Volume 20 No 9 (2022)
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EXCIPIENTS COMPATIBILITY STUDY OF ANTILIPIDEMIC AND ANTIHYPERTENSIVE DRUGS IN ORAL SOLID DOSAGE FORM
Satpute Vivek Mahavirm, Dr. Punit R. Rachh
Abstract
Excipients compatibilitystudy of antilipidemic and antihypertensive drugs like Selexipag and Ezetimibe respectively was carried out with selected generally regarded as safeexcipients to prepare oral solid dosage formi.e.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
Keywords
Ezetimibe, Selexipag, Compatibility, Isothermal stress testing, Bilayer tablet.
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