Naik Shivangi, Hancock Bruno, Abramov Yuriy, Yu Weili, Rowland Martin, Huang Zhonghui, Chaudhuri Bodhisattwa
Department of Pharmaceutical Sciences, University of Connecticut, Storrs, Connecticut 06269.
Material Sciences, Pfizer Inc, Groton, Connecticut 06340.
J Pharm Sci. 2016 Apr;105(4):1467-77. doi: 10.1016/j.xphs.2015.12.024. Epub 2016 Feb 23.
Pharmaceutical powders are very prone to electrostatic charging by colliding and sliding contacts. In pharmaceutical formulation processes, particle charging is often a nuisance and can cause problems in the manufacture of products, such as affecting powder flow, fill, and dose uniformity. For a fundamental understanding of the powder triboelectrification, it is essential to study charge transfer under well-defined conditions. Hence, all experiments in the present study were conducted in a V-blender located inside a glove box with a controlled humidity of 20%. To understand tribocharging, different contact surfaces, namely aluminum, Teflon, poly methyl methacrylate, and nylon were used along with 2 pharmaceutical excipients and 2 drug substances. For the pharmaceutical materials, the work function values were estimated using MOPAC, a semiempirical molecular orbital package which has been previously used for the solid-state studies and molecular structure predictions. For a mechanistic understanding of tribocharging, a discrete element model incorporating charge transfer and electrostatic forces was developed. An effort was made to correlate tribocharging of pharmaceutical powders to properties such as cohesive energy density and surface energy. The multiscale model used is restricted as it considers only spherical particles with smooth surfaces. It should be used judiciously for other experimental assemblies because it does not represent a full validation of a tightly integrated model.
药物粉末极易因碰撞和滑动接触而产生静电。在药物制剂过程中,颗粒带电常常是个麻烦事,会在产品制造过程中引发问题,比如影响粉末流动性、装填和剂量均匀性。为了从根本上理解粉末摩擦起电现象,在明确界定的条件下研究电荷转移至关重要。因此,本研究中的所有实验均在湿度控制为20%的手套箱内的V型混合器中进行。为了理解摩擦起电,使用了不同的接触表面,即铝、聚四氟乙烯、聚甲基丙烯酸甲酯和尼龙,以及两种药用辅料和两种原料药。对于药物材料,使用MOPAC估算功函数值,MOPAC是一种半经验分子轨道程序包,此前已用于固态研究和分子结构预测。为了从机理上理解摩擦起电,开发了一个包含电荷转移和静电力的离散元模型。人们努力将药物粉末的摩擦起电与内聚能密度和表面能等性质联系起来。所使用的多尺度模型存在局限性,因为它只考虑表面光滑的球形颗粒。由于它不能代表紧密集成模型的全面验证,因此在其他实验装置中应谨慎使用。