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Newfangled Topical Film-Forming Solution for Facilitated Antifungal Therapy: Design, Development, Characterization,

Bhakti Dhimmar1, Rahul Pokale1, Mohamed Rahamathulla2

  • 1Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research (JSS AHER), Mysuru 570 015, Karnataka, India.

Polymers
|February 28, 2023
PubMed

Insights

This study developed an alkaline antifungal spray using luliconazole to combat fungal infections. The novel formulation demonstrated effective drug diffusion and antifungal activity, suggesting improved topical treatment for skin conditions.

Area of Science:

  • Pharmaceutical Sciences
  • Dermatology
  • Mycology

Background:

  • Fungal infections often recur due to the acidic skin pH (3-5) favoring fungal growth.
  • Altering the skin's pH is a potential strategy to prevent fungal infection recurrence.
  • Luliconazole is a topical antifungal agent targeting fungal cell membrane synthesis.

Purpose of the Study:

  • To design, develop, characterize, and evaluate an alkaline pH-based topical antifungal spray solution.
  • To investigate the potential of an alkaline environment in enhancing antifungal efficacy.
  • To formulate a stable and effective luliconazole delivery system for topical application.

Main Methods:

  • Formulation of an alkaline spray using luliconazole, Eudragit RS 100, propylene glycol (PG), sodium bicarbonate, and ethanol via solubilization.
  • Characterization using Differential Scanning Calorimetry (DSC), Fourier-Transform Infrared Spectroscopy (FTIR), Powder X-ray Diffraction (PXRD), Scanning Electron Microscopy (SEM), and rheological analysis.
  • Optimization using Quality by Design (QbD) and Design of Experiments (DoE) software.
  • Evaluation through in vitro drug diffusion studies and antifungal trials against Candida albicans.

Main Results:

  • Drug-polymer compatibility confirmed through various analytical techniques (DSC, FTIR, PXRD, SEM).
  • Optimized F-14 formulation exhibited desirable physicochemical properties: pH 8, viscosity 14.99 cp, drying time 60s, spray volume 0.25 mL, and spray angle 80°.
  • Achieved 98.0% in vitro drug diffusion and a 9 mm zone of inhibition against Candida albicans.

Conclusions:

  • The developed alkaline luliconazole topical film-forming spray is compatible with human skin.
  • The formulation demonstrates sustained drug release and significant in vitro antifungal activity.
  • This alkaline spray represents a promising approach for enhanced topical antifungal treatment.
Keywords:
Candida albicansdrug deliveryfungal infectionsin vitro antifungal activityluliconazolepolymerstopical film forming solution

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