Making a relatively small investment in systems that enhance the clinical realism of standard pharmacopoeial in-vitro test set-ups for the delivered dose uniformity (DDU) testing and aerodynamic particle size distribution (APSD) measurement may help bridge the gap between data collected during QC testing and in vivo performance helping to accelerate and improve R&D.
Two factors have been identified as being critical to improving the clinical relevance of DDU testing and APSD measurement: realistic breathing profiles and realistic throat and nasal models.
Whilst cascade impaction provides a useful indication of where inhaled drug particles are likely to deposit within the respiratory tract, it does not profile the morphological properties of these particles.
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