Studies have shown that the United States has one of the highest incidences of fatal anaphylaxis in the world. For anaphylaxis treatment in community settings, epinephrine intramuscular injection using an auto-injector, e.g. EpiPen®, in the thigh is universally recommended. Despite this, many people at risk of anaphylaxis in community settings do not carry their prescribed auto-injectors consistently and hesitate to use them when anaphylaxis occurs.
Mutasem Rawas-Qalaji, B. Pharm., Ph.D., associate professor of pharmaceutics at NSU’s College of Pharmacy, along with his research team, developed a novel sublingual tablet that disintegrates and releases the medicinal ingredient, epinephrine, under the patient’s tongue within less than 30 seconds. These rapidly disintegrating sublingual epinephrine tablets are taste-masked to enhance tablet’s palatability and patients’ acceptance. Recently, the NSU research team was able to significantly enhance the amount of drug that gets absorbed from the sublingual cavity into the blood, i.e. the relative bioavailability, through reducing the particles size of epinephrine using micro and nanotechnology.
Such an orally disintegrating tablet (ODT) is good for people who have trouble swallowing. It is also a way to deliver medicine orally without getting the digestive tract involved, so the drug can quickly flow into the bloodstream in seconds.
“This new sublingual epinephrine tablets will offer a non-invasive, user-friendly, cost-effective, and more stable alternative dosage form compared to auto-injectors,” Qalaji said.
Rawas-Qalaji has already met with the FDA and filed for a Pre-Investigational New Drug meeting. In the first meeting, the agency discussed its expectations for Epi-Pill registration, the design of Rawas-Qalaji’s planned studies and any additional studies that may be necessary afterward.
The research team is led by Mutasem Rawas-Qalaji, B. Pharm., Ph.D., at NSU and Keith J. Simons, Ph.D., F. Estelle Simons, MD, FAAAAI, and Ousama Rachid, Ph.D. at the University of Manitoba, Winnipeg, Canada.
Their findings are published in the peer-reviewed AAPS PharmSciTech, Mar 4, 2015 (Epub ahead of print), the official journal of the American Association of Pharmaceutical Scientists (AAPS)