Biomedical Engineering Graduate Program, The University of Western Ontario, London, N6A 5B9, Canada.
AAPS PharmSciTech. 2013 Sep;14(3):1158-68. doi: 10.1208/s12249-013-0007-5. Epub 2013 Jul 30.
Pharmaceutical tablets are manufactured through a series of batch steps finishing with compression into a form using a tablet press. Lubricants are added to the powder mixture prior to the tabletting step to ensure that the tablet is ejected properly from the press. The addition of lubricants also affects tablet properties and can affect the behavior of the powder mixture. The objective of this research was to investigate the effect of lubricants on powder flowability as flowability into the tablet press is critical. Four lubricants (magnesium stearate, magnesium silicate, stearic acid, and calcium stearate) were mixed, in varying amounts, with spray-dried lactose. In addition, magnesium stearate was also mixed with placebo granules from a high-shear granulator. Measurements based on avalanche behavior indicated flowability potential and dynamic density and were more sensitive to changes in the mixture and provided a more accurate and reproducible indication of flowability than traditional static measurements. Of the tested lubricants, magnesium stearate provided the best increase in flowability even in the low amounts commonly added in formulations.
药用片剂是通过一系列批量步骤制造的,最后使用压片机将粉末压缩成片剂。在压片步骤之前,将润滑剂添加到粉末混合物中,以确保片剂从压片机中正确弹出。润滑剂的添加还会影响片剂的性质,并影响粉末混合物的行为。本研究的目的是研究润滑剂对粉末流动性的影响,因为粉末进入压片机的流动性至关重要。四种润滑剂(硬脂酸镁、硅酸镁、硬脂酸和硬脂酸钙)与喷雾干燥乳糖以不同的量混合。此外,硬脂酸镁还与高剪切制粒机中的安慰剂颗粒混合。基于崩落行为的测量表明了流动性潜力和动态密度,并且对混合物的变化更敏感,并且比传统的静态测量更准确和可重复地指示了流动性。在所测试的润滑剂中,即使在配方中通常添加的低用量下,硬脂酸镁也能提供最佳的流动性改善。