Generic Formulation Development of Misoprostol 200 Tablet and Its Evaluation

Abstract

This thesis paper was accomplished in a way to establish generic formulations with Misoprostol in the dosage form of 200 microgram tablet. Direct compression method is used for the tablet manufacturing same as innovator’s. This dissertation has been carried out with a view to getting some information, and to know the changes in physical and chemical attributes of finished dosage form (tablet) using different generic formulations. Since the onset of action of this product needs to be within 30 minutes, dissolution, an in-vitro technique to assess bioavailability, is emphasized over other attributes in each formulation. The results obtained from the analysis have been compared with that of the innovator’s product and proceeded according to further requirement. The generic formulas presented here are developed using the same excipients as innovator’s but there are changes in terms of amount of disintegration and commercial grade of diluents. On this note, besides justifying the generic formulations with physical and chemical analysis, the changes in excipient quantity and grade are justified by evaluating API-excipient compatibility in terms of potency degradation and impurity generation. In this thesis work, the values determined by assay and dissolution tests of the products, potency and impurity analysis of API-excipient mix are represented graphically along with tabular presentation. All of the studies presented in this thesis have been performed following the direction for controlled room condition and storage condition in order to proceed for further study. This developed generic formulation for the thesis project has shown better dissolution and lesser generation of impurities with a slight changes in excipients in comparison to innovators formula. The formula may be beneficial for manufacturing the product containing Misoprostol 200 microgram.