Issue link: https://www.e-digitaleditions.com/i/341135
Tablets & Capsules July 2014 37 the case of simple process changes, providing the clients with process and tablet analytical data that sup- ports their communications with the FDA or other regulatory agencies. What ever the need, the Natoli Institute staff will interact closely with the client's technical team to properly identify it and propose appropriate experiments. LIU's phar- macy school faculty can also initiate pro- jects. "We actu- ally look for- ward to that h a p p e n i n g , " Kettler said. "It's a resource for them if they want to revise their under- graduate industrial pharmacy class and write new experiments to create learning opportunities for students." Regardless of whether the graduate students work on Natoli projects or conduct their own research, they will be well prepared to work in pharma- ceutical manufacturing. "It will be an eye-opener for a lot of them to see full-scale operations running," Kettler said. "It's pretty impressive to watch a big tablet press cranking out a half million tablets an hour. Many haven't had a chance to see that." T&C Natoli Scientific, St. Charles, MO Tel. 636 926 8900 Fax 636 926 8910 Website: www.natoli.com/NatoliScienti fic LIU Pharmacy School, Brooklyn, NY Tel. 718 488 1004 Fax 718 780 4586 Website: www.liu.edu/pharmacy Dual-purpose endeavor The joint Natoli-LIU effort fulfills a need of academia and industry, Kettler said. "One of the realities about the pharmacy programs around the United States is that not many of them still offer industrial pharmacy opportunities. Many of the students go to Walgreens, CVS, and Rite Aid, or they'll work at the hospital formu- lary. Not as many go to tablet manu- facturing companies." In fact, LIU's pharmacy school was having trouble getting faculty support for an industrial pharmacy program, Kettler said. At the same time, Natoli Scientific "needed to take some of the problems that our customers have and address them in the laboratory. By partnering with LIU and providing them with a significant payment to help them build the Na toli In - stitute, we help them bring their program back and we have access to capa- ble ex peri ment - ers. We also have Prof. Dave, who has a finger on the pulse of the formulation world, including topics addressing the need to research methods to formulate properly drugs that exhibit low solu- bility and permeability." The Institute will likely appeal to manufacturers of generic drug prod- ucts, Kettler said, especially those on a tight timeline or those whose processes may not be as robust as expected. Without help, these manu- facturers may not be ready to supply launch quantities of a product and may miss their opportunity to cap- ture market share once the product is approved and authorized, Kettler said. He also noted that many prod- ucts don't scale up as readily as expected, and unanticipated issues arise that require additional develop- ment work. "The Natoli Institute is prepared to work with manufacturers to build their portfolio of scale-up data in support of SUPAC changes," Kettler said. Services include con- ducting designed experiments or, in Dave and Natoli at the Institute's entrance. LIU students learn about unit operations and Natoli customers have their tabletting problems investigated. packaging production formulation w w w . t a b l e t s c a p s u l e s . c o m g-Natoli_36-37_Masters 7/2/14 11:10 AM Page 37