Formulation of Itraconazole Loaded Clove Oil based Nanoemulsion using Pseudoternary Phase Diagram for Improved Thermodynamic Stability

Abstract

The present study focuses on formulating, developing, and characterizing nanoemulsions (NE) of antifungal drug (Itraconazole) for its better thermodynamic stability. This way it is expected to be better utilized as a carrier for the transdermal delivery of the drug against Candida albicans infection. The solubility of the drug in various oils was investigated, leading to the identification of an oil phase (clove oil) that not only met the desired solubility criteria but also is reported to exhibit an antifungal effect. The subsequent step involves constructing a pseudo-ternary phase diagram and performing associated mathematical calculations to achieve a thermodynamically stable NE, utilizing the titration method at a constant temperature. The 4:1 ratio of Smix (a mixture of polysorbate 80 as a surfactant and polyethylene glycol 400 as a co-surfactant) was selected based on the largest area of transparency. This study aims to give an insight into the importance of pseudo ternary phase diagram construction and its evaluation, as a significant means for the development of NE. Furthermore, the optimized formulation was chosen and evaluated for key parameters, such as droplet size, polydispersity index, zeta potential, and viscosity. The results exhibited promising characteristics in terms of droplet size and zeta potential indicating the stability of the formulation which can be further explored for suitable dermal drug delivery.