- Author(s):
- Organization(s):
Jolyon Mitchell Inhaler Consulting Services, Inc. Merck OINDP In Vitro Analysis PPD—Thermo Fisher Scientific
In 2020 and 2021, Inhalation published three articles by the Cascade Impaction Working Group of the International Pharmaceutical Aerosol Consortium for Regulation and Science (IPAC-RS): (1) The liability of fine particle dose (FPD); (2) Cascade impactor stage groupings: Poor decisions from degraded data; and (3) Efficient data analysis (EDA): Size, mass and common sense. In this interview, one of the authors, Adrian Goodey, talks about reactions to the articles in the inhaler community since their publication.
The first and second articles discussed limitations of metrics commonly used in the regulation of aerodynamic particle size distributions (APSDs) of orally inhaled products (OIPs). The third article proposed using independent assessment of the dimensions of APSD (size and mass) by Efficient Data Analysis. The articles were written to educate, dispel common misconceptions, raise awareness of risks and encourage scientists to scrutinize current practices. “We have had a lot of positive feedback from our peers and that’s always rewarding,” explained Goodey. “We’ve also gained some interest from health authorities and pharmacopeial organizations. That said, any actual progress towards regulatory acceptance is imperceptible, which is obviously frustrating.”
Read part one – The liability of fine particle dose (FPD)
Read part two – Cascade impactor stage groupings: Poor decisions from degraded data
Read part three – Efficient data analysis (EDA): Size, mass and common sense