Long-Term In-Vitro Aerosol Performance and Drug Retention of a Cardboard-Based Spacer (MDI PLUS®) Compared with Conventional Spacer Designs

IF 2.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Ahmed H.M. Sobh, Marina E. Boules, Mohammed A. Amin, Mohamed E. A. Abdelrahim, Mina Nicola
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引用次数: 0

Abstract

Background

Spacers and valved holding chambers improve drug delivery. However, plastic versions are bulky, costly, and susceptible to electrostatic effects. Newer cardboard or portable designs are affordable and convenient, though evidence regarding long-term aerosol performance remains limited.

Methods

This study assessed the durability, drug retention, and aerosol emission performance of a cardboard-based spacer (MDI PLUS®) over 200 repeated actuations. Aerosol emission of salbutamol (Ventolin®, 100 µg/actuation) and beclometasone (Clenil Forte®, 250 µg/actuation) was measured at set intervals using an Andersen cascade impactor (28.3 L/min), determining total emitted dose (TED) and aerodynamic particle size characteristics. Single-puff deposition within the MDI PLUS®, on the pressurized metered dose inhaler (pMDI), and on a user’s hand was also compared with two commercial plastic spacers, AeroChamber Plus® and AeroChamber2go™.

Results

Over 200 uses, MDI PLUS® maintained a stable delivered dose for salbutamol (TED 221–198 µg) and beclometasone (506–532 µg), without significant change in mass median aerodynamic diameter (≈ 3.97–4.45 μm). Salbutamol fine particle dose (FPD) and fraction (FPF) declined non-significantly, from 165 µg/75% to 119 µg/60%, while beclometasone FPD (307–393 µg) and FPF (61–75%) remained largely unchanged. Drug retention within the spacer increased with repeated use across all devices but was significantly lower for MDI PLUS® (p < 0.05) than for either AeroChamber device. Deposition on the pMDI and on the hand was negligible for all devices.

Conclusion

MDI PLUS® showed durable, consistent aerosol performance across repeated use, with lower drug retention supporting its suitability as a reliable long-term spacer.

与传统隔离剂设计相比,基于纸板的隔离剂(MDI PLUS®)的长期体外气溶胶性能和药物保留
间隔器和带阀的保持室改善了药物输送。然而,塑料版体积庞大,价格昂贵,易受静电影响。新的硬纸板或便携式设计既便宜又方便,尽管关于长期气溶胶性能的证据仍然有限。方法本研究评估了纸板基隔离器(MDI PLUS®)的耐久性、药物滞留性和气溶胶排放性能,并进行了200多次重复操作。使用Andersen级联冲击器(28.3 L/min)以设定间隔测量沙丁胺醇(Ventolin®,100µg/驱动)和倍氯米松(Clenil Forte®,250µg/驱动)的气溶胶排放,确定总排放剂量(TED)和空气动力学粒径特征。MDI PLUS®内、加压计量吸入器(pMDI)上和使用者手上的单吸沉积也与两种商用塑料垫片AeroChamber PLUS®和AeroChamber2go™进行了比较。结果在200次使用中,MDI PLUS®对沙丁胺醇(TED 221-198µg)和倍氯米松(506-532µg)的给药剂量保持稳定,质量中位数气动直径(≈3.97-4.45 μm)无显著变化。沙丁胺醇细颗粒剂量(FPD)和分数(FPF)从165µg/75%下降到119µg/60%,而倍氯米松FPD(307-393µg)和FPF(61-75%)基本保持不变。在所有装置中,间隔器内的药物潴留随着重复使用而增加,但MDI PLUS®的药物潴留明显低于任何一种AeroChamber装置(p < 0.05)。pMDI和手上的沉积对所有装置来说都是可以忽略不计的。结论mdi PLUS®在重复使用中表现出持久、一致的雾化性能,具有较低的药物滞留率,支持其作为可靠的长期隔离剂的适用性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Pharmaceutical Innovation
Journal of Pharmaceutical Innovation PHARMACOLOGY & PHARMACY-
CiteScore
3.70
自引率
3.80%
发文量
90
审稿时长
>12 weeks
期刊介绍: The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories: Materials science, Product design, Process design, optimization, automation and control, Facilities; Information management, Regulatory policy and strategy, Supply chain developments , Education and professional development, Journal of Pharmaceutical Innovation publishes four issues a year.
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