Bowel Preparation Composition Using Non-Fermentable Sugar Alcohols

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Solution Overview

Problem

Current bowel preparation solutions for colonoscopy face challenges in maintaining electrolyte balance, avoiding sugar-induced fermentation, and minimizing side effects such as headaches, while ensuring effective bowel cleansing and patient compliance.

Innovation Solution

A composition comprising bisoxatin, erythritol, and pharmaceutically acceptable salts like sodium phosphate and sulfate, which are designed to be administered in a split protocol to enhance purgative action, maintain electrolyte homeostasis, and reduce fermentation risks, thereby improving bowel cleansing and patient tolerance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional sugars (glucose, sucrose, fructose, lactose, maltose) are used in bowel preparation solutions, then electrolyte co-transportation and fluid absorption are improved, but sugar fermentation by colonic bacteria produces combustible gases that pose explosion risks during electro-cautery procedures

Engineering Contradiction:
Improveelectrolyte balance maintenanceVSAvoidexplosion risk from gas fermentation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts and removes the harmful fermentable sugar components from the bowel preparation solution, replacing them with non-fermentable alternatives. Specifically, conventional sugars that undergo bacterial fermentation are eliminated and substituted with sugar alcohols like sorbitol, mannitol, or xylitol, which do not produce combustible gases through fermentation, thereby eliminating the explosion risk while maintaining electrolyte transport function

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent combines multiple functional components into a single safe formulation: non-fermentable sugar alcohols provide both the osmotic purgative effect and the co-transportation mechanism for electrolyte absorption, while simultaneously eliminating fermentation byproducts. The formulation merges electrolytes (sodium, potassium, magnesium, calcium), non-fermentable carbohydrates, and buffering agents into an integrated solution that achieves electrolyte balance without generating combustible gases

Inventive Principle:
Principle #5Merging (Combining)

2Productivity

If high volumes of conventional bowel preparation solutions are administered to ensure effective cleansing, then bowel cleaning efficacy is improved, but patient tolerance deteriorates due to increased side effects and discomfort

Engineering Contradiction:
Improvebowel cleansing efficacyVSAvoidpatient compliance and tolerance
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The patent changes the chemical parameters of the bowel preparation solution by replacing fermentable sugars with non-fermentable sugar alcohols and optimizing electrolyte concentrations. This parameter modification allows for reduced solution volume while maintaining effective purgative action, as the non-fermentable carbohydrates provide sustained osmotic effect without the discomfort of gas production, thereby improving patient tolerance and compliance

Inventive Principle:
Principle #35Parameter changes

3Reliability

If minimally degradable carbohydrates are added to facilitate sodium-glucose transport and reduce electrolyte loss, then electrolyte balance is improved, but the risk of fermentation and gas production increases

Engineering Contradiction:
Improveelectrolyte homeostasisVSAvoidfermentation products and gas
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent employs sugar alcohols (sorbitol, mannitol, xylitol) as temporary, non-fermentable carbohydrate substitutes that perform the essential function of co-transporting electrolytes through the small intestine but are not degraded by colonic bacteria. These substances are effectively 'disposable' in the sense that they fulfill their transport function and are excreted without undergoing harmful fermentation, thus providing electrolyte balance without generating gas

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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 effectively cleanses the bowel, reduces side effects like headaches, and improves patient compliance by maintaining electrolyte balance and avoiding sugar-induced fermentation, resulting in superior bowel preparation compared to existing products.

Implementation Method 1

most oral rehydration solutions rely on glucose for co-transportation of electrolytes across the brush border of the small bowel utilizing the GLUT1 transport mechanism

Methodology Applied
Scientific EffectCo-transportation:

Implementation Method 2

compositions comprising: (a) a stimulant purgative agent, optionally in combination with (b) a hyperosmotic purgative agent

Methodology Applied
Scientific EffectStimulatory purgative action:

Implementation Method 3

maintaining fluid and electrolyte homeostasis in the patient

Methodology Applied
Scientific EffectOsmotic pressure: Osmotic Pressure

Data Source

PatentEP2651415B1Gastric and colonic formulations and methods for making and using them
Publication Date: 2020.10.07 RITE PREP PTY LTD
  • EP2651415B1 patent drawing
  • EP2651415B1 patent drawing
  • EP2651415B1 patent drawing

AI summary

In alternative embodiments, the invention provides compositions, e.g., formulations, used for gastric, gastrointestinal and/or colonic treatments or lavage, e.g., orthostatic lavage, e.g., for inducing the purgation (e.g., cleansing) of a gastrointestinal (GI) tract, including a colon; and methods for making and using them. In alternative embodiments, compositions and methods of the invention are used for the amelioration, treatment and/or prevention of constipation, for the treatment of abdominal pain, particularly non-specific abdominal pain, and diarrhea, including diarrhea caused by a drug side effect, a psychological condition, a disease or a condition such as Crohn's Disease, a poison, a toxin or an infection, e.g., a toxin-mediated traveler's diarrhea. In alternative embodiments, the invention provides pharmaceuticals and products (articles) of manufacture for delivering these compositions and formulations to an individual, e.g., a human or an animal.