Yan Peng, Hou Zhiyuan, Ding Jinsong
Xiangya School of Pharmaceutical Sciences, Central South University, Changsha, 410006, China.
Changsha Jingyi Pharmaceutical Technology Co., Ltd., Changsha, 410006, China.
J Pharm Anal. 2025 May;15(5):101156. doi: 10.1016/j.jpha.2024.101156. Epub 2024 Nov 26.
The microstructures of pharmaceutical preparations play a pivotal role in determining their critical quality attributes (CQAs), such as drug release, content uniformity, and stability, which greatly impact the safety and efficacy of drugs. Unlike the inherent molecular structures of active pharmaceutical ingredients (APIs) and excipients, the microstructures of pharmaceutical preparations are developed during the formulation process, presenting unique analytical challenges. In this review, we primarily focus on presenting the research methods used to elucidate the microstructures of pharmaceutical preparations, including X-ray imaging (XRI), scanning electron microscopy (SEM), atomic force microscopy (AFM), Raman spectroscopy, infrared (IR) spectroscopy, and rheometer technology. Subsequently, we highlight the applications, advantages, and limitations of these methods. Finally, we discuss the current challenges and future perspectives in this field. This review aims to provide a comprehensive reference for understanding the microstructures of pharmaceutical preparations, offering new insights and potential advancements in their development.
药物制剂的微观结构在决定其关键质量属性（CQAs）方面起着关键作用，如药物释放、含量均匀度和稳定性，这些对药物的安全性和有效性有很大影响。与活性药物成分（APIs）和辅料的固有分子结构不同，药物制剂的微观结构是在制剂过程中形成的，这带来了独特的分析挑战。在本综述中，我们主要专注于介绍用于阐明药物制剂微观结构的研究方法，包括X射线成像（XRI）、扫描电子显微镜（SEM）、原子力显微镜（AFM）、拉曼光谱、红外（IR）光谱和流变仪技术，并随后强调这些方法的应用、优点和局限性。最后，我们讨论该领域当前的挑战和未来展望。本综述旨在为理解药物制剂的微观结构提供全面的参考，为其开发提供新的见解和潜在进展。
