Use of a quality by design approach to optimize andrographolide solid lipid nanaparticles / 中草药

ABSTRACT

Objective: The aim of this investigation was to use a quality by design (QbD) approach to optimize andrographolide solid lipid nanoparticles (And-SLNs). Methods: The And-SLNs were prepared by melt-emulsion and followed by high pressure homogenization methods. The And-SLNs with ideal encapsulation efficiency (EE) and particle size distribution were used various experimental statistical design modules. Plackett-Burman design for independent variables was first conducted to prescreen various formulation and process variables during the development of SLNs. Selected primary variables were further optimized by Box-Behnken design. The particle size distribution, Zeta potential, morphology, and in vitro drug release behavior of And-SLNs were studied by Malvern Particle Size Analyzer and Transmission Electron Microscope (TEM), respectively. Results: The EE, particle size, and Zeta potential of And-SLNs were found to be (91.4 ± 3.7)%, (258.4 ± 42.1) nm, and (-36.1 ± 3.4) mV, respectively. The And-SLNs were found to be small and spherical with uniform particle size and smooth surface as seen in TEM. The in vitro accumulated release of And reached up to 52.4% within 48 h. Conclusion: This study demonstrates that the QbD approach could optimize the formulation and process variables to achieve favorable responses for And-SLNs.