Issue link: https://www.e-digitaleditions.com/i/1056686
Technical articles discuss recent updates to USP informative chapters and spray-dry manufacturing as a useful tool for development of inhalation products that pursue US FDA 505(b)(2) submission. 2 December 2018 Inhalation Inhalation (ISSN 1937-0717 print; ISSN 1940-414X online) is published six times per year in February, April, June, August, October and December by CSC Publishing, Inc., 1155 Northland Drive, Saint Paul, MN 55120. w w w . i n h a l a t i o n m a g . c o m December 2018 Volume 12 Number 6 Cover image shows the Xelair® 5 Series fully automated system for testing dose content uniformity of the emitted dose, from Astech Projects, 15 Berkeley Court, Manor Park, Runcorn, Cheshire, WA7 1TQ, UK, Tel: +44 1928 571797, www.astechprojects.co.uk Inhalation quality/compliance 12 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> Kahkashan Zaidi, Paul Curry, Anthony J. Hickey, Stefan Leiner, Jolyon P. Mitchell, Guirag Poochikian and Jason Suggett 20 Issue focus: Quality/Compliance 22 Respirable, engineered, spray-dried dry powders for 505(b)(2) drug product development Jeffrey Breit and Aditya R. Das capsules/blisters 10 Special section: Capsules/Blisters additional features 6 Cross-industry organizations: ISAM: 2018 highlights and a preview of the 2019 Congress 27 Extra focus: Product development 32 Back Page: The pediatric asthma yardstick meetings 11 Previewing Drug Delivery Partnerships 2019 departments 8 Industry news 9 Respiratory medicine news 29 Calendar 30 Web review