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Structured Organic Particulate Systems Engineering Research Center

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Commercializing of Continuous Pharmaceutical Manufacturing Technology  (Rutgers University New Brunswick)

Research Focus & Anticipated Benefits

 

One might think that pressing pharmaceutical materials into tablet form would be simple and straightforward. But it’s not. This manufacturing step is critical and complex in many ways for the pharmaceutical industry. The process of “tableting” is one of the research areas of the NSF-funded Center for Structured Organic Particulate Systems (C-SOPS), an Engineering Research Center (ERC) based at Rutgers University.  A continuous pharmaceutical tablet manufacturing system, thought to be the first ever assembled in academia, has been operating at C-SOPS since early 2008.  Center researchers led by Marianthi Ierapetritou are using this system to develop and integrate technologies for the continuous manufacturing of solid dosage forms under automatic control, and to develop and optimize models and strategies for process control. 

The equipment employed is well established in the industry, but its use for continuous processing, without the conventional breaks in production, has not been demonstrated.  Also, an integrated control platform for all the relevant steps currently does not exist, and predictive design models to set processing conditions for new products also are generally not available. These are both targets of C-SOPS research. 

Work on continuous tableting has led to two C-SOPS test lines.  One, at Rutgers University, features feeders, a mixer, tablet press, and controller.  At Center affiliate Purdue University, the line includes a mixer, granulator, mill, and controller.  These testbeds help develop the science and technology needed for continuous manufacturing that can accommodate the large range of materials and compositions used in tablet manufacture.  This research will lead to faster time-to-market, reduced cost, and higher product quality.  Through it, researchers are developing an understanding of how the individual units operate, as well as pinpointing and measuring critical variables and how their parameters can be adjusted in real time as the lines operate.  These efforts respond to the shortcomings of the batch processing technology that is used now for producing the tablets and capsules that deliver 85% of pharmaceuticals.  Among other issues, batch processing has meant longer manufacturing development time, poor process control, variations in tablets, and many rejects due to poor quality.

In a clear endorsement of Center research advances, C-SOPS industrial partners are already assembling their own continuous tableting lines, C-SOPS’ research on continuous tableting is generating changes in design concepts, and pharmaceutical companies are putting together their own lines by purchasing individual components from the Center's feeder/mixer member companies.  Several pharma companies have said they're ready to purchase the entire integrated system being developed at the Center. As a result, at least one member company is putting together a proposal to become a system integrator and offer customized versions of the entire continuous tableting line.

 

Education & Outreach

The Center for Structured Organic Particulate Systems (C-SOPS) at Rutgers University focuses on improving how pharmaceuticals, foods, and agricultural products are manufactured.  But as part of its mission as an Engineering Research Center funded by the NSF, the Center also organizes outreach projects to introduce area students to the sciences in fun and engaging ways. C-SOPS is developing interactive modules that will demonstrate the often-unexpected nature of particulate and fluid systems.

The modules will become part of the Rutgers Science Explorer—a custom-built bus for bringing demonstrations and interactive science activities to New Jersey’s middle school students.  Already, students who visit the bus can engage in activities dealing with gold panning, electricity generation, and transmission batteries and volcanoes.

The Rutgers Science Explorer is integrated with Rutgers’ Graduate Teaching Fellows in K-12 Education (GK-12) program, which is also funded by NSF.  The GK-12 program places advanced graduate and undergraduate students alongside middle school teachers in the classrooms, where they can help teach and generate interest in the sciences.  Rutgers has eight graduate GK-12 fellows and three undergraduates working with the Science Explorer program.  They staff the bus, develop and conduct demonstrations, and lead activities for the middle school students, presenting themselves as knowledgeable, approachable, and enthusiastic role models for the middle school students. 

 

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  • Image from a National Science Foundation-funded ERC.
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