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Good Practices for the Laboratory Performance Testing of Aqueous Oral Inhaled Products (OIPs): an Assessment from the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS)

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Abstract

Multiple sources must be consulted to determine the most appropriate procedures for the laboratory-based performance evaluation of aqueous oral inhaled products (OIPs) for the primary measures, dose uniformity/delivery, and aerodynamic particle (droplet) size distribution (APSD). These sources have been developed at different times, mainly in Europe and North America, during the past 25 years by diverse organizations, including pharmacopeial chapter/monograph development committees, regulatory agencies, and national and international standards bodies. As a result, there is a lack of consistency across all the recommendations, with the potential to cause confusion to those developing performance test methods. We have reviewed key methodological aspects of source guidance documents identified by a survey of the pertinent literature and evaluated the underlying evidence supporting their recommendations for the evaluation of these performance measures. We have also subsequently developed a consistent series of solutions to guide those faced with the various associated challenges when developing OIP performance testing methods for oral aqueous inhaled products.

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Acknowledgements

The authors wish to acknowledge support and advice from colleagues working within individual member companies of IPAC-RS who are involved with the day-to-day performance testing of aqueous inhalers for oral use.

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Authors and Affiliations

  1. Jolyon Mitchell Inhaler Consulting Services Inc., 1154 St. Anthony Road, London, Ontario, N6H2R1, Canada

    Jolyon P. Mitchell

  2. PPD Inc., Part of Thermo Fisher Scientific, Athlone, Ireland

    I. Carter

  3. Merck & Co. Inc., Kenilworth, New Jersey, 07033, USA

    J. D. Christopher & A. Goodey

  4. Copley Scientific Ltd., Nottingham, UK

    M. Copley

  5. OINDP In Vitro Analysis, Kirkwood, Missouri, 63122, USA

    W. H. Doub

  6. PPD Inc., Part of Thermo Fisher Scientific, Middleton, Wisconsin, 53562-466, USA

    C. J. Gruenloh & B. B. Larson

  7. Faegre Drinker Biddle & Reath LLP, Washington, District of Columbia, 20005, USA

    S. Lyapustina

  8. Intellectual Designs LLC, Brookfield, Connecticut, 06804, USA

    R. B. Patel

  9. Kindeva Drug Delivery, Woodbury, Minnesota, 55129, USA

    S. W. Stein

  10. Next Breath LLC, a Division of Aptar Group, Halethorpe, Maryland, 21227, USA

    J. D. Suman

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  1. Jolyon P. Mitchell
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Contributions

JPM and WHD led the preparation of the manuscript and undertook surveys of the pertinent literature; CJG and BBL provided perspective from a high throughput testing lab, including the two specific examples to illustrate challenges in adhering to the compendial methodology when testing specific nebulizers; all authors contributed to the discussion surrounding content; all authors reviewed draft versions of the manuscript, contributing to the technical content.

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Correspondence to Jolyon P. Mitchell.

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Apart from MC, who is the CEO of a company that manufactures inhaler test equipment, there are no conflicts of interest to declare.

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Mitchell, J.P., Carter, I., Christopher, J.D. et al. Good Practices for the Laboratory Performance Testing of Aqueous Oral Inhaled Products (OIPs): an Assessment from the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). AAPS PharmSciTech 24, 73 (2023). https://doi.org/10.1208/s12249-023-02528-5

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