In vitro performance testing of medicated chewing gums

Abstract

The oromucosal route of therapeutic administration can be targeted by medicated chewing gums (MCGs) loaded with locally or systemically acting active pharmaceutical ingredients (API). Compared to other dosage forms, release of the API is mainly determined and controlled by the patient’s mastication. These unique characteristics create attractive opportunities for the delivery of API, but at the same time, they challenge safety and efficacy of the drug product. In vitro release testing is a vital tool for the assessment of the drug product’s quality and performance, but the pharmacopeial procedure is solely described in the European Pharmacopoeia. Given this background, this review focuses on parameters influencing in vitro release testing of MCG related to the testing device, the formulation and manufacturing of MCG, as well as the operational parameters adapted to the physiological conditions in the oral cavity. Furthermore, the unique features of MCG for a reliable in vitro-in vivo correlation approach will be introduced along with the existing hurdles to standardise and verifiy the methods for MCG release testing.