リポソーム製剤の研究開発における薬物放出評価法

抄録

Over the past few decades, liposome drug delivery systems (liposome DDS) have attracted much attention as the most advanced DDS. Efficacy and toxicity profiles of liposomes are based on their characteristic pharmacokinetics, drug release, and disposition after administration. Many attempts have been made to develop these systems especially as liposomal anti-cancer drugs. In the development of liposome DDS, identification of critical quality attributes and establishment of a control strategy to ensure consistent drug product quality are crucial. Among the quality attributes, particle size, drug encapsulation, and drug release from liposomes would affect their in vivo pharmacokinetic and pharmacodynamic properties. Thus these features need to be evaluated with appropriate analytical methods to confirm the quality and performance of the drug products. This article focuses on drug release from liposomes and reviews the effects of physicochemical properties of loaded drugs on release, simulation of drug release from liposomes, and design of a simulated body fluid for drug release assay of drug products.