Development of Metformin Hydrochloride-Linagliptin Controlled Release Tablet Using Hydrophilic Polymers for Type 2 Diabetes in Asians

Metformin hydrochloride, used for treatment of type 2 diabetes, is a drug belonging to the biopharmaceutical classification system III and has a high solubility in water. Therefore, hypoglycemia occurs in Asians who have lower weight and body fat than Westerners because of the rapid initial release. Accordingly, a hydrophilic polymer was used to reduce the risk of hypoglycemia due to the rapid increase in blood concentration of the drug, and a combination of metformin hydrochloride and linagliptin fixed -dose triple -layer tablet was prepared through a wet granulation process. The crystallinity and inclusion of drugs were evaluated through X-ray diffractometer (XRD), and chemical changes were confirmed through Fourier transform infrared spectroscopy (FTIR). Finally, tablets prepared by inducing a sustained release pattern and Trajenta duo tablets were analyzed by comparative dissolution test and confirmed to be available as type 2 diabetes treatments suitable for Asians.