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

Abstract

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.

Clinical Effectiveness of Budesonide/Formoterol Fumarate Easyhaler® for Patients with Poorly Controlled Obstructive Airway Disease: a Real-World Study of Patient-Reported Outcomes

“…Furthermore, study physicians reported that use of the Bufomix Easyhaler ® was easy to teach, with their patients learning inhaler use quickly. Our data support previous patient preference data (based on studies in children and adults) that demonstrated the Easyhaler ® was easy to teach, learn and use, coupled with more user satisfaction [ 18 , 32 ]; findings were recently confirmed by a meta-analysis [ 19 ].…”

“…The Bufomix Easyhaler ® has demonstrated similar in vitro flow rate dependency compared with the Turbuhaler ® , using clinically relevant air flow rates collected from patients with asthma and COPD [ 18 ]. Additionally, superior dose consistency was observed compared with the Turbuhaler ® at different clinically relevant in vitro flow rates [ 19 ]. Therapeutic equivalence and equivalent bronchodilator efficacy have also been reported between the two inhalers [ 20 , 21 ].…”

Effectiveness and Patient Satisfaction with Budesonide/Formoterol Easyhaler® Among Patients with Asthma or COPD Switching from Previous Treatment: a Real-World Study of Patient-Reported Outcomes

“…A pooled analysis of two randomized, multicenter, crossover, open-label studies in patients aged 6-88 years with asthma (n = 287) or COPD (n = 96) found that by using the Easyhaler, most could achieve or exceed a peak inspiratory flow rate of 30 l/min, which is the minimum required to ensure optimal and consistent dose delivery [36]. Recent dose uniformity analyses also confirmed consistent delivered dose using the Easyhaler under simulated real-world conditions and a variety of inspiratory flow rates [37].…”

Asthma patient satisfaction with different dry powder inhalers

“…Easyhaler TM (EH) (Orion Corporation, Finland), is a three-step, light, compact, and user-friendly DPI. It has advantages over older DPIs [6], including dose uniformity in different real-world conditions [7]. With regard to features such as perception of inhalation, size, discreetness, mouthpiece comfort, and dose counter, EH was rated higher than other inhaler devices by asthma patients [8].…”