COMPATIBILITY STUDY OF ALOGLIPTIN BENZOATE WITH WIDELY USED PHARMACEUTICAL EXCIPIENTS FOR SOLID DOSAGE FORM

Abstract

Alogliptin is a new dipeptidyl peptidase-4 (DPP-4) inhibitor for oral diabetes care. The present study aims to evaluate the compatibility of alogliptin benzoate with the extensively used pharmaceutical excipients for solid dosage form. This can be achieved by applying Differential Scanning Calorimetry (DSC) and Thermal Gravimetric Analysis (TGA) techniques together with Fourier-Transform Infrared spectroscopy (FT-IR) as paired technique to aid in the interpretation of outcome. Chosen excipients were Cross carmellose sodium, microcrystalline cellulose, magnesium stearate, sodium starch glycolate, and pregelatinised starch. Results illustrated that drug was compatible with all the excipients except magnesium stearate where a slight degree of physical interaction was observed but mass loss due to degradation was not hastened in TGA. FT-IR study lined out any chemical change of drug with magnesium stearate. These results would be valuable for formulation development of the film coated tablets of alogliptin benzoate.