PEMBUATAN DISPERSI PADAT SINIVASTATIN DENGAN EUDRAGIT E 100 UNTUK MENINGKATKAN KELARUTAN DAN DISOLUSI

• Main Author: Agus Wijaya, Rangga
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/64314
• Institution: Institut Teknologi Bandung

Solid dispersions of simvastatin and Eudragit E 100 were made and evaluated. Simvastatin and Eudragit E 100 in a certain mass ratio (1:1, 1:2, 1:3) were dissolved in methanol using separate beaker glasses and stirred by magnetic stirrer until both substance completely dissolved. Both solutions of methanol were mixed in a beaker glass and stirred by magnetic stirrer until most of the methanol evaporates and a viscous mass was formed. The viscous mass then poured into a stainless steel tray. The tray then stored in a desiccator for two days until the mass solidified. After two days the solid was taken from the tray and sieved through mesh 40. Physical mixture was made by mixing eudragit and simvastatin in 1:1 mass ratio in a evaporatin dish. Simvastatin, solid dispersion and physical mixture were assayed in solubility and dissolution test. The best substance on the assays was analyzed using instruments such as infra-red spectrophotometry, Scanning Electron Microscopy, X-ray diffactometry, and Differential Scanning Calorimetry. Solid dispersion of simvastatin in 1:3 mass ratio has the best solubility. Simvastatin has a solubility of 1.2 mg/mL, physical mixture has 1.4 mg/mL, solid dispersion (1:1) has 1.8 mg/mi., solid dispersion (1:2) has 3.1 mg/mL, and solid dispersion (1:3) has 3.4 mg/mL after 24 hours. Dissolution test had shown that solid dispersion of 1:2 ratio has the best dissolution profile. The results of the dissolution test in 300 minutes were 60%, 58%, 80%. 87%, and 84% for simvastatin, physical mixture, solid dispersion 1:1, solid dispersion 1:2, and solid dispersion 1:3 respectively. Solid dispersion 1:3 was analyzed using the said instruments and the results were compared with that of pure simvastatin. There was no interaction between simvastatin and Eudragit E 100 based on the infra red spectrophotometry results. X-ray analysis showed that the making of the solid dispersions caused simvastatin to become amorph, which was also confirmed through SEM observation which showed the transformation of crystal habit. Solid dispersion of simvastatin with Eudragit E 100 as carrier showed a significant increase on solubility, but the improvement of dissolution profile was not so significant. The DSC results shown that the simvastatin particles were no longer in crystalline state and there were physical interaction between simvastatin and Eudragit E 100. Simvastatin particles were covered and surrounded by the Eudragit E 100 particles.