Formulation, optimization, characterization and evaluation of Simvastatin loaded solid lipid nanoparticles using quality by design approach

Abstract

In recent years, lipid nanoparticles (SLNs) have attracted increasing attention. This article describes a systematic approach for the design, optimization, and characterization of Simvastatin (SIM)loaded lipid nanoparticles (SLNs). Optimization was performed using a 32 response surface approach, the effect of glyceryl monostearate (GMS) (X1) and poloxamer 407 (X2) content was optimized as independent variables, % encapsulation efficiency (E) (Y1) and Particle size (Y2) served as variables. The optimized formulation is characterized by EE, particle size, Fourier transform infrared spectroscopy (FTIR), Xray diffraction (XRD), differential scanning calorimetry (DSC), scanning electron microscopy (SEM), in vitro and ex vivo drug release. The percentage of EE is 56% to 89%, the size is 339.8 to 1371.2 nm, the in vitro drug release is 83.60%. SIM SLNs are fully prepared and can effectively release drugs in a sustained mode.