Uniformity of delivered dose from the first to last dose of the BF Spiromax® inhaler in the laboratory and under ‘real-world’ conditions

Jan Arp, Michael Goller, Hans Keegstra

Summary
Budesonide/formoterol Spiromax® ([BF Spiromax], Teva Pharmaceuticals) is a dry-powder inhaler delivering budesonide and formoterol for the treatment of asthma and COPD. BF Spiromax has been developed in low strength, middle strength and high strength formulations (80 μg/4.5 μg, 160 μg/4.5 μg and 320 μg/9 μg of budesonide/formoterol per inhalation, respectively).
Dose consistency was evaluated using uniformity of delivered dose (UDD) assessments. UDD was tested using low, medium and high strength inhalers. Doses from different stages of the BF Spiromax lifespan were collected using a Dose Uniformity Sampling Apparatus. To simulate real-world conditions, inhalers were subjected to natural knocks/vibrations and temperature/humidity variations. Inhalers were assessed at the beginning, middle and end of their lifespan and UDD measured over a ≤90 day period until the last labelled dose. Five simulation schemes were assessed using low, medium and high strength BF Spiromax with variations in the number of
inhalations twice daily.  The BF Spiromax devices delivered consistent doses throughout inhaler lifetime. Delivered doses increased in proportion with the labelled doses for each strength. Using real-world simulations, for all five schemes, UDD was also consistent throughout inhaler lifetime. Dosing regimen had no impact on UDD for each BF Spiromax formulation.
All three strengths of BF Spiromax delivered consistent doses throughout their lifetimes and over five real-world dose and schedule regimens.

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