形态定向拉曼光谱检测在混悬型鼻喷剂生物等效性研究中的应用

Application of Morphologically-directed Raman Spectroscopy in the Bioequivalence Study of Suspension-based Nasal Spray

混悬型鼻用喷雾剂的生物等效性研究对于仿制药开发者而言是一项具有挑战性的任务。研究者不仅要按照指导原则的要求,对辅料用量和制剂特性进行一致性研究,更需要通过分析工具来确定活性药物成分的粒径大小、粒度分布等关键质量属性的一致性。该文探讨了形态定向拉曼光谱法在研究鼻腔悬浮液粒度分布中的应用。该方法已被美国FDA批准用于替代临床终点生物等效性的研究,对降低混悬型鼻用喷雾剂类产品一致性评价的成本、加快其研发速度有重要作用。

Bioequivalence studies of suspension-based nasal sprays are challenging tasks for generic drug developers.Researchers should not only conduct consistency studies on the dosage and formulation characteristics of excipients in accordance with the requirements of the guidelines,but also need to use analytical tools to determine the consistency of key quality attributes such as particle size and particle size distribution of active pharmaceutical ingredients.This study explored the application of morphologically-directed Raman spectroscopy in the study of particle size distribution of nasal suspensions.The method has been approved by the U.S.FDA for the studies that substitute bioequivalence of clinical endpoints,which is critical for cost reduction and faster development for consistency evaluation of suspension-based nasal spray products.