Tablets & Capsules

TC1019

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TABLETS & CAPSULES Tablets & Capsules (ISSN 1549-9928 print; ISSN 1938-9159 online) is published by CSC Publishing, Inc, 1155 Northland Drive, Saint Paul, MN 55120. w w w . t a b l e t s c a p s u l e s . c o m October 2019 Volume 17 Number 7 Cover photo shows a fast-dis- solving tablet about 10 sec- onds after being placed in dissolution media. Drug disso- lution testing is routinely used to provide critical in vitro drug release information for qual- ity control purposes and in drug development to predict in vivo drug release pro les. The photo is from a recent series of time-lapse videos by Sotax called "Dissolution Is Beautiful" highlighting the complexities of tableted dosage forms and their designed formulation release. View the video at www.youtube.com/ watch?v=su2NlMFD4wk. For more information, call 508 417 1112 or visit www.sotax.com. QUALITY, VALIDATION, & REGULATORY COMPLIANCE FDA warning letters cite drug manufacturers for failing to test excipients or verify COAs 10 John Giannone, Michael Rashed, Peter Claise, and Doug Podolsky Pharma 4.0: Building quality into pharma manufacturing from molecule to medicine 15 Bikash Chatterjee Issue focus: Quality, validation, and regulatory compliance 22 Overcoming the challenges of continuous solid oral dosage manufacturing 24 Fritz-Martin Scholz Using multivariate analysis of batch-to-batch excipient variation to reduce risk 33 B. H. J. Dickhoff, T. Schigt, H. L. Blaauw, and A. W. van Gessel Back page Cover 3 Andrew Kolbert ALSO IN THIS ISSUE Formulation effects on tablet surface properties and lm coating adhesion 27 Blister packaging: A survey of what's available 31 PharmSci 360 preview 40 Eye on Excipients 42 Javier Camargo and Carolina Diaz Quijano Tablet & capsule identi cation: A survey of what's available 50 CPhI Worldwide preview 52 DEPARTMENTS Correction 6 Research 6 Markets 6 Industry news 8 Calendar 54 Supplier news 55 People news 55 Advertiser index 56 Industry innovations 56 Spotlight on Nutraceuticals 32A (This section appears four times yearly in issues delivered to our nutraceutical readership.)

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