Development and Statistical Optimization of Solid Lipid Nanoparticle Formulations of Fluticasone Propionate.

ABSTRACT

OBJECTIVES: The aim of this study was to develop fluticasone propionate (FP)-loaded solid lipid nanoparticle (SLN) formulations by using factorial design approach. MATERIALS AND METHODS: Tristearin percentages (X1) (1%, 2%, and 4%) and homogenization cycles (X2) (2, 4, and 8 cycles) were selected as independent variables in the factorial design. SLN formulations were optimized by multiple linear regression (MLR) to evaluate the influence of the selected process and formulation independent variables on SLNs' characteristics, namely as encapsulation efficiency (Q1) and particle size (Q2). The polydispersity index and surface charge of the SLNs were also evaluated in this research. Moreover, transmission electron microscopy, differential scanning calorimetry, and in vitro drug release studies were carried out on the optimum SLN formulation. RESULTS: The MLR analysis indicated that as the homogenization cycle (X2) increased in the production process, the mean particle size decreased. CONCLUSION: This research showed that FP-encapsulated SLNs with desired characteristics can be produced by varying the production and content variables of the formulations.