Abstract
Polymeric micelles are nanoparticles formed upon self-assembly of amphiphilic (block co-)polymers in aqueous solutions. The resulting structure is a usually spherical nanoparticle with a hydrophobic core acting as a reservoir for poorly soluble active pharmaceutical ingredients (APIs) and a hydrophilic shell which provides colloidal stability and limits protein adsorption and opsonisation, resulting in long-circulation times. Since the physicochemical properties, and ultimately the in vivo distribution, safety and efficacy, of the final drug product are highly dependent on the chosen polymer chemistry and manufacturing process, classification of polymeric micelles as nonbiological complex drugs is justified. This chapter provides an overview of the most important/common chemistry, manufacturing processes and control strategies used to manufacture polymeric micelles for medicinal products. Next, the pharmacology of polymeric micelles tested in the clinic is summarized and the relation between physicochemical characteristics and PK/PD as well as evaluation of choice and value of specific PK-parameters and required assay development are discussed. Regulatory aspects will be discussed based on currently available guidance of direct relevance for polymeric micelles as well as related guidance and suggestions for updates will be provided. The chapter will end with a preview of important developments and breakthroughs that can be anticipated in the (nearby) future and prospects for innovative and generic polymeric micelle drug products.
Published Version
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