Abstract
The aim of this study was to screen the formulation and process variables affecting the characteristics and quality of solid lipid nanoparticles (SLNs) loaded with carvedilol through the utilization of homogenization followed by ultra-sonication. The screened variables were lipid concentration (X1), surfactant concentration (X2), drug loading (X3), lecithin concentration (X4), charge-inducing agent concentration (X5), homogenization time (X6), and sonication time (X7). The nanoparticles properties deemed important were size (Y1), zeta potential (Y2), entrapment efficiency (Y3), amount released after 1 h (Y4) and time for 85% of drug released (Y5). Results of the experimental design helped to determine significant variables influencing the quality of formulations. The prepared nanoparticles were characterized for particle size, zeta potential, entrapment efficiency, and in vitro release. The combination of independent variables (X1-X7) showed variability of Y1, Y2 and Y3 equal to 23–53 nm, 5.02–30.8 mV, and 71–92%, respectively. In the in vitro release study, the SLNs exhibited a sudden burst and then sustained the release for up to 12 h, whereas Y5 varied from to 4.25–11.25 h. In conclusion, the Plackett-Burman design proved its impact and significance in determining and understanding both process and formulation variables affecting the quality of carvedilol-based nanostructured lipid particles.
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