Future Directions for the AIM and EDA Concepts - Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products - page 399

Fig. 13.1 Concept for a combined AIM-DDU apparatus

The thought process in relation to inhaler lifecycle management could poten-
tially be extended to integrate the measurement of dose content uniformity and
AIM-based APSD metrics into a single apparatus (Fig. 13.1 [ 5 ]).
This combined testing approach could thereby achieve the desirable goal from
the statistical perspective of making only a single simultaneous measurement of
inhaler aerosol quality.
Such an apparatus (which is in early development at the concept stage within
IPAC-RS) will require experimental validation with a variety of inhaler products before
gaining acceptance both from the industry and regulatory perspective. Nevertheless, by
combining these measurements, intrinsic variability introduced by making them sepa-
rately could be eliminated, resulting in improved overall measurement precision.
The initial designed experiment orchestrated through the CI Working Group of
IPAC-RS and described in detail in Chap. 10 assessed relative precision of metrics
obtained by abbreviated versus full-resolution CI, using drug product from a short
period during the manufacture of a particular lot so that measurement variability