Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, P.O. Box 56, (Viikinkaari 5E), FIN-00014, Finland.
Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, P.O. Box 56, (Viikinkaari 5E), FIN-00014, Finland.
Int J Pharm. 2020 May 15;581:119280. doi: 10.1016/j.ijpharm.2020.119280. Epub 2020 Mar 27.
Powder flowability plays an important role in die filling during tablet manufacturing. The present study introduces a novel small-scale measuring technique for powder flow. Based on image analysis, the flow was defined depending on the variation of luminous intensity and the movement of powder inside the measurement cuvette. Using quantities around 100 mg it was possible to characterize a wide range of common pharmaceutical powders, especially in distinguishing subtle differences in flow caused by minor changes in samples characteristics. The method was compared with powder rheometry, which is widely used in the pharmaceutical literature, and showed a significant improvement in predicting the success of pharmaceutical minitablet manufacture (d = 5 mm). Tablet weight variation (RSD) was defined as the most efficient way to assess relevant powder flow behaviour in tablet production when using the novel device. The proposed method was distinguished from others by its ability to classify different grades of microcrystalline cellulose in the die-filling process. Subsequently, eight common pharmaceutical powders, both excipients and APIs, were properly ranked as a function of flowability based on their physical properties. The method showed a high repeatability, with a relative standard deviation not more than 10%.
粉末流动性在片剂制造过程中的压模填充中起着重要作用。本研究介绍了一种粉末流动的新型小规模测量技术。基于图像分析，流动取决于测量小瓶内光强度的变化和粉末的运动。使用约 100mg 的粉末，可以对各种常见的医药粉末进行特性描述，特别是在区分由于样品特性的微小变化而导致的细微流动差异方面。该方法与在医药文献中广泛使用的粉末流变学进行了比较，结果表明，该方法在预测医药迷你片剂制造的成功方面有了显著的改进（d=5mm）。当使用新型装置时，片剂重量变化（RSD）被定义为评估相关粉末流动行为的最有效方法。该方法的特点是能够在压模填充过程中对不同等级的微晶纤维素进行分类。随后，根据其物理性质，将八种常用的医药粉末（赋形剂和原料药）进行了适当的流动性排序。该方法具有较高的重复性，相对标准偏差不超过 10%。
