Nanoemulsion-Based Nystatin Delivery: Formulation and Characterization Studies

Nanoemulsions are colloidal dispersion systems utilized to enhance the solubility of water-insoluble drugs. This study aimed to develop nystatin-loaded nanoemulsion through a high-pressure homogenization and subsequently analyze the effects of various process variables (oil concentration, S_mix ratio surfactant and co-surfactant, and homogenization pressure) on particle size, zeta potential, PDI, FTIR, entrapment efficiency, and in vitro drug release. FTIR findings suggest that there is no incompatibility issue between formulation ingredients and nystatin. The optimized formulation (formulation NM-11) had highest entrapment efficiency (90.00 ± 2.62%) and smallest droplet size (19.00 ± 0.82 nm) and demonstrated highest in vitro drug release (90.64 ± 1.13% after 45 min) in phosphate buffer (pH 7.4). Nanoemulsion was stable after 3 months of storage at 4 ± 1 °C and 25 ± 2 °C/60 ± 5%RH. The results suggest that a high-pressure homogenization method may improve therapeutic efficacy of nystatin. Formulated nanoemulsion has demonstrated favorable outcomes in laboratory evaluations. However, scaling up studies and evaluating biopharmaceutic properties need to be conducted to validate these formulations.