FORMULATION AND CHARACTERIZATION OF MEDICATED CHEWING GUMS OF DEXTROMETHORPHAN HYDROBROMIDE

Chewing gums are mobile drug delivery systems, with a potential for administering drugs either for local action or for systemic absorption via buccal route. Dextromethorphan hydrobromide chewing gum formulations were made employing Pharmagum M as the base with an aim to overcome the firstpass effect, reducing the risk of overdosing, ease of administration and for achieving faster systemic absorption. Dextromethorphan hydrobromide was further transformed into spray dried form and incorporated into Pharmagum M base with the object of solubility enhancement and masking the bitter taste of the drug. The prepared medicated chewing gums were evaluated for various precompression and postcompression parameters. The in vitro drug release profiles were carried out employing Erweka DRT chewing apparatus. It was observed that increasing the chewing gum base concentration resulted in a decreased drug release profile. The drug in the spray dried form revealed improved performance in comparison to the directly contained drug. The drug release data were fitted into various kinetic models. It was observed that the drug release was matrix diffusion controlled and revealed a non-Fickian drug release mechanism. Accelerated stability studies were carried out on select formulations as per ICH guidelines. The formulations were found to be stable in respect to physical parameters and no significant deviations were seen in respect to in vitro drug release characteristics.