Princeton Instruments, C-SOPS Partner for Drug Monitoring

Princeton Instruments Inc. and the Center for Structured Organic Particulate Systems (C-SOPS) are entering into a six-month collaboration on a novel pharmaceutical technology to enable the 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 (NJIT) and the site leader of C-SOPS. C-SOPS is a National Science Foundation-funded Engineering Research Center. 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. He will use them in the drying process during manufacturing to determine drug amount, uniformity, and form. In addition, Davé 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,” said Peng Zou, product manager at Princeton Instruments. “We are convinced that high-performance spectrometers can provide unmatched capabilities for some of the most challenging applications in the pharmaceutical industry, [such as] process monitoring of low-dose and thin-film-coated drug manufacture.”

The primary instrument used in this collaboration is the Princeton Instruments FERGIE spectrometer, which has integrated Princeton’s proprietary aberration-free optical design and deep-cooled CCD detector.

“We are excited to use this technology, which allows us to better understand the manufacturing of these thin films,” Davé said. “Without disturbing the film, this monitoring, or nondestructive 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 closely 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 structured organic particulate systems with advanced functionality while developing the methodologies for their active control and manufacturing.

Headquartered at Rutgers University, C-SOPS partners include NJIT, Purdue University, the University of Puerto Rico at Mayaguez, and more than 40 industrial consortium member companies.