• Publication Date: 04/01/2012
  • Author(s):
    Leiner, Stefan Schumacher, Jackie
  • Organization(s):
    International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS)
  • Article Type: Technical Articles
  • Subjects: Device Design, Industry Issues and Trends, Product Development/Formulation, Testing, Validation, and Regulatory Compliance
USP proposes more restrictive criteria for delivered dose uniformity (DDU). This is the second of two articles published by Inhalation, presenting opinions from representatives of IPAC-RS on the proposed revised and new USP Chapters for Aerosols <601> and <5>.

The June 2011 issue of the Pharmacopeial Forum [Pharm Forum 2011; 37(4)] contains a 110-page re-write (an in-process-revision) of USP General Chapter, which had been known under the title of “Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers” but is now called “Product Performance Tests—Nasal And Inhalation Aerosols, Sprays, And Powders.” In this article, one of the most critical aspects of the USP proposal – the new acceptance criteria for delivered dose uniformity (DDU) of orally inhaled products (OIPs) is discussed.

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