The development and in vitro evaluation of benzydamine hydrochloride medicated chewing gum formulations

Abstract

The objective of this study was to develop a chewing gum formulation for benzydamine hydrochloride (BN) and evaluate the effect of different co-compression agents on physicochemical parameters and in vitro drug release profile. BN has been utilized in symptomatic treatment for pain and irritations of the mouth and throat. Chewing gum formulations of BN were produced using direct compression method. In fabricated chewing gums, except pharmacopeia analysis, physical and structural analysis like thickness, weight variation, elasticity and compressibility were evaluated. The release of BN from the gum was studied using the chewing apparatus which have been designed for procuring the release of BN from the chewing gum. The quantity of BN present in the chewing gum and the release medium were quantified by spectrophotometric method. Gum formulations showed promising in vitro release profiles, in which 80-90% BN was released in a sustained manner over 20 min of chewing time. In addition, it was observed that the drug release was fitted into matrix diffusion kinetic and revealed a non-Fickian drug release mechanism. This study suggests that BN in a gum formulation is a suitable dosage form for the delivery in the oral cavity, thereby and serving as an instant analgesic.