The purpose of this publication is to introduce a new, simpler and
more effective way in which to interpret pharmaceutical aerosol
particle size data from orally inhaled products (OIPs). Currently,
the compendial and regulatory requirements dictate the need for
measurements by full resolution multi-stage cascade impactor (CI),
a process that is demanding for the operator, time consuming, prone
to experimental error, and challenging for method transfers from
one laboratory to another. Furthermore, we shall show that the
current practice of reducing information from mass-weighted
aerodynamic particle size distribution (APSD) measurements through
the use of CI stage groupings is not the most effective
decision-making tool for OIP quality control (QC) in comparison
with newly introduced, mutually-independent efficient data analysis
(EDA) metrics that can be derived either from full resolution or
abbreviated impactor measurements (AIM).
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