In Vitro Tests for Aerosol Deposition II: IVIVCs for Different Dry Powder Inhalers in Normal Adults
In Vitro Tests for Aerosol Deposition II: IVIVCs for Different Dry Powder Inhalers in Normal Adults
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DOI：
10.1089/jamp.2012.0975
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发表时间：
2013-06-01
影响因子：
3.4
通讯作者：
Byron, Peter R.
中科院分区：
文献类型：
--
作者：
Delvadia, Renishkumar;Hindle, Michael;Byron, Peter R.
背景：最近发现一种新的干粉吸入器 (DPI) 体外测试方法可以预测已发表的 Budelin Novolizer 体内结果。本研究旨在通过评估五种不同 DPI 的体外和体内平均药物沉积之间的相关性来评估该方法的稳健性。方法：在实验设置中，在“中等”体型成人的真实物理气道模型中评估五种市售 DPI 的体外药物沉积，该实验设置允许对沉积进行区域性表征，以精确选择模拟空气流速与时间曲线。研究的 DPI 包括 Spiriva (R) HandiHaler (R)、Relenza (R) Diskhaler (R)、Salbutamol Easyhaler (R)、Pulmicort (R) Turbuhaler (R) 和 Foradil (R) Aerolizer (R)。将体外区域沉积结果与文献中报道的结果进行比较，以便建立每个吸入器的体外-体内相关性 (IVIVC)。结果：Spiriva HandiHaler、Relenza Diskhaler、Salbutamol Easyhaler、Pulmicort Turbuhaler 和 Foradil Aerolizer 的体外平均总肺沉积百分比 (TLD-SD) 分别为 17.3 +/- 1.2、22.6 +/-分别为 1.1、29.0 +/- 1.1、28.0 +/- 3.0 和 21.7 +/- 1.2。这些结果与报道的体内值非常一致，TLD 的绝对预测误差为
Background: A new in vitro test method for dry powder inhalers (DPIs) was recently found to be predictive of the published in vivo results for Budelin Novolizer. The present study was intended to assess the method's robustness by evaluating correlations between average drug deposition in vitro and in vivo from five different DPIs.Methods: In vitro drug deposition from five marketed DPIs was assessed in a realistic physical airway model of a "medium" sized adult in an experimental setup that allowed deposition to be characterized regionally for carefully selected simulated air flow rate versus time profiles. The DPIs studied were Spiriva (R) HandiHaler (R), Relenza (R) Diskhaler (R), Salbutamol Easyhaler (R), Pulmicort (R) Turbuhaler (R), and Foradil (R) Aerolizer (R). In vitro regional deposition results were compared with those reported in the literature in order to create in vitro-in vivo correlations (IVIVCs) for each inhaler.Results: Mean percent total lung deposition (TLD-SD) in vitro for Spiriva HandiHaler, Relenza Diskhaler, Salbutamol Easyhaler, Pulmicort Turbuhaler, and Foradil Aerolizer were 17.3 +/- 1.2, 22.6 +/- 1.1, 29.0 +/- 1.1, 28.0 +/- 3.0, and 21.7 +/- 1.2, respectively. These results showed excellent agreement with reported in vivo values, with absolute prediction errors in TLD of