The University of Copenhagen, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, 2100 Copenhagen, Denmark.
Department of Pharmaceutics, University of Minnesota, 308 Harvard St. S.E, Minneapolis, MN 55455.
J Pharm Sci. 2019 Aug;108(8):2613-2620. doi: 10.1016/j.xphs.2019.03.012. Epub 2019 Mar 20.
The storage of bulk powders in suboptimal conditions can affect their handling, processing, and performance. The aim of this work was to assess the influence of storage conditions on powder flowability, which is a crucial property in powder processing. The 7 model compounds were common tablet excipients with varying crystallinity ranging from amorphous to partially crystalline, and 2 crystalline materials. The water sorption-desorption isotherms of all the excipients were analyzed with dynamic vapor sorption, and the kinetics of the water sorption at 75% relative humidity were investigated using isothermal microcalorimetry. In addition, the powders were conditioned at 3 relative humidities 23%, 43%, and 75% at ambient temperature, and their flowability was measured using 3 different techniques: ring shear testing, basic flowability energy, and flow through an orifice. All 3 methods were able to detect the storage-related change in flowability induced by varying storage conditions. With increasing storage humidity, a trend toward a decrease in powder flowability could be detected with the chosen instruments. Furthermore, the same rank order of powder flowability could be observed using the flow through an orifice and ring shear testing method.
散装粉末在不理想的条件下储存会影响其处理、加工和性能。本工作旨在评估储存条件对粉末流变性的影响,粉末流变性是粉末加工中的一个关键性质。7 种模型化合物为常见的片剂赋形剂,结晶度从无定形到部分结晶,以及 2 种结晶材料不等。所有赋形剂的水分吸附-解吸等温线均采用动态蒸汽吸附法进行分析,并采用等温微量热法研究了在 75%相对湿度下的水分吸附动力学。此外,将粉末在 3 种相对湿度(23%、43%和 75%)和环境温度下进行条件处理,并使用 3 种不同技术测量其流动性:环剪测试、基本流动性能量和通过孔口流动。所有 3 种方法都能够检测到由于储存条件的变化而导致的与储存相关的流动性变化。随着储存湿度的增加,可以用所选仪器检测到粉末流动性的下降趋势。此外,使用通过孔口和环剪测试的方法可以观察到相同的粉末流动性顺序。