Kuentz Martin
Institute of Pharma Technology, University of Applied Sciences and Arts Northwestern Switzerland, Muttenz, Switzerland.
J Pharm Pharmacol. 2015 Feb;67(2):143-59. doi: 10.1111/jphp.12271. Epub 2014 May 18.
This review focuses on real-time analytics of drug dissolution and precipitation testing on a comparatively small scale.
Miniaturisation of test equipment is an important trend in pharmaceutics, and several small-scale experiments have been reported for drug dissolution and precipitation testing. Such tests typically employ analytics in real-time. Fibre optic ultraviolet (UV) analytics has become a well-established method in this field. Novel imaging techniques are emerging that use visible or UV light; also promising is Fourier transform infrared imaging based on attenuated total reflection. More information than just a rate constant is obtained from these methods. The early phase of a dissolution process can be assessed and drug precipitation may eventually be observed. Some real-time techniques are particularly well suited to studying drug precipitation during formulation dispersion; for example, turbidity, focused beam reflectance measurement and Raman spectroscopy.
Small-scale dissolution tests equipped with real-time analytics have become important to screen drug candidates as well as to study prototype formulations in early development. Future approaches are likely to combine different analytical techniques including imaging. Miniaturisation started with mini-vessels or small vials and future assays of dissolution research will probably more often reach the level of parallel well plates and microfluidic channels.
本综述聚焦于相对小规模的药物溶解和沉淀测试的实时分析。
测试设备的小型化是pharmaceutics领域的一个重要趋势，并且已经报道了一些用于药物溶解和沉淀测试的小规模实验。此类测试通常采用实时分析。光纤紫外（UV）分析已成为该领域一种成熟的方法。正在出现使用可见光或紫外光的新型成像技术；基于衰减全反射的傅里叶变换红外成像也很有前景。这些方法获得的信息不止是速率常数。可以评估溶解过程的早期阶段，最终可能观察到药物沉淀。一些实时技术特别适合研究制剂分散过程中的药物沉淀；例如，浊度、聚焦光束反射测量和拉曼光谱。
配备实时分析的小规模溶解测试对于筛选候选药物以及研究早期开发中的原型制剂已变得很重要。未来的方法可能会结合包括成像在内的不同分析技术。小型化始于小型容器或小瓶，未来的溶解研究分析可能会更频繁地达到平行孔板和微流控通道的水平。
