Buschmüller Caroline, Wiedey Wolfgang, Döscher Claas, Dressler Jochen, Breitkreutz Jörg
Institute of Pharmaceutics and Biopharmaceutics, Heinrich - Heine University, Düsseldorf, Germany.
Eur J Pharm Biopharm. 2008 May;69(1):380-7. doi: 10.1016/j.ejpb.2007.09.014. Epub 2007 Oct 1.
This is the first report on in-line moisture measurement of pharmaceutical products by microwave resonance technology. In order to meet the FDA's PAT approach, a microwave resonance sensor appropriate for pharmaceutical use was developed and implemented into two different fluidized-bed dryers. The novel sensor enables a continuous moisture measurement independent from the product density. Hence, for the first time precise real time determination of the moisture in pharmaceutical granules becomes possible. The qualification of the newly developed sensor was performed by drying placebo granules under experimental conditions and the validation using drug loaded granules under real process conditions. The results of the investigations show good correlations between water content of the granules determined by the microwave resonance sensor and both reference methods, loss on drying by infrared light exposure and Karl Fischer titration. Furthermore, a considerable time saving in the drying process was achieved through monitoring the residual water content continuously by microwave resonance technology instead of the formerly used discontinuous methods.
这是关于采用微波共振技术对药品进行在线水分测量的首份报告。为满足美国食品药品监督管理局（FDA）的过程分析技术（PAT）方法，开发了一种适用于制药用途的微波共振传感器，并将其应用于两种不同的流化床干燥机中。这种新型传感器能够独立于产品密度进行连续水分测量。因此，首次实现了对药物颗粒水分的精确实时测定。通过在实验条件下干燥安慰剂颗粒以及在实际生产条件下使用载药颗粒进行验证，对新开发的传感器进行了鉴定。研究结果表明，微波共振传感器测定的颗粒含水量与两种参考方法（红外光照射干燥失重法和卡尔费休滴定法）之间具有良好的相关性。此外，通过使用微波共振技术连续监测残留水分含量，而非以前使用的间断方法，在干燥过程中节省了大量时间。
