Gamble John F, Tobyn Mike, Hamey Rhye
Drug Product Science and Technology, Bristol-Myers Squibb, Reeds Lane, Moreton, Wirral, CH46 1QW, UK.
J Pharm Sci. 2015 May;104(5):1563-74. doi: 10.1002/jps.24382. Epub 2015 Feb 17.
With the introduction of Quality by Design (QbD) to the pharmaceutical industry, there has been an increased focus on understanding the nature of particles and composites, with the aim of understanding and modeling how they interact in complex systems, leading to robust dosage forms. Particle characterization tools have evolved and now enable a greater level of understanding of powder systems and blends. Tools that can elucidate the size and shape of particulate systems can provide significantly more information about the nature of the particles being analyzed, than a conventional particle size measurement. Although accurate size and shape analysis has always been regarded as the "gold standard" in understanding the nature of particulate systems, neither imaging systems nor IT infrastructure was sufficiently developed to allow this to be performed with sufficient accuracy in a timely manner. The aim of this review is to provide an insight into developments in the field of size and shape analysis of pharmaceutical systems, and how these can now realistically be used as robust development tools. Examples of current uses of such technologies will be explored as well as investigating future applications such as combined image/spectroscopic analyses to track single components within blended systems.
随着质量源于设计（QbD）引入制药行业，人们越来越关注颗粒和复合材料的性质，目的是了解并建立它们在复杂系统中相互作用的模型，从而得到稳健的剂型。颗粒表征工具不断发展，现在能够更深入地了解粉末系统和混合物。与传统的粒度测量相比，能够阐明颗粒系统尺寸和形状的工具可以提供关于被分析颗粒性质的更多信息。尽管准确的尺寸和形状分析一直被视为理解颗粒系统性质的“金标准”，但成像系统和信息技术基础设施都不够发达，无法及时以足够的精度进行此项分析。本综述的目的是深入了解制药系统尺寸和形状分析领域的发展情况，以及现在如何切实地将这些分析用作稳健的研发工具。将探讨此类技术的当前应用实例，并研究未来的应用，如联合图像/光谱分析以追踪混合系统中的单个成分。
