Research seeks to improve formulation and manufacturing of opioid medications; deter individuals from abusing powerful pain relievers.
By: Malissa Carroll
Wednesday, November 6, 2013
The Food and Drug Administration (FDA) has awarded the University of Maryland School of Pharmacy, in conjunction with the National Institute for Pharmaceutical Technology and Education (NIPTE) and Purdue University, a two-year, $499,000 contract to examine formulation effects on abuse deterrence properties in solid oral dosage forms of opioids. According to the FDA, the science of abuse deterrence is fairly new, with formulation technologies as well as analytical, clinical, and statistical methods for assessing those technologies continuing to evolve.
“Prescription opioid abuse is one of the leading public health challenges for the United States,” says Andrew Coop, PhD, professor and chair of the Department of Pharmaceutical Sciences (PSC). “The FDA continues to work with its partners in academia, industry, and other government organizations to address the widespread misuse and abuse of opioid pain relievers, while still ensuring that patients with chronic pain have appropriate access to these important medications. It is our hope that the results of this collaboration will lead to safer opioid medications and the development of new formulations that reduce the likelihood of individuals abusing these medications.”
According to the Centers for Disease Control and Prevention (CDC), approximately three out of four prescription drug overdoses are caused by opioid pain relievers. These drugs can be abused in a number of ways, such as crushing to smoke or dissolving to inject. Through this contract, the FDA seeks to improve the formulation and manufacturing of these drugs in a way that targets expected routes of abuse, with the intent of deterring individuals from using these drugs in ways other than as prescribed by a health care provider.
Stephen W. Hoag, PhD, professor in PSC and director of the School’s Good Manufacturing Practice (GMP) Facility, will serve as co-principal investigator on the contract with Stephen R. Byrn, PhD, the Charles B. Jordan Professor of Medicinal Chemistry at Purdue University.
“We will assess different formulation components and manufacturing processes used to make abuse deterrent formulations,” says Hoag. “This assessment will provide a scientific basis from which the FDA can evaluate the risk of abuse and the effectiveness of abuse deterrent technologies engineered into prescription opioid products.”
The School of Pharmacy and Purdue University are members of NIPTE, Inc., an academic not-for-profit organization dedicated to fundamental research and education in development and manufacturing of pharmaceutical products and translational science. Its 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.
“Abuse of prescription opioids is an area of significant public and scientific interest, and we are pleased to partner with the FDA on this project,” says Vadim J. Gurvich, PhD, associate director of NIPTE 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.”
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