Future Directions for the AIM and EDA Concepts - Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products - page 400

was not confounded by product variability. Although helpful at identifying the
capability of the abbreviated measurement methods, its chief limitation was that the
fi ndings are nor directly applicable to the assessment of commercially available
product samples, subject to normal batch release testing. A further designed experi-
ment that will take place in late 2012 or early 2013 is in the process of addressing
this defi ciency, again being implemented through the CI-WG of IPAC-RS, which is
coordinating the activities of several independent laboratories. In this instance, the
samples of drug product are coming from commercially available lots without pre-
selection in terms of time of manufacture within the batch, so that the normal intra-
lot variability will be present. It is anticipated that the outcome from this investigation
will provide a more realistic assessment of the comparability of abbreviated with
full-resolution techniques when applied in the routine OIP QC environment.
By now, it should be evident that the ability to employ both concepts to make
more measurements of higher quality in terms of being able to discriminate mean-
ingful changes in APSD-based metrics is central to both AIM and EDA concepts.
Given these attributes, it is therefore anticipated that both AIM and EDA concepts
will fi nd increasing application in the QbD environment [ 8 ], in which more
laboratory-based assessments in early stage product development are likely to be
undertaken so that design space can be properly mapped and understood. Such an
approach, rather than simply relying on end-product testing, would be in harmony
with current thinking by regulatory agencies [ 9 , 10 ] and add to the assurance that
the fi nal APSD specifi cations for the OIP in question would be appropriate.

References

1. IPAC-RS (2011) Satellite conference at RDD-Europe 2011: Perspectives on Effi cient Data
Analysis methods and Abbreviated Impactor Measurements as quality assessment tools.
Presentations and Summary Report. Available at: http://www.ipacrs.com/CI.html . Accessed
27 Jan 2012
2. Tougas T (2011) Lifecycle aspects of incorporating AIM-EDA into development cycle:
Q&A Technical aspects presented at satellite conference at RDD-Europe 2011: Perspectives
on effi cient data analysis methods and abbreviated impactor measurements as quality assess-
ment tools. Presentations and Summary Report. Available at: http://www.ipacrs.com/CI.html .
Accessed 27 Jan 2012
3. Effi cient data analysis, abbreviated impactor measurements, aerodynamic particle size distri-
butions: publications and presentations by members of the IPAC-RS Cascade Impaction
Working Group and EPAG (2011). Available at: http://www.ipacrs.com/CI.html . Accessed 27

Jan 2012
4. Christopher D, Dey M, Lyapustina S, Mitchell J, Tougas T, Van Oort M, Strickland H, Wyka
B (2010) Generalized simplifi ed approaches For MMAD determination. Pharm Forum
36(2):812-823
5. Mitchell J, Tougas T, Christopher JD, Lyapustina S (2010) Extension of the Abbreviated
Impactor Measurement (AIM) concept to incorporate simultaneous determination of Delivered
Dose Uniformity with Effi cient Data Analysis metrics pertinent to aerodynamic particle size
(AIM-DDU Apparatus). Drug Delivery to the Lungs-21, The Aerosol Society, Edinburgh,
221-214. Available at: http://ddl-conference.org.uk/index.php?q=previous_conferences .
Visited 4 Aug 2012