Formulation and in Vitro Evaluation of Chlorpropamide Immediate-Release Tablets Using Superdisintegrants for Enhanced Glycemic Control in Type 2 Diabetes Mellitus

Abstract

first-generation sulfonylurea, aimed at achieving rapid glycemic control in patients with Type 2 Diabetes Mellitus (T2DM). Utilizing a 3×3 factorial design, nine formulations (C1–C9) were prepared using three different superdisintegrants sodium starch glycolate (SSG), croscarmellose sodium (CCS), and crospovidone (CP) each at varying concentrations (25, 50, and 75 mg). The formulations were evaluated for pre- and post-compression parameters including flow properties, hardness, friability, drug content uniformity, disintegration time, and in vitro drug release. Among all, formulation C4, containing 25 mg of CCS, demonstrated optimal performance with the shortest disintegration time (35 seconds) and the highest cumulative drug release (99.67%) at 60 minutes. FTIR studies confirmed the absence of chemical interactions between the drug and excipients. The calibration curve of chlorpropamide showed excellent linearity (R² = 0.999) at 240 nm in pH 6.8 phosphate buffer. The findings highlight the potential of CCS at optimal concentration in enhancing the performance of chlorpropamide IR tablets, thereby offering a promising approach for improved therapeutic management of T2DM.