Abstract
The aim of this work was to evaluate the quantitative characterization and pharmaceutical compatibility study of teneligliptin (TNG) with the commonly used excipients for solid dosage form employing thermogravimetric analysis, differential scanning calorimetry, liquid chromatography–mass spectrometer, powder X-ray diffraction, isothermal stress testing, optical microscopy and Fourier transform infrared spectroscopy as a supporting technique to contribute to the interpretation of results. The selected excipients were magnesium stearate (MS), sodium starch glycolate (SSG), croscarmellose sodium (CCS), pregelatinized starch (PS) and microcrystalline cellulose (MCC). On the basis of the DSC results, some interactions were found with TNG–CCS, TNG–MCC, TNG–MS, TNG–SSG and TNG–PS. However, during IST studies less than 3% change in TNG content was observed in all stressed binary mixtures except TNG–CCS, TNG–SSG (< 10%) which showed incompatibility with TNG. These results would be suitable for the formulation development of the solid dosage forms of TNG.
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