Product Performance Test for Medicated Chewing Gums

Abstract

The nature and type of performance tests used to characterize dosage forms administered to the oral cavity differ significantly and thus demand different release testing apparatus. For many dosage forms given orally but not limited to muco-adhesive buccal tablets, chewable tablets, and sublingual preparations, product performance tests are adapted from existing procedures and are well characterized in the United States Pharmacopeia (USP). Unlike chewable tablets, medicated gums are not supposed to be swallowed and may be removed from the site of application without resort to invasive means. Moreover, medicated gums require the active and continuous masticatory activities for activation and continuation of drug release. Medicated chewing gums are dosage forms given orally for both local and therapeutic effect, and no performance test has been indicated for medicated chewing gums in USP. This Stimuli article outlines the importance and rationale of in vitro drug release testing and the product quality tests used during the development of medicated chewing gums and their quality control for market release.