Harnessing Novel Tetra-Synergistic Bilosomes for Effective Otomycosis Management: Integrated In-Vitro, Microbiological and In-vivo Studies
Abstract
Abstract This study introduces and statistically optimizes novel Tetra-Synergistic Bilosomes (TSB), an advanced nano-platform for topical delivery of voriconazole (VOR) in otomycosis therapy. The term “Tetra-Synergistic” reflects the incorporation of four complementary components: Cremophor® EL, sodium deoxycholate, Brij® 58, and Brij® S2, working in synergy to enhance therapeutic efficacy. TSB was fabricated using the thin-film hydration method and optimized through a 2 3 D-optimal design. Three formulation factors were investigated: Cremophor® EL: VOR ratio, sodium deoxycholate: cholesterol ratio, and Brij® 58: Brij® S2 ratio, with the optimization goal of maximizing EE%, minimizing vesicular size, and maintaining ZP within the acceptable stability range. The model demonstrated excellent predictability, achieving a desirability value of 0.888. The optimized TSB exhibited high EE% (91.6%), a suitably small VS (217.9nm), and stable ZP (− 24.1mV). FTIR confirmed VOR entrapment, while TEM revealed nano-sized spherical vesicles. Moreover, TSB displayed a biphasic In-vitro release profile and remained stable for three months under refrigeration. Importantly, microbiological evaluation confirmed the superior antifungal performance of TSB. Compared with VOR suspension, TSB showed a larger inhibition zone, a lower minimum inhibitory concentration (MIC) and minimum fungicidal concentration (MFC), and a faster fungicidal effect, eradicating fungal growth in 33% less time. Ex-vivo…
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