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Nanoparticles can encapsulate a range of therapeutics, from small molecule drugs to sensitive biologics, to significantly improve their biodistribution and biostability. Whilst the regulatory approval of several of these nanoformulations has proven their translatability, there remain several hurdles to the translation of future nanoformulations, leading to a high rate of candidate nanoformulations failing during the drug development process. One barrier is that the difficulty in tightly controlling nanoscale particle synthesis leads to particle-to-particle heterogeneity, which hinders manufacturing and quality control, and regulatory quality checks. To understand and mitigate this heterogeneity requires advancements in nanoformulation characterisation beyond traditional bulk methods to more precise, single particle techniques. In this review, we compare commercially available single particle techniques, with a particular focus on single particle Raman spectroscopy, to provide a guide to adoption of these methods into development workflows, to ultimately reduce barriers to the translation of future nanoformulations.

Original publication

DOI

10.1208/s12248-023-00855-w

Type

Journal article

Journal

AAPS J

Publication Date

02/10/2023

Volume

25

Keywords

cargo loading, nanoformulations, nanoparticle drug delivery, single particle Raman spectroscopy, surface interactions, Tissue Distribution, Nanoparticles, Pharmaceutical Preparations, Particle Size