Berg E, Svensson J O
AstraZeneca R&D, Analytical Development, Scheelevägen 2, S-221 87 Lund, Sweden.
Pharmeur Sci Notes. 2006 Dec;2006(2):9-15.
Aerosol inhalers are widely used to deliver drug directly to the respiratory system in patients with respiratory disease. Currently available nebulisers only deliver a proportion of the loaded or charged dose to the patient. The proportion of the charged dose received by the patient can be considered as the inhalable dose and is that part of the dose generated during inhalation and breathed in by the patient. As such, it is important to fully characterise the performance of new nebuliser brands to assess the proportion of the charged dose actually delivered to the patient. Despite the large variety of nebulisers, driver units and formulations currently on the market, often little is known about the performance of new nebulisers in terms of inhalable dose under a variety of breathing patterns and with different drug formulations. The results presented here highlight the variation in performance in terms of inhalable dose and droplet distribution of a breath-enhanced jet nebuliser when tested with a number of formulations and under different breathing patterns. Based on the results presented here we propose that a standard protocol for evaluating the performance of established and developmental nebulisers should include breathing patterns appropriate to the intended use and a variety of test formulations to capture those currently available for nebulisation.
气雾剂吸入器被广泛用于将药物直接递送至呼吸系统疾病患者体内。目前市面上的雾化器仅能将一部分加载或充电剂量的药物递送至患者体内。患者所接受的充电剂量的比例可被视为可吸入剂量，即吸入过程中产生并被患者吸入的那部分剂量。因此，全面表征新型雾化器品牌的性能以评估实际递送至患者体内的充电剂量比例非常重要。尽管目前市场上有各种各样的雾化器、驱动装置和制剂，但对于新型雾化器在各种呼吸模式下以及使用不同药物制剂时的可吸入剂量性能，人们往往知之甚少。此处呈现的结果突出了一种呼吸增强型喷射雾化器在使用多种制剂并在不同呼吸模式下进行测试时，其在可吸入剂量和液滴分布方面的性能差异。基于此处呈现的结果，我们建议，用于评估现有和研发中的雾化器性能的标准方案应包括适合预期用途的呼吸模式以及多种测试制剂，以涵盖目前可用于雾化的制剂。
