| 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.
In December 2009, NSF awarded
C-SOPS a $1.8M grant for Commercializing of Continuous Pharmaceutical Manufacturing
Technology to support a vigorous on-going effort to commercialize continuous
pharmaceutical manufacturing technology.
| CSOPS is performing the
underlying research and developing the enabling technologies for a new
integrated, continuous pharmaceutical tableting system that is already
beginning to be adopted by the industry. |
|
