薬剤学
Online ISSN : 2188-3149
Print ISSN : 0372-7629
ISSN-L : 0372-7629
総説
ナノ製剤のCharacterization
園部 尚
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ジャーナル フリー

2007 年 67 巻 4 号 p. 214-219

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To properly assign biological effects and adverse effects of nanoproducts, their identity and integrity must be well defined and assured. Proper characterization of test materials is important to ensure that results are reproducible and to provide the basis for understanding that determines their biological effects. Scientists have many tools for studying the physical and chemical properties, e.g. size, shape, and surface properties of particulates, for quality control of established pharmaceutical products, however, it is rather difficult to measure many of these same properties for the emerging new dosage form, nanoproducts. There is growing consensus that a series of guidelines or recommended practices is necessary for basic characterization of nanoproducts. Complete characterization of nanoproducts includes size and size distribution, shape and other morphological features (e.g. crystallinity, porosity, surface roughness), chemistry of the material, solubility, surface area, state of dispersion, surface chemistry, and other physicochemical properties.

In addition, there exist uncertainties around the health and environment impact of nanoproducts. In this article, some of physical and chemical characteristics, analytical instruments for their measurement and, also, toxicological concerns of nanoproducts are reviewed.

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© 2007 公益社団法人 日本薬剤学会
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