Lipid Nanoparticulate system of Simvastatin- A method for solubility enhancement

Aim: In the present work, solid lipid nanoparticles (SLNs) of simvastatin was formulated with an aim to increase the solubility, rate of dissolution and drug stability. Method: The formulations were prepared by hot homogenization technique using lipids such as stearic acid, glycerol monostearate and tween 20 as a surfactant. The coarse emulsion was homogenized by using Polytron PT 1600 E homogenizer at 30000 rpm. Nanoparticles obtained were characterized for particle size analysis, zeta potential, SEM, DSC, FTIR and also analyzed for drug content and in vitro drug release profile. Results: Out of 12 formulations, selected 5 formulations (F1 to F5) were found to be free flowing. The drug content of the selected formulations was ranging between 61.56 ± 1.02% to 78.34 ± 1.03%. The average particle size and zeta potential of selected formulas, F2 was found to be 795.7nm and -33.7mV and F4 was found to be 369nm and -34mV respectively. The comparative release profile of F1 to F5 was found to be in between 92.05 ± 0.004% to 97.65 ± 0.005% in comparison to pure drug profile of 72.00 ± 0.003% at 24hr release study. The DSC thermogram indicates the melting point of the drug was decreased from 140.95 oC to 57.30 oC, due to molecular dispersion of drug in lipids. Conclusion: Solid lipid nanoparticles can be alternate stable cost effective approach for improving dissolution rate of poorly soluble drugs.