Compatability study of selexipag and ezetimibe with selected excipients in formulation of bilayer tablet

Abstract

Present study was carried out to study compatibility of Selexipag and Ezetimibe with selected generally regarded as safe excipients and to prepare bilayer tablet. Isothermal stress testing was performed in binary a mixture which was subjected to 50°C for 4 weeks. Isothermal stressed samples were evaluated with RP-HPLC method and FTIR analysis. A trial was conducted with single disintegrants and diluent with direct compression technique and in-vitro dissolution was carried out. To improve the release profile of Immediate Release layer of Selexipag, multiple disintegrants were used namely croscarmellose sodium (CCS), sodium starch glycolate (SSG) and Crospovidone (CP). Similarly, extended release layer of Ezetimibe was prepared by wet granulation technique. Intra and extra granulation was done with mixtures of disintegrants. Extended release layer of Ezetimibe was formulated using polymers and gums like HPMC, MCC, PVP, Talc, Gaur gum, and Xanthan gum, Magnesium stearate. The results show that Selexipag and Ezetimibe were compatible with the all the polymers used in the study. The polymers used in the present study and the formulations developed using the compatible excipients were found to be stable.