Liposomal Pharmaceutical Products: Methods of Analytical Characterization and Quality Control

Modern methods of analytical characterization and quality control of liposomal pharmaceutical products are reviewed. Analytical studies are shown to be extremely important not only for the development and quality control of liposomes but also for understanding the possible clinical safety and efficacy of liposomes with encapsulated drugs. The complicated analytical characteristics of liposomes that are determined by their unique structure, nanoscopic dimensions, and excipients, primarily lipids, are highlighted. Critical quality attributes of liposomes, e.g., qualitative and quantitative determination of the lipid components of the liposomal shell, nanoparticle morphology, encapsulation efficiency, and drug release are discussed. Available analytical approaches and determination methods are summarized. Examples of analytical studies of liposomes with encapsulated anticancer drugs are given.