Introduction Studies to test the delivered dose uniformity (DDU) and fine particle dose (FPD) delivery over inhaler life 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 after release, and after 24 months of protected (pouched samples) stability storage at climatic zone II conditions. In-use tests were performed with unprotected samples over 2 months at climatic zone II conditions, both shortly after batch production (‘fresh samples’) and after protected pre-storage at climatic zone II conditions for 35 months. In addition, mass balance and mouthpiece deposition were assessed.
Results The studies show consistent performance through inhaler life from release up to 24 months of protected storage; all data were well inside the acceptance criteria applied during development. An example for the LABA active ingredient, formoterol fumarate dihydrate, is given in Figure 1. Furthermore, during in-use studies over 2 months, no impact of climatic zone II conditions on DDU and FPD could be detected, both for fresh samples and samples pre-stored for up to 35 months. No significant first delivered dose effect was seen; the slightly lower first doses are explained by mouthpiece deposition, as shown in Figure 1 for the LABA and the LAMA (aclidinium bromide) active ingredient. The mouthpiece deposition per actuation/dose ranged from 6.5% for actuation 1 to 1.3% for actuation 60 for the LABA active ingredient, and from 4.9% for actuation 1 to 1.2% for actuation 60 for the LAMA active ingredient.
Conclusions The drug product delivers consistent doses and fine particle doses through inhaler life. Mouthpiece deposition is determined to be low, showing no effect on the drug product performance.
*Registered trademark of AstraZeneca group of companies; for use within the USA as Pressair® and Genuair™ within all other licensed territories.
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