GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore 117543, Singapore.
GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore 117543, Singapore.
Eur J Pharm Sci. 2018 Sep 15;122:105-115. doi: 10.1016/j.ejps.2018.06.026. Epub 2018 Jun 27.
Die filling is a critical step during pharmaceutical tablet production and is still not well understood due to the rather complex interplay between particle attributes, die orifice diameter and fill energetics. While shoe-die filling models have been used to simulate die filling conditions, they typically lack the sophistication of the actual production-scale, feeder-based die filling conditions. The relationship between tableting process parameters and filling into die orifices of different diameters by powders of different flowabilities requires critical examination and understanding. In this study, a special die filling contraption was designed and custom-made to simulate the effects of gravity, suction and feeder paddle assistance as present in modern rotary tablet presses. Die fill performance was studied using powders with different flow properties. Suction impact was greatest on die fill, in particular, for small orifice diameters and less permeable powders. Effect of paddle velocity on die fill was greater for compressible powders and larger orifice diameters. In comparison to suction and paddle velocity, forced feeding did not significantly affect die fill performance. Relationship between process parameters and die fill performance was found to be highly dependent on the material and orifice diameter.
压片是制药片剂生产过程中的一个关键步骤，但由于颗粒特性、模孔直径和填充能量之间相当复杂的相互作用，其仍未得到很好的理解。虽然鞋模填充模型已被用于模拟压模填充条件，但它们通常缺乏实际生产规模、基于给料器的压模填充条件的复杂性。需要对片剂工艺参数与不同流动性粉末在不同直径模孔中的填充之间的关系进行严格检查和理解。在这项研究中，设计并定制了一种特殊的压模填充装置，以模拟现代旋转压片机中存在的重力、抽吸和给料器桨叶辅助的影响。使用具有不同流动性能的粉末研究了压模填充性能。抽吸对压模填充的影响最大，特别是对于小模孔直径和渗透性较差的粉末。桨叶速度对压模填充的影响对于可压缩粉末和较大的模孔直径更大。与抽吸和桨叶速度相比，强制进料对压模填充性能的影响并不显著。发现工艺参数与压模填充性能之间的关系高度依赖于材料和模孔直径。
