Calibration of a novel in-line technology for assessment of pulmonary drug delivery

The novel technology provides a real-time in-line assessment of the dose dynamics during drug release by an inhaler. This method is capable to assess dose variability with respect to drug formulation design, inhaler-device design and user breathing profile. To demonstrate the unique measuring ability of the novel technology we completed a comparative study with the regulatory testing technology. For this study we chose Bricanyl® Turbohaler® as a reservoir dose metering dry powder inhaler, which has been thoroughly investigated and is exhibiting a significant variation of the delivered dose and the dose fine particle fraction, even for the standard breathing manoeuvre.