Novartis Pharma AG, Global Development, Novartis Campus, 4056 Basel, Switzerland; Novartis Pharma AG, Novartis Technical Operations Aseptics, 4332 Stein, Switzerland; Department of Pharmaceutical Sciences, University of Basel, Klingelbergstrasse 50, 4056 Basel, Switzerland.
Novartis Pharma AG, Global Development, Novartis Campus, 4056 Basel, Switzerland.
J Pharm Sci. 2019 Sep;108(9):2949-2963. doi: 10.1016/j.xphs.2019.04.013. Epub 2019 Apr 18.
The accumulation of electrostatic charge on drug particles and excipient powders arising from interparticulate collisions or contacts with other surfaces can lead to agglomeration and adhesion problems during the manufacturing process, filling, and delivery of dry powder inhaler (DPI) formulations. The objective of the study was to investigate the role of triboelectrification to better understand the influence of electrostatic charge on the performance of DPIs with 2 capsule-based dimensionally similar devices constructed with different materials. In addition, strategies to reduce electrostatic charge build up during the manufacturing process, and the processes involved in this phenomenon were investigated. Electrostatic charge measurements showed that there was a significant difference in electrostatic charge generated between tested formulations and devices. This affects particle detachment from carrier and thus significantly impacts aerosol performance. Conditioning fluticasone DPI capsules at defined temperature and humidity conditions reduced electrostatic charges acquired during manufacturing. Conditioning salmeterol DPI capsules at same conditions seemed disadvantageous for their aerosol performance because of increasing capillary forces and solid bridge formation caused by water absorption. Knowledge and understanding of the role of electrostatic forces in influencing DPI formulation performance was increased by these studies.
药物颗粒和赋形剂粉末由于颗粒间的碰撞或与其他表面接触而产生的静电积累,可能导致干粉吸入剂(DPI)制剂在制造、填充和输送过程中出现团聚和粘附问题。本研究的目的是探讨电摩擦起电的作用,以便更好地了解静电电荷对具有两种基于胶囊的尺寸相似装置的 DPI 性能的影响,这两种装置由不同的材料制成。此外,还研究了减少制造过程中静电积累的策略,以及这一现象涉及的过程。静电电荷测量表明,测试配方和装置之间产生的静电电荷有很大差异。这会影响载药颗粒从载体上的脱落,从而显著影响气溶胶性能。在规定的温度和湿度条件下对氟替卡松 DPI 胶囊进行调理,可以减少制造过程中获得的静电电荷。然而,在相同条件下对沙美特罗 DPI 胶囊进行调理,由于吸水引起的毛细作用力和固体桥形成,似乎对其气溶胶性能不利。这些研究增加了我们对静电在影响 DPI 制剂性能方面的作用的认识和理解。