A Quality by Design update on nano-drug delivery systems

Abstract

The production of nanoparticles is a very promising approach for improving the delivery of hydrophobic drugs due to their unique properties and advantages. Even though such nanostructures are very attractive for their applications in human medicine, the optimization of the formulations and manufacturing methodologies to obtain a product with the desired quality is a very difficult and time-consuming task. The conventional strategy applied for the optimization of these drug delivery systems is the study of one variable at a time while maintaining the others constant. In this regard, the application of the quality by design approach may avoid such drawbacks in addition to improving the efficiency and safety of the drug product. The design of experiments allows prediction of the properties of the pharmaceutical formulations even without preparing them as well as identifying potential interactions between the variables. Thus, the implementation of multivariate design of experiments and optimization of processes by means of the response surface methodology led to novel nano-scale drug delivery systems with desired properties. In this regard, this chapter reviews the latest advances on the development and optimization of drug nanocrystals, loaded polymeric nanoparticles, and loaded lipid vesicles.