一种新型基于卡片的间隔器（MDI PLUS®）与传统的aerochamber PLUS®的比较评估：体内和体外生物利用度研究

IF 4.7 3区医学 Q1 PHARMACOLOGY & PHARMACY

European Journal of Pharmaceutical Sciences Pub Date : 2025-07-22 DOI:10.1016/j.ejps.2025.107215

Hasnaa Osama , Wesam G. Ammari , Ahmed H.M. Sobh , Marwa Mohsen , Marina Emad Boules , Basma M.E. Mohamed , Omar Ahmed Sayed , Mohamed E.A. Abdelrahim , Haitham Saeed

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引用次数: 0

摘要

背景：通过加压计量吸入器（pmdi）的有效气溶胶输送常常受到不良的驱动-吸入协调的影响。间隔装置通常用于改善肺沉积。本研究旨在比较单独通过pMDI、传统的AeroChamber Plus®隔离器和新型一次性MDI Plus®纸盒隔离器给药沙丁胺醇的肺部和全身生物利用度。方法在一项随机、三期交叉研究中，20名健康成人在每次吸入设置中接受5次（100µg/puff）沙丁胺醇。在吸入后30分钟（用于肺部生物利用度）和24小时（用于全身吸收）采集尿样。使用吸入过滤器的离体装置也用于量化总递送剂量。结果pMDI组沙丁胺醇离体平均±SD总收集剂量（352.35±23.41µg）显著高于AeroChamber Plus组（196.57±13.32µg）；0.001)和MDI Plus(182.86±11.34µg, p <；0.001)。使用AeroChamber Plus后30 min尿沙丁胺醇值显著升高(14.61±4.36µg, p <；0.001)和MDI Plus(10.97±3.83µg, p <；0.01)，与单独pMDI（5.92±1.07µg）相比。与同时使用AeroChamber Plus和MDI Plus时相比，单独使用pMDI时24 h尿沙丁胺醇的系统生物利用度（139.09±15.68µg）更高，分别为79.57±19.48和59.26±18.12µg, p <；0.001,分别。结论与单独使用pMDI相比，两种间隔剂均能显著增强肺输送，降低全身吸收。虽然AeroChamber Plus®向肺部输送的药物稍微多一些，但MDI Plus®垫片提供了一种具有成本效益的替代方案，适用于紧急情况和户外使用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Comparative evaluation of a novel card-based spacer (MDI PLUS®) versus traditional aerochamber plus®: In-vivo and ex-vivo bioavailability study

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Comparative evaluation of a novel card-based spacer (MDI PLUS®) versus traditional aerochamber plus®: In-vivo and ex-vivo bioavailability study

Background

Effective aerosol delivery via pressurized metered dose inhalers (pMDIs) is often compromised by poor actuation–inhalation coordination. Spacer devices are commonly used to improve lung deposition. This study aimed to compare the lung and systemic bioavailability of salbutamol delivered via pMDI alone, with a traditional AeroChamber Plus® spacer, and with a novel disposable MDI Plus® carton spacer.

Methods

In a randomized, three-period crossover study, 20 healthy adults received 5 puffs (100 µg/puff) of salbutamol via each inhalation setup. Urine samples were collected 30 min post-inhalation (for lung bioavailability) and over 24 h (for systemic absorption). An ex-vivo setup using inhalation filters was also employed to quantify total delivered dose.

Results

The ex-vivo mean ± SD total collected dose of salbutamol was significantly higher with pMDI alone (352.35±23.41 µg) than AeroChamber Plus (196.57±13.32 µg, p < 0.001) and MDI Plus (182.86±11.34 µg, p < 0.001). Urinary salbutamol values at 30 min were significantly greater with AeroChamber Plus (14.61±4.36 µg, p < 0.001) and MDI Plus (10.97±3.83 µg, p < 0.01) compared to pMDI alone (5.92±1.07 µg). Urinary salbutamol at 24 h showed higher systemic bioavailability with pMDI alone (139.09±15.68 µg) versus when connected with both AeroChamber Plus and MDI Plus, 79.57±19.48, and 59.26±18.12 µg, p < 0.001, respectively.

Conclusion

Compared to the pMDI alone, both spacers significantly enhanced lung delivery and reduced systemic absorption. Whilst the AeroChamber Plus® delivered slightly more medication to the lung, the MDI Plus® spacer offers a cost-effective alternative that is suitable for emergencies and outdoor use.

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来源期刊

European Journal of Pharmaceutical Sciences 医学-药学

CiteScore

9.60

自引率

2.20%

发文量

248

审稿时长

50 days

期刊介绍： The journal publishes research articles, review articles and scientific commentaries on all aspects of the pharmaceutical sciences with emphasis on conceptual novelty and scientific quality. The Editors welcome articles in this multidisciplinary field, with a focus on topics relevant for drug discovery and development. More specifically, the Journal publishes reports on medicinal chemistry, pharmacology, drug absorption and metabolism, pharmacokinetics and pharmacodynamics, pharmaceutical and biomedical analysis, drug delivery (including gene delivery), drug targeting, pharmaceutical technology, pharmaceutical biotechnology and clinical drug evaluation. The journal will typically not give priority to manuscripts focusing primarily on organic synthesis, natural products, adaptation of analytical approaches, or discussions pertaining to drug policy making. Scientific commentaries and review articles are generally by invitation only or by consent of the Editors. Proceedings of scientific meetings may be published as special issues or supplements to the Journal.