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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
The Polymer Processing Institute (PPI), an independent, not-for-profit, research and development organization that is headquartered at the New Jersey Institute of Technology (NJIT), has expanded its mission of working with industry and government to advance the field of polymer processing to include generating and using fundamental knowledge related to incorporating APIs into polymer excipients through hot-melt extrusion.
The Polymer Processing Institute (PPI), an independent, not-for-profit, research and development organization that is headquartered at the New Jersey Institute of Technology (NJIT), has expanded its mission of working with industry and government to advance the field of polymer processing to include generating and using fundamental knowledge related to incorporating APIs into polymer excipients through hot-melt extrusion. I recently visited with the PPI researchers and toured their facilities.
PPI was founded 30 years ago at Stevens Institute of Technology in New Jersey and relocated to NJIT in 1998. It is recognized in the plastics industry for its expertise in polymer processing and its relationship with NJIT, through which PPI collaborates with the University’s faculty and provides research opportunities and experience to NJIT graduate students at PPI’s laboratory facilities. PPI became actively involved with pharmaceutical extrusion about four years ago and has ongoing collaborations with pharmaceutical-industry companies, such as Merck, BMS, FMC, BASF, Evonik, and Colorcon.
Dr. Nicolas Ioannidis, PPI polymer research engineer, gave me a tour of PPI’s laboratories, which are located on the NJIT campus. The extrusion laboratory includes a 16-mm Leistritz co-rotating twin-screw extruder, a 15-mm APV co-rotating twin-screw extruder, and a 34-mm Leistritz co-rotating twin-screw extruder that is capable of foaming, all dedicated to pharma HME applications. I also had an opportunity to see the characterization laboratory, managed by rheologist Dr. Herman Suwardie, which has a wide range of polymer characterization equipment that is a focus of some of PPI’s current pharma research.
Recent research at the PPI Center for Fundamental HME Studies and the Department of Chemical, Biological, and Pharmaceutical Engineering (CBPE) at NJIT has focused on establishing simple and reliable methodologies for determining the solubility and dissolution kinetics of API-polymer excipient pairs. Currently, common tools for determining solubility include hot-stage polarized optical microscopy (HS-POM) and differential scanning calorimetry (DSC). HS-POM, however, is qualitative, and DSC may result in thermal degradation, because the sample must be exposed to heat for a long time, explained Dr. Ioannidis. PPI has developed an alternative method that uses rheometry, which avoids degradation and results in quantitative data that can be correlated to DSC results. PPI researchers are now focusing on determining dissolution kinetics, which is important for design and scale-up of the HME process for given API/excipient pairs, said Ioannidis. Other HME work at PPI includes studying foamed structures and formulations used in HME.
Complementary to its focus on fundamental knowledge development, PPI focuses on innovation and technology transfer and, therefore, continually seeks new industry partnerships, explained Dr. Costas Gogos, distinguished research professor at NJIT’s CBPE and chairman of the board of PPI.