Introduction - Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products - page 1

Chapter 1
Introduction
Terrence P. Tougas ,Jolyon P.Mitchell,Beth Morgan , and Helen Strickland
Abstract The abbreviated impactor measurement (AIM) and effi cient data analysis
(EDA) concepts for the in vitro assessment of orally inhaled drug products (OIPs),
comprising pressurized metered-dose inhalers (MDIs), soft mist inhalers (SMIs),
dry powder inhalers (DPIs), and nebulizing systems, are the topics covered by this
topic. The chief aims are to provide to potential adoptees of these new methods
answers to “how to” questions, as well as to those charged with regulatory oversight
assurance that both concepts are fully founded on valid scientifi c principles.
A chapter reviewing the cascade impaction method applied to the assessment of
OIPs is also included in order to provide the reader with the necessary background
material before exploring the extensions to current methodologies associated with
AIM and EDA. Both concepts are related, but do not necessarily need to be applied
together, nor is AIM an all-purpose replacement for OIP aerodynamic particle size
distribution (APSD) measurements by full-resolution cascade impactor (CI).