Dose uniformity of budesonide Easyhaler? under simulated real-life conditions and with low inspiration flow rates

摘要

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.