Department of Pharmaceutical Sciences, Wegmans School of Pharmacy, St. John Fisher College, Rochester, New York, USA.
Faculty of Pharmaceutical Sciences & Pharmaceutical Industries, Future University in Egypt, Cairo, Egypt.
Int J Pharm. 2017 Oct 30;532(1):299-312. doi: 10.1016/j.ijpharm.2017.09.009. Epub 2017 Sep 6.
The density, porosity, breaking force, viscoelastic properties, and the presence or absence of any structural defects or irregularities are important physical-mechanical quality attributes of popular solid dosage forms like tablets. The irregularities associated with these attributes may influence the drug product functionality. Thus, an accurate and efficient characterization of these properties is critical for successful development and manufacturing of a robust tablets. These properties are mainly analyzed and monitored with traditional pharmacopeial and non-pharmacopeial methods. Such methods are associated with several challenges such as lack of spatial resolution, efficiency, or sample-sparing attributes. Recent advances in technology, design, instrumentation, and software have led to the emergence of newer techniques for non-invasive characterization of physical-mechanical properties of tablets. These techniques include near infrared spectroscopy, Raman spectroscopy, X-ray microtomography, nuclear magnetic resonance (NMR) imaging, terahertz pulsed imaging, laser-induced breakdown spectroscopy, and various acoustic- and thermal-based techniques. Such state-of-the-art techniques are currently applied at various stages of development and manufacturing of tablets at industrial scale. Each technique has specific advantages or challenges with respect to operational efficiency and cost, compared to traditional analytical methods. Currently, most of these techniques are used as secondary analytical tools to support the traditional methods in characterizing or monitoring tablet quality attributes. Therefore, further development in the instrumentation and software, and studies on the applications are necessary for their adoption in routine analysis and monitoring of tablet physical-mechanical properties.
密度、孔隙率、断裂力、粘弹性特性以及是否存在任何结构缺陷或不规则性，都是片剂等常见固体制剂的重要物理机械质量属性。这些属性相关的不规则性可能会影响药物产品的功能。因此，准确高效地对这些特性进行表征，对于成功开发和制造坚固的片剂至关重要。这些特性主要通过传统药典和非药典方法进行分析和监测。这些方法存在一些问题，例如空间分辨率、效率或节省样本的特性不足。近年来，技术、设计、仪器和软件的进步，催生了用于非侵入式表征片剂物理机械特性的新技术。这些技术包括近红外光谱、拉曼光谱、X 射线断层摄影术、核磁共振（NMR）成像、太赫兹脉冲成像、激光诱导击穿光谱以及各种基于声和热的技术。这些最先进的技术目前在工业规模的片剂开发和制造的各个阶段得到应用。与传统分析方法相比，每种技术在操作效率和成本方面都具有特定的优势或挑战。目前，这些技术中的大多数都被用作辅助分析工具，用于支持传统方法对片剂质量属性进行表征或监测。因此，有必要在仪器和软件方面进行进一步的开发，并对这些技术的应用进行研究，以将其用于片剂物理机械特性的常规分析和监测。
