用于货物递送的纳米制剂的单颗粒化学特征分析。

Single Particle Chemical Characterisation of Nanoformulations for Cargo Delivery.

机构信息

Department of Materials, Department of Bioengineering, and Institute of Biomedical Engineering, Imperial College London, London, SW7 2AZ, UK.

The Kavli Institute for Nanoscience Discovery, University of Oxford, Oxford, OX1 3QU, UK.

出版信息

AAPS J. 2023 Oct 2;25(6):94. doi: 10.1208/s12248-023-00855-w.

Abstract

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.

摘要

纳米颗粒可以包裹一系列治疗药物,从小分子药物到敏感的生物制剂,从而显著改善它们的生物分布和生物稳定性。尽管已经有几种纳米制剂获得了监管部门的批准,证明了它们的可转化性,但未来纳米制剂的转化仍存在一些障碍,导致候选纳米制剂在药物开发过程中失败率很高。其中一个障碍是,纳米级颗粒合成的精确控制难度较大,导致颗粒之间存在异质性,从而阻碍了制造和质量控制以及监管质量检查。为了理解和减轻这种异质性,需要在纳米制剂特性表征方面取得进展,超越传统的批量方法,采用更精确的单颗粒技术。在这篇综述中,我们比较了商业上可用的单颗粒技术,特别关注单颗粒拉曼光谱,以提供一个指南,帮助采用这些方法进入开发工作流程,最终减少未来纳米制剂转化的障碍。

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