ABSTRACT
Thermal analysis and calorimetric methods have demonstrated a wide array of applications in the pharmaceutical industry spanning drug discovery, preformulation, and formulation development (Table 1). One of the most critical tasks of the preformulation scientist in the evaluation of new crystal forms is to ensure that the most appropriate physical form is selected for development. A major facet of this task is to characterize the thermal properties of the solid form to determine if it demonstrates adequate physical and chemical stability to withstand the rigors of processing during drug substance manufacture, formulation development, and long-term storage. The compound should be characterized adequately so that there is a high degree of certainty that a physically and chemically stable, manufacturable, and registerable dosage form can be developed.
