Princeton Instruments and the Center for Structured Organic Particulate Systems (C-SOPS) have announced a six-month collaboration on a novel pharmaceutical technology that enables close monitoring and control of drug manufacturing processes. The research will be carried out by Rajesh Davé, distinguished professor of chemical engineering at the New Jersey Institute of Technology and the site-leader of C-SOPS. Dr Davé will use Raman spectroscopic measurements to monitor the formation of thin oral films, which contain medicine and dissolve in the mouth without the need for water, including in the drying process during manufacturing, in order to determine drug amount, uniformity and form. In addition, he will investigate the degradation processes of active pharmaceutical ingredients in solid-dose drugs.
“We are extremely excited about this collaboration with Dr Davé and C-SOPS. We are convinced that high performance spectrometers can provide unmatched capabilities for some of the most challenging applications in the pharmaceutical industry, like process monitoring of low dose and thin film coated drug manufacture,” said Dr Peng Zou, product manager at Princeton Instruments. The primary instrument to be used in this collaboration is the FERGIE spectrometer.
“We are excited to use this technology, which allows us to better understand the manufacturing of these thin films that are loaded with drug particles and, depending on how the wet film dries, how that could potentially change the way drug particles are distributed”, Dr Davé said. “Without disturbing the film, this monitoring, or ‘non-destructive testing’, will allow pharmaceutical companies to not only improve film product quality, but guarantee their performance without additional testing, which can involve physically destroying some of the film samples.”
C-SOPS works with industry leaders and regulatory authorities to improve the way pharmaceuticals, foods and agriculture products are manufactured. The group focuses on advancing the scientific foundation for the optimal design of SOPS with advanced functionality while developing the methodologies for their active control and manufacturing. C-SOPS is based at Rutgers University, and works with partners including the New Jersey Institute of Technology, Purdue University, the University of Puerto Rico at Mayaguez, and more than 40 industrial consortium member companies.