Optimization of Bifonazole-Loaded Nisomal Formulation Using Plackett-Burman Design and 23 Factorial Design

Harshal Ashok Pawar*, Vibhavari Bhaskar Attarde, Gide Parag Subhash
Dr. L. H. Hiranandani College of Pharmacy, Ulhasnagar Railway Station, Ulhasnagar-421003, Maharashtra, India

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Pawar et al. ; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution-Non-Commercial 4.0 International Public License (CC BY-NC 4.0) (, which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at the Dr. L. H. Hiranandani College of Pharmacy, Smt. CHM Campus, Opp. Ulhasnagar Railway Station, Ulhasnagar-421003, Maharashtra, India; Tel: +91-8097148638; E-mail:



Bifonazole is an imidazole antifungal drug. It is highly lipophilic drug with a very short half-life and is minimally absorbed following dermal application. Niosomes are excellent candidate as potential drug delivery system because of their improved drug solubilization, enhanced penetration power, long shelf life and ease of preparation and administration.


The aim of the study was to enhance permeability of bifonazole by incorporating it into niosomes and formulating its gel formulation.


Niosomes were prepared by thin film hydration method. The statistical approach was used to optimize the parameters for niosome formation. The process parameters among six factors influencing in vitro diffusion study were identified using plackett burman design. The Plackett–Burnan design described in this study was applied for the identification of the significant factors and 23 factorial design was used to obtain optimized batch. The prepared niosomes were evaluated for various parameters such as vesicular size, drug entrapment, surface morphology, drug release characteristics, ex vivo deposition and stability.


Niosomal gel showed significantly enhanced drug permeation through the skin as compared to the marketed formulation. The optimized niosomal gel formulation also showed drug release in a controlled manner. The stability study at two different temperatures (25 ± 2°C and and 5 ± 3 °C) confirmed that the optimized formulation is stable even at the end of 3 months.


It has been concluded that niosomal gel is an efficient carrier for the delivery of bifonazole with improved permeability.

Keywords: Bifonazole, ex vivo, 23 factorial design, Gel, in vitro Study, Niosome, Optimization, Plackett Burman.