Stability of aclidinium bromide inhalation powder (200 (mu)g per dose) delivered from the Genuair(registered trademark) inhaler

Abstract

Rationale: Aclidinium bromide is currently in Phase III development for the treatment of chronic obstructive pulmonary disease. Drug stability and inhaler performance can be affected by environmental conditions. This study evaluated the effect of temperature and humidity on the stability of the aclidinium 200 (mu)g formulation delivered from the Genuair(registered trademark) inhalernull. Methods: Two laboratory scale (LS) batches and 3 pilot scale (PS) batches of aclidinium were stored (for up to 3 years and 2 years, respectively) and periodically analyzed for purity and stability. Storage conditions were for climatic zones II (25(degrees)C/60% relative humidity [RH]) and IV (30(degrees)C/65% RH), as well as accelerated conditions of 25(degrees)C/75% RH (ACI) and 40(degrees)C/75% RH (ACII). Results: No change in delivered dose and no significant change in particle size were observed with different storage conditions. The initial impurity profile was very low (total impurity <0.9% for LS batches and below reporting level in PS batches) and remained largely unchanged throughout storage. (Table presented) Conclusions: The Genuair(registered trademark) inhaler delivers aclidinium dry powder for inhalation, consistently and without loss of quality, throughout a 36-month time period and over a wide range of environmental conditions.