Product Life Cycle Approach to Cascade Impaction Measurements - Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products - page 135

Fig. 6.2 Scheme for full-resolution CI and abbreviated impactor confi gurations together with
likely relative use during development and production phases of the OIP life cycle ( From [ 4 ] —used
by permission )

APSD-pertinent data is identifi ed in relation to several distinct but complementary
processes. While this example uses the ACI for full characterization, the approach
would apply equally to the NGI and the related rNGI or FSI abbreviated systems.

6.4.2.1 During Product Development

1. Select an appropriate AIM apparatus (guidance on the performance of the differ-
ent options is given as part of Chap. 10 ).
2. Use either the AIM-pHRT or the AIM-QC CIs as screening tools in early for-
mulation development, noting that the AIM-QC system may provide greater
sensitivity for detecting important changes in the APSD profi le while taking
advantage of higher throughput. The AIM-pHRT confi guration could be used to
obtain additional resolution if an in-vivo, in-vitro (IVIV) relationship has already
been established. Note, however, that once the formulation and delivery system
(MDI, DPI, etc.) have been developed, the full-resolution CI would still be used
to defi ne product's APSD characteristics for the clinical batches.
3. Establish the full-resolution APSD profi le of the OIP with full-resolution CI based
measurements. This process would require multiple determinations representative