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<p>The current study investigated the systematic development of topical film forming spray (FFS) of Bifonazole (BFN). The BFN FFS was designed with polymers Eudragit RLPO and ethyl cellulose and was optimized using Design of Experiment (DoE) approach employing central composite design. Concentration of Eudragit RLPO, ethyl cellulose and propylene glycol were selected as independent variables whereas viscosity, drying time, time to 80% drug release (T80) were set as response variables. The optimised BFN FFS exhibited rapid film formation (11.08 ± 1.1&#xa0;s), low viscosity (8.60 ± 0.3 cP) and sustained drug release (T80- 8.7 ± 0.7&#xa0;h). The formulation had desirable mechanical and rheological characteristics in terms of tensile strength, elongation, folding endurance, Young’s modulus and showed plastic thixotropic nature. The droplet size distribution studies verified a narrow and uniform distribution of spray droplets less than 68.8 ± 9.2&#xa0;μm. The scanning electron micrographs illustrated the formation of a composite film. The ex-vivo permeation studies confirmed significant drug deposition in dermal layers. The optimized BFN FFS was demonstrated as safe in cytotoxicity studies in A431 cell line. Antifungal studies affirmed the potential of developed formulation. These exploratory studies highlighted the potential of the developed formulation for management of dermal fungal infections.</p> Graphical Abstract <p></p>

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Sustained Release Bifonazole Film Forming Spray for Effective Fungal Treatment

  • 期刊论文

  • 发表日期：

    2026年2月5日

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  • Manisha S. Lalan,
  • Pranav Shah,
  • Meenakshi Patel,
  • Malharikant V. Naik,
  • Nirmal Shah,
  • Bhupendra G. Prajapati

摘要

The current study investigated the systematic development of topical film forming spray (FFS) of Bifonazole (BFN). The BFN FFS was designed with polymers Eudragit RLPO and ethyl cellulose and was optimized using Design of Experiment (DoE) approach employing central composite design. Concentration of Eudragit RLPO, ethyl cellulose and propylene glycol were selected as independent variables whereas viscosity, drying time, time to 80% drug release (T80) were set as response variables. The optimised BFN FFS exhibited rapid film formation (11.08 ± 1.1 s), low viscosity (8.60 ± 0.3 cP) and sustained drug release (T80- 8.7 ± 0.7 h). The formulation had desirable mechanical and rheological characteristics in terms of tensile strength, elongation, folding endurance, Young’s modulus and showed plastic thixotropic nature. The droplet size distribution studies verified a narrow and uniform distribution of spray droplets less than 68.8 ± 9.2 μm. The scanning electron micrographs illustrated the formation of a composite film. The ex-vivo permeation studies confirmed significant drug deposition in dermal layers. The optimized BFN FFS was demonstrated as safe in cytotoxicity studies in A431 cell line. Antifungal studies affirmed the potential of developed formulation. These exploratory studies highlighted the potential of the developed formulation for management of dermal fungal infections.

Graphical Abstract