Drug-excipient compatibility screening--role of thermoanalytical and spectroscopic techniques.

Estimation of drug-excipient interactions is a crucial step in preformulation studies of drug development to achieve consistent stability, bioavailability and manufacturability of solid dosage forms. The advent of thermoanalytical and spectroscopic methods like DSC, isothermal microcalorimetry, HSM, SEM, FT-IR, solid state NMR and PXRD into pre-formulation studies have contributed significantly to early prediction, monitoring and characterization of the active pharmaceutical ingredient incompatibility with pharmaceutical excipients to avoid expensive material wastage and considerably reduce the time required to arrive at an appropriate formulation. Concomitant use of several thermal and spectroscopic techniques allows an in-depth understanding of physical or chemical drug-excipient interactions and aids in selection of the most appropriate excipients in dosage form design. The present review focuses on the techniques for compatibility screening of active pharmaceutical ingredient with their potential merits and demerits. Further, the review highlights the applicability of these techniques using specific drug-excipient compatibility case studies.