Ophthalmic Dye Composition Stabilized by Polyol for Autoclave Sterilization

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Solution Overview

Problem

Current ophthalmic dye compositions used for diagnostic and therapeutic purposes are toxic to cellular tissues, unstable over time, and cannot be effectively sterilized, posing challenges for safe and long-term use in clinical applications.

Innovation Solution

A stable ophthalmic coloring composition comprising a dye and a water-soluble polyol in an aqueous solution, which is compatible with autoclave sterilization and maintains physiological pH and osmolarity, reducing cytotoxicity while preserving the dye's coloring power, using polyols like mannitol to enhance stability and safety.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If glucose is added to densify the composition, then the composition can be sterilized, but the composition becomes unstable at autoclave sterilization temperatures and degrades over time

Engineering Contradiction:
Improvesterilization capabilityVSAvoidcomposition stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent changes the chemical parameter of the stabilizing agent from glucose to polyol (such as mannitol, sorbitol, or xylitol). This parameter change allows the composition to withstand autoclave sterilization temperatures while maintaining long-term stability at room temperature, resolving the contradiction between sterilization capability and composition stability.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If PEG is added to reduce toxicity, then the toxicity of the dye is reduced, but the composition contains residual ethylene oxide which is highly toxic and the polymer promotes diffusion under the retina

Engineering Contradiction:
Improvedye toxicityVSAvoidethylene oxide residue and surfactant effect
Core Design Contradiction:
Object-affected harmful factorsVSObject-generated harmful factors

Solution Approach 1:

The patent extracts and removes PEG from the composition and replaces it with polyol. This elimination of the harmful substance (PEG) that contains toxic ethylene oxide residues and exhibits surfactant properties, while retaining the toxicity-reducing benefit, resolves the contradiction between reducing dye toxicity and avoiding new harmful factors.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses simple, small-molecule polyols (mannitol, sorbitol, xylitol) instead of complex polymers like PEG. These simpler compounds are completely metabolizable, leave no toxic residues, and do not exhibit surfactant properties, thereby eliminating the harmful effects associated with PEG while maintaining the desired toxicity-reducing effect.

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

3Stability of the object's composition

If the composition is made stable for long-term storage, then the dye degrades less over time, but the composition cannot be effectively sterilized

Engineering Contradiction:
Improvelong-term stabilityVSAvoidsterilization capability
Core Design Contradiction:
Stability of the object's compositionVSReliability

Solution Approach 1:

The patent changes the chemical nature of the stabilizing agent from glucose to polyol, which has different thermal and chemical properties. This parameter change enables the composition to maintain stability during autoclave sterilization and long-term storage while remaining sterilizable, resolving the contradiction between long-term stability and sterilization capability.

Inventive Principle:
Principle #35Parameter changes

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 is stable for several months at room temperature, non-toxic, and suitable for use in ophthalmic surgeries and diagnostics, with reduced cytotoxicity and maintained dye properties, allowing for safe and effective selective coloring of ophthalmic tissues.

Implementation Method 1

The composition is stable for several months at room temperature, non-toxic, and suitable for use in ophthalmic surgeries and diagnostics, with reduced cytotoxicity and maintained dye properties

Methodology Applied
Scientific EffectStabilization:

Implementation Method 2

A stable ophthalmic coloring composition comprising a dye and a water-soluble polyol in an aqueous solution, which is compatible with autoclave sterilization

Methodology Applied
Scientific EffectSterilization:

Implementation Method 3

reducing cytotoxicity while preserving the dye's coloring power, using polyols like mannitol to enhance stability and safety

Methodology Applied
Scientific EffectToxicity reduction:

Data Source

PatentEP2758042B1Stable, low-toxicity, sterilizable composition for ophthalmic dying
Publication Date: 2016.08.17 ARCADOPHTA SARL

AI summary

The invention relates to a stable composition for ophthalmic dying, suitable for sterilization in an autoclave, comprising the following in an aqueous solution: - at least a dye, - at least a water-soluble polyol with formula H(HCOH)nH, where n is a whole number greater than 3, for use in either of the two following methods: an ophthalmic surgical treatment method and a diagnosis method.