CHEMOMETRIC APPROACH FOR THE DEVELOPMENT OF A NANOEMULSION INTENDED FOR TOPICAL USE

In this work, a chemometric approach was taken to help optimize a previously developed nanoemulsion (NE) formulation in order to make it suitable for topical application to help treat superficial fungal infections. A 2-level factorial design and a surface response methodology (SRM) based on a 2-factor Doehlert matrix were used to optimize the amounts of surfactants, oil and encapsulated Fluconazole (FCZ).1,2,3 The response parameters were droplet size, polydispersity index (PDI) and droplet surface electric potential (ζ), these were combined using a desirability function (D) to maximize the lowest values for all three parameters. All the measurements were obtained using a Malvern Zetasizer Nano ZS. The NE with the best combined response showed a droplet size of 141,4 ± 2,3 nm; PDI of 0,104 ± 0,017; ζ potential of -33,2 ± 0,9 mV. This data is in accordance with TEM micrographs obtained for this formulation. The SRM data was obtained via TIBCO’s Statistica (v13.5) software. The critical values obtained via software (SRM) for the optimal amounts of FCZ and oil were 162 mg and -50 mg, respectively. Some caution should be exercised when it comes to using these chemometric tools and interpreting the critical values found for a system such as a NE. Therefore, the amount of oil chosen as “optimal” was the lowest limit evaluated, which was 100 mg and corresponds to the NE cited above, which encapsulated 150 mg of FCZ with an EE% of 75,5%.