DSC in Drug-excipient Compatibility: From Lab Data to Formulation Design

Quality assurance and quality control are essential in the pharmaceutical industry to ensure product safety and effectiveness. Various analytical tools and techniques have been used in pharmaceutical analysis to evaluate the quality and quantity of drugs/APIs/and additives. Differential Scanning Calorimetry (DSC) is a crucial thermoanalytical technique widely used in the development of pharmaceutical formulations and in quality control. It provides comprehensive insights into the thermal behavior of drug substances, excipients, and final dosage forms by measuring enthalpy changes during phase transitions. DSC plays a significant role in assessing drug-excipient compatibility, stability studies, polymorphism, and crystallization behavior. It also contributes to optimizing lyophilization processes and evaluating the thermal stability of pharmaceutical compounds under varying conditions. This review highlights the underexplored limitations of DSC in predicting long-term stability and its reduced interpretability in complex multicomponent systems. It also comprehensively presents the diverse applications of DSC in pharmaceutical research, emphasizing its importance in formulation development, quality assurance, and drug stability evaluation. Additionally, three key unmet needs are identified that hinder the effective translation of DSC findings into clinically relevant pharmaceutical formulations. Furthermore, a comprehensive discussion of DSC and Thermogravimetric Analysis (TGA) is provided, highlighting their fundamental differences in measuring thermal properties.