Physico-Chemical Characterization of Rivaroxaban and Compatibility Studies with Its Pharmaceutical Excipients

Abstract

Physico-chemical compatibility studies were performed to check the effect of different excipients on API and it is the prerequisite in the preformulation studies. The main aim of this research is to study the behavior of the API individually and with the selected pharmaceutical excipients which mainly contribute in the selection of suitable excipients for developing an ideal dosage form. Rivaroxaban is an oral anticoagulant that mainly acts by blocking coagulant factor Xa. Incompatibility studies were performed for rivaroxaban with selected pharmaceutical excipients like HPMC, lactose, magnesium stearate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium, HPC using the Scanning electron microscopy, X-ray powder diffraction and differential scanning calorimeter. A 1:1 physical mixture of rivaroxaban and selected excipient was analysed using differential scanning calorimeter. Rivaroxaban showed the transition at 231.79 0C with 114.2J/g specific heat of fusion. The transition temperature of rivaroxaban has not changed much when compared with the combination of rivaroxaban with excipients. The 2θ values of the standard drug were compared with the spectrum obtained from the XRD study. This comparison showed that there was no evidence regarding the incompatibility of the drug with excipients. The photomicrographs obtained by SEM did not showed any interaction between rivaroxaban and the excipients, providing visual support for the results.