Pharmacokinetic Considerations of Local Drug Delivery to the Inner Ear by Round Window Application

Although there is increasing interest in the local delivery of drugs to the inner ear by applying them to the round window (RW) membrane, most drug application protocols have been empiricallybased. As a result, consequences of changes in delivery method, applied drug concentration or even small alterations in treatment protocols have been difficult to predict. Since direct measurements of drug concentration time courses (as required in phase I clinical studies) are not presently possible in the human inner ear, computer simulations provide a valuable tool for estimating drug concentrations in the inner ear for phase II clinical studies. The ultimate goal is to simulate drug movements in the inner ear sized appropriately to the human after topical application to the RW membrane.