Issue link: https://www.e-digitaleditions.com/i/1056686
The second article in a two-part series by members of the USP Aerosols Sub-Committee, focusing on recent updates to chapters within the committee’s remit. 12 December 2018 Inhalation An overview of general chapter development for oral and nasal drug products (OINDPs) at the United States Pharmacopeia (USP): Part 2—Informative chapters <1601>, <1602>, <1603> and <1604> This is the second article of a two-part series that provides an overview of the work currently undertaken by members of the Aerosols Sub-Committee at the USP, focusing on recent updates to the normative and informative chapters within the committee's remit. Kahkashan Zaidi, PhD; Paul Curry, PhD; Anthony J. Hickey, PhD, DSc; Stefan Leiner, PhD; Jolyon P. Mitchell, PhD; Guirag Poochikian, PhD and Jason Suggett, PhD Members of the Aerosols Sub-Committee of the General Chapters—Dosage Forms Expert Committee, United States Pharmacopeial Convention (USP), Rockville, Maryland, US AEROSOLS—CHARACTERIZATION TESTS (official) • <1603> GOOD CASCADE IMPACTOR PRAC- TICES (in draft) • <1604> DATA INTERPRETATION OF AERO- DYNAMIC PARTICLE SIZE DISTRIBUTION MEASUREMENTS FOR ORALLY INHALED PRODUCTS (in draft) e information provided on draft chapters <1603> and <1604> is based on previously published Stimuli articles, 2, 3 and should therefore be construed as only being indicative of likely content, given the USP reserves the right to change content, in particular to meet objectives in support of the United States Food and Drug Administration (FDA). General Chapter <1601> PRODUCTS FOR NEBULIZATION e development of the content for this chapter origi- nated with the Inhalanda Working Party of the Euro- pean Pharmacopoeia in the period from 2005-2009, eventually appearing as Monograph 2.9.44: Prepara- tions for Nebulisation. Chapter <1601> is an excellent example of chapters harmonized since its inception; it is Introduction A previous article 1 in Inhalation's April 2018 issue described the work of USP's Aerosols Sub-Committee of the General Chapters—Dosage Forms Expert Com- mittee on the normative chapters <5> INHALATION AND NASAL DRUG PRODUCTS—GENERAL INFORMATION AND PRODUCT QUALITY TESTS, <601> INHALATION AND NASAL DRUG PRODUCTS: AEROSOLS, SPRAYS, AND P OW D E R S — P E R F O R M A N C E Q U A L I T Y TESTS, <602> PROPELLANTS, <603> TOPICAL AEROSOLS, and <604> LEAK RATE. As a reminder, USP's general chapters are subdivided into those numbered below <1000> that are generally normative (applicable) chapters and those numbered above <1000> that are informational chapters (Figure 1). is article is the second in the two-part series. It focuses on the informative chapters that are either official text or are in draft, and fall under the remit of the sub-committee: • <1601> PRODUCTS FOR NEBULIZATION (official) • <1602> SPACERS AND VALVED HOLDING CHAMBERS USED WITH INHALATION