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Response surface methodological approach for optimization of photodynamic therapy of onychomycosis using chlorin e6
Ghada Yasin1, Maha Nasr2, Sara A Abdel Gaber3
1Pharmaceutical Nano-Technology Laboratory, Department of Medical Applications of Laser, National Institute of Laser Enhanced Sciences (NILES), Cairo University, Cairo, Egypt.
Abstract:
Antimicrobial photodynamic inactivation (aPDI) has a tremendous potential as an alternative therapeutic modality to conventional antifungals in treatment of onychomycosis, yet the nail barrier properties and the deep-seated nature of fungi within the nails remain challenging. Therefore, the aim of this study was to prepare, optimize, and characterize Chorin e6 (Ce6) nail penetration enhancer containing vesicles (Ce6-nPEVs) and evaluate their photodynamic mediated effect against Trichophyton rubrum (T.rubrum); the main causative agent of onychomycosis. Optimization of the particle size and encapsulation efficiency of nPEVs was performed using a four-factor two-level full factorial design. The transungual delivery potential of the selected formulation was assessed in comparison with the free drug. The photodynamic treatment conditions for T.rubrum aPDI by free Ce6 was optimized using response surface methodology based on Box-Behnken design, and the aPDI effect of the selected Ce6-nPEVs was evaluated versus the free Ce6 at the optimized condition. Results showed that formulations exhibited high encapsulation efficiency for Ce6 ranging from 79.4 to 98%, particle sizes ranging from 225 to 859 nm, positive zeta potential values ranging from +30 to +70 mV, and viscosity ranging from 1.26 to 3.43 cP. The predominant parameters for maximizing the encapsulation efficiency and minimizing the particle size of Ce6-nPEVs were identified. The selected formulation showed 1.8-folds higher nail hydration and 2.3 folds improvement in percentage of Ce6 up-taken by nails compared to the free drug. Results of the microbiological study confirmed the reliability and adequacy of the Box-Behnken model, and delineated Ce6 concentration and incubation time as the significant model terms. Free Ce6 and Ce6-nPEVs showed an equipotent in vitro fungicidal effect on T.rubrum at the optimized conditions, however Ce6-nPEVs is expected to show a differential effect at the in vivo level where the advantage of the enhanced nail penetration feature will be demonstrated.
Insights
Antimicrobial photodynamic inactivation (aPDI) offers a new way to treat nail fungus. Researchers developed Chorin e6-containing vesicles (Ce6-nPEVs) that improve drug delivery into nails, showing promise for onychomycosis treatment.
Area of Science:
- Pharmaceutical Sciences
- Dermatology
- Photomedicine
Background:
- Onychomycosis, a fungal nail infection, is difficult to treat due to the nail barrier.
- Conventional antifungals have limited efficacy against deep-seated nail fungi.
- Antimicrobial photodynamic inactivation (aPDI) is a promising alternative therapy.
Purpose of the Study:
- To prepare, optimize, and characterize Chorin e6 (Ce6) nail penetration enhancer containing vesicles (Ce6-nPEVs).
- To evaluate the photodynamic efficacy of Ce6-nPEVs against Trichophyton rubrum, a common cause of onychomycosis.
- To assess the transungual delivery potential of Ce6-nPEVs compared to free Ce6.
Main Methods:
- Formulation optimization using a full factorial design for particle size and encapsulation efficiency.
- Characterization of Ce6-nPEVs for particle size, zeta potential, and viscosity.
- Assessment of nail penetration and hydration enhancement.
- Optimization of aPDI conditions for T. rubrum using response surface methodology (Box-Behnken design).
- In vitro evaluation of aPDI efficacy of Ce6-nPEVs versus free Ce6.
Main Results:
- Optimized Ce6-nPEVs exhibited high encapsulation efficiency (79.4-98%) and suitable physical properties (particle size 225-859 nm, zeta potential +30 to +70 mV).
- The selected formulation significantly enhanced nail hydration (1.8-fold) and Ce6 uptake (2.3-fold) compared to free Ce6.
- Both free Ce6 and Ce6-nPEVs demonstrated equipotent in vitro fungicidal effects against T. rubrum under optimized conditions.
Conclusions:
- Ce6-nPEVs effectively enhance nail penetration and hydration, addressing key challenges in onychomycosis treatment.
- The optimized formulation shows potential for improved in vivo therapeutic outcomes in aPDI for onychomycosis.
- Further in vivo studies are warranted to demonstrate the clinical advantage of enhanced nail penetration.
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