Development of an In Vitro Dissolution Method for Novel Formulation: A Systematic and Scientific Approach

The development of a discriminatory dissolution method for novel drug formulations has been a challenge to the pharmaceutical industry. Most of the times official dissolution method is not available for newly developed dosage forms. Parameters such as saturation solubility in different pH medium, dissolution behavior of formulations, influence of sink conditions, stability, and discriminatory effect of dissolution testing need to be studied for the selection of a proper dissolution medium for novel formulations. The present paper suggests a simple, scientific and systematic approach for development of an in vitro dissolution method for such novel formulations. In-house developed Metoprolol tartrate matrix tablet and Captopril sustained release beads were used as a model formulation. The developed methods were successfully applied for in vitro dissolution study of in-house developed novel formulations.