In Vitro Performance of the Wixela Inhub Inhaler Using Severe Chronic Obstructive Pulmonary Disease Patient Inhalation Profiles.

IF 2 4区 医学 Q3 RESPIRATORY SYSTEM
Thomas Shepherd, Matthew Kennett, Andrew Cooper, Adrian Parkinson
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引用次数: 0

Abstract

Background: Wixela Inhub (trademarks of Viatris, Inc.) is a dry powder inhaler (DPI) that delivers a fixed-dose combination of fluticasone propionate and salmeterol and is approved as a generic equivalent to Advair Diskus (trademarks of GlaxoSmithKline plc) for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The dosing performance of DPIs is dependent on the patient's inspiratory capability, which may be impacted in disease populations such as those with severe COPD. The objective of this study was to evaluate the in vitro dose delivery of fluticasone propionate and salmeterol from the Inhub inhaler with in vivo inhalation profiles of severe COPD patients, using two types of breathing simulator with different modes of operation. Materials and Methods: Two breathing simulators (Si-Plan and Copley BRS3100) were used with United States Pharmacopoeia (USP) <601> apparatus 5 (Next Generation Impactor and accessories) to measure the total emitted dose and fine particle mass of fluticasone propionate and salmeterol for Wixela Inhub (250/50 mcg) using 13 severe COPD patient inhalation profiles. Results: Wixela Inhub demonstrated low flow dependency across the range of COPD patient profiles tested (peak inspiratory flow rate 60.8-84.9 L minute-1), when assessed by total emitted dose and fine particle mass. The results were similar to literature results reported for fluticasone propionate from the Diskus inhaler, tested using a proprietary breathing simulator and Andersen Cascade Impactor. Comparison between the breathing simulators showed no significant difference in fluticasone propionate results, but a small difference was observed between the breathing simulators for salmeterol total emitted dose and fine particle mass. Conclusions: This study demonstrates that severe COPD patients are likely to achieve a consistent inhaled dose from Wixela Inhub, with low flow dependency observed within this patient population. In addition, both breathing simulators, which differ significantly in design, produced similar results for fluticasone propionate, but yielded slightly (but statistically significant) different results for salmeterol.

Wixela Inhub吸入器对重度慢性阻塞性肺疾病患者吸入特性的体外研究
背景:Wixela Inhub (Viatris, Inc.的商标)是一种干粉吸入器(DPI),提供丙酸氟替卡松和沙美特罗的固定剂量组合,被批准为相当于Advair Diskus(葛兰素史克公司的商标)的仿制药,用于治疗哮喘和慢性阻塞性肺疾病(COPD)。dpi的剂量表现取决于患者的吸气能力,这可能会影响疾病人群,如严重COPD患者。本研究的目的是通过使用两种不同操作模式的呼吸模拟器,评估Inhub吸入器中丙酸氟替卡松和沙美特罗对重度COPD患者体内吸入情况的体外剂量传递。材料和方法:使用两个呼吸模拟器(Si-Plan和Copley BRS3100)与美国药典(USP)器械5(下一代冲击器和附件)一起测量丙酸氟替卡松和沙美特罗用于Wixela Inhub (250/50 mcg)的总释放剂量和细颗粒质量,使用13例严重COPD患者的吸入谱。结果:当通过总释放剂量和细颗粒质量评估时,Wixela Inhub在测试的COPD患者谱范围内表现出低流量依赖性(峰值吸气流量60.8-84.9 L min -1)。结果与文献报道的Diskus吸入器丙酸氟替卡松的结果相似,使用专有的呼吸模拟器和Andersen级联冲击器进行测试。两种呼吸模拟器对丙酸氟替卡松的测量结果无显著性差异,但对沙美特罗总放射剂量和细颗粒质量的测量结果差异较小。结论:本研究表明,重症COPD患者可能获得一致的吸入剂量,在该患者群体中观察到低流量依赖性。此外,两种呼吸模拟器在设计上有显著差异,但对丙酸氟替卡松产生相似的结果,但对沙美特罗产生轻微(但有统计学意义)不同的结果。
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来源期刊
CiteScore
6.70
自引率
2.90%
发文量
34
审稿时长
>12 weeks
期刊介绍: Journal of Aerosol Medicine and Pulmonary Drug Delivery is the only peer-reviewed journal delivering innovative, authoritative coverage of the health effects of inhaled aerosols and delivery of drugs through the pulmonary system. The Journal is a forum for leading experts, addressing novel topics such as aerosolized chemotherapy, aerosolized vaccines, methods to determine toxicities, and delivery of aerosolized drugs in the intubated patient. Journal of Aerosol Medicine and Pulmonary Drug Delivery coverage includes: Pulmonary drug delivery Airway reactivity and asthma treatment Inhalation of particles and gases in the respiratory tract Toxic effects of inhaled agents Aerosols as tools for studying basic physiologic phenomena.
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