1 Orion Corporation, Orion Pharma, Espoo, Finland.
2 Medfiles Ltd, Kuopio, Finland.
Chron Respir Dis. 2018 Aug;15(3):265-271. doi: 10.1177/1479972317745733. Epub 2017 Dec 7.
Budesonide Easyhaler® multidose dry powder inhaler is approved for the treatment of asthma. Objectives were to determine the delivered dose (DD) uniformity of budesonide Easyhaler® in simulated real-world conditions and with different inspiration flow rates (IFRs). Three dose delivery studies were performed using 100, 200, and 400 µg/dose strengths of budesonide. Dose uniformity was assessed during in-use periods of 4-6 months after exposure to high temperature (30°C) and humidity (60% relative humidity) and after dropping and vibration testing. The influence of various IFRs (31, 43, and 54 L/min) on the DD was also investigated. Acceptable dose uniformity was declared when mean DD were within 80-120% of expected dose; all data reported descriptively. DD was constant (range: 93-109% of expected dose) at all in-use periods and after exposure to high temperature and humidity for a duration of up to 6 months. DD post-dropping and -vibration were unaffected (range 98-105% of expected dose). Similarly, DD was constant and within 10% of expected dose across all IFRs. Results indicate that budesonide Easyhaler® delivers consistently accurate doses in various real-life conditions. Budesonide Easyhaler® can be expected to consistently deliver a uniform dose and improve asthma control regardless of high temperature and humidity or varying IFR.
布地奈德 Easyhaler®多剂量干粉吸入器已获批准用于治疗哮喘。目的是确定布地奈德 Easyhaler®在模拟现实条件下以及不同吸气流量（IFR）下的输送剂量（DD）均匀性。使用 100、200 和 400μg/剂量强度的布地奈德进行了三项剂量输送研究。在暴露于高温（30°C）和高湿度（60%相对湿度）以及跌落和振动测试后，在使用期的 4-6 个月内评估剂量均匀性。还研究了各种 IFR（31、43 和 54 L/min）对 DD 的影响。当平均 DD 在预期剂量的 80-120%范围内时，宣布可接受的剂量均匀性；所有数据均以描述性方式报告。在所有使用期间以及暴露于高温和高湿度长达 6 个月后，DD 保持不变（范围：预期剂量的 93-109%）。DD 经跌落和振动后无影响（预期剂量的 98-105%）。同样，DD 在所有 IFR 下均保持不变且在预期剂量的 10%以内。结果表明，布地奈德 Easyhaler®在各种现实生活条件下均能输送一致准确的剂量。无论高温和高湿度或 IFR 变化如何，预计布地奈德 Easyhaler®都能始终如一地输送均匀剂量并改善哮喘控制。
