Soluble Binder Colonic Purgative Tablets for Colonoscopy

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Solution Overview

Problem

Current colonic purgative formulations often cause discomfort and adverse side effects, such as nausea and bloating, due to high volume requirements and the presence of insoluble binders like microcrystalline cellulose, which impede visualization of the colon during procedures like colonoscopy.

Innovation Solution

A solid dosage form colonic purgative formulation comprising a soluble, nonfermentable binder like polyethylene glycol and osmotic or non-osmotic purgatives, with minimal or no insoluble binder to enhance patient tolerance and visualization of the colon.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If insoluble binder like microcrystalline cellulose is used in tablet formulation, then tablet structural integrity is improved, but visualization of the colon during colonoscopy deteriorates due to visible residue

Engineering Contradiction:
Improvetablet structural integrityVSAvoidcolon visualization quality
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent removes insoluble binders (microcrystalline cellulose) from the tablet formulation and replaces them with soluble binders (polyethylene glycol, starch, dextrin). This extraction of the harmful component eliminates the white powdery residue that impairs colon visualization during colonoscopy, while maintaining tablet structural integrity through the soluble binder system.

Inventive Principle:
Principle #2Taking out (Extraction)

2Reliability

If high volume of polyethylene glycol-electrolyte solution is administered, then complete bowel cleansing is achieved, but patient tolerance deteriorates due to nausea, cramping, and vomiting

Engineering Contradiction:
Improvebowel cleansing effectivenessVSAvoidpatient adverse side effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the physical form parameter from liquid solution to solid tablet dosage. This transformation allows the same polyethylene glycol-electrolyte components to be administered in a much smaller volume (tablets vs. liters of liquid), thereby achieving complete bowel cleansing while eliminating volume-related adverse effects such as nausea, cramping, and vomiting.

Inventive Principle:
Principle #35Parameter changes

3Volume of moving object

If phosphate salt solution is used to reduce volume, then patient volume discomfort is reduced, but adverse side effects such as nausea and vomiting remain frequent due to unpalatable taste

Engineering Contradiction:
Improvepreparation volumeVSAvoidpatient adverse side effects
Core Design Contradiction:
Volume of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent changes the administration form from liquid solution to solid tablet, which eliminates the taste problem entirely. The tablets contain the same phosphate salt or polyethylene glycol-electrolyte components but in a form that does not require ingestion of large volumes of unpalatable liquid, thereby reducing both volume discomfort and taste-related adverse effects.

Inventive Principle:
Principle #35Parameter changes

4Ease of manufacture

If microcrystalline cellulose is used as binder, then tablet manufacturing is simplified, but additional removal steps are required during colonoscopy procedure

Engineering Contradiction:
Improvetablet manufacturing simplicityVSAvoidcolonoscopy procedure time
Core Design Contradiction:
Ease of manufactureVSLoss of time

Solution Approach 1:

The patent removes microcrystalline cellulose from the formulation and replaces it with soluble binders. This extraction eliminates the need for additional suctioning or irrigation steps during colonoscopy that would be required to remove visible MCC residue, thereby simplifying the manufacturing requirements while reducing procedure time and improving productivity.

Inventive Principle:
Principle #2Taking out (Extraction)

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 formulation improves patient tolerance and visualization of the colon by reducing residue and side effects, allowing for effective bowel preparation without the need for additional removal steps, and can function as both a laxative and complete purgative depending on dosage.

Implementation Method 1

The binder may be nonfermentable in certain embodiments of the invention. In one embodiment of the invention, the binder is soluble in the alimentary fluid.

Methodology Applied
Scientific EffectSolubility:

Implementation Method 2

The phosphate salt solution produces an osmotic effect, causing large amounts of water to be drawn into the bowel, thereby promoting bowel evacuation.

Methodology Applied
Scientific EffectOsmosis: Osmosis

Implementation Method 3

at least one purgative... used to treat constipation and promote fecal elimination

Methodology Applied
Scientific EffectPeristalsis: Peristalsis

Data Source

PatentUS7687075B2Colonic purgative composition with soluble binding agent
Publication Date: 2010.03.30 SALIX PHARMA INC
  • US7687075B2 patent drawing
  • US7687075B2 patent drawing
  • US7687075B2 patent drawing

AI summary

This invention relates to novel colonic purgative compositions in a solid dosage form, comprising at least one purgative and at least one soluble, or soluble, nonfermentable binder, such as polyethylene glycol. Further, this invention relates to methods of using the colonic purgative compositions. The present compositions and methods are designed to improve patient tolerance and compliance, while at the same time improving the quality of bowel cleansing. The formulations and methods of this invention are particularly useful to cleanse the bowel prior to diagnostic and surgical procedures and can also be employed in lower dosages as a laxative to promote elimination and/or to relieve constipation.