Design, development and evaluation of ketotifen fumarate solid lipid nanoparticles

Abstract

The aim of the present study is to develop Ketotifen Fumarate solid lipid nanoparticles and to evaluate them. Suitable lipids (Tristearin, GMS and Campritol), stabilizer (Soy lecithin) and surfactant (Polaxomer) were selected. FT-IR studies were carried to check drug-excipient compatibility. In the present study nine formulations were formulated by using three prepared by hot homogenization followed by ultra-sonication technique. The nanoparticles were evaluated for particle size, PDI, zeta potential Drug content, percentage drug entrapment efficiency, in vitro drug release studies, release kinetics. FT-IR drug-excipient compatibility studies were revealed that there was no interaction between drug and selected lipids. The particle size ranged from 120.4 to 359.5 nm, PDI of all formulations were good within the range of 0.410 to 0.856, zeta potential ranged from -11.25 mV to -26.5 mV, Percentage drug entrapment efficiency of all formulations were observed were in the range of 78.88 to 93.67%. The cumulative percentage release of Ketotifen Fumarate from different formulations varied from 76.61 to 93.88%. Among all formulations, the formulation F1 showed highest drug release of 93.88% and considered as optimized formulation. The release kinetic studies showed that the release was first order (R2= 0.9123) diffusion controlled and the ‘n’ value obtained from the Korsmeyer-Peppas model indicated the release mechanism was Anomalous diffusion (non-fickian type) (n-value of F1 was 0.613). The developed SLNs were able to sustain the drug release for 12hrs.