Hydrogel Formulation for Onychomycosis Keratolysis
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Solution Overview
Problem
Current topical formulations for treating onychomycosis without antifungal drugs, such as lacquers containing urea and propylene glycol, face limitations in providing satisfactory keratolytic effects due to their form and moisture retention issues, which hinder therapeutic activity.
Innovation Solution
A hydrogel formulation containing urea, fumaric acid, 1,3-butylene glycol, a gel-forming polymer, and a crosslinking agent with a water content of 45 to 60% is developed, enhancing keratolytic and moisture-retention abilities, and optionally including biotin to relieve ingrown toenail pain.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If topical formulations are prepared in lacquer form containing urea and propylene glycol, then the formulations can be applied directly to infected sites, but the keratolytic effects are insufficient and moisture retention is poor
Solution Approach 1:
The patent changes the physical and chemical parameters of the formulation by switching from lacquer to hydrogel form, increasing water content to 40-70%, and adjusting the concentration of keratolytic agents (urea 10-30%, lactic acid 5-20%, propylene glycol 10-30%). These parameter changes enhance both moisture retention and keratolytic effectiveness simultaneously.
Solution Approach 2:
The patent creates a composite hydrogel formulation combining multiple keratolytic agents (urea, lactic acid, propylene glycol) with humectants and antifungal compounds. This composite approach synergistically improves moisture retention while maintaining enhanced keratolytic activity beyond what single ingredients can achieve.
2Reliability
If antifungal agents are used for systemic treatment of onychomycosis, then the treatment can address the infection internally, but side effects such as gastrointestinal issues, headache, and hepatotoxicity occur
Solution Approach 1:
The patent extracts the therapeutic function from systemic antifungal drugs and relocates it to a topical formulation. By using high-concentration keratolytic agents applied directly to the nail, the treatment achieves local efficacy without introducing systemic side effects, effectively separating the therapeutic action from harmful systemic exposure.
Solution Approach 2:
The hydrogel formulation acts as an intermediary delivery system that provides high concentrations of keratolytic agents directly at the infection site. This localized delivery mechanism achieves treatment efficacy comparable to systemic drugs while avoiding their harmful systemic effects, serving as a safe intermediate approach.
3Reliability
If high water content is maintained in the nail, then drying phenomena are prevented and active ingredients penetrate more easily, but the formulation complexity increases
Solution Approach 1:
The patent simplifies formulation complexity by establishing specific parameter ranges rather than optimizing each component individually. The hydrogel contains 40-70% water, 10-30% urea, 5-20% lactic acid, and 10-30% propylene glycol, with these defined ranges providing effective keratolysis and moisture retention without requiring complex formulation development.
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 hydrogel formulation effectively prevents drying of the nail, allows active ingredients to penetrate easily, and exhibits remarkable keratolytic activity and moisture-retention, providing effective treatment for onychomycosis and alleviating ingrown toenail pain.
Implementation Method 1
Urea is known to have a nail dissolving effect
Implementation Method 2
Lactic acid is used as an additive to dermatological products where it is included mainly for its exfoliating properties
Implementation Method 3
The mode of action of said topical formulation in the form of lacquer is not fully known, but may be mainly attributable to the osmotic effect of propylene glycol
Implementation Method 4
1,3-butylene glycol is a diol compound that has keratolytic effects and moisture-retention ability
Implementation Method 5
a base for adjusting the pH to 2 to 6
Implementation Method 6
when urea in combination with a specific acid and diol compound, i.e., fumaric acid and 1,3-butylene glycol, is formulated in the form of a hydrogel having a water content of at least about 45%
Data Source
AI summary
A pharmaceutical composition in the form of a hydrogel for preventing or treating onychomycosis or relieving ingrown toenail pain, the pharmaceutical composition containing urea, biotin, fumaric acid, 1,3-butylene glycol, a gel-forming polymer, a crosslinking agent, and 45 to 60 wt % of water, and having keratolytic and moisture-retention abilities to provide a hydrated environment for fingernails, toenails and surrounding tissues.