Liposomes: The science and the regulatory landscape

Abstract

Liposomes are vesicular (phospho)lipid-based drug carrier systems in the nanometer/micrometer range. The therapeutic performance of these ‘composite’ drug products heavily depends on their supramolecular structure. They are heterodisperse, difficult to fully characterize by physicochemical means and produced via complex manufacturing processes. This renders them part of the NBCD group. The first liposome based drug formulation received market authorization over 20 years ago (Ambisome™ 1990). Since then a number of liposome drug products were approved by the FDA and the EM(E)A. The first generic versions of the innovator products are now being registered. In this chapter the CMC (Chemistry, Manufacturing and Control) aspects of liposomes will be discussed, followed by a short overview of pharmacological aspects (e.g., pharmacokinetics/disposition, dosing, hypersensitivity). The regulatory landscape as it developed over the years is described next, followed by reflections on the future of this family of lipid, vesicular drug carrier systems.