Optimized Nanostructured Lipid Carriers for Dutasteride Delivery: Improving Therapeutic Efficiency and Minimizing Adverse Effects

Dutasteride is a BCS Class II medication that is frequently employed in the treatment of benign prostatic hyperplasia. It has limited solubility and strong penetration. Nevertheless, using it frequently results in side effects like sexual dysfunction and urination problems. This work aims to decrease these side effects by developing a novel delivery system entitled Nano-Structured Lipid Carriers (NLCs) that will maintain the expulsion of dutasteride, potentially boosting their therapeutic efficiency while minimizing unwanted effects. This study details the construction of a unique NLC composition with two different variables at three levels using a design of experiments (32 factorial layouts) and pseudo-ternary phase diagrams. Following the design phase, the right proportions of water, Omix, and surfactant were chosen to create several DUT-NLC formulations using the Hot Melt-Emulsification Ultrasonication Technique. Among the techniques used to evaluate the formulations were analyses of particle sizes, zeta potency measurement, polydispersity index (PDI) assessment, the use of transmission electron microscopy (TEM), differentiation scanning calorimetry (DSC), X-ray diffraction (XRD), release kinetics, as stability testing, and in vitro cytotoxicity analysis. The design, advancement, & characterization of a novel NLC composition are described in this paper. 7% (Omix) and 20% (Surfactant concentration) were the optimized batch parameters, resulting in an 81% mean Percentage EE, a zeta potential value of -37.5 MV, and an average particle size of 109.3 nanometers. Further in vitro cytotoxicity tests employing PC3 cell lines showed that the created system was more efficient because IC50 values in DUT-NLCS treated cells were lower than in pure drug-treated cells. The experiment revealed that surfactant (Omix) and water phases had a significant effect on the physicochemical features of NLCs. Based on the results of an in vitro cytotoxicity research (MTT Assay), it appears that the suggested formulation has a higher cytotoxic effect on cancer cells. With notable anticancer benefits and long-term release, DUT-NLCs show great promise for a drug delivery technology that may lessen systemic adverse effects in clinical circumstances when DUT dosages are lower.