INCREASING SOLUTION IN THE DRUG SIMVASTATIN WITH SOLID DISPERSION TECHNIQUE USING POLYMER SOLUPLUS

Abstract

Objective: Simvastatin is a bioactive compound belonging to the class II Biopharmaceutic Classification System (BSC), which has high permeability but low solubility. The low solubility of Simvastatin showed by low bioavailability so modification is required for its solubility. Methods: There are many techniques to improve the solubility of poorly water-soluble drug; one of them is solid dispersion prepared by the solvent evaporation method. This study aims to determine the solid dispersion formulation of simvastatin using soluplus as a polymer with a ratio of 1:1, 1:2, 1:3, and 1:4 which is employed to increase the solubility and dissolution rate of simvastatin. Furthermore, characterization was carried out using IR spectrophotometry, differential scanning calorimetry (DSC), and powder X-ray diffraction (PXRD). Results: The maximum solubility test yielded a 1:4 solid dispersion, which is up to 20 times more potent than pure simvastatin. Simvastatin's solubility increased from 17.33% to 82.50% for a 1:4 solid dispersion at 60 min, affecting the dissolution rate as well. Conclusion: A solid dispersion was formed in an amorphous state, as evidenced by the fact that the results of characterization using IR spectrophotometry showed no new functional groups were formed in the solid dispersion, the results of characterization using Differential Scanning Calorimetry (DSC) showed a decrease in melting point, and the results of x-ray diffraction characteristics did not show a sharp peak.