Abedin, Saba2026-04-162026-04-162026-04-14https://hdl.handle.net/10222/86020Metformin is known as the first-line pharmacotherapy for the management of type 2 diabetes mellitus due to its well-established efficacy, safety profile, and affordability. However, currently available metformin dosage forms, including immediate-release (IR) and extended-release (ER) tablets, pose serious limitations. IR formulations may cause gastrointestinal (GI) adverse effects and require multiple daily dosing. Although ER formulations reduce dosing frequency, they are typically large and may have a rough surface, which can reduce patient compliance and ease of swallowing. Furthermore, ER tablets have limited flexibility in dose adjustment since they cannot be cut or crushed due to their modified-release coating systems, and this would compromise their controlled-release mechanism. ER tablets may also contribute to GI adverse effects. This study successfully developed and evaluated a novel dual-release metformin bead formulation designed to overcome limitations associated with conventional metformin tablets. The results demonstrate that alginate-based bead carriers can provide an effective delivery system for high-dose hydrophilic drugs such as metformin. The metformin beads formulation with high encapsulation efficiency and controlled drug-release properties was developed through several stages, including polymer screening, experimental design optimization, and coating technology. The combination of alginate and gelatin polymer proved to be the most effective polymeric system for the highest drug encapsulation. The coating system composed of ethyl cellulose and Eudragit® L100 produced the desired dual-release profile. The enteric coating effectively prevented drug release in gastric conditions while allowing extended drug release in intestinal media. Comprehensive physicochemical characterization proved the compatibility between metformin and the excipients. FTIR, DSC, TGA, and XRD analyses showed the stability of the drug within the bead matrix. SEM analysis confirmed successful coating and effective masking of the drug on the beads’ surface. The examinations showed acceptable mechanical strength, low residual moisture, and consistent drug content uniformity. An in vitro study demonstrated that the formulation was biocompatible and did not produce significant cytotoxic effects in HepG2 cells. Stability evaluations also confirmed that the optimized formulation remained stable for six months under both room and accelerated storage conditions, with no significant changes in drug content, encapsulation efficiency, or dissolution behaviour. Overall, the developed dual-release bead system containing metformin represents a promising alternative to conventional metformin tablets by providing enhanced swallowability, dose flexibility, taste masking, and controlled drug release, which may ultimately improve patient adherence and therapeutic outcomes in the management of type 2 diabetes mellitus.Diabetes is a chronic disease characterized by high blood glucose levels, which leads to serious organ damage. Diabetes is one of the most prevalent chronic diseases in Canada and the world, which can cause 1.5 million deaths per year globally. Type 2 diabetes accounts for 90% of all diabetes cases, which is a major public health issue in Canada. Metformin is recommended as a first-line treatment for type 2 diabetes due to its safety, possible heart benefits, and low cost. However, patients’ adherence to metformin is low, which can lead to higher rates of adverse effects and healthcare costs. There is an urgent need for innovative and patient-friendly drug delivery systems to enhance treatment adherence and efficacy for patients of all ages. This study aimed to develop alginate-based metformin-loaded beads with a delayed-release profile to minimize gastrointestinal side effects, as well as an extended-release profile to reduce dosing frequency.enMetforminDiabetesOral Formulation