Regulatory Perspective on the Development of Polymer Nanomaterials

Abstract

The book edited by Drs. Vauthier and Ponchel, Polymer Nanoparticles for Nanomedicines: A Guide for their Design, Preparation and Development, represents a crucial and comprehensive work of information with highly advanced research about the construction of polymer nanoparticles. The logical succession of the different chapters runs in the following way. Part I is devoted to the different methods for manufacturing nanoparticles with clear explanations about the physicochemical principles allowing their formation. Nanoparticles may be built using various preparation methodologies. For instance, the so-called nanoprecipitation technique based on the “Ouzo” effect, the flash nanoprecipitation process, and the solvent evaporation methods with their numerous adaptations, are well explained. Apart from being prepared by pre-formed polymers, nanoparticles may be constructed through the in situ polymerization of monomers which sometimes allows better drug loading. Thanks to the versatility of these different preparation processes, the size and the shape of the nanoparticles may be controlled, which may further influence in vivo pharmacokinetic and biodistribution after administration. Therefore, the characterization of the nanoparticles is logically addressed in Part II of the book. Physicochemical characterization includes polymer characterization, nanoparticle size, nanoparticle surface properties, drug loading and release, nanoparticle stability, and batch-to-batch reproducibility. Electron microscopy, both transmission and scanning, are also important methodologies for the direct visualization of nanoparticles. The interactions with the immune system, the activation of the complement at the surface of the nanoparticles, as well as the interaction with cells and intracellular trafficking are dramatically influenced by the characteristics of the nanoparticles. These processes are discussed in great detail. Part III of the book discusses how to adjust the characteristics of polymer nanoparticles with functionalities needed for specific pharmacological applications. In this view, the choice of the best polymer, the encapsulation process and the drug loading, as well as, the control of the drug release are at disposal of the formulation scientists to construct the more efficient nanomedicines. Of course, the toxicological aspects have to be taken into great consideration, especially the biodegradation of the nanoparticle polymer core, the safety of the metabolites, the excretion pathways, and the interaction with blood proteins which may also dramaticallyinfluence the nanoparticle biodistribution. A special chapter describes the conception of theranostic nanoparticles combining therapeutic and imaging properties for personalized medicine. The last part of the book discusses why polymer-based nanoparticles have attracted so much interest, whereas only a few of them have been approved and have reached the market or even the third phase of clinical trials. Regulatory developments are also considered in a separate chapter. I recommend reading this book, which assembles a profuse array of knowledge on the conception and the development of polymer nanoparticles. It represents an essential reference for a broad scientific community, including academic researchers and industrial deciders. It should also attract students pursuing a master’s degree or doctorate in the field of nanomedicine, whether their background is in education, pharmaceuticals, chemistry, physico-chemistry, or even physics.