NIPTE Will Work with FDA on Abuse Deterrence of Opioid-Based Drugs

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CHICAGO--(BUSINESS WIRE)--The National Institute for Pharmaceutical Technology and Education, Inc. (NIPTE) has been awarded a $499K two-year FDA contract to examine formulation effects on abuse deterrence properties in solid oral dosage forms of opioids. The project will investigate the effect of physicochemical properties of active ingredients and excipients, as well as overall composition and manufacturing technology, on the manipulation of the drug product for extraction of the active ingredient for putative abuse.

The studies will be carried out by two NIPTE member institutions, Purdue University and the University of Maryland – Baltimore. Professors Stephen R. Byrn and Stephen W. Hoag will serve as principal investigators in their respective universities.

NIPTE, Inc. is an academic not-for-profit organization dedicated to fundamental research and education in development and manufacturing of pharmaceutical products and translational science. NIPTE's goal is to increase science and engineering-based understanding of this area so that novel state-of- the-art technologies can be developed and science-based regulations can be implemented. These technologies will also enable new drug discoveries to be brought to market faster with less variability, higher predictability of performance and at a significantly lower cost.

“This is the area of a significant public and scientific interest and we are pleased to be a partner,” said Vadim J. Gurvich, Ph.D., NIPTE associate director and research associate professor of medicinal chemistry at the University of Minnesota. “This contract expands our already robust scientific collaboration with the FDA and its Office of Generic Drugs into a new area.”

NIPTE is a Chicago-based non-profit research organization whose membership includes 13 top US universities in pharmaceutical science and engineering. Current members are Duquesne University, Illinois Institute of Technology, Purdue University, Rutgers University, University of Puerto Rico, University of Connecticut, University of Iowa, University of Kansas, University of Kentucky, University of Maryland - Baltimore, University of Michigan, University of Minnesota, and the University of Wisconsin.