Eur J Pharm Sci 2019 Jan 19;126:33-48. Epub 2018 Jun 19.
Otomagnetics, Inc., Rockville, MD 20852, United States of America; Fischell Department of Bioengineering, University of Maryland, College Park, MD 20742, United States of America; Institute for Systems Research (ISR), University of Maryland, College Park, MD 20742, United States of America.
This paper investigates the safety of a novel 'magnetic injection' method of delivering therapy to the cochlea, in a rodent model. In this method of administration, a magnetic field is employed to actively transport drug-eluting superparamagnetic iron-oxide core nanoparticles into the cochlea, where they then release their drug payload (we delivered the steroid prednisolone). Our study design and selection of control groups was based on published regulatory guidance for safety studies that involve local drug delivery. Read More