Pengaruh Hydroxypropyl Methylcellulose (HPMC) pada Proses Kristalisasi Terhadap Sifat Tabletabilitas Gemfibrozil

Abstract

Gemfibrozil is an active ingredient intended for the therapy of hyperlipidemia patients type IV and V; the poor tabletability properties may challenging in tablet form. This research will determine the characteristics of solids (PXRD, FTIR, DSC, polarized light microscopy, and moisture content) in gemfibrozil crystals with the addition of HPMC polymer and to determine the effect of HPMC polymer in gemfibrozil crystals on tabletability properties. The results showed that the addition of HPMC on gemfibrozil crystallization process using the solvent evaporation method changed the crystal habit from irregular to prismatic and plate shape. Adding HPMC on gemfibrozil crystallization also impact increase significantly on moisture content. Nothing new crystals were formed which could be proven through PXRD, FTIR, and DSC characterization. The addition of HPMC at concentrations of 0,5%; 1%; or 1,5% in crystallization process gave a significant effect in improving tabletability properties of gemfibrozil shown with increase tensile strength and decrease percentage elastic recovery. The tensile strength value increase pure gemfibrozil from 0.1772±0.0289 N/mm2 - 0.2930±0.0135 N/mm2 become 0.8168±0.0894 N/mm2 – 0.9941±0.0727 N/mm2; 0.6800±0.0543 N/mm2 - 1.3714±0.0989 N/mm2; 0.4636±0.0501 N/mm2 – 1.1713±0.0459 N/mm2 respectively in the gemfibrozil+HPMC 0,5%; gemfibrozil+HPMC 1%; and gemfibrozil+HPMC 1,5%. The % elastic recovery value decrease pure gemfibrozil from 2.760±0.271% - 4.902±0.024% become 1.019±0.029% - 2.858±0.072%; 1.347±0.305% - 2.480±0.043%; 1.033±0.031% - 4.162±0.246% respectively in the gemfbrozil+HPMC 0,5%; gemfibrozil+HPMC 1%; and gemfibrozil+HPMC 1,5%. Modification crystal habit become a prismatic and plate shape using addition of HPMC at process crystallization indicate effective improving tabletability of gemfibrozil.