Compatibility study of rivaroxaban and its pharmaceutical excipients

Rivaroxaban is an oral direct Factor Xa inhibitor to treat thrombus. The aim of this study is to investigate the drug-excipient compatibility between rivaroxaban tablet and pharmaceutical excipients by a combination of thermal and spectroscopic methods. Differential scanning calorimetry (DSC) is the most important technique to evaluate the compatibility. In addition, X-ray powder diffraction (XRPD) is a complementary technique to explain the DSC result and exclude relevant interaction. On the basis of DSC curves about rivaroxaban and excipient and mixture (1:1, w/w), the rivaroxaban was considered to be compatible with the most excipients (microcrystalline cellulose, lactose, hydroxyl propyl methyl cellulose, magnesium stearate). Meanwhile, the XRPD studies also showed the compatibility of rivaroxaban and pharmaceutical excipients, especially for the sodium lauryl sulfate. Overall, the compatibility of the excipients with rivaroxaban was assessed successfully by DSC and XRPD, and the formulations developed using the compatible excipient were found to be stable.