Issue link: https://www.e-digitaleditions.com/i/341135
Tablets & Capsules July 2014 23 Ingredient Archival System (GInAS), which gives each material a unique identification number, or UNII, that is required to add a material to the Inactive Ingredient Database (IID). Kathy Ulman discussed how IPEC- Americas is helping to improve the IID, including standardizing names, improving usability, identifying miss- ing ingredients, and cross-referenc- ing multiple names for the same ingredient. FDA has drafted a docu- ment that answers frequently asked questions, and it is now under inter- nal review. IPEC-Americas has a copy. Other presentations Wednesday addressed formulating solid dosage forms for pediatric applications, coat- ing technologies for taste-masking particles, combining flavors and colors for dietary supplement and pharma- ceutical applications, and how indus- try can help in the science-based implementation of the new elemental impurities standards. Slides and audio from most of the presentations are available at IPEC-Americas' website: ipecamericas.org. The 3-day conference and expo returns to Puerto Rico in April next year. ExcipientFest Asia takes place March 2015 in Shanghai, China, and ExcipientFest Europe was underway in Amsterdam at press time. T&C ents (APIs), no one wants to be first. "It is a very brave pharmaceutical exec- utive who would use a new excipient on a potential blockbuster." Keith Horspool of Boehringer Ingelheim said APIs have been modified to suit the excipient, and products have failed because they couldn't be made small enough using available excipients. Nigel Langley of BASF, which has developed a new excipient, said that developing a new API and a new excipient is very similar, and excipient manufacturers need the support of pharmaceutical companies in order to get a return on the investment. Lang - ley also said lowering the regulatory barrier would help. "We sense the time is right to have this discussion with the FDA and make it work. Patients will suffer otherwise," he said. Added Horspool: "We have to have independent approval for our industry to progress." Dave Schone ker of Colorcon agreed: "Without inde- pendent review of excipients, innova- tion is dead. We need a clear pathway. We will be giving the FDA a proposal about how we can take the next step. We've been talking about this since IPEC started in 1990. The time is now. We can't take 'no' for an answer. We're not waiting another 24 years." On Wednesday, FDA representa- tives discussed the Agency's "Global Chris Moreton contributes to a roundtable discussion about novel excipients. Also on the panel were Chris DeMerlis of Colorcon, Nigel Langley of BASF, Keith Horspool of Boehringer Ingelheim, and Vinod Tulani of GlaxoSmithKline. USA +1 973 467 8140 CAN +1 514 667 6777 UK +44 (0)1782 597540 BB-1243 SCREEN DISASSEMBLE RAPIDLY, AND SANITIZE MANUALLY OR IN AN AUTOCLAVE SMALL BATCH QUICK-CLEAN SIFTERS SCALP MATERIAL LOADED INTO PROCESS EQUIPMENT, CONTAINERS OR VESSELS PORTABLE BATCH SIFTERS BULK PHARMACEUTICALS AND NUTRACEUTICALS 5 SPECIALIZED WAYS SCALP OR DEDUST, THEN CLEAN OR STEAMINPLACE, OR DISASSEMBLE IN MINUTES C.I.P/S.I.P. VIBRATORY SCREENERS BATCH OR INLINE CENTRIFUGAL SCREENERS SLIDE INTERNALS FREELY FROM THE DISCHARGE END OF CANTILEVERED SHAFT FOR SANITIZING BAG DUMP VIBRATORY SCREENERS REMOVE BAG SCRAPS AND OTHER OVER SIZE MATERIALS DUSTFREE • Contamination-free • Sealed, dust-tight systems • Crevice-free designs • Highest sanitary standards • Virtually zero residual • Fast, thorough wash down • Capacities from grams to tons/h • Batch or continuous • Standard and highly custom designs e-ExcipFest_22-23_Masters 7/2/14 11:08 AM Page 23