Tablets & Capsules

TC0915

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ers it decreases again shortly after leveling off. Further study at higher tangential velocities would be required to deter- mine the category to which this formulation belongs. Conclusions The first goal for this study was to investigate the tabletability of a model DC formulation based on Retalac. In the compaction profile, viable tablets were made at 100 to 300 MPa, and it was observed that Retalac retained lac- tose's ability to increase tablet tensile strength as long as 4 hours after compression. The lubrication study showed that Retalac can maintain relatively low ejection forces, even at high compaction levels. The strain-rate study revealed that the formulation is sensitive to loading rate, which may or may not lead to issues when scaling up to production; this would require monitoring during the development process. But even if a small reduction in tablet press speed were required due to strain rate sensitivity, it would likely be out- weighed by the time and cost savings of eliminating the equipment train, labor, and validation requirements of gran- ulating, wet-sizing, drying, milling, and final blending. These findings demonstrate that Retalac is a viable option for DC formulations that use HPMC. The second goal of this study was to demonstrate the advantages of an instrumented tablet press in formulation development, and the studies discussed above are based on data acquired by the tablet press's instrumentation. These data are very helpful. Ejection forces, for example, must be quantified to identify over lubrication. The force during the main compression event must be known to plot a com- paction curve, which formulators use to determine the max- imum tensile strength of a formulation. Likewise, perform- ing an effective strain-rate study requires knowing the speed of the turret and verifying that a constant compres- sive force is maintained. In this era of QbD and total process understanding, process instrumentation isn't just a powerful development tool, it's the key to unlocking the potential of your research and development operations. T&C References 1. Rogers, T., Hewlett, K., Theuerkauf, J., Balwinski, K., and Kodam, M. Assessing how the physical properties and enhanced powder flow of HMPC translate to process con- trol during direct compression of matrix tablets. Tablets & Capsules, 12(7), 2014, pp. 14-22. 2. Rojas, J., Buckner, I., and Kumar, V. Drug Dev Ind Pharm, 38(10), 2012, pp. 1159-1170. 3. Sebhatu T., Elamin A.A., Ahlneck C. Effect of mois- ture sorption on tableting characteristics of spray dried (15 percent amorphous) lactose. Pharm Res, 11(9) 1994, pp. 1233-8. Muralikrishnan Angamuthu is in his fourth year of a Ph.D. pro- gram in pharmaceutics and drug delivery at the University of Mis- sissippi in Oxford. His research mainly focuses on product devel- opment of solid oral, topical, and transdermal dosage forms, as well as drug delivery. He worked at Onyx Pharmaceutical as a product development intern. Swetha Ainampudi is in her third year of a Ph.D. program in chemical engineering at the University of Mis- sissippi. Her research focuses on product development of immediate- and modified-release dosage forms, material science, and drug deliv- ery. She worked at GlaxoSmithKline as a product development intern for about a year. John Sturgis Jr. is a service engineer at SMI, 1309 Route 22 East, Lebanon, NJ 08833. Tel. 908 329 8334. Website: www.smitmc.com. SMI supplies tablet presses and data- acquisition systems. Tablets & Capsules September 2015 19 TABLETS & CAPSULES BOOKSTORE Go to www.tabletscapsules.com and click on "Bookstore."

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