Development of Miconazole-Loaded Microemulsions for Enhanced Topical Delivery and Non-Destructive Analysis by...

Area of Science:

• Pharmaceutical Sciences
• Dermatology
• Analytical Chemistry

Background:

• Miconazole nitrate exhibits poor water solubility, limiting its topical therapeutic efficacy.
• Developing advanced drug delivery systems is crucial for improving antifungal treatment outcomes.

Purpose of the Study:

• To formulate and characterize miconazole nitrate-loaded microemulsions for enhanced topical skin delivery.
• To evaluate the physicochemical stability and antifungal activity of the developed microemulsions.
• To establish a non-destructive analytical method for miconazole nitrate quantification in microemulsions.

Main Methods:

• Spontaneous emulsification technique using oleic acid, water, polyoxyethylene sorbitan monooleate (PSM), and cosurfactants (ethanol, 2-(2-ethoxyethoxy) ethanol, or 2-propanol).
• In vitro permeation studies across pig skin and antifungal activity assays against Candida albicans.
• Physicochemical stability assessment under accelerated conditions (30°C for 3 months).
• Development of a near-infrared spectroscopy (NIRS) method coupled with partial least-squares regression (PLSR) for quantitative analysis.

Main Results:

• The optimal miconazole-loaded microemulsion (PSM:ethanol 1:1) demonstrated a high cumulative drug permeation (87.6 ± 5.8 μg/cm²).
• Microemulsions showed significantly enhanced permeation, flux, and skin deposition compared to conventional cream.
• Formulations exhibited superior in vitro inhibition of Candida albicans and favorable physicochemical stability.
• The NIRS-PLSR model achieved high accuracy (R² = 0.9919) for non-destructive miconazole nitrate quantification.

Conclusions:

• Miconazole-loaded microemulsions are effective carriers for improving topical miconazole nitrate delivery and antifungal efficacy.
• The developed NIRS-PLSR method offers a rapid and accurate approach for quality control of miconazole nitrate formulations.