Formulation, development and evalution of an immediate release tablet of Methotrexate.

ABSTRACT

Methotrexate is a Folic Acid Antagonist and used as an Antineoplastic agent. In this study Methotrexate immediate release tablet is developed, which was stable and bioequivalent generic tablet formulation equivalent to innovator’s product. The developed tablet formulation shows similar dissolution and disintegration profile as that of innovator tablet. The immediate release tablet was prepared by Wet Granulation method. The in vitro release was carried out in 0.1N Hydrochloric Acid. The in-vitro release at 50 rpm showed similar dissolution profile when compared with the innovator tablet. The stability studies were carried out and there was no significant change in the drug content, assay, and DT and dissolution rate.