Pharmaceutical Research

, Volume 21, Issue 12, pp 2137–2147 | Cite as

Foreign Particles Testing in Orally Inhaled and Nasal Drug Products

  • James Blanchard
  • James Coleman
  • Claire D’Abreu Hayling
  • Raouf Ghaderi
  • Barbara Haeberlin
  • John Hart
  • Steen Jensen
  • Richard Malcolmson
  • Stanley Mittelman
  • Lee M. Nagao
  • Sonja Sekulic
  • Caesar Snodgrass-Pilla
  • Mikael Sundahl
  • Glenn Thompson
  • Ronald Wolff
Article

No Heading

The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) presents this paper in order to contribute to public discussion regarding best approaches to foreign particles testing in orally inhaled and nasal drug products (OINDPs) and to help facilitate development of consensus views on this subject. We performed a comprehensive review of industry experience and best practices regarding foreign particles testing in OINDPs, reviewed current guidances and techniques, and considered health and safety perspectives. We also conducted and assessed results of an industry survey on U.S. Food and Drug Administration requirements for foreign particles testing. We provide here a result of our review and survey: a summary of industry best practices for testing and controlling foreign particles in OINDPs and proposals for developmental characterization and quality control strategies for foreign particles. We believe that clear consensus-based recommendations and standards for foreign particles testing and control in OINDPs are needed. The proposals contained in this paper could provide a starting point for developing such consensus recommendations and standards.

Key words:

characterization foreign particles foreign particulates quality control techniques testing 

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Copyright information

© Springer Science+Business Media, Inc. 2004

Authors and Affiliations

  • James Blanchard
    • 1
  • James Coleman
    • 1
  • Claire D’Abreu Hayling
    • 1
  • Raouf Ghaderi
    • 1
  • Barbara Haeberlin
    • 1
  • John Hart
    • 1
  • Steen Jensen
    • 1
  • Richard Malcolmson
    • 1
  • Stanley Mittelman
    • 1
  • Lee M. Nagao
    • 1
  • Sonja Sekulic
    • 1
  • Caesar Snodgrass-Pilla
    • 1
  • Mikael Sundahl
    • 1
  • Glenn Thompson
    • 1
  • Ronald Wolff
    • 1
  1. 1.International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) Foreign Particles Working Group. IPAC-RS members are Aradigm, AstraZeneca, Aventis, Boerhinger Ingelheim, Chiron, Eli Lilly, GlaxoSmithKline, Kos, Nektar, Novartis, Novo Nordisk, Pfizer, Schering-Plough: http://www.ipacrs.com.

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