Formulation, Characterization and Evaluation of Sustained Release Matrix Tablet of Antiemetic Agent

Matrix Tablet Formulation

Abstract

A sustained release matrix tablet of ondansetron HCl was prepared by the direct compression method using eudragit RL 100 and eudragit RS 100 with reduced dose, dosing frequency, improved bioavailability and prolonged release of the drug. Pre-compression and post-compression parameters were found to be uniform with their low standard deviation values. The similar characteristics of the IR peaks with few alterations observed in the spectra of the mixture of drugs and polymers and the uniform dispersion of the drug in an amorphous form in the tablets were revealed from the DSC thermogram, indicating the chemical stability of the drug. The in vitro drug release study in 0.1 N HCl, pH 1.2 for 2 h and remaining in phosphate buffer pH 6.8 indicated that the prepared tablets were capable of releasing drugs upto 12 h in the formulations F4 to F6 releasing drugs early, this might be due to using eudragit RL 100 polymer which is relatively more hydrophilic than eudragit RS 100. Among all the formulations, the F7 formulation was optimized as having sustained release properties and released 92.89% at the end of the 12 h from all nine (F1-F9) formulations. The optimized F7 batch showed no significant changes when subjected to stability at 40±20 °C temperature and relative humidity 75±5% for three months.