Successful project completion- Controlled release, gel‐based ear drops for treatment of otitis media

By Yash Mokashi, CMI Fellow

otitis media

Source: Mayo Clinic 

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.

CMI funding 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.

An 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.