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药物粉末摩擦荷电研究。第二部分:对相对湿度的敏感性。

Investigation into powder tribo-charging of pharmaceuticals. Part II: Sensitivity to relative humidity.

机构信息

Research Center Pharmaceutical Engineering GmbH, Graz 8010, Austria; European Consortium for Continuous Pharmaceutical Manufacturing (ECCPM), Graz 8010, Austria; Institute of Process and Particle Engineering, Graz University of Technology, Graz 8010, Austria.

Research Center Pharmaceutical Engineering GmbH, Graz 8010, Austria; European Consortium for Continuous Pharmaceutical Manufacturing (ECCPM), Graz 8010, Austria.

出版信息

Int J Pharm. 2020 Dec 15;591:120015. doi: 10.1016/j.ijpharm.2020.120015. Epub 2020 Oct 22.

Abstract

Environmental conditions can have a profound impact on the bulk behaviour of pharmaceutical powders, including their tribo-charging tendency. Typically, high relative humidity (RH) has been associated to a reduction in the electrostatic charge of the material. However, the occurrence of charge mitigation seems to be related to the quantity of water molecules at the powder surface, which depends on intrinsic material attributes (i.e., water sorption propensity), and external factors (i.e., RH level). In the present study, pharmaceutical powders (i.e., microcrystalline cellulose, D-mannitol, paracetamol and magnesium stearate) were conditioned at three levels of RH, relevant for pharmaceutical operations, and their bulk behaviour, including charging propensity, was analyzed. Depending on the material type, powders sorbed water from the humid atmosphere to different extents, resulting in different charging behaviours. Overall, the charge density of the materials was found to decrease after a certain RH or monotonically decrease with an increase of RH, except for D-mannitol. For this material, a contrasting trend of increase in charging was observed with an increase in RH. Moreover, the powders showed a distinct tribo-charging sensitivity to RH, with paracetamol being the most affected. These findings suggest that a careful consideration on solid material-moisture interactions is needed when using RH as strategy to minimize electrostatic effects in powder processing.

摘要

环境条件会对药物粉末的整体行为产生深远影响,包括其摩擦带电倾向。通常,相对湿度(RH)较高会导致材料的静电电荷减少。然而,电荷缓解的发生似乎与粉末表面水分子的数量有关,而这又取决于内在材料属性(即水分吸附倾向)和外部因素(即 RH 水平)。在本研究中,将三种与药物操作相关的 RH 水平下对药物粉末(即微晶纤维素、D-甘露醇、对乙酰氨基酚和硬脂酸镁)进行了调节,并分析了它们的整体行为,包括带电倾向。根据材料类型的不同,粉末从潮湿的空气中吸附水分的程度不同,导致不同的带电行为。总体而言,除了 D-甘露醇外,材料的电荷密度在达到一定 RH 或随 RH 增加而单调下降。对于这种材料,观察到随着 RH 的增加,充电呈相反的增加趋势。此外,粉末对 RH 的摩擦带电敏感性明显不同,对乙酰氨基酚受影响最大。这些发现表明,在使用 RH 作为最小化粉末处理中静电效应的策略时,需要仔细考虑固体材料与水分的相互作用。

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