Polymorphism in Antidiabetic Drugs: Analytical Characterization and its Impact on Pharmaceutical Performance

AbstractPolymorphism is the phenomenon in which a chemical substance can crystallize inmultiple structural forms. This property is highly significant in pharmaceuticaldevelopment, especially for antidiabetic drugs, as different polymorphs can displayvariations in solubility, dissolution behavior, stability, and bioavailability. Thesedifferences ultimately affect therapeutic efficacy and manufacturing reliability. Thisreview outlines the analytical techniques used to identify and evaluate polymorphs of antidiabetic agents, particularly metformin and dapagliflozin. Methods such as powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), Fourier-transform infrared spectroscopy (FTIR), and solid-state nuclear magnetic resonance (ss-NMR) arediscussed in terms of their accuracy, strengths, and limitations. Reported studies show thatmetformin requires strict control of its solid-state form to retain optimal therapeuticactivity, whereas dapagliflozin undergoes polymorphic changes that can affect its stabilityduring processing and storage. Overall, this review emphasizes the critical role of properpolymorph detection and control in ensuring the safety, quality, and clinical performanceof antidiabetic formulations, providing essential insights for researchers, formulators, andregulatory bodies.