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)

Author:

Mitchell Jolyon P.,Carter I.,Christopher J. D.,Copley M.,Doub W. H.,Goodey A.,Gruenloh C. J.,Larson B. B.,Lyapustina S.,Patel R. B.,Stein S. W.,Suman J. D.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Reference77 articles.

1. VanOort M. In vitro testing of dry powder inhalers. Aerosol Sci Technol. 1995;22(4):364–73.

2. 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.

3. 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).

4. 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).

5. 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.

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