Title : Comparative dissolution profiling using solid dosage forms to compare the difference between branded and generic medicines
Abstract:
The current study intends to investigate the dissolving characteristics of a generic medicine products and it’s matching with brand standard reference medication. Through this comprehensive analysis, we compare the solubility test of the generic medicine products with the brand reference medicine at three different media. Consequently, it may potentially serve as a cost-effective alternative with therapeutic equivalence to the standard reference drug. These findings emphasize the significance of dissolution profiling in supporting the assessment of pharmaceutical quality and regulatory decision-making. This study also provides an overview of methodologies and statistical techniques used to compare dissolution profiles, which is a critical aspect of pharmaceutical quality assessment. The study investigates various approaches, including acidic media, at pH 6.8 and basic media with regulatory guidelines for evaluating whether the dissolution profiles are equivalent or comparable. We discuss the significance of choosing suitable metrics and acceptability criteria, and the effects of process and formulation modifications on dissolving profiles. The study's findings show that dissolving profiles are similar, suggesting that the generic drug's formulation satisfies the requirements to be eligible for bioequivalence. Therefore, it possesses potential for substitution with the standard drug under appropriate circumstances.
