The New Jersey Chapter of the International Society for Pharmaceutical Engineering recently named Mahesh Karwa, of Kearny, in the chemistry department at NJIT, and Ge Bai, of Newark, in the chemical engineering department, also at NJIT, among winners of the society's annual research competition. Karwa's work focused on purifying DNA. Bai showed possible problems associated with the current drug testing apparatus and procedure prescribed by the US Pharmacopeial Convention Inc (USP).
"I am very proud of our two winners," said Piero M. Armenante, PhD., distinguished professor of chemical engineering, director of the graduate program in pharmaceutical engineering and advisor to the society's student chapter. Bai and Karwa will compete in the society's national competition at its annual meeting next fall.
Karwa's research showed a faster, cheaper and easier way to purify DNA. "DNA must be free from other contaminants after isolating it from a source such as plant, bacteria or virus cells," he said.
The current method is often laborious and time consuming. If the extraction procedure could be incorporated onto a chip, then the laboratory based analysis could be simplified dramatically and transformed to a home diagnostic test kit. This small scale integration would cut costs from dollars to pennies and decrease analysis time from hours to seconds.
"My research can have a potential impact in the fields of rapid disease diagnostics, environmental testing and biological warfare detection," Karwa added.
Bai's work showed that there could be problems with USP's testing apparatus. He examined the equipment to measure the dissolution rate of solid dosage forms of drugs. In addition to being a regulatory requirement, in vitro dissolution testing is used to assist with formulation design, process development, and the demonstration of batch-to-batch reproducibility in production. "Failure in a dissolution test can lead to the Food and Drug Administration (FDA) turning down a medication for approval," Bai said. "Reports have shown that the test results from the USP Dissolution Test Apparatus II are often inconsistent and difficult to reproduce. Despite the widespread use of this test, little information is available on the hydrodynamics of the test and how they affect the tablet's dissolution."
Using both experiments and computational models, Bai's work showed that small variations in the typical operation of the dissolution test device produces large changes in the hydrodynamics of the liquid in the apparatus. The result is that that fluid velocities vary dramatically within the device. This is especially relevant at the bottom of the vessel where the tablet dissolution process takes place. Bai also found that if the agitator's location in the dissolution vessel is changed from the centerline, even a small distance, results could be affected.
Bai said his finding can be important for the pharmaceutical industry. "The companies lose huge sums of money if a drug fails a dissolution test. My research can shed more light on what is happening and perhaps correct a problem."
A blue ribbon panel from industry chose the winning students. Judges included representatives from the following companies: Hoffmann LaRoche, Schering-Plough, Bristol-Myers Squibb, Wyeth, Novartis and Becton-Dickinson.