Faculty of Pharmacy, Meijo University, 150 Yagotoyama, Tempaku-ku, Nagoya, Aichi 468-8503, Japan; College of Pharmaceutical Sciences, Ritsumeikan University, Noji-higashi 1-1-1, Kusatsu, Shiga 525-8577, Japan; Department of Pharmacy, Shiga University of Medical Science Hospital, Seta Tsukinowa-cho, Otsu, Shiga 520-2192, Japan.
Faculty of Pharmacy, Meijo University, 150 Yagotoyama, Tempaku-ku, Nagoya, Aichi 468-8503, Japan.
J Pharm Sci. 2018 Jun;107(6):1731-1735. doi: 10.1016/j.xphs.2018.02.002. Epub 2018 Feb 8.
This study aimed at developing a novel analytical method to identify optimal inhalation flow patterns for commercial dry powder inhalers (DPIs) and pressurized metered dose inhalers (pMDIs). As typical commercial DPI and pMDI, Pulmicort Turbuhaler, and Sultanol Inhaler were evaluated by an in vitro inhalation performance testing system with a flow pattern simulator. An 8-stage Andersen cascade impactor (ACI) or twin stage liquid impinger (TSLI) was applied to determine the inhalation performance. The peak flow rate (PFR) of the inhalation flow pattern was set from 15 to 80 L/min in reference to our previous study. From TSLI test results, a higher PFR improved the inhalation performance of the DPI, while the performance of the pMDI was less affected by the PFR. Conversely, from ACI test results, the pMDI performance decreased with a higher PFR, while the DPI followed a similar pattern as in the TSLI test results, because ACI is a finer aerodynamic classification apparatus than TSLI. These results suggested that our in vitro system using a human inhalation flow pattern simulator successfully detected different optimal inhalation patterns between DPI and pMDI. That is, the higher PFR is better for Pulmicort Turbuhaler (DPI). Conversely, lower PFR is desirable for Sultanol Inhaler (pMDI).
本研究旨在开发一种新的分析方法，以确定商业干粉吸入器（DPI）和压力定量吸入器（pMDI）的最佳吸入气流模式。采用气流模式模拟器的体外吸入性能测试系统对典型的商业 DPI 和 pMDI（普米克都保和速乐特吸入器）进行评估。采用 8 级安德森级联撞击器（ACI）或双级液体撞击器（TSLI）来确定吸入性能。参考我们之前的研究，将吸入气流模式的峰值流速（PFR）设定为 15 至 80 L/min。从 TSLI 测试结果来看，较高的 PFR 提高了 DPI 的吸入性能，而 PFR 对 pMDI 的性能影响较小。相反，从 ACI 测试结果来看，pMDI 的性能随着 PFR 的升高而降低，而 DPI 的结果与 TSLI 测试结果相似，因为 ACI 是一种比 TSLI 更精细的空气动力学分类装置。这些结果表明，我们使用人体吸入气流模式模拟器的体外系统成功地检测到 DPI 和 pMDI 之间不同的最佳吸入模式。即，较高的 PFR 对普米克都保（DPI）更有利。相反，较低的 PFR 对速乐特吸入器（pMDI）更为理想。
