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Impact of Inhalation Flow, Inhalation Volume and Critical Handling Errors on Delivered Budesonide/Formoterol Dose in Different Inhalers: An In Vitro Study

机译:吸入流量,吸入量和关键操作错误对不同吸入器中布地奈德/福莫特罗剂量的影响:一项体外研究

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IntroductionInhaled drugs are essential for treatment of asthma and chronic obstructive pulmonary disease, but drug delivery via the respiratory tract is complex. Correct inhaler use is challenging as inhalers differ and inhaler technique errors are common. This in vitro study examined impact of inhalation flow, volume, and shaking of commonly used budesonide/formoterol (BUD/FORM) dry powder inhalers (DPIs). MethodsTwo strengths of each included BUD/FORM DPI, Turbuhaler, Easyhaler and Spiromax, were examined. Fine particle dose (FPD) was measured using the Next Generation Impactor, at fixed pressure drops of 2, 4 and 6?kPa. Delivered dose (DD) for inhalation volume and shaking tests was performed at an airflow rate equivalent to a 4-kPa pressure drop, collected on Respirgard II, 303EU filters. ResultsFPD flow rate dependence was similar for all inhalers and strengths. BUD/FORM Turbuhaler and Easyhaler were unaffected by inhalation volume, whereas Spiromax showed significant inhalation volume dependence with about 50% decrease for both inhaler strengths. For a BUD/FORM Turbuhaler 160/4.5-μg/dose, there were no differences in the DD between shaking and no shaking, whereas the higher strength showed a 10% decrease after shaking. BUD/FORM Easyhaler DD decreased with about 50% for both strengths when the device was not shaken, while Spiromax decreased with 20% for the lower strength and 80% for the higher strength when shaken. ConclusionThis study revealed significant differences in inhaler performance after testing at different inhalation flow and volume and following exposure to potential pre-inhalation handling errors, which may lead to decreased drug delivery to the lungs. FundingAstraZeneca
机译:简介吸入药物对于治疗哮喘和慢性阻塞性肺疾病必不可少,但通过呼吸道的药物输送非常复杂。正确使用吸入器具有挑战性,因为吸入器存在差异,并且吸入器技术错误很常见。这项体外研究检查了常用布地奈德/福莫特罗(BUD / FORM)干粉吸入器(DPI)的吸入流量,体积和摇动的影响。方法检查两种强度,包括BUD / FORM DPI,Turbuhaler,Easyhaler和Spiromax。使用下一代撞击器在2、4和6?kPa的固定压降下测量细颗粒剂量(FPD)。吸入量和摇动测试的输送剂量(DD)以等于4-kPa压降的气流速率进行,并通过Respirgard II,303EU过滤器收集。结果FPD对所有吸入器和强度的流速依赖性相似。 BUD / FORM Turbuhaler和Easyhaler不受吸入量的影响,而Spiromax表现出明显的吸入量依赖性,两种吸入器强度均降低了约50%。对于BUD / FORM Turbuhaler 160 /4.5-μg/剂量,摇晃和不摇晃之间的DD值没有差异,而较高的强度表明摇晃后降低了10%。当不摇晃设备时,两种强度的BUD / FORM Easyhaler DD均下降约50%,而摇晃较低时,Spiromax下降20%,而较高时下降80%。结论:这项研究表明,在不同的吸入流量和体积下以及在暴露于潜在的吸入前处理错误后进行测试后,吸入器的性能存在显着差异,这可能导致药物向肺部的递送减少。资金阿斯利康

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