Application of Rotatable Central Composite Design in the Preparation and Optimization of Poly (Lactic-co-Glycolic Acid) Nanoparticles for Controlled Delivery of HSA

Abstract

The purpose of this work was to obtain an optimized Human Serum Albumin (HSA)-loaded poly(lactic- co -glycolic acid) (PLGA) nanoparticles (NPs). A rotatable central composite design (RCCD) was applied to evaluate the joint influence of three formulation variables: the duration time of homogenization, agitation speed of homogenization, and volume ratio of organic solvent phase to external aqueous phase. The experimental datum allowed the development quadratic models ( P <0.05) describing the inter-relationship between the dependent and independent variables. To enhance the protein content and minimize the particle size of the NPs simultaneously, a response surface methodology was employed. By solving the regression equation, and analyzing the response surface contour and plots, the optimal conditions for the preparation of HSA-loaded NPs were found to be: the duration time of homogenization was 4 min, the agitation speed of homogenization was 3.5 krpm and the volume ratio of organic solvent phase to external aqueous phase was 0.6. The entrapment efficiency (E.E.) was 54.52 ± 5.86% and the average particle size is 252.7 ± 17.90 nm. The NPs, as examined by scanning electron microscopy (SEM), have a smooth and spherical surface and particle sizes are less than 500 nm. The results indicated that RCCD represents an ideal and potential technique for NPs preparation optimization.