Creation and Design of a Metformin Hydrochloride Sustained Release Matrix Tablet and Analysis of Different Factors Influencing Dissolution Rate

Abstract

An oral hypoglycemic medication called metformin hydrochloride (MET) lowers baseline plasma glucose levels and increases glucose tolerance in people with type 2 diabetes. The development and optimisation of MET matrix tablets for SR use was the goal of this work. Sodium carboxymethyl cellulose and hydroxyl propyl methylcellulose of various viscosity classes (HPMC K4M, HPMC K15M, and HPMC K100M) were used in the wet granulation process to create the SR matrix tablet of MET. The impact of altering the ratios of polymers was assessed. The drug's physicochemical characteristics were not altered by the excipients employed in this investigation. MET has a low absolute bioavailability and a comparatively short plasma half-life. Patient satisfaction may suffer if bigger doses must be administered two or three times each day. For daily MET dosage, an SR formulation that would sustain plasma levels for 8–12 hours might be adequate. For MET to increase patient compliance and extend its duration of action, SR products are required. The pre-compression and post-compression methods were used to assess the created tablet formulation (F1 to F6). Every parameter's results were found to be within the acceptable range. Stability investigations of the optimised formulations (F6) revealed no appreciable changes in the drug content, physicochemical characteristics, or release pattern. The RP-HPLC and UV methods were used to assay the formulation and pure medication. Using the Basket method and USP apparatus Type I, the in vitro drug dissolving investigation was conducted, and the release processes were investigated. The drug release rate from a dosage form is characterised by the mean dissolution time, which shows that the drug release is degrading the polymer's efficiency. The extended release profile of formulation (F6) after 12 hours in comparison to the marketed formulation is confirmed by the in vitro release studies, which show release up to 94.8% over an extended period of time. The in vitro drug release data were fitted to different release models beyond the potential mechanism of the drug release. To sum up, the creation of MET SR tablets is a smart way to manage the release rate in order to avoid frequent administration and to release the medication for an extended amount of time, keeping the plasma level above the MEC for the appropriate amount of time. Additionally, pharmacokinetic studies in humans are required to evaluate the effectiveness of the produced formulations.