[Overview of Analytical Techniques for Evaluation of Nano-DDS Formulations]

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.