A Quality by Design update on nano-drug delivery systems

LEONARDI, DARÍO; LAMAS, M. C; SALOMON C.J.

Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development

Springer Cham

Año: 2023; p. 120 - 129

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 its application in human medicine, the optimization of the formulations and manufacturing methodologies to reach 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 time while maintaining constant the others. In this regard, the application of Quality by Design approach may avoid such drawbacks in addition to improve the efficiency and safety of the drug product. The design of experiments allows to predict the properties of the pharmaceutical formulations even without preparing them as well as to identify 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