Formulation, optimization, characterization and in vitro-ex vivo evaluation of atorvastatin loaded solid lipid nanoparticles using quality by design approach

Abstract

Solid lipid nanoparticles (SLN) have engrossed snowballing consideration throughout recent years. This paper depicts an impression about the quality by design approach on formulation, optimization, characterization of solid lipid nanoparticles (SLN) loaded with Atorvastatin (AT). A unique microwave-assisted microemulsion technique of preparation was contemplated to formulate AT SLN. Optimization was executed using 32 response surface methodology where optimized the effect of Glyceryl monostearate (GMS) (X1) and Poloxamer 407 (X2) concentration as an independent variable on % entrapment efficiency (EE) (Y1) and particle size (Y2) as dependent variables. Characterization of optimized formulation was done by employing EE, particle size, Fourier transformed infrared spectroscopy (FTIR), X-ray diffraction (XRD), Differential Scanning Calorimetry (DSC), scanning electron microscopy (SEM), in vitro and ex vivo drug release. The percentages of EE fell within the range of 55 to 82%, particle size was in between the range of 290.3 to 890.4 nm and in vitro drug release was found to be 63.8% also ex vivo absorption was found to be 59.8 % for the duration of 8 hours. The AT SLN was successfully prepared and effective in releasing the drug in sustained mode.