Trudell Medical International, London, Ontario, Canada.
AAPS PharmSciTech. 2011 Sep;12(3):965-88. doi: 10.1208/s12249-011-9662-6. Epub 2011 Jul 22.
The purpose of this article is to review non-impactor-based methods for measuring particle size distributions of orally inhaled and nasal pharmaceutical aerosols. The assessment of the size distributions of sprays and aerosols from orally inhaled and nasal drug products by methods not involving multi-stage cascade impaction may offer significant potential advantages in terms of labor savings and reducing the risk for operator-related errors associated with complex-to-undertake impactor-based methods. Indeed, in the case of nasal spray products, cascade impaction is inappropriate and alternative, and preferably non-invasive methods must be sought that minimize size-related bias associated with the measurement process for these relatively large droplets. This review highlights the options that are available to those involved with product quality assessments, providing guidance on relative strengths and weaknesses, as well as highlighting precautions that should be observed to minimize bias. The advent of Raman chemical imaging, which enables an estimate to be made of the proportion of each particle comprising active pharmaceutical ingredient(s) (APIs), necessitates a re-think about the value of classical microscopy image analysis as now being capable of providing API-relevant information from collected aerosols and sprays.
本文旨在综述非撞击器法在测量吸入式和鼻用药物气溶胶的粒径分布中的应用。对于吸入式和鼻用药物产品的喷雾和气溶胶，采用不涉及多级级联撞击器的方法评估其粒径分布，在节省劳动力和降低与复杂撞击器法相关的操作人员误差风险方面具有显著的潜在优势。事实上，在鼻喷雾剂产品的情况下，级联撞击器法是不适用的，必须寻求替代方法，最好是采用非侵入性方法，以尽量减少与这些相对较大液滴的测量过程相关的尺寸偏差。本综述突出了那些参与产品质量评估的人员可选择的方法，提供了关于相对优缺点的指导，并强调了应注意的注意事项，以尽量减少偏差。拉曼化学成像的出现使人们能够估计包含活性药物成分（APIs）的每个颗粒的比例，这就需要重新考虑经典显微镜图像分析的价值，因为现在它能够从收集的气溶胶和喷雾中提供与 API 相关的信息。
