GRAS Bowel Cleansing Composition to Reduce Stool and Foam
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Solution Overview
Problem
Conventional bowel cleansing methods using water and PEG-based solutions are inadequate, leading to residual stool, secretions, and foam during endoscopic procedures, which hinder visualization and result in suboptimal examinations, and existing solutions like simethicone pose safety risks due to non-GRAS ingredients.
Innovation Solution
A bowel cleansing chemical composition comprising GRAS-listed ingredients, including PEG 3350, sodium docusate, and simethicone, is used to effectively clean the gastrointestinal tract during endoscopic procedures, reducing foam and ensuring safety by avoiding non-GRAS components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional water-based cleansing methods are used, then the procedure is simple and safe, but residual stool and secretions remain that hinder visualization
Solution Approach 1:
The patent applies composite materials by combining multiple GRAS-listed ingredients (PEG 3350, sodium docusate, simethicone, and water) to create a bowel cleansing composition that achieves superior visualization quality. Each component contributes specific properties: PEG 3350 provides osmotic cleansing, sodium docusate acts as a surfactant to reduce surface tension and remove secretions, and simethicone eliminates foam. This composite formulation resolves the contradiction by delivering reliable visualization without requiring complex external devices or procedures.
2Reliability
If PEG-based solutions are used, then cleansing effectiveness improves, but foam formation increases that obstructs view
Solution Approach 1:
The patent uses simethicone as an intermediary substance that specifically addresses foam formation without interfering with the cleansing action of PEG 3350. Simethicone acts as a defoaming agent that breaks down surface tension of foam bubbles, allowing gas to escape and eliminating the obstructive foam layer. This intermediary component resolves the contradiction by neutralizing the harmful foam effect while preserving the beneficial cleansing effectiveness of the PEG-based solution.
3Object-generated harmful factors
If simethicone is added to conventional solutions, then foam is reduced, but safety risks increase due to non-GRAS ingredients
Solution Approach 1:
The patent applies parameter changes by carefully controlling the concentration of simethicone within GRAS-approved limits and combining it with other GRAS-listed ingredients. By adjusting the formulation parameters (concentrations of PEG 3350, sodium docusate, and simethicone) to fall within established safety thresholds, the composition achieves effective foam reduction while maintaining a safe profile. This resolves the contradiction by modifying the concentration parameters to simultaneously achieve foam control and safety compliance.
4Reliability
If multiple cleansing agents are combined, then cleaning efficacy improves, but risk of bacterial growth increases
Solution Approach 1:
The patent adopts a disposable approach by formulating a single-use bowel cleansing composition that is administered orally and eliminated naturally. The composition is designed to be used once per procedure, eliminating the need for repeated applications or prolonged presence in the system. This disposable nature reduces bacterial growth risk because the composition is not retained or reused, while still achieving superior cleaning efficacy through the combined action of its GRAS-listed ingredients during the single use.
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 composition provides superior cleaning efficacy, reducing adherence of stool and foam, enhancing visualization, and minimizing the risk of bacterial growth, thereby improving the quality and safety of endoscopic examinations.
Implementation Method 1
PEG 3350 (polyethylene glycol 3350), a well-known bowel cleansing agent
Implementation Method 2
sodium docusate, a surfactant
Implementation Method 3
simethicone, which is an anti-foaming agent
Data Source
AI summary
A GRAS list chemical composition (containing only GRAS list approved ingredients) including a water-based bowel cleansing solution (either in concentrate form or diluted form) to clean a gastrointestinal (GI) tract before and/or during performance of an endoscopy procedure such as a colonoscopy, enteroscopy, upper gastrointestinal endoscopy, and small bowel capsule endoscopy, for example. The GRAS list bowel cleansing chemical composition includes at least one of a chemical composition as a liquid, tablet or powder concentrate that can be added to sterile water or other solution by the end-user to make the chemical composition solution; and a pre-mixed chemical composition solution diluted in up to 1000 ml of sterile water.