Zimmermann Maren, Michel Felix, Bartsch Jens, Thommes Markus
Laboratory of Solids Process Engineering, Department of Biochemical and Chemical Engineering, TU Dortmund University, Dortmund, Germany.
Drug Dev Ind Pharm. 2022 Dec;48(12):737-744. doi: 10.1080/03639045.2023.2165662. Epub 2023 Jan 12.
In powder compaction on rotary tablet presses, the addition of a lubricant is normally mandatory. However, the typical internal lubrication method tends toward overlubrication, resulting in an alteration of the critical quality attributes of the product. In this study, the feasibility of an external lubrication system only using electrostatics for the application was investigated.
Three well-established lubricants were analyzed regarding their ability to accumulate and retain charge. In subsequent tableting experiments, the impact of different lubrication methods on critical quality attributes and process parameters was investigated.
Due to material characteristics, the charge on magnesium stearate particles was most stable over time. The application of this lubricant on the punches via external lubrication with electrostatic forces resulted in a significant reduction of the ejection forces. Furthermore, the tensile strength of the tablets produced in these trials was significantly higher compared to tablets that were produced with internal lubrication.
The external lubrication method with an electrostatically charged lubricant is a promising method for reducing both the necessary amount of lubricant and the impact of the lubricant on the product.
在旋转式压片机进行粉末压片时,通常必须添加润滑剂。然而,典型的内部润滑方法容易导致润滑过度,从而改变产品的关键质量属性。在本研究中,对仅使用静电的外部润滑系统用于该应用的可行性进行了研究。
分析了三种常用润滑剂积累和保留电荷的能力。在随后的压片实验中,研究了不同润滑方法对关键质量属性和工艺参数的影响。
由于材料特性,硬脂酸镁颗粒上的电荷随时间最为稳定。通过静电力进行外部润滑将这种润滑剂施加到冲头上,显著降低了顶出力。此外,与采用内部润滑生产的片剂相比,这些试验中生产的片剂的抗张强度显著更高。
使用带静电润滑剂的外部润滑方法是一种有前景的方法,可减少所需润滑剂的用量以及润滑剂对产品的影响。