Optimization of process parameters for emulsion solvent evaporation technique in the preparation of nano lipid carriers using definitive screening design.

The present study focuses on the optimization of process parameters for preparation of nano lipid carriers (NLC's) by emulsion solvent evaporation technique. A definitive screening design using JMP I 3 was used to analyze the effect of process parameters on nano lipid carriers. The critical process parameters evaluated were solid lipid- liquid lipid ratio, phase volume ratio, surfactant concentration and homogenization speed. Each variable was tested at two different levels. Thirteen formulations were prepared as per the design. The design was employed to estimate the effect of each variable on particle size, PDI and surface charge. Model validation was carried out at a significance level of p<0.05 and the process was optimized at a desirability of 0.90. Three optimized formulations were prepared in the design space using optimized process parameters. The percentage bias of particle size, PDI and zeta potential of the predicted and the observed values were found to be less than 5%. The optimized formulations were subjected for SEM study, which revealed the formation of nano particles. Gas chromatography of the optimized formulation showed the residual solvent content was within the limit as per ICH Q3 R6 guidelines. The suitability of the process to Improve solubility was proved by formulation of nano lipid carriers of highly lipophilic drugs. Therefore, the design was found to be effective for production of nano lipid carriers by emulsion solvent evaporation technique. [ABSTRACT FROM AUTHOR]