Product Life Cycle Approach to Cascade Impaction Measurements - Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products - page 139

2. A developer of OIP add-on devices, or a pharmaceutical manufacturer interested
in including such add-on device information in their product label, would also
determine characteristic values of coarse ( CPM ), fi ne ( FPM ), and extra-fi ne ( EPM )
particle mass of the product ideally by means of an AIM-pHRT approach, likely
using either the ACI or NGI as the full-resolution CI benchmark apparatus (see
Sect. 6.4 ). Ultimately, it is anticipated that these metrics would be correlated to
clinical response if an adequate IVIVC or IVIVR for product effi cacy can be dem-
onstrated, although it is recognized that such correlations are notoriously diffi cult
to attain for OIP for a variety of reasons [ 10 ]. In the absence of an established
IVIVR, the add-on device developer would have to resort to correlating AIM-
pHRT-based measurements with their equivalents obtained by full-resolution CI to
provide baseline data for comparisons if any changes are introduced post-approval
or if add-on devices are to be recommended with the OIP.

3. Use the AIM-pHRT system to manage uses with either bespoke or commercially
available add-on devices (e.g., spacers, VHCs), which are well known to attenu-
ate and therefore modify the oropharyngeal deposition of aerosol particles emit-
ted from an OIP.

6.4.2.4 Summary of Approaches in OIP Life Cycle Management

Table 6.1 (a-d) together maps out a series of considerations as an aid in the under-
standing of the AIM/EDA life cycle approach. Its underlying purpose is to ensure a
cascading fl ow of information as the product and associated aerosol particle size
measurement equipment are moved through the process of development, character-
ization, approval, and manufacturing.

6.5 Additional Considerations Concerning AIM and EDA

Approaches in the Product Life Cycle

A number of additional considerations may be of concern to individual organizations
considering the implementation of AIM with or without EDA. These matters tend
to be misunderstandings concerning either or both concepts, or product specifi c,
making it more appropriate to deal with as a series of topics here, rather than in the
previous section, where issues likely to be of more general concern were addressed.

6.5.1 Use of MMAD as One of APSD Quality Metrics

In discussions with stakeholders, there has been some hesitancy regarding the use of
MMAD as an indicator of the OIP quality based on APSD. Such hesitation may have