Clinical Evaluation of a Telemedically Linked Intraoral Drug Delivery System

Abstract

The miniaturized intraoral drug delivery system BuccalDose is composed of a replaceable cartridge which is worn in a removable prosthesis and an external base station for telemedical therapy monitoring. The system has now been tested for the first time with Parkinson’s disease (PD) patients. The study evaluated the usability of the entire system, the functionality of the telemedical transmission path and the functionality of the cartridge, which uses an osmotic pumping principle to release a liquid drug formulation to the buccal mucosa. The BuccalDose system was generally considered to be easy to handle, even with movement disorders, up to a mild-moderate disease stage. In addition, the obtained in vivo release rates of the cartridges confirmed the previously achieved in vitro release behavior.