Preparation and characterization of orally fast disintegrating tablet formulations

Rapidly disintegrating/dissolving tablets (RDT) are solid dosage forms that allowed to disperse/dissolve in the saliva and then swallowed without need of water when they are placed in the mouth. Rapidly disintegrating/dissolving tablets are appreciated by a significant segment of the population, particularly children, elderly and psychiatric patients who have difficulty swallowing conventional tabletsThe aim of this study was to develop rapidly disintegrating tablet formulation of ondansetron by direct compression which is a convenient and cheap manufacturing methodCrospovidone, hydroxypropyl cellulose and poloxamers were used to prepare rapidly disintegrating tablets. Ondansetron hydrochloride which is a widely used to prevent nausea and vomiting after cancer chemotherapy and radiotherapy was incorporated into the formulationsRapidly disintegrating tablets were prepared using direct compression and wet granulation method. Disintegration time of the tablets was determined according to the USP monograph. In vitro dissolution studies were performed using the paddle method in distilled water. The properties of the rapidly disintegrating tablets, such as porosity, hardness, disintegration time and dissolution profiles were investigated. The results of the dissolution profiles and disintegration times of the tablets were compared with the Zofran Zydis® reference productIt was found that direct compression method gave better disintegration and dissolution results compared to wet granulation methodIt was observed that crospovidone and L-HPC LH-22® are good disintegrants for the tablets compressed with direct compression method. Poloxamer 407 and poloxamer 188 can be suggested as good wetting agents to prepare rapid disintegrating tablet formulations with direct compression method. The increase of the concentration of binding agent did not effect the drug release significantly from the tablets compressed with wet granulation methodIt was found that F1 formulation manufactured by simple and low-cost manufacturing process, disintegrated and dissolved less than one minute, and at the same time, possess sufficient mechanical strength so that they will withstand the course of manufacture and subsequent packaging. The F1 formulation developed in this study can be suggested as an alternative to Zofran Zydis® reference product manufactured with liyophilization method.