Development & Characterization of Orodispersible Tablet of Glimepiride and Metformin HCl

AbstractThe present research emphasizes the development and evaluation of orodispersible tablets(ODTs) incorporating glimepiride and metformin hydrochloride (HCl), two key oralantihyperglycemic agents used in the treatment of Type 2 Diabetes Mellitus (T2DM).Considering the need for patient-centric drug delivery systems, especially for geriatric,pediatric, and dysphagic patients, ODTs serve as an ideal dosage form. The primary goal wasto formulate a dual-drug ODT that disintegrates in the oral cavity within seconds, eliminatingthe need for water intake and thereby enhancing patient compliance. The study involvedsystematic formulation trials using direct compression technique and three widely usedsuperdisintegrants—crospovidone, croscarmellose sodium, and sodium starch glycolate.Evaluation of the prepared tablets demonstrated acceptable physical parameters, rapiddisintegration (within 30 seconds), and more than 90% cumulative drug release within 30minutes. The most optimized batch (F2) was subjected to ICH stability testing, showingexcellent physicochemical integrity over time. Overall, this study provides a robustgroundwork for the development of commercially viable orodispersible tablets for bettermanagement of T2DM.