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Experimental and computational study of the effect of breath-actuated mechanism built in the NEXThaler® dry powder inhaler

机译:NEXThaler ®干粉吸入器内置的呼吸致动机制效果的实验和计算研究

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摘要

The breath-actuated mechanism (BAM) is a mechanical unit included in NEXThaler® with the role of delaying the emission of the drug until the inhalation flow rate of the patient is sufficiently high to detach the drug particles from their carriers.The main objective of this work was to analyse the effect of the presence of BAM on the size distribution of the emitted drug and its airway deposition efficiency and distribution. Study of the hygroscopic growth of the emitted drug particles and its effect on the deposition was another goal of this study.Size distributions of Foster® NEXThaler® drug particles emitted by dry powder inhalers with and without BAM have been measured by a Next Generation Impactor. Three characteristic inhalation profiles of asthmatic patients (low, moderate and high flow rates) were used for both experimental and modelling purposes. Particle hygroscopic growth was determined by a new method, where experimental measurements are combined with simulations. Upper airway and lung deposition fractions were computed assuming 5 s and 10 s breath-hold times.By the inclusion of BAM the fine particle fraction of the steroid component increased from 24-30% to 47-51%, while that of bronchodilator from 25-34% to 52-55%. The predicted upper airway steroid and bronchodilator doses decreased from about 60% to 35-40% due to BAM. At the same time, predicted lung doses increased from about 20% to 35% (steroid) and from 22% to 38% (bronchodilator) for the moderate flow profile and from about 25% to 40% (steroid) and from 29% to 47% (bronchodilator) for the high inhalation flow profile. Lung doses of both components were about the same in the BAM and no-BAM configurations at the weakest flow profile. However, lung dose increased by 2-3% even for this profile when hygroscopic growth was taken into account.In conclusion, the Chiesi NEXThaler® BAM mechanism is a unique feature enabling high emitted fine particle fraction and enhanced drug delivery to the lungs.
机译:呼吸致动机构(BAM)是NEXThaler®中包含的机械单元,其作用是延迟药物的释放,直到患者的吸入流速足够高,以使药物颗粒从其载体上分离出来。这项工作旨在分析BAM的存在对所散发药物的大小分布及其气道沉积效率和分布的影响。研究散发的药物颗粒的吸湿性及其对沉积的影响是本研究的另一个目标。下一代撞击器已测量了带或不带BAM的干粉吸入器散发的Foster®NEXThaler®药物颗粒的粒径分布。实验和建模目的均使用了三种哮喘患者的特征性吸入曲线(低,中和高流速)。颗粒吸湿性生长是通过一种新方法确定的,该方法将实验测量结果与模拟结果结合起来。假设屏气时间为5 s和10 s,计算了上呼吸道和肺部沉积分数。通过加入BAM,类固醇成分的细颗粒分数从24-30%增加到47-51%,而支气管扩张剂的细颗粒分数则从25 -34%至52-55%。由于BAM,预计的上呼吸道类固醇和支气管扩张剂的剂量从约60%降至35-40%。同时,对于中等流量曲线,预计的肺部剂量从约20%增加到35%(类固醇),从22%增加到38%(支气管扩张剂),从约25%增加到40%(类固醇),从29%增加到高吸入流量曲线为47%(支气管扩张剂)。在最弱的流量曲线下,BAM和no-BAM配置中两种成分的肺部剂量大致相同。但是,考虑到吸湿性的增长,即使在这种情况下,肺部剂量也增加了2-3%。总之,ChiesiNEXThaler®BAM机制是独特的功能,可实现高释放的细颗粒级分并增强向肺部的药物输送。

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