Scale-up of the preparation process of solid lipid nanospheres. Part I.

An apparatus was designed to prepare solid lipid nanospheres (SLN), potential colloidal therapeutic system obtained by dispersing a warm oil-in-water (o/w) microemulsion in cold water. The apparatus, consisting mainly of a thermostated aluminium chamber and a pneumatic piston, permitted to disperse through a needle up to 100 ml of warm microemulsion and to vary the temperature, the dispersing rate and the drop size of the warm o/w microemulsion. Experimental design was applied to study the effect of four experimental factors, such as chamber temperature, piston pressure, needle gauge and volume of dispersing water, on average diameter and polydispersity index of SLN and on dispersing time of microemulsion (the time required for the microemulsion to drip completely from the apparatus). The results showed that temperature and pressure play the most important roles depending on the needle gauge used. In particular, the smallest SLN were obtained using high temperature and pressure values and a small needle gauge.