Preparation and evaluation of release characteristics of 3TabGum, a novel chewing device.

A new chewing gum device in the form of a three layers tablet (3TabGum) has been developed. The new drug delivery system is obtained, at room temperature, by direct compression using conventional pharmaceutical equipment. Basically, the resulting chewing gum tablets comprise a gum core combined with two protective antiadherent external layers, which prevent gum adhesion to the punches of the tableting machine. Drug release from a dosage form is the critical step in drug absorption and bioavailability, thus an experimental protocol has been designed to evaluate the efficiency of this kind of therapeutic system by verifying its capability to release the drug dose and by assessing the delivery rate. Simple diffusion into the medium causes the release of only a small percentage of the drug contained in the medicated chewing gum, while the delivery of the major part of the dose occurs during mastication. The results obtained in this study suggest that water soluble drugs are freely and easily released by chewing gums, while for actives characterized by reduced water solubility the release rate depends on the chewing time although all the drugs tested are completely released after a reasonable mastication time.