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Budesonide/Formoterol Easyhaler?: Performance Under Simulated Real-Life Conditions

机译：布地奈德/福莫特罗Easyhaler ?：在模拟现实生活条件下的性能

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IntroductionWe compared in vitro drug delivery characteristics of two budesonide/formoterol dry powder inhalers, the Bufomix Easyhaler? and the budesonide/formoterol Turbuhaler?, at different patient air flow rates, and to test dose delivery from the Easyhaler in stressed conditions exposed to moisture, dropping, vibration and freezing/thawing. MethodsA total of 36 inhalers from two batches of both products (160/4.5?μg strength) were used when comparing the effect of flow rate; six inhalers for each of the three flow rates for uniformity of delivered dose (DD), fine particle dose (FPD), mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD). Consistency of DD, FPD, MMAD and GSD were determined for each inhaler at three different flow rates: 10th, 50th and 90th percentile air flows. Dosing properties as a function of inhaler life were tested. The effects of moisture, dropping, vibration and freezing/thawing on DD and FPD were tested with two to four inhalers per test using all three strengths of Easyhaler: 80/4.5, 160/4.5 and 320/9?μg. ResultsThe Easyhaler, 160/4.5?μg, showed statistically significantly better dose consistency (expressed as percentage of labelled dose) at all three inhalation flows compared with the Turbuhaler, 160/4.5?μg, ( p ConclusionIn vitro performance of the Easyhaler indicates reliable dosing. Dose consistency was superior compared with the Turbuhaler at all tested flow rates. Environmental moisture, dropping, vibration and freezing/thawing did not affect the performance. FundingOrion Corporation Orion Pharma.
机译：简介我们比较了两种布地奈德/福莫特罗干粉吸入器，Bufomix Easyhaler ？和布地奈德/福莫特罗Turbuhaler ？在不同患者空气流速下的体外药物输送特性，以及在暴露于潮湿，掉落，振动和冷冻/融化的压力条件下测试Easyhaler的剂量。方法比较两批产品的36种吸入器（强度分别为160 /4.5μg），以比较流速的影响。三种流速中的每一种均具有六个吸入器，以确保输送剂量（DD），细颗粒剂量（FPD），质量中位数空气动力学直径（MMAD）和几何标准偏差（GSD）的均匀性。确定了每种吸入器在三种不同流速下的DD，FPD，MMAD和GSD的一致性：空气流量的第10、50和90％。测试了作为吸入器寿命的函数的剂量特性。使用Easyhaler的所有三种强度：80 / 4.5、160 / 4.5和320/9？g，每个测试使用2至4个吸入器来测试水分，掉落，振动和冻融对DD和FPD的影响。结果Easyhaler的160 /4.5μg在所有三个吸入流中均显示出与Turbuhaler的160 /4.5μg相比在统计学上显着更好的剂量一致性（以标记剂量的百分比表示）（p结论Easyhaler的体外性能表明剂量可靠在所有测试流速下，剂量一致性均优于Turbuhaler，环境湿度，滴落，振动和冻融均不影响性能。

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