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Review
. 2019 Dec 11;37(1):6.
doi: 10.1007/s11095-019-2736-y.

Sizing up the Next Generation of Nanomedicines

Jeffrey D Clogston  1 , Vincent A Hackley  2 , Adriele Prina-Mello  3 , Sanyogitta Puri  4 , Silvia Sonzini  4 , Patrick Lim Soo  5
Affiliations
Review

Sizing up the Next Generation of Nanomedicines

Jeffrey D Clogston et al. Pharm Res. .

Abstract

During the past two decades the nanomedicine field has experienced significant progress. To date, over sixty nanoparticle (NP) formulations have been approved in the US and EU while many others are in clinical or preclinical development, indicating a concerted effort to translate promising bench research to commercially viable pharmaceutical products. The use of NPs as novel drug delivery systems, for example, can improve drug safety and efficacy profiles and enable access to intracellular domains of diseased cells, thus paving the way to previously intractable biological targets. However, the measurement of their physicochemical properties presents substantial challenges relative to conventional injectable formulations. In this perspective, we focus exclusively on particle size, a core property and critical quality attribute of nanomedicines. We present an overview of relevant state-of-the-art technologies for particle sizing, highlighting the main parameters that can influence the selection of techniques suitable for a specific size range or material. We consider the increasing need, and associated challenge, to measure size in physiologically relevant media. We detail the importance of standards, key to validate any measurement, and the need for suitable reference materials for processes used to characterize novel and complex NPs. This perspective highlights issues critical to achieve compliance with regulatory guidelines and to support research and manufacturing quality control.

Keywords: Physicochemical characterization; particle sizing; reference materials/standards, critical quality attributes, physiological conditions.

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Conflict of interest statement

The authors confirm that this article has no conflict of interest to declare in the contents of the manuscript. The identification of any commercial product or trade name does not imply endorsement or recommendation by the National Institute of Standards and Technology, the Nanotechnology Characterization Lab, AstraZeneca or Pfizer.

Figures

Figure 1.
Figure 1.
Pie chart showing relative distribution of nanomaterials used in drug products that were submitted to the FDA from 2010–2015 (Adapted from D’Mello et al.(5)). The chart has been simplified by grouping related materials. For example, polymeric NPs includes iron-polymer complexes, micelles, dendrimers, and polymeric NPs.
Figure 2.
Figure 2.
Schematic representation comparing the applicable size (diameter) range for different sizing techniques of nanoparticles. Note that these ranges are approximate and can depend highly on other material or matrix properties.
See this image and copyright information in PMC

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