Sakai-Kato Kumiko
Division of Drugs, National Institute of Health Sciences.
Yakugaku Zasshi. 2019;139(2):255-260. doi: 10.1248/yakushi.18-00171-3.
Nanotechnology-based formulations have attracted much attention as delivery tools for a variety of payloads. These payloads include oligonucleotides, peptides, and low-molecular weight chemical entities. Guidelines and reflection papers for nanotechnology-based drug products have been published by the Japanese Ministry of Health, Labour, and Welfare. These documents include the concept of quality by design (QbD) approach, as described in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The quality attributes that affect efficacy and safety of nanotechnology-based drug products should be identified to establish the entire picture of the drug products. Hence it is essential to develop analytical methods for characterizing these attributes. Furthermore, to evaluate the comparability of nano-drug delivery system (DDS) formulations before and after changes to their manufacturing process, it is desirable to characterize the key attributes using more than one analytical method for each. Standardization of these analytical methods is underway. This paper provides an overview of the concept and significance of the QbD approach for nano-DDS formulations, guidelines for the development of nano-DDS formulations, and standardization of analytical methods for nano-DDS formulations.
基于纳米技术的制剂作为各种药物载体已备受关注。这些药物载体包括寡核苷酸、肽和低分子量化学实体。日本厚生劳动省已发布了基于纳米技术的药品指南和反思文件。这些文件包含了国际人用药品注册技术协调会（ICH）指南中所述的质量源于设计（QbD）方法的概念。应确定影响基于纳米技术的药品有效性和安全性的质量属性，以全面了解这些药品。因此，开发用于表征这些属性的分析方法至关重要。此外，为了评估纳米药物递送系统（DDS）制剂在制造工艺变更前后的可比性，最好对每个关键属性使用多种分析方法进行表征。这些分析方法的标准化工作正在进行中。本文概述了纳米DDS制剂的QbD方法的概念和意义、纳米DDS制剂的开发指南以及纳米DDS制剂分析方法的标准化。
