Purpose. The purpose of this study was to develop a new method to produce albumin particles in the sub-200-nanometer range with a narrow size distribution and in a controlled and reproducible manner.
Methods. A new emulsion crosslinking method was developed using ultrasound and static mixing as homogenization steps and a central composite design was used to evaluate the influence of different process parameters on particle size, polydispersity and yield.
Results. Response surface analysis allowed the location of the most important factors. Of all the factors investigated, only the albumin concentration and the aqueous phase volume showed a significant influence on response parameters. Albumin nanospheres with sizes below 200 nm in diameter and very narrow size distributions were obtained in high yields (>80%).
Conclusions. This study describes a new preparation method for albumin nanoparticles which are suitable for future drug targeting studies.