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首頁(yè)> 美國(guó)衛(wèi)生研究院文獻(xiàn)>Journal of Aerosol Medicine and Pulmonary Drug Delivery >Wixela Inhub: Dosing Performance In Vitro and Inhaled Flow Rates in Healthy Subjects and Patients Compared with Advair Diskus
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Wixela Inhub: Dosing Performance In Vitro and Inhaled Flow Rates in Healthy Subjects and Patients Compared with Advair Diskus

機(jī)譯：Wixela Inhub：與 Advair Diskus 相比健康受試者和患者的體外和吸入流速給藥性能

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Background: Wixela? Inhub? is a fluticasone propionate/salmeterol dry powder inhaler developed as a generic equivalent of Advair Diskus? for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Wixela Inhub and Advair Diskus are comparable in terms of functionality, user interface, and device resistance. The primary objectives of the studies were to evaluate in vitro dose delivery with Wixela Inhub compared with Advair Diskus at relevant flow rates and to explore inhalation profiles generated by patients with asthma or COPD.Methods: In vitro studies: Emitted dose (ED) and individual dose aerodynamic particle size distribution (APSD) were measured at flow rates ranging from 30 to 90 L min?1. Patient inhalation study: Inhalation profile recording was conducted three times in each patient (40 children with asthma, 14 adults with asthma, and 14 adults with severe-to-very-severe COPD) with an empty Inhub in an open-label study. The primary endpoint was peak inhaled flow rate (PIFR). An additional endpoint was peak pressure drop.Results: In vitro studies: ED and APSD delivered from Wixela Inhub showed low flow dependency across the patient-relevant flow-rate range. Wixela Inhub gave in vitro performance comparable with Advair Diskus for all strengths and flow rates. Patient inhalation study: For Inhub, mean PIFR was lowest for children with asthma ages 4 to 7 years (50.6 L min?1) and highest for adults with asthma (74.8 L min?1). For adults with severe-to-very-severe COPD, mean PIFR was 69.5 L min?1 with Inhub. The PIFRs observed with Diskus were higher than those with Inhub, consistent with slightly higher resistance measured in vitro. The difference in resistance did not impact demonstration of bioequivalence and does not impact substitutability of the product. Peak pressure drop values were comparable between Diskus and Inhub.Conclusions: Comparable in vitro performance of Wixela Inhub to Advair Diskus confirmed that Wixela Inhub is a generic equivalent to Advair Diskus across all patient groups.
機(jī)譯：背景：Wixela? Inhub? 是一種丙酸氟替卡松/沙美特羅干粉吸入器，是 Advair Diskus? 的仿制藥，用于治療哮喘和慢性阻塞性肺病 （COPD）。Wixela Inhub 和 Advair Diskus 在功能、用戶(hù)界面和設(shè)備阻力方面具有可比性。研究的主要目的是評(píng)估 Wixela Inhub 與 Advair Diskus 在相關(guān)流速下的體外劑量給藥，并探索哮喘或 COPD 患者產(chǎn)生的吸入曲線。方法：體外研究：在 30 至 90 L min-1 的流速范圍內(nèi)測(cè)量發(fā)射劑量 （ED） 和個(gè)體劑量空氣動(dòng)力學(xué)粒徑分布 （APSD）?；颊呶胙芯浚涸谝豁?xiàng)開(kāi)放標(biāo)簽研究中，對(duì)每位患者 （40 名哮喘兒童、14 名成人哮喘患者和 14 名成人重度至極重度 COPD） 進(jìn)行 3 次吸入曲線記錄。主要終點(diǎn)是峰值吸入流速 （PIFR）。另一個(gè)終點(diǎn)是峰值壓降。結(jié)果：體外研究：Wixela Inhub 提供的 ED 和 APSD 在患者相關(guān)流速范圍內(nèi)顯示出低流依賴(lài)性。Wixela Inhub 在所有強(qiáng)度和流速方面都與 Advair Diskus 的體外性能相當(dāng)。患者吸入研究：對(duì)于 Inhub，4 至 7 歲哮喘兒童的平均 PIFR 最低 （50.6 L min-1），成人哮喘最高 （74.8 L min-1）。對(duì)于患有重度至極重度 COPD 的成人，使用 Inhub 的平均 PIFR 為 69.5 L min-1。用 Diskus 觀察到的 PIFRs 高于 Inhub，與體外測(cè)得的耐藥性略高一致。耐藥性的差異不會(huì)影響生物等效性的證明，也不會(huì)影響產(chǎn)品的可替代性。Diskus 和 Inhub 之間的峰值壓降值相當(dāng)。結(jié)論：Wixela Inhub 與 Advair Diskus 的體外性能相當(dāng)，證實(shí) Wixela Inhub 在所有患者組中都是 Advair Diskus 的通用等效物。

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