%0 Journal Article
%T Dose uniformity of budesonide Easyhaler£¿ under simulated real
%A Anita Happonen
%A Jussi Haikarainen
%A Paula Rytil£¿
%A Sirkku Roos
%A Sirpa Mets£¿rinne
%J Chronic Respiratory Disease
%@ 1479-9731
%D 2018
%R 10.1177/1479972317745733
%X 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 ¦Ìg/dose strengths of budesonide. Dose uniformity was assessed during in-use periods of 4¨C6 months after exposure to high temperature (30¡ãC) 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¨C120% of expected dose; all data reported descriptively. DD was constant (range: 93¨C109% 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¨C105% 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
%K Asthma
%K budesonide
%K dose uniformity
%K dry powder inhaler
%K Easyhaler£¿
%U https://journals.sagepub.com/doi/full/10.1177/1479972317745733