Design and Development of Ondansetron Orally Disintegrating Tablets and Its Optimization Using Design of Experiment

Ondansetron is the first of a new class of drugs, selective serotonin receptor antagonist (5 hydroxy tryptamine type 3) used as an anti emetic associated with cancer chemotherapy. Its Orally Disintegrating Tablet has been developed for patients who find swallowing difficult by freeze dried technology by RP Scherer Corporation and Scherer DDS. The aim of this study was to design a new orally disintegrating tablet that has high hardness and a fast disintegration rate using conventional tablet technology. Ondansetron ODT was prepared by using traditional technology like direct compression and wet granulation technique. As blend exhibited poor flow in direct compression process, so wet granulation process was finalized. Bitter taste of Ondansetron has been masked by use of sweetener like aspartame and peppermint flavor. Quick disintegration has been achieved by use of surfactant in the granulating solvent and superdisintegrant like crospovidone in both intra and extragranular part. Design space has been created by use of different concentrations of both binders as well as disintegrant with the help of DOE and a robust formulation has been made. In vitro release profile of both formulations prepared by freeze drying and wet granulation is matching. Formulation prepared by wet granulation process has been found acceptable to volunteers in term of taste, mouth feel and convenience of administration.