Formulation and evaluation of clozapine solidlipidnanoparticles with natural lipid

Abstract

Solid lipid nanoparticles of poorly soluble drug (Clozapine) were prepared by using different lipids (Ghee, BBS-C, Dynasan118) with different surfactants (Acconon  MC8 EP/NF, Gelucire 44/14, Labrasol, Tween 80, Capmul MCM) in the ratio 1:1. Clozapine SLNs were prepared by hot homogenization technique followed by ultrasonication and its particle size, zeta potential, morphology, entrapment efficiency and drug release in vitro were studied. The FT-IR and DSC studies of prepared formulations revealed that the drug was existed in amorphous state. SEM studies revealed that Clozapine loaded SLNs were almost spherical in shape with particle size range of below 50nm.

The optimized formulations of Clozapine loaded SLNs F1 and F5 exhibits a mean particle size of 10.59 and 9.574nm respectively. The polydispersity index values of Clozapine SLNs (F1 and F5) were found to be 0.256 and 0.231. The zeta potential of optimized Clozapine SLN formulations (F1 and F5) was found to be -2.70 and -3.14 respectively. Entrapment efficiency of Clozapine formulated with ghee as lipid ranging from 99.15 to 99.80 % was observed. The drug release of Clozapine from SLNs showed first order release kinetics, best-fitted to Higuchi equation and it follows non Fickian diffusion.

Key words: Solid lipid nanoparticles, Clozapine, Ghee, Hot homogenization method.