Successful project completion- Controlled release, gel‐based ear drops for
treatment of otitis media
By Yash Mokashi, CMI Fellow
CMI would like to congratulate
Dr. Morgan Fedorchak and Dr. Cuneyt Alper, the investigators of the project
titled: “Controlled release, gel‐based ear drops for treatment of otitis media,”
for the successful completion of their project with the aid of CMI funding. The
engineering co-investigator of the project is Dr. Morgan Fedorchak and the
clinical co-investigator is Dr. Cuneyt Alper.
Otitis media is responsible for the
greatest number of antibiotic prescriptions in children. Otitis media accounts
for 20 million annual pediatrician visits in the US, with one third of children
experiencing six or more cases before age 7, resulting in significant domestic
economic impact. Current treatment options include systemic antibiotics and topical antibiotic eardrops.
Antibiotics carry a risk of resistance development. Eardrops are
inefficient due to low bioavailability and poor patient compliance due to the
need for frequent drop administration.
To address these shortcomings the
team has proposed adapting their existing ocular drug delivery system for use
in the ear as a treatment for otitis media. This enables gradual release of the desired drug over the necessary time frame.
of $25,000, along with a dedicated one-year research phase, allowed the team to
provide proof of concept. The team developed and characterized a microsphere
formulation capable of releasing therapeutic levels of drugs over a period of 2
weeks. In an ex-vivo setup, the team tested the permeability of the released
drug through dissected tympanic membrane tissue in guinea pig models with the
use of their device. The guinea pig model was also used to perform pilot
in-vivo efficacy as well as safety testing. The team successfully designed and
fabricated a prototype application capable of consistently administering the
two-phase drops in the ear.
invention disclosure has been made by the team to the University of Pittsburgh Office
of Technology Management. An application was submitted for an R21 grant to the
NIAID in February 2017 and a pediatric drug delivery R01 grant application is
in preparation for submission to the NICHD. The team is currently
seeking additional funding to continue the otitis media project.