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Advanced microscopy techniques to assess solid-state properties of inhalation medicines

机译：先进的显微镜技术可评估吸入药的固态特性

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摘要

Efficient control and characterisation of the physico-chemical properties of active pharmaceutical ingredients (APIs) and excipients for orally inhaled drug products (OIDPs) are critical to successful product development. Control and reduction of risk require the introduction of a material science based approach to product development and the use of advanced analytical tools in understanding how the solid-state properties of the input materials influence structure and product functionality. The key issues to be addressed, at a microscopic scale, are understanding how the critical quality attributes of input materials influence surface, interfacial and particulate interactions within OIDPs. This review offers an in-depth discussion on the use of advanced microscopy techniques in characterising of the solid-state properties of particulate materials for OIDPs. The review covers the fundamental principles of the techniques, instrumentation types, data interpretation and specific applications in relation to the product development of OIDPs.
机译：有效控制和表征口服药物产品（OIDP）的活性药物成分（API）和赋形剂的理化性质对于成功开发产品至关重要。控制和降低风险要求在产品开发中采用基于材料科学的方法，并使用先进的分析工具来了解输入材料的固态特性如何影响结构和产品功能。在微观尺度上要解决的关键问题是了解输入材料的关键质量属性如何影响OIDP内部的表面，界面和微粒相互作用。这篇综述深入讨论了使用先进的显微镜技术表征OIDP颗粒材料的固态特性。审查涵盖了与OIDP产品开发相关的技术，仪器类型，数据解释和特定应用的基本原理。

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