Chlorhexidine Antimicrobial Composition Stabilization

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Solution Overview

Problem

Chlorhexidine gluconate solutions are prone to spontaneous calcium gluconate crystallization when formulated with high alcohol levels, leading to the formation of glass-like crystals, which is undesirable while maintaining antimicrobial potency.

Innovation Solution

Incorporating a chelating agent, such as a polyanionic chelating agent with a high formation constant with calcium, into the chlorhexidine antimicrobial composition to inhibit or reverse crystal formation, along with a chlorhexidine-soluble solvent and a chlorhexidine-insoluble solvent, particularly a C2-C5 lower alcohol, to stabilize the solution.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If high levels of alcohol solvent (C2-C5) are used in chlorhexidine gluconate solution, then the antimicrobial potency is enhanced, but calcium gluconate crystallization occurs forming glass-like crystals

Engineering Contradiction:

Improveantimicrobial potencyVSAvoidsolution stability

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

A chelating agent is introduced as an intermediary substance that binds calcium ions, preventing them from reacting with gluconate to form crystals. The chelating agent mediates between the calcium present in the solution and the gluconate, maintaining solution stability while allowing high alcohol content for antimicrobial efficacy.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the chemical parameters of the solution by adding a chelating agent that alters the calcium-gluconate interaction. This parameter change prevents crystallization while maintaining the high alcohol content necessary for antimicrobial potency, thus resolving the contradiction between reliability and stability.

Inventive Principle:

Principle #35Parameter changes

2Productivity

If chlorhexidine gluconate is formulated with high alcohol content, then antimicrobial efficacy is improved, but the solution becomes susceptible to spontaneous crystal formation

Engineering Contradiction:

Improveantimicrobial efficacyVSAvoidcrystal formation

Core Design Contradiction:

ProductivityVSObject-generated harmful factors

Solution Approach 1:

The chelating agent serves as a mediator that interferes with the harmful crystallization process. It binds calcium ions before they can form crystals with gluconate, thereby eliminating the harmful effect while preserving the beneficial high alcohol content for antimicrobial efficacy.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent converts the potential harm of calcium-gluconate crystallization into a benefit by using the chelating agent to control calcium binding. The chelating agent transforms the problematic calcium ions into beneficial components that do not interfere with antimicrobial efficacy while preventing crystal formation.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

3Reliability

If chlorhexidine gluconate solution is made with high solvent content, then the solution stability is compromised, but the antimicrobial potency is maintained

Engineering Contradiction:

Improveantimicrobial potencyVSAvoidcalcium gluconate crystallization

Core Design Contradiction:

ReliabilityVSLoss of substance

Solution Approach 1:

The chelating agent acts as an intermediary that prevents the loss of calcium gluconate through crystallization. It binds calcium ions in solution, keeping them dissolved and preventing precipitation, thus maintaining the integrity of the formulation while allowing high solvent content for antimicrobial efficacy.

Inventive Principle:

Principle #24Intermediary (Mediator)

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 addition of a chelating agent effectively prevents or reverses calcium gluconate crystal formation, maintaining the antimicrobial efficacy and stability of the chlorhexidine solution without affecting its potency.

Implementation Method 1

The disclosed chlorhexidine antimicrobial composition includes a chelating agent to inhibit formation of this salt or reverse crystal formation

Methodology Applied

Scientific EffectChelation:

Data Source

PatentUS20210299068A1Antimicrobial compositions comprising chlorhexidine

Publication Date: 2021.09.30 SOLVENTUM INTELLECTUAL PROPERTIES CO

AI summary

Chlorhexidine gluconate is a commonly used disinfectant that is soluble in aqueous solutions. Because it is a common disinfectant, chlorhexidine gluconate is often used in alcohol solvents, but chlorhexidine gluconate is not soluble in C2-05 alcohol solvents. Also, a chlorhexidine gluconate containing solution can be susceptible to spontaneous calcium gluconate crystallization when formulated with high levels of solvent such as alcohol. These calcium gluconate crystals appear like glass shards. It is desirable to inhibit the formation of these crystals without affecting the antimicrobial potency of the solution. The disclosed chlorhexidine antimicrobial composition includes a chelating agent to inhibit formation of this salt or reverse crystal formation.