The IPS Expert Group, created at the last International Pharmaceutical Federation (FIP) congress in Istanbul, is examining the root cause of tablet sticking and other tooling issues. Its goal is to use the principles of pharmaceutical Quality by Design to optimize tooling.
Leading the group are Tom Sam of Schering-Plough, Gabriele Betz of the University of Basel’s Industrial Pharmacy Lab and Dale Natoli of Natoli Engineering Co. As demand continues for higher manufacturing speeds, direct compression formulas and improved product quality, sticking is becoming more common, and cannot simply be solved by slowing speeds or adjusting tooling. The group is looking for companies interested in contributing to this research by providing information on specific sticking issues and their resolution. Those selected will be listed as contributors in the IPS Expert Group’s final report. Results will be reported on at the 2011 FIB Congress in Hyderabad, India. Those interested should contact Dr. Sam at [email protected].
At the same time, analytical technology vendors are working on solutions to facilitate the use of PAT to optimize tableting. TeraView has been working with the equipment vendor Oystar Manesty, and with Liverpool and Cambridge Universities in the U.K. to demonstrate its terahertz sensors’ capability to measure the coating thickness distribution on a batch of tablets, online, in real time and within a production-scale coating pan.
TeraView claims that its measurements require no calibration and are made on individual tablets, allowing users to assess tablet-to-tablet and batch-to-batch variability. Alternative techniques, such as NIR, measure multiple tablets, the company says. “It is well documented that not all tablets in a batch are of the same quality,” said Don Armone, TeraView’s CEO, “and this method offers a quick and easy way of measuring and ultimately controlling this variability. It builds on the considerable body of work to date with our existing pharma customers and with the FDA.”
Among other vendors actively examining tableting applications is Malvern Instruments, which has published an application note showing how data from its SyNIRgi NIR chemical imaging system can be used to reverse engineer tablets, offering extensive information about formulation and processing. NIR can offer more information about tablet manufacturing than HPLC, according to the application note, “NIR Chemical Imaging for Tablet Deconstruction: A Case Study for Solid Dosage Forms,” and can be downloaded at www.malvern.com/nircitablets.