Impact of Vertical Blender Unit Parameters on Subsequent Process Parameters and Tablet Properties in a Continuous Direct Compression Line
The continuous manufacturing of solid oral-dosage forms represents an emerging technology among the pharmaceutical industry, where several process steps are combined in one production line. As all mixture components, including the lubricant (magnesium stearate), are passing simultaneously through one blender, an impact on the subsequent process steps and critical product properties, such as content uniformity and tablet tensile strength, is to be expected.
进行实验（DOE）的设计，以研究搅拌器变量保持质量（HUM），叶轮速度（IMP）和通量（THR）对混合步骤的影响和随后的连续制造工艺步骤。对混合参数的显着影响（退出阀开口宽度（EV），出口阀开口宽度标准偏差（EV SD），下叶轮的扭矩（TL），较低叶轮SD的扭矩（tLSD), HUM SD and blend potency SD), material attributes of the blend (conditioned bulk density (CBD), flow rate index (FRI) and particle size (d10值）），压片参数（填充深度（FD），底部主压缩高度（BCH）和喷射力（EF））和片剂性能（平板电脑厚度（TT），平板重量（TW）和拉伸强度（TS））可以被发现。
Furthermore, relations between these process parameters were evaluated to define which process states were caused by which input variables. For example, the mixing parameters were mainly impacted by impeller speed, and material attributes, FD and TS were mainly influenced by variations in total blade passes (TBP). The current work presents a rational methodology to minimize process variability based on the main blender variables hold-up mass, impeller speed and throughput. Moreover, the results facilitated a knowledge-based optimization of the process parameters for optimum product properties.
Download the full article as a PDF here要么阅读这里
Materials:For this trial, saccharin sodium monohydrate (JMC, Ulsan, South Korea), microcrystalline cellulose (Avicel PH 102, FMC, Cork, Ireland), calcium di-phosphate (A-Tab, Innophos, Chicago Heights, IL, USA),淀粉糖酸钠(Roquette，法国，法国）和镁硬脂酸盐V (Mallinckrodt, St. Louis, MO, USA) were used.
文章信息：Kreiser，M.J .;Wabel，C .;瓦格纳，K.G.垂直搅拌机单元参数对连续直接压缩线的后续工艺参数和平板电脑特性的影响。药剂学2022,14, 278. https://doi.org/10.3390/pharmaceutics14020278
