Use of dye as tracer of drug release from medicated chewing gums

The evaluation of the potential use of a dye as indicator of in vivo drug release from a medicated chewing gum is described. The device is a three-layer tablet obtained by direct compression consisting of a gum core and two external protective soluble layers to prevent gum adhesion to the punches of the tableting machine. The active ingredient and a colour are contained in the gum core. To evaluate the drug and the dye release from the formulations, a chew-out study was performed by a panel of volunteers. The results obtained suggest that the use of a dye could be useful to indicate the chewing time necessary to complete drug delivery from medicated chewing gums.