Regulatory Science of Medical Products
Online ISSN : 2189-0447
Print ISSN : 2185-7113
ISSN-L : 2185-7113
The Leading-edge Drug Formulation Technology “Nanotechnology” and Challenges for the Regulatory Science Research
Kumiko SAKAI-KATOHaruhiro OKUDA
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2017 Volume 7 Issue 2 Pages 105-111

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Abstract

Nanotechnology is a leading tool for manufacturing highly functional drug formulations. The formulation techniques using nanotechnology include liposome, polymer nanoparticle, iron nanoparticle, nanoemulsion such as lipid microsphere, micelles, vaccine adjuvant, and nanocrystal technology. Some drug products using these techniques have been approved in Japan. Most of them have been used for the low-molecular-weight active substances. However, these techniques are recently used as the carriers for nucleic acids or proteins. Internationally, there has been a progress in nanomaterial measurement methods, development of reference materials, consensus-based documentary standards for nanotechnology. These activities are also important issues for us. Furthermore, we are involved in the development of new measurement methods for quality attributes which reflect the product performance of nanomedicines. We introduce our research to develop the evaluation method for bending modulus of liposomes using atomic force microscopy.

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© 2017 Society for Regulatory Science of Medical Products
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