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Abstract
Introduction Three studies simulating various patient handling effects were performed with aclidinium bromide 400 μg/formoterol fumarate dihydrate 12 μg inhalation powder in the Genuair™* inhaler.
Methods Developmental batches representative for commercial production were used. Samples were tested before and after cleaning of the mouthpiece with a dry tissue, after dosing at various orientations (+45°/−45°) to the horizontal axis of the inhaler, or before and after dropping the inhaler in different orientations from a 1 m height. Test parameters included delivered dose uniformity (DDU) and fine particle dose (FPD).
Results All results for the LAMA (aclidinium bromide) and LABA (formoterol fumarate dihydrate) active ingredients were within the expected ranges and well inside the acceptance criteria applied during development (Figure 1). For aclidinium bromide, DDU mean values between 388 and 424 µg (specification range 320–480 µg), and single values between 343 and 464 µg (not specified) were observed. Mean FPD was tested within 156 and 175 µg (specification range 120–200 µg), and FPD single values between 136 and 198 µg (not specified). Results for the LABA active ingredient, formoterol fumarate dihydrate, were between 11.7 and 12.8 µg for DDU mean values (specification range 9.6–14.4 µg) and between 9.6 and 13.8 µg for DDU single values (not specified). Mean FPD was observed within 3.1 and 3.5 µg (specification range 2.2–4.5 µg), and FPD single values between 2.6 and 4.0 µg (not specified).
Conclusions The studies show that stable pharmaceutical quality can be guaranteed even if the device is used in different positions to the one explained in the patient information leaflet, after cleaning the mouthpiece, or after dropping the device in different orientations.
*Registered trademark of AstraZeneca group of companies; for use within the USA as Pressair® and Genuair™ within all other licensed territories.
Delivered dose uniformity (DDU) and fine particle dose (FPD) of LAMA (upper ) and LABA (lower) active ingredient after simulated patient handling (erroe bars:± min/max)