Application of Statistical Design to Assess the Critical Process Parameters of Ethanol Injection Method for the Preparation of Liposomes

Abstract

In the present study custom screening design was employed to observe the effect of four critical
process parameters on particle size and polydispersity index of the liposomal formulation made by ethanol injection
method. The four process parameters selected were lipid ratio, rate of injection, phase volume ratio and rotational
speed of magnetic stirring. Eight different liposomal formulations were prepared using the design. The formulations
were subjected to particle size analysis. The analysis was done at a significance level p<0.05 and found that the
process parameters had significant effect on the particle size and polydispersity index of the formulations. The
design was optimized for the individual responses with an overall desirability of more than 50%. Three batches of
liposomes were formulated at optimized process parameters which matched the target as predicted by the design.
Therefore, it can be concluded that the design was effective in production of nano sized stable monodisperse
liposomes by ethanol injection method.