The Epinephrine Project Research Team (from left to right): Patricia Back, Brazilian exchange student; Yousif Rojeab, ONU associate professor of pharmaceutics; Christina Liebrecht, assistant professor of nursing; Cynthia Woodfield, visiting assistant professor of nursing; Mohamad Hassoun, study subject volunteer and fourth-year pharmacy student; Nancy Schroeder, assistant professor of nursing; and Fernanda Salles, Brazilian exchange student.
Getting stung by a bee or encountering a peanut product isn’t a big deal for most people. But for some, it triggers a severe and life-threatening allergic reaction that requires immediate medical intervention.
EpiPen® – an auto-injection formulation of epinephrine – is considered the “gold standard” treatment for anaphylactic shock. But Dr. Yousif Rojeab, ONU associate professor of pharmaceutics, with the assistance of two pharmacy students from Brazil, is testing a new formulation of epinephrine – a fast-dissolving tablet – for its potential use as an alternative frontline treatment.
“I’m excited about this project because it coincides with my passion for oral drug delivery and novel formulation development,” says Rojeab. “And for the Brazilian students, it’s a unique opportunity to participate in translational research and learn about the early stages of drug development in the U.S.”
Dr. Yousif Rojeab, ONU associate professor of pharmaceutics,with Brazilian
exchange students Fernanda Salles and Patricia Back
The number of children with allergies to food, medicines, pollens and more is on the rise in the U.S. While scientists don’t know for certain what is causing the increase in allergic disease, some speculate that our society’s focus on cleanliness has reduced the amount of germs, bacteria and other parasites that children encounter, thereby interrupting the normal development of the immune system.
“Allergic disease is absolutely a growing trend,” explains Rojeab. “And because of this, many states, including Ohio, are passing laws that encourage or require schools to have EpiPens® on hand.”
Although EpiPen® is highly effective, it does have downsides, says Rojeab. EpiPen® is expensive – around $140 each. It’s bulky compared to a small pill, and people need to be trained in how to administer the injection.
Rojeab’s former colleague – a retired medical doctor at Nobel Laboratories Inc. in Austin, Texas – came up with the idea of delivering epinephrine via a fast-dissolving oral tablet. “There are several advantages for this approach,” says Rojeab. “A fast-dissolving oral tablet would be more convenient, handy, portable and economical should it eventually make its way to the market.”
Rojeab’s research lab at ONU is working with Nobel Laboratories to test the absorption kinetics of epinephrine from the fast-dissolving tablet. Healthy subjects (who are hooked up to a cardiac monitor) ingest the tablet, and then Rojeab and his assistants closely monitor them for a three-hour period, obtaining frequent blood samples and blood pressure and heart rate readings. “We are evaluating how fast the drug gets into the bloodstream and if it hits the right amounts, comparing it to the EpiPen®,” says Rojeab.
ONU pharmacy students Patricia Back and Fernanda Salles in action.
For two Brazilian students – Fernanda Salles and Patricia Back – serving as research assistants for this project is an incredible opportunity, one not readily available in their home country. Third-year pharmacy students, they are participating in the Brazil Scientific Mobility Program, a government initiative that enables them to study in another country. They arrived at ONU in August 2013 and will return to their home country to finish their studies in December 2014.
“I am learning about how a clinical study is conducted, complementing what I learned theoretically during class,” says Back. “The whole process, before and after collecting samples from the individuals, is improving my technique.”
Both students are driven to become pharmacists because they want to help people achieve the best health outcomes possible. “I want to help relieve pain and suffering,” says Back. “To me, there is nothing worse than seeing a person suffering because there is not adequate medicine to treat him or her.”
Salles agrees. “Being a pharmacist is more than a profession; it means to live for the well-being of others,” she adds.
Since both students dream of working as researchers in the pharmaceutical industry, says Rojeab, working on a clinical trial will help them develop the skills and experiences that will open doors for them in the future.
“The U.S. is known all over the world for its pharmaceutical industry,” says Salles. “This experience is unique and will certainly help me achieve my goal, and make a difference in people’s health.”