PEG Bowel Cleansing Composition Reducing Volume and Gas
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Solution Overview
Problem
Current bowel cleansing solutions for colon procedures are often ineffective due to high volume requirements, poor palatability, and associated risks such as dehydration and electrolyte imbalances, leading to inadequate cleansing and patient discomfort.
Innovation Solution
A dry composition for reconstitution in water, comprising polyethylene glycol (PEG), sodium sulphate, citric acid, sodium citrate, sodium chloride, potassium chloride, and simethicone, which when reconstituted, provides a low-volume, effective bowel cleansing solution with improved palatability and cathartic effect, potentially reducing the volume needed from 4 liters to 2 liters while maintaining equivalent cleansing efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high volume solutions (7-12 litres) are used for bowel cleansing, then adequate cleansing is achieved, but water retention and gas production occur
Solution Approach 1:
The patent changes the chemical composition parameters of the cleansing solution by incorporating non-absorbable sugars (mannitol, sorbitol, xylitol) in specific concentrations (5-20g/L each) alongside PEG 3350 (20-40g/L). This parameter modification allows achieving adequate bowel cleansing with reduced volume (2-4 litres) while minimizing water retention and gas production through the synergistic osmotic effect of multiple agents.
2Productivity
If hyperosmotic saline laxatives are used, then cathartic effect is achieved, but dehydration and electrolyte imbalances occur
Solution Approach 1:
The patent creates a composite cleansing solution combining PEG 3350 (macrogol) with multiple non-absorbable sugars (mannitol, sorbitol, xylitol) and optional electrolytes. This composite formulation produces a milder osmotic cathartic effect compared to hyperosmotic saline alone, reducing the risk of dehydration and electrolyte imbalances while maintaining effective bowel cleansing capability.
3Reliability
If four litres of PEG-based formulation are administered, then adequate bowel preparation is achieved, but poor palatability and large volume remain issues
Solution Approach 1:
The patent modifies the solution composition by adding non-absorbable sugars that enhance the cathartic effect per unit volume, allowing reduction of total administered volume from 4 litres to 2-4 litres. The inclusion of flavorings and the specific sugar composition improves palatability, directly addressing patient compliance issues while maintaining preparation adequacy.
4Reliability
If 10-15% of patients do not complete preparation due to poor palatability and large volume, then inadequate cleansing occurs, but repeating the procedure increases discomfort
Solution Approach 1:
The patent optimizes the concentration parameters of PEG 3350 (20-40g/L) combined with non-absorbable sugars (5-20g/L each) to achieve effective cleansing with reduced volume (2-4 litres). This parameter optimization improves palatability and reduces the burden of ingestion, thereby increasing completion rates and reducing the need for repeated procedures.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution achieves satisfactory bowel cleansing with reduced volume, improved patient compliance, and enhanced palatability, ensuring effective removal of solid residuals and intestinal wall cleansing, while minimizing fluid and electrolyte absorption, thus reducing procedural complications and discomfort.
Implementation Method 1
a polyethylene glycol (PEG) based solution was first described by the Fordtran's group in '80 (WO87/00754 and Davis GR, Santa Ana CA, Morawski SG, Fordtran JS. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology 1980; 78: 991-5). This formulation has the advantage of being poorly absorbed during gut transit and thus avoiding retention or loss of fluids and electrolytes from the body.
Implementation Method 2
EP 1 567 193 - B1 describes a composition comprising, per litre of aqueous solution, from 30 to 350 g polyethylene glycol, from 3 to 20 g of an ascorbic acid component selected from the group consisting of ascorbic acid, a salt of ascorbic acid, or a mixture thereof, an alkali metal or alkaline earth metal sulphate, preferably from 1 to 15 g thereof, and optionally one or more electrolytes selected from sodium chloride, potassium chloride, and sodium hydrogen carbonate
Implementation Method 3
a variant of Fordtran's preparation with in addition simethicone has been proposed (Shaver WA, Storms P, Peterson WL. Improvement of oral colonic lavage with supplemental simethicone. Dig Dis Sci 1988;33(2):185-8)
Implementation Method 4
WO-A2009/ 052256 discloses a dry powder composition for reconstitution with water used for bowel cleansing comprising PEG3350, sodium sulphate, sodium chloride, potassium chloride, simethicone as well as aspartame, acesulfam potassium and lemon flavoring
Data Source
AI summary
The present invention relates to a dry composition for reconstitution in water comprising polyethylene glycol (PEG), optionally sodium sulphate, citric acid, sodium citrate, sodium chloride, potassium chloride, simethicone, effective for bowel cleansing, in particular of colon, prior to diagnostic, surgical or therapeutical procedures, in particular colonoscopy.