Compatibility Studies Between Carbamazepine and Tablet Excipients Using Thermal and Non-thermal Methods

ABSTRACT Proper formulation is an important aspect of any dosage form design. As a part of preformulation studies, differential scanning calorimetry (DSC) was used to investigate the physicochemical compatibility between Carbamazepine and various excipients commonly used in tablet manufacturing, supported by Fourier transform infrared (FTIR) and x-ray powder diffraction (XRPD) studies. Compatibility studies were conducted on samples kept at room temperature and at an elevated temperature of 55°C for 3 weeks. Carbamazepine was found to be compatible with all lactose-based components, such as Granulac 230®, Flowlac 100®, and Microcelac 100®. Differential scanning calorimetry studies indicated incompatibility with mannitol, microcrystalline cellulose, starch, and stearic acid. However, XRPD and FTIR studies implied that all the above excipients are compatible with Carbamazepine. X-ray powder diffraction demonstrated incompatibility with stearic acid for samples stored at 55°C for 3 weeks, indicative of formation of a solid solution. Thus, DSC being a thermal method of analysis should not be used singly to detect any inherent incompatibility. It has to be supported sufficiently by other non-thermal techniques, such as XRPD and FTIR.