61K9/00A61K45/06A61K31/375
CPCA61K31/4402A61K45/06A61K31/375A23V2002/00A61K9/0095A23L2/52A61K31/047A61P1/00A61P1/04A61P1/08A61P1/10A61P29/00A61P31/04A61P43/00A61K2300/00A61K31/045
Inventor KANG, YOON SIKSHIN, CHUNG YOONKANG, HYUN SUKKANG, HYUN YEE
Owner KANG YOON SIK
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