Investigation into powder tribo-charging of pharmaceuticals. Part I: Process-induced charge via twin-screw feeding

被引:12
作者
Beretta, M. [1 ,2 ,3 ]
Hoermann, T. R. [1 ,2 ]
Hainz, P. [1 ]
Hsiao, W-K [1 ,2 ]
Paudel, A. [1 ,2 ,3 ]
机构
[1] Res Ctr Pharmaceut Engn GmbH, Inffeldgasse 13-2, A-8010 Graz, Austria
[2] European Consortium Continuous Pharmaceut Mfg ECC, Graz, Austria
[3] Graz Univ Technol, Inst Proc & Particle Engn, Graz, Austria
关键词
Tribo-charging; Pharmaceutical powders; Powder processing; Twin-screw feeding; Continuous manufacturing; Powder characterization; MICROCRYSTALLINE CELLULOSE; COMPACTION PROPERTIES; HUMIDITY; FLOW; TRIBOELECTRIFICATION; ELECTROSTATICS; CRYSTALLINITY; ADDITIVES; EQUIPMENT; MANNITOL;
D O I
10.1016/j.ijpharm.2020.120014
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Powder feeding is a crucial unit operation in continuous manufacturing (CM) of pharmaceutical products. Twin-screw feeders are typically employed to ensure the accurate mass flow of pharmaceutical materials throughout the production process. Here, contact and separation of particles can give rise to electrostatic charges, affecting feeder performance and final product quality. The knowledge of the material charging tendency would therefore be beneficial for both formulation and process design. At the early stage of product development, only a limited amount of material is available and the propensity of the powders to charge needs to be assessed on lab test equipment, which not necessarily represent the material state during processing. In this study, the tribo-charging behaviour of a set of common pharmaceutical materials (i.e., microcrystalline cellulose, D-mannitol, paracetamol and magnesium stearate) was experimentally evaluated. To this end, powder materials were let to flow over the stainless-steel pipes of the GranuCharge (TM) instrument. The resulting charge was compared to the one acquired during twin-screw feeding. In both cases, paracetamol exhibited the highest charging tendency followed by D-mannitol and microcrystalline cellulose and last by magnesium stearate. A good correlation was found for charge values obtained for both methods, despite the different tribo-charging mechanisms involved in the two set-ups. However, these differences in experimental set-ups led to diverse magnitudes and, in one case, polarity of charge. Additionally, an extensive material characterization was performed on the selected powders and results were statistically analyzed to identify critical material attributes (CMAs) affecting powder tribo-charging. A strong correlation was obtained between the measured charge and inter-particle friction. This indicated the latter as one of the most influencing material characteristic impacting the powder tribo-charging phenomenon of the selected materials.
引用
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页数:11
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