Pengaruh PVP K90 pada Proses Kristalisasi terhadap Sifat Tabletabilitas Metformin HCl

Abstract

Metformin HCl is a biguanide antidiabetic that is used to treat type 2 diabetes mellitus. Metformin HCl has poor compressibility, compactibility, and tabletability which causes brittleness problems in tablets. Alternative methods are needed to improve the tabletability of metformin HCl effectively and efficiently. The study was carried out to increase the tabletability of metformin HCl by crystallizing metformin HCl using solvent evaporation methods with methanol and the addition of PVP K90 at 3 concentration: 0.5%, 1%, and 1.5%. The crystal results were characterized, including FTIR, PXRD, DSC, and light microscopy. The crystal tabletability profile was evaluated with elastic recovery and tensile strength. The crystals were also evaluated for their moisture content. The tabletability profile and moisture content was analyzed using SPSS 26 to discover the significant differences. The results showed no change in FTIR spectrum, PXRD diffraction pattern, and DSC profile between metformin HCl and metformin HCl-PVP K90 crystals. However, there was a change in the crystal shape from the lamellar metformin HCl form to the plate metformin HCl-PVP K90 crystal form. The physical and tabletability property evaluation showed increasing the concentration of PVP K90 in metformin HCl crystallization can significantly increase the moisture content and tensile strength. The addition of PVP K90 to metformin HCl did not result in a significant decrease in the percentage of elastic recover. Based on the research, it can be concluded that the crystallization of metformin HCl with the addition of PVP K90 was successfully carried out and produced plate-like crystals with no changes in FTIR spectrum, PXRD diffraction pattern, and DSC profile between metformin HCl and metformin HCl-PVP K90 crystals. The addition of PVP K90 to metformin HCl can affect tabletability properties through changes in the crystal habits of metformin HCl-PVP K90 which can increase the tensile strength.