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Performance of Dry Powder Inhalers with Single Dosed Capsules in Preschool Children and Adults Using Improved Upper Airway Models

机译:改进的上呼吸道模型在学龄前儿童和成人中使用单剂量干粉吸入器的性能

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摘要

The pulmonary administration of pharmaceutical aerosols to patients is affected by age-dependent variations in the anatomy of the upper airways and the inhalation pattern. Considering this aspect, different upper airway models, representing the geometries of adults and preschool children, and a conventional induction port according to the European Pharmacopeia were used for in vitro testing of dry powder inhalers with single dosed capsules (Cyclohaler®, Handihaler® and Spinhaler®). Deposition measurements were performed using steady flow rates of 30 and 60 L/min for the Handihaler®/Spinhaler® and 30, 60 and 75 L/min for the Cyclohaler®. The inhalation volume was set at 1 L. For the Cyclohaler®, the in vitro testing was supplemented by a pediatric inhalation profile. Slight differences of pulmonary deposition between the idealized adult (11%–15%) and pediatric (9%–11%) upper airway model were observed for the Cyclohaler®. The applied pediatric inhalation profile resulted in a reduction of pulmonary deposition by 5% compared to steady conditions and indicated the influence of the inhalation pattern on the amount of pulmonary deposited particles. The comparison of two pediatric upper airway models showed no differences. The performance of the Handihaler® was similar to the Cyclohaler®. The Spinhaler® showed an insufficient performance and limited reproducibility in our investigations.
机译:肺部给药药物气雾剂受上呼吸道解剖结构和吸入模式随年龄变化的影响。考虑到这一方面,代表成人和学龄前儿童的几何形状的不同上呼吸道模型和根据欧洲药典的常规进气口用于单剂量胶囊干粉吸入器的体外测试(Cyclohaler ®,Handihaler ®和Spinhaler ®)。使用Handihaler ® / Spinhaler ®的稳定流速和30、60和75 L / min的Cyclohaler 的稳定流速进行沉积测量>®。吸入量设置为1L。对于Cyclohaler ®,儿科吸入曲线补充了体外测试。 Cyclohaler ®在理想的成年人(11%–15%)和儿科(9%–11%)上呼吸道模型之间观察到了轻微的肺沉积差异。与稳定状态相比,所应用的儿科吸入曲线使肺部沉积减少了5%,并表明了吸入方式对肺部沉积颗粒量的影响。两种儿科上呼吸道模型的比较没有差异。 Handihaler ®的性能类似于Cyclohaler ®。 Spinhaler ®在我们的研究中显示出不足的性能和有限的可重复性。

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