In Vitro Dissolution Behaviors of Glimepiride Tablets / 中国药学杂志

ABSTRACT

OBJECTIVE: To study and compare the dissolution behaviors of glimepiride tablets from two manufacturers, and investigate the correlation between dissolution and absorption. METHODS: The solubility and permeability of glimepiride in different pH media were determined, and the biopharmaceutical characteristics of glimepiride tablets were studied and analyzed. The dissolution curves of glimepiride tablets in different media were plotted by the second dissolution method. The dissolution behaviors of glimepiride tablets from two manufacturers were studied and compared. Based on the data of dissolution curves in vitro, the correlation between dissolution and absorption of glimepiride tablets was studied by computer simulation. The virtual bioequivalence study of the two preparations was evaluated in silico. RESULTS: The solubility of glimepiride increased with the increase of pH value; the permeability decreased with the increase of pH value; the dissolution of glimepiride tablets was less than 10% in the media of pH 1.2 and pH 5.0; the dissolution of principal components in the media of pH 6.0-7.4, FaSSIF and FeSSIF ranged from 20% to 90%; the dissolution and absorption of glimepiride tablets in FaSSIF showed high correlation. CONCLUSION: Glimepiride is classified as a BCS Ⅱ class drug (low solubility and high permeability drugs).The dissolution amount and rate of glimepiride tablets increase with the increase of pH value of the medium. The dissolution curves of glimepiride tablets in media of pH 1.2, pH 6.0, pH 6.8 and pH 7.4 could be used as the characteristic dissolution curves of the preparation. The reference preparation A and generic preparation B of glimepiride tablets are similar in dissolution behavior and shows bioequivalence in the virtual bioequivalence study (n=24). This study can provide reference for drug formulation screening, biopharmaceuticals classification determination and bioequivalence risk assessment.