Center for Pharmaceutical Processing Research (CPPR)
A National Science Foundation Industry/University Cooperative Research Center since 1995
University of Connecticut
University of Puerto Rico
Reducing time to market and controlling manufacturing costs are key components of future competitive success for the pharmaceutical industry
Center Mission and Rationale
The Center for Pharmaceutical Processing Research (CPPR) was established to advance understanding of how unit operations in the manufacture of pharmaceutical dosage forms influence critical quality attributes of pharmaceutical products, to explore novel processing technology aimed at improving product quality or decreasing cost, to develop and implement improved process monitoring methods, to foster an interdisciplinary approach to pharmaceutical processing research, and to catalyze scientific interaction between academic scientists and their counterparts in the pharmaceutical industry.
The theme of the Center's research program is the application of physical chemistry and materials science to better understand, at a molecular level, the influence of processing conditions on the quality of pharmaceutical dosage forms. Major areas of research interest are:
- Process Modeling -- Application of mathematical algorithms
can minimize the amount of trial and error experimentation needed to
develop optimized processes. In the "Smart Freeze Dryer" project, a
model of heat and mass transfer is applied to the analysis of the transient
pressure response when the valve between the chamber and condenser is
briefly closed during primary drying. This analysis gives product temperature
data as well as vial heat transfer coefficient and product mass transfer
coefficient. When fully developed, this method will allow development
of an optimized drying cycle in one trial batch.
- Sterilization of Disperse Systems -- The method of choice
for sterilization of injectable drug products is terminal sterilization.
This presents a special challenge for disperse systems, such as suspensions
and emulsions, where thermal treatment can result in breaking of emulsions
and particle growth in suspensions. The long-range goal of the research
is to develop a better understanding of how formulation factors and
processing conditions interact to influence the behavior of these systems
during terminal sterilization.
- Monitoring of Powder Processing -- As the trend toward development
of drug products containing lower doses of more potent drugs continues,
the importance of validating the effectiveness of powder blending operations
becomes more critical. Photon migration measurements have the potential
for allowing non-destructive, real-time measurement of content uniformity
during powder blending operations. Center investigators have also developed
an instrument for measuring the chargeability of pharmaceutical powders,
along with an empirical database of electrical chargeability of pharmaceutical
excipients. The long- term objective of this project is to understand
the role of electrical charge in blend uniformity of powders.
- Drying -- Drying is often a poorly controlled step in the
production of a drug substance, particularly when hydrates or solvates
are formed. Current effort is directed at using model drug compounds
to test the hypothesis that drying is really a crystal growth process
involving the nucleation and crystal growth of the anhydrous phase in
the presence of a hydrate. Freeze drying is also a major research program
in the Center. The goals of this program are to establish an analytical
basis for development of freeze-dried formulations and processes instead
of the traditional empirical approach, and to improve the technology
for monitoring the freeze-drying process.
- Granulation Processes -- Granulation is a critical unit operation
in manufacture of solid oral drug products that are not directly compressed.
Current research interest in granulation is directed toward developing
a better ability to predict outcomes such as granule strength and shape
after wet granulation as a function of the morphology and physical-chemical
properties of particles prior to the granulation process. Roller compaction
is another aspect of granulation, which is being studied with an overall
objective of better prediction of the characteristics of the granule
as a function of characteristics of the powder blend and operating parameters
of the equipment.
Special Center Activities
With the inclusion of the University of Connecticut and the University of Puerto Rico, CPPR is now a multi-university Center.
CPPR has sponsored two international symposia on the freeze-drying of pharmaceuticals and biologicals.
Center for Pharmaceutical Processing Research
Department of Industrial and Physical Pharmacy
1336 Pharmacy Building
West Lafayette, IN 47907-1336
Tel (765) 494-1401 * Fax (765) 494-6545
Center Director: Dr. Steven L. Nail
Associate Director: Dr. Dane O. Kildsig
(765) 494-1484 * firstname.lastname@example.org
Associate Director: Dr. Evone Ghaly
(787) 758-2525 * email@example.com
Associate Director: Dr. Michael J. Pikal
(860) 486-3202 * firstname.lastname@example.org
Center Evaluator: Dr. Kenneth R. Heimlich
(610) 738-0984 * email@example.com