Abstract

The novel itraconazole (ITZ) nail penetration enhancing self-emulsifying nanovesicles (ITZ-nPEVs) loaded in carboxymethyl fenugreek gum (CMFG) gel circumvent the systemic onychomycosis treatment. The ITZ-nPEVs were prepared by the thin film hydration technique, and the particle size (PS), zeta potential (ZP), drug content (DC), entrapment efficiency (% EE), deformity index (DI), viscosity, morphology, and physical stability of the ITZ-nPEVs were measured. In terms of nail hydration, transungual drug absorption, and antifungal efficacy against Candida albicans, the chosen ITZ-nPEVs, nPEV-loaded CMFG (CMFG-ITZ-nPEVs) gel, and the commercialized Itrostred gel were compared. The ITZ-nPEVs showed spherical structure with high DC, % EE, low PS and PDI and positive ZP of ITZ ranging from 95.36 to 93.89 mg/5 mL and 95.36–96.94%, 196.55–252.5 nm, 0.092–0.49, and +11.1 to +22.5 mV, respectively. Compared to the Itrostred gel, the novel ITZ-nPEVs exhibited hydration enhancement factor for 24 h (HE24) of 1.53 and 1.39 drug uptake enhancement factor into nail clippings. Moreover, zone of inhibitions for ITZ-nPEVs (27.0 ± 0.25 mm) and CMFG-ITZ-nPEVs (33.2 ± 0.09 mm) against Candida albicans were significantly greater than that of Itrostred gel (22.9 ± 0.44 mm). For clinical investigation on onychomycotic patients, a nail penetration enhancer containing ITZ-nPEV-loaded CMFG gel presents a highly promising approach.

Highlights

  • Results and DiscussionWith a correlation value of 0.9991, a linear response was seen in range of 5 to 50 μg/mL (Figure S1b and Table S1)

  • Introduction iationsOnychomycosis is a fungal infection that affects both the fingernail and toenail

  • According to the earlier work [9], the ITZ-nPEVs were effectively produced by employing the thin film hydration approach

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Summary

Results and Discussion

With a correlation value of 0.9991, a linear response was seen in range of 5 to 50 μg/mL (Figure S1b and Table S1). The derivatized ITZ had a retention time of. 7.8 min, a limit of identification of 110 μg/mL, and a limit of detection of 32 μg/mL (Figure S1a), respectively

Preparation of ITZ-nPEVs
Elasticity
Viscosity
ITZ- nPEVs Shape
In Vitro ITZ Release
Antifungal
2.11. Stability Study
Reagents
HPLC Analysis
Elimination of Unentrapped ITZ from ITZ-nPEVs
Preparation of CMFG-ITZ-nPEVs Gel
Characterization
Deformability Index
Viscosity of nPEVs
In Vitro Drug Release and Kinetics
Nail Hydration Study
Transungual Drug Uptake Study
3.6.10. Anti-Microbiological Efficacy
3.6.11. Stability Study
Conclusions
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