فهرست نشریات علمی دسترسی آزاد ایران

Type 2 diabetes, a chronic metabolic condition characterized by hyperglycemia, frequently requires combination medication to maintain optimal glycemic control. Metformin, a biguanide, and linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, have shown synergistic effects in improving glycemic outcomes. A unique and effective strategy for improving patient compliance and ensuring prolonged medication administration is to formulate a fixed-dose combination (FDC) as an extended-release (ER) tablet utilizing the drug layering technique. Creating a single ER tablet containing both medications can improve patient compliance by minimizing pill burden and ensuring consistent drug levels. The drug layering technique provides a possible strategy to develop such a combination product. This study covers how to formulate, optimize, and evaluate Linagliptin and Metformin ER tablets using this technique. The current work focuses on the formulation and optimization of extended-release (ER) tablets comprising Linagliptin and Metformin Hydrochloride, which employ a drug stacking approach. To improve patient compliance and maintain optimal glycemic control, drug layering tablet was developed with an immediate-release (IR) drug coating of Linagliptin and an ER layer of Metformin. The formulation approach required stacking Linagliptin onto inert cores with an appropriate binder solution in a fluid bed processor to ensure consistency and quick release. The ER Metformin layer was formulated with hydrophilic matrix-forming agents such hydroxypropyl methylcellulose (HPMC) to achieve regulated drug release over 12-24 h. The developed tablets were evaluated for physicochemical properties, drug release profiles, and stability in accordance with ICH recommendations. In vitro dissolution experiments revealed a biphasic release profile rapid release of Linagliptin and sustained release of Metformin which met USP criteria. The improved formulation had adequate drug content, friability, hardness, and predictable release kinetics.