eng Oriental Scientific Publishing Company Biosciences Biotechnology Research Asia 0973-1245 2025-12-30 22 4 1587 1604 10.13005/bbra/3462 56851 article Karuna Priya Chitra 1 Srinath Nissankararao 2 Deepika Srinivasan 1 Sai Harini Sai Mohan 3 Department of Pharmacology, Tagore College of Pharmacy, Rathinamangalam, Chennai, Tamilnadu, India Plainsboro, New Jersey, USA Department of Pharmacology, School of Pharmacy, Sathyabama Institute of Science and Technology, Chennai, Tamilnadu, India The objective of this study was to formulate, optimize, and evaluate bilayered floating tablets containing dapagliflozin and metformin hydrochloride for sustained drug release and improved glycemic control compared with a marketed innovator product. Combination therapy of dapagliflozin, a sodium-glucose co-transporter-2 inhibitor, and metformin, a biguanide, provides effective management of type 2 diabetes mellitus but often requires multiple daily doses. To enhance therapeutic efficiency and patient compliance, a bilayered dosage form combining immediate and sustained release was developed. The formulation consisted of an immediate-release (IR) layer of dapagliflozin for rapid onset of action and a sustained-release (SR) layer of metformin HCl to maintain prolonged plasma concentration. Various batches (B7–B21) were prepared using different gas-generating agents and release-retarding polymers such as Hypromellose (HPMC K100M) and Carbopol 934P. Optimization was carried out to assess the effects of excipient concentration on key parameters including hardness, friability, floating lag time, total floating duration, and in vitro drug release. Among all formulations, Batch B17 showed superior performance with hardness of 5.4 kg/cm², friability of 0.19%, floating lag time of 60 seconds, and total floating duration of 12 hours. The in vitro release profile demonstrated 99.83% dapagliflozin release within 30 minutes and sustained metformin HCl release up to 12 hours (99.31%), closely comparable to the marketed product (XIDUGO XR). The combination of HPMC K100M and Carbopol 934P provided excellent matrix stability and prolonged gastric retention. In conclusion, the optimized bilayered floating tablet (B17) effectively combines immediate and sustained release profiles, reducing dosing frequency and improving patient adherence in diabetes management. Further in vivo, preclinical, and clinical studies are required to establish bioequivalence and confirm therapeutic performance. https://www.biotech-asia.org/vol22no4/optimization-and-evaluation-of-dapagliflozin-and-metformin-hcl-bilayered-tablets-compared-with-marketed-product/ Carbapol; Dapagliflozin; Formulation study; Metformin; Release Retarding agents