NDLI: Minimizing Variability of Cascade Impaction Measurements in Inhalers and Nebulizers

Content Provider	Springer Nature Link
Author	Bonam, Matthew Christopher, David Cipolla, David Dovan, Brent Goodwin, David Holmes, Susan Lyapustina, Svetlana Mitchell, Jolyon Nichols, Steve Pettersson, Gunilla Quale, Chris Rao, Nagaraja Singh, Dilraj Tougas, Terrence Oort, Mike Walther, Bernd Wyka, Bruce
Copyright Year	2007
Abstract	The purpose of this article is to catalogue in a systematic way the available information about factors that may influence the outcome and variability of cascade impactor (CI) measurements of pharmaceutical aerosols for inhalation, such as those obtained from metered dose inhalers (MDIs), dry powder inhalers (DPIs) or products for nebulization; and to suggest ways to minimize the influence of such factors. To accomplish this task, the authors constructed a cause-and-effect Ishikawa diagram for a CI measurement and considered the influence of each root cause based on industry experience and thorough literature review. The results illustrate the intricate network of underlying causes of CI variability, with the potential for several multi-way statistical interactions. It was also found that significantly more quantitative information exists about impactor-related causes than about operator-derived influences, the contribution of drug assay methodology and product-related causes, suggesting a need for further research in those areas. The understanding and awareness of all these factors should aid in the development of optimized CI methods and appropriate quality control measures for aerodynamic particle size distribution (APSD) of pharmaceutical aerosols, in line with the current regulatory initiatives involving quality-by-design (QbD).
Starting Page	404
Ending Page	413
Page Count	10
File Format	PDF
Journal	AAPS PharmSciTech
Volume Number	9
Issue Number	2
e-ISSN	15309932
Language	English
Publisher	Springer US
Publisher Date	2008-02-28
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	aerosol impactor inhaler nebulizer variability Biochemistry Biotechnology Pharmacy Pharmacology/Toxicology
Content Type	Text
Resource Type	Article

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