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Industry news 6 Industry innovations 46 Calendar 47 Supplier news 47 TABLETS & CAPSULES outsourcing Effect of roller compaction pressure on the blend and tablet properties of a formulation containing a poorly 8 soluble drug E. E. Robles, P. M. Ved, N. Vora, T-Y. Kim, D. Cartwright, J. A. Williamson, N. Kanikkannan, and P. Skultety QbD and co-processed excipients: A low-risk alternative to API-in-capsule for expediting first-in-human studies 18 Adam Lambert Metrics' Hodges looks back—and ahead 22 Issue focus: Outsourcing 24 Metal detectors help ensure product purity at Global Health Industries 30 Counters and bottle fillers: A survey of what's available 32 Management responsibility for a serialization and aggregation system 33 Marcus Pabsch Dedusters: A survey of what's available 37 ExcipientFest preview 38 Eye on Excipients 41 Alen Guy Back Page 48 M. Teresa Carvajal Tablets & Capsules (ISSN 1549-9928 print; ISSN 1938-9159 online) is published eight times a year in January, March, April, May, July, September, October, and November by CSC Publishing, Inc., 1155 Northland Drive, Saint Paul, MN 55120. Periodicals postage paid at Saint Paul, MN, and additional mailing office. POSTMASTER: Send address changes to Tablets & Capsules, 1155 Northland Drive, Saint Paul, MN 55120. departments w w w . t a b l e t s c a p s u l e s . c o m March 2014 Volume 12 Number 2 also in this issue Cover photo shows staff engineer preparing a Collette Gral-300 Pro high-shear mixer-granulator at a DEA- approved pilot plant. The 8,000-square-foot facility, capable of handling solvents and potent compounds, includes two laboratories dedicated to R&D and GMP- co m p l i a n t d e v e l o p m e n t p r o jects. Company also operates a 375,000-square- foot commercial production facility dedicated to solid dosage development, manufacture, and packaging. Courtesy of Norwich Pharma Services, Norwich, NY. Tel. 888 674 7979, fax 607 335 3100. Website: www.norwich pharma.com. b-TOCFN_1-7_Masters 3/5/14 10:02 AM Page 2