Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2023 Mar 3;24(3):73.
doi: 10.1208/s12249-023-02528-5.

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)

Jolyon P Mitchell  1 , I Carter  2 , J D Christopher  3 , M Copley  4 , W H Doub  5 , A Goodey  3 , C J Gruenloh  6 , B B Larson  6 , S Lyapustina  7 , R B Patel  8 , S W Stein  9 , J D Suman  10
Affiliations
Review

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)

Jolyon P Mitchell et al. AAPS PharmSciTech. .

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.

Keywords: cascade impactor; droplet sizing; laser diffractometry; nebulizer; soft mist inhaler.

PubMed Disclaimer

References

    1. VanOort M. In vitro testing of dry powder inhalers. Aerosol Sci Technol. 1995;22(4):364–73. - DOI
    1. Mitchell JP, Stein SW, Doub W, Goodey AP, Christopher JD, Patel RB, et al. Determination of passive dry powder inhaler aerodynamic particle size distribution by multi-stage cascade impactor: International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) recommendations to support both product quality control and clinical programs. AAPS PharmSciTech. 2019;20 article 206.
    1. United States Pharmacopeial Convention. United States Pharmacopeia. Chapter <601>: Inhalation and nasal drug products: aerosols, sprays, and powders – performance quality tests. Rockwell, MD, USA. https://uspnf.com/uspnf/ (visited April 18, 2022).
    1. European Directorate for the Quality of Medicines and Healthcare (EDQM). Strasbourg, France. Monograph 2.9.18: preparations for inhalation: aerodynamic assessment of fine particles. https://edqm.eu/en/european-pharmacopoeia-ph-eur-10th-edition (visited April 18, 2022).
    1. Mitchell JP, Nagel MW. Cascade impactors for the size characterization of aerosols from medical inhalers: their use and limitations. J Aerosol Med. 2003;16(4):341–77. - PubMed - DOI

LinkOut - more resources