Varacca Giada, D'Angelo Davide, Glieca Stefania, Cavalieri Luca, Piraino Alessio, Quarta Eride, Sonvico Fabio, Buttini Francesca
Food and Drug Department, University of Parma, Parco Area delle Scienze 27/A, Parma 43124, Italy.
Medical Affairs Chiesi Italy S.p.A., Via Giacomo Chiesi 1, Parma 43122, Italy.
Eur J Pharm Sci. 2023 Apr 1;183:106385. doi: 10.1016/j.ejps.2023.106385. Epub 2023 Jan 13.
The correct use of dry powder inhalers by the patients is essential to ensure effective treatment and management of the disease. The purpose of the work was to assess the consequence of inhaler misuse in terms of emitted dose and aerodynamic parameters. One reservoir multidose device (Foster-NEXThaler®) and one pre-dosed device (Relvar-Ellipta®), both sharing the "open, inhale and close" procedure, were the subject of the study. NEXThaler activated at different degrees of inclination showed a consistent dose delivery for both the drugs included in the formulation (beclometasone dipropionate/formoterol fumarate). Contrary, Ellipta showed a decrease of the emitted dose for both fluticasone furoate (FluF) and vilanterol trifenatate (VT) when the device was operated facing downward (-14% at 45° and -22% at 90°). Similarly, the delivered dose of NEXThaler was unaffected by an accidental fall, while Ellipta released FluF and VT doses 50% lower than control values. The presence of the dose protector in NEXThaler offers the advantage of retaining the powder if the inhaler is subjected to incorrect manipulations. Both products proved to be reliable in double activation. Finally, simulation exhalation conditions impaired, although not significantly, the aerodynamic profile of the two products.
患者正确使用干粉吸入器对于确保疾病的有效治疗和管理至关重要。这项工作的目的是评估吸入器误用在喷出剂量和空气动力学参数方面的后果。一种储库多剂量装置(福斯特-下一代吸入器®)和一种预填充剂量装置(信必可都保®),两者都采用“打开、吸入和关闭”程序,是该研究的对象。下一代吸入器在不同倾斜度下启动时,制剂中所含的两种药物(丙酸倍氯米松/富马酸福莫特罗)的剂量输送均保持一致。相反,当都保装置向下操作时(45°时降低14%,90°时降低22%),氟替卡松糠酸酯(FluF)和三苯乙酸维兰特罗(VT)的喷出剂量均降低。同样,下一代吸入器的输送剂量不受意外掉落的影响,而都保释放的FluF和VT剂量比对照值低50%。下一代吸入器中的剂量保护器具有这样的优势,即如果吸入器受到不正确操作,它可以保留粉末。两种产品在重复启动时都被证明是可靠的。最后,模拟呼气条件虽然对两种产品的空气动力学特性影响不显著,但还是造成了一定损害。