Department of Pharmacy, GEA-NUS Pharmaceutical Processing Research Laboratory, National University of Singapore, 18 Science Drive 4, Singapore 117543, Singapore.
Department of Pharmacy, GEA-NUS Pharmaceutical Processing Research Laboratory, National University of Singapore, 18 Science Drive 4, Singapore 117543, Singapore.
J Pharm Sci. 2019 Mar;108(3):1161-1171. doi: 10.1016/j.xphs.2018.09.005. Epub 2018 Sep 17.
Die filling is a critical process step during tablet production as it defines the tablet weight. Achieving die fill consistency during production of mini-tablets, tablets with diameters ≤6 mm, is considerably more challenging. Although die filling in rotary presses had been studied in relation to the feed paddle design, paddle speed, and turret speed, it is unclear how these process variables could impact mini-tablet production and product properties. In this study, 1.8 and 3 mm mini-tablets were prepared using a rotary press with multiple-tip tooling using different process configurations. Mini-tablet weight variation within and across compaction cycles were determined using data from compression roller displacement and mini-tablet weight. Higher die fill densities were achieved with a flat feed wheel paddle and high paddle speed. This was attributed to better granule fluidization in the feed frame, which also increased the intercycle weight variation and reduced tensile strength. The turret speed did not impact mini-tablet properties significantly. Granule overlubrication in the feed frame potentially reduced mini-tablet tensile strength during compaction. The number of paddle passes in the die fill region was correlated to mini-tablet die fill performance. Findings from this study could provide better insights into the relationship between process variables and mini-tablet product quality.
压片是片剂生产过程中的一个关键步骤,因为它决定了片剂的重量。在生产直径≤6 毫米的微型片剂时,实现压模填充的一致性具有相当大的挑战性。尽管已经研究了旋转压片机中的压模填充与给料桨设计、桨叶速度和转塔速度之间的关系,但尚不清楚这些工艺变量如何影响微型片剂的生产和产品性能。在这项研究中,使用具有多尖端工具的旋转压片机,采用不同的工艺配置,制备了 1.8 毫米和 3 毫米的微型片剂。通过从压辊位移和微型片剂重量中获取数据,确定了压模填充过程中微型片剂在单个和多个压缩循环内的重量变化。采用平桨叶和高桨叶速度的进料轮可实现更高的压模填充密度。这归因于在给料框中更好的颗粒流化,这也增加了循环间的重量变化并降低了拉伸强度。转塔速度对微型片剂性能的影响不大。在给料框中颗粒过度润滑可能会降低微型片剂在压缩过程中的拉伸强度。模具填充区域中桨叶的通过次数与微型片剂的模具填充性能相关。本研究的结果可以提供更好的见解,了解工艺变量与微型片剂产品质量之间的关系。