Wahl Verena, Leitgeb Stefan, Laggner Peter, Pichler Harald, Liebminger Andreas, Khinast Johannes
Research Center Pharmaceutical Engineering, Graz, Austria; Institute for Process and Particle Engineering, University of Technology, Graz, Austria.
Research Center Pharmaceutical Engineering, Graz, Austria.
Eur J Pharm Biopharm. 2015 Apr;91:1-8. doi: 10.1016/j.ejpb.2015.01.006. Epub 2015 Jan 21.
The purpose of this work was to investigate the influence of residual water in freeze-dried protein powders on the dissolution behavior of the solid-state proteins. To that end, six freeze-dried fibrinogen powder lots were stored at four levels of relative humidity and analyzed with regard to the particle size and shape, the specific surface area, the solid state of protein and the inner surface. Furthermore, the dissolution behavior of the powders was investigated. We clearly identified differences in the specific surface area, specific inner surface area, crystallinity, particle size and shape, which we were able to correlate to the dissolution behavior. These differences were triggered due to the different levels of residual moisture during two weeks of storage. Thus, we were able to show that the storage conditions have significant impact on the processing of pharmaceutical protein materials.
这项工作的目的是研究冻干蛋白质粉末中的残留水分对固态蛋白质溶解行为的影响。为此，将六批冻干纤维蛋白原粉末在四个相对湿度水平下储存，并对其粒度和形状、比表面积、蛋白质的固态和内表面进行分析。此外，还研究了这些粉末的溶解行为。我们明确确定了比表面积、比内表面积、结晶度、粒度和形状方面的差异，并能够将这些差异与溶解行为联系起来。这些差异是由于储存两周期间残留水分水平不同而引发的。因此，我们能够证明储存条件对药用蛋白质材料的加工有重大影响。
