Addressing the Need for Controls on Particle Bounce and Re-entrainment in the Cascade Impactor and for the Mitigation of Electrostatic Charge for Aerodynamic Particle Size Assessment of Orally Inhaled Products: an Assessment by the International Consortium on Regulation and Science (IPAC-RS)-Reference-Cited by-同舟云学术

Addressing the Need for Controls on Particle Bounce and Re-entrainment in the Cascade Impactor and for the Mitigation of Electrostatic Charge for Aerodynamic Particle Size Assessment of Orally Inhaled Products: an Assessment by the International Consortium on Regulation and Science (IPAC-RS)

Published:2020-08-21 Issue:7 Volume:21 Page:
ISSN:1530-9932
Container-title:AAPS PharmSciTech
language:en
Short-container-title:AAPS PharmSciTech

Author:

Doub William^ORCID,Stein Stephen,Mitchell Jolyon,Goodey Adrian P.

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

Link

https://link.springer.com/content/pdf/10.1208/s12249-020-01720-1.pdf

Reference109 articles.

1. EMEA. Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products. London June 21, 2006.

2. United States Food and Drug Administration. Draft Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality Considerations. Silver Spring, MD Revised April 2018.

3. Mitchell JP, Nagel MW. Cascade impactors for the size characterization of aerosols from medical inhalers: their uses and limitations. J Aerosol Med. 2003;16(4):341–77.

4. United States Pharmacopeial Convention. Aerosols, nasal sprays, metered-dose inhalers and dry powder inhalers. United States Pharmacopeia 42/National Formulary 37, Chapter 601. Rockville, MD 2018.

5. European Directorate for Quality in Medicines and Healthcare. Preparations for inhalation: aerodynamic assessment of fine particles. European Pharmacopeia 10.0, Chapter 2.9.18. Strasbourg, FR 2019.

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