Formulation and Assessment of Solid Dosage Form of sotagliflozin with Controlled Release

Abstract

This study focuses on the development and evaluation of controlled-release (CR) tablets of Sotagliflozin, an anti-diabetic drug. A calibration curve in 6.8 phosphate buffer showed linearity in the 2-10 µg/ml range, with a regression coefficient of 0.999. Pre-compression assessments, including Carr's index (≤ 18), Hausner's ratio (1.09-1.21), and angle of repose (22.17-31.11°), indicated good flow properties. Post-compression results showed tablet weights from 498.0 to 502.2 mg, thicknesses between 5.82 and 5.91 mm, hardness values from 5.9 to 6.3 kg/cm², and friability below 1%, indicating robust tablets. Drug content was within the 98-102% range. In vitro dissolution studies, conducted using a USPType2 apparatus in 6.8 sodium phosphate buffer, demonstrated over 99% drug release within 12 hours, with release rates depending on polymer composition. FTIR analysis confirmed the absence of significant interactions among Sotagliflozin, HPMC, and Sodium Alginate. The findings suggest that Sotagliflozin CR tablets possess suitable physicochemical properties and effective release profiles for diabetes management.