Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine University, Düsseldorf, Germany.
Int J Pharm. 2013 Feb 28;444(1-2):169-74. doi: 10.1016/j.ijpharm.2013.01.007. Epub 2013 Jan 17.
High prevalence of pulmonary diseases in childhood requires inhalable medication even for young children. Little is known about the efficiency of aerosol therapy especially in preschool children. One factor which limits the lung dose is the upper airway geometry. Based on clinical data a recently developed idealized pediatric upper airway model (children 4-5 years) was used to investigate the performance of two dry powder inhalers (Easyhaler and Novolizer). In vitro investigations were first examined using steady flow rates and an inhalation volume of 1L. Chosen flow rates were 28, 41 and 60L/min (Easyhaler) and 45, 60 and 75L/min (Novolizer). Afterwards inhalation profiles simulated by an electronic lung were included. The investigations showed high amounts of drug particles (up to 80%) which were deposited in the upper airway model. The pulmonary deposition in vitro using the Easyhaler was about 28% (28-60L/min) and 22% (inhalation profile). Using the Novolizer in vitro pulmonary doses of 8-12% (45-75L/min) and about 5% (inhalation profile) were observed. The idealized model shows good performance reproducibility of dry powder inhalers. We have shown that age-dependent models might be appropriate tools for formulation and device development in pediatric age groups.
儿童期肺部疾病高发,即使是幼儿也需要使用可吸入药物。关于气雾剂疗法的疗效,特别是在学龄前儿童中的疗效,我们知之甚少。限制肺部药物剂量的一个因素是上呼吸道的几何形状。基于临床数据,我们使用最近开发的理想化儿科上呼吸道模型(4-5 岁儿童)来研究两种干粉吸入器(Easyhaler 和 Novolizer)的性能。首先在稳定的流速和 1L 的吸入量下进行体外研究。选择的流速为 28、41 和 60L/min(Easyhaler)和 45、60 和 75L/min(Novolizer)。然后包括电子肺部模拟的吸入曲线。研究表明,大量药物颗粒(高达 80%)沉积在上呼吸道模型中。使用 Easyhaler 的体外肺沉积率约为 28%(28-60L/min)和 22%(吸入曲线)。使用 Novolizer 的体外肺剂量为 8-12%(45-75L/min)和约 5%(吸入曲线)。理想化模型显示出干粉吸入器性能具有良好的可重复性。我们已经表明,年龄相关模型可能是儿科年龄组制剂和设备开发的合适工具。