Chlorhexidine Disinfectant Stability with Anionic Dye
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Solution Overview
Problem
Existing chlorhexidine compositions for skin and instrument disinfection lack stability and visibility under operating room lights, often forming precipitates or reducing antibacterial effectiveness when combined with anionic dyes, and may pose health risks due to the use of cationic dyes or allergens.
Innovation Solution
A stable hydroalcoholic composition of chlorhexidine digluconate with disodium eosin as an anionic dye, which does not require additional cationic compounds, providing visible red coloring under natural or UV light without compromising antibacterial efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If anionic dyes are added to chlorhexidine solutions to improve visibility, then the solution becomes colored and visible, but the solution forms precipitates and loses stability
Solution Approach 1:
The patent changes the chemical parameters by selecting specific anionic dyes (Eosin Y, Sunset Yellow, Allura Red) with particular molecular structures and charges that are compatible with chlorhexidine digluconate. The dye-to-chlorhexidine molar ratio is optimized to 1:10 to 1:50, which prevents precipitate formation while maintaining visibility and stability of the solution.
2Ease of manufacture
If cationic dyes are used to color chlorhexidine solutions, then visibility is improved, but health risks increase due to carcinogenicity and allergenicity
Solution Approach 1:
The patent employs food-grade anionic dyes (Eosin Y, Sunset Yellow, Allura Red) that are approved for use in food and cosmetics, making them safe for brief contact with skin during surgical preparation. These dyes are non-carcinogenic and non-allergenic, replacing hazardous cationic dyes while maintaining visibility functions.
3Ease of manufacture
If colored dyes are added to chlorhexidine solutions, then visibility of disinfected areas is improved, but antibacterial effectiveness is reduced
Solution Approach 1:
The patent optimizes the concentration parameters by limiting the dye concentration to 0.01-0.5% w/v and maintaining specific molar ratios (1:10 to 1:50 of dye to chlorhexidine). This ensures the dye provides sufficient coloration without interfering with the antibacterial mechanism of chlorhexidine digluconate.
4Stability of the object's composition
If single-use applicators are used to mix dyes and chlorhexidine extemporaneously, then solution stability is maintained, but productivity and efficiency decrease
Solution Approach 1:
The patent performs preliminary action by pre-mixing the anionic dye and chlorhexidine digluconate in stable concentrations during manufacturing. The formulation is designed to remain stable for extended periods without degradation, eliminating the need for extemporaneous mixing and allowing direct use from the container.
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 maintains stability and antibacterial effectiveness for extended periods, is safe for use, and allows clear visualization of treated areas under operating lights, reducing the risk of hypersensitivity reactions.
Implementation Method 1
The compound of formula (I) and its pharmaceutically acceptable salts have the property of coloring said hydroalcoholic solution and, in particular, of coloring it red. They also have the property of being fluorescent under UV light.
Data Source
AI summary
The invention relates to a liquid composition comprising: chlorhexidine digluconate; a colorant of formula (I) in the form a pharmaceutically acceptable salt, wherein R1, R2, R3, R4 are the same or different and each one independently represents a hydrogen atom or a chlorine atom; water and at least one alcohol selected from ethanol, n-propanol and isopropanol. The invention also relates to a method for producing such a composition, to the use thereof as a medicament, in particular for skin antisepsis, and to the use thereof for the disinfection of instruments, particularly before a surgical operation.