The dissolution profile (DP) of a glyburide containing tablet - Daonil (supplied by Hoechst, Germany and used as the reference sample) was compared with those obtained from thirty-four commercial glyburide tablets in this study. Dissolution tests were performed by using a USP XXIII aparatus-II (paddle type) at 75 rpm, and three buffer solutions of pH 7.8, 6.8 and 5.8, respectively, were used as the media. Released percentages of the active ingredient were meassured at 15, 30, 45, 60, 90 and 120 minutes. SUPAC* f2 factor proposed by FDA was applied to verify the similarity between the DP of Daonil and that of each investigated samples. Results indicated that 10 out of 34 case samples (29.4%) were similar in DPs to Daonil 1 in all of three media. In the meantime, three samples (8.8%) gave similar profiles as the control in two media of pH 7.8 and pH 5.8. It was also found that thirteen tested samples (38.2%) were similar in DPs to Daonil in a buffer solution of pH 5.8, but different in both media of pH 6.8 and pH 7.8. Furthermore, only one case sample gaved a completely different profile compared with that of Daonil no matter what pH of dissolution media was. Finally, statistics on the number of tested samples having similar DPs as Daonil in individual media are as follows: 13 in pH 7.8 (38.2%); 17 in pH 6.8 (50%); and 33 in pH 5.8 (97.1%).
Lee, M.-S.; Chang, Y.-C.; Shih, C.-C.; Chen, C.-J.; and Chang, B.-L.
"Study on Dissolution Profile of Commercial Glyburide Tablets,"
Journal of Food and Drug Analysis: Vol. 7
, Article 4.
Available at: https://doi.org/10.38212/2224-6614.2882