Thiazides IV: Comparison of dissolution with bioavailability of chlorothiazide tablets.
Based on the initial dissolution rate profiles in water, a slow-dissolving, an intermediate-dissolving, and a fast-dissolving chlorothiazide 250-mg tablet were selected for the bioavailability and bioequivalence study. In addition, two marketed 500-mg chlorothiazide tablets were studied. The three 250-mg tablets were bioequivalent, as were the two 500-mg tablets. Therefore, the dissolution test conditions were modified to associate in vitro dissolution with in vivo performance of the product. Based on these results, it was concluded that a dissolution of 75% in 60 min by paddle method at 75 rpm in pH 7.4 phosphate buffer can be used as a quality assurance test for 250- and 500-mg chlorothiazide tablets.
D001682:Biological Availability; D002626:Chemistry, Pharmaceutical / Q000379:methods; D002740:Chlorothiazide / Q000008:administration & dosage*; D006801:Humans; D012995:Solubility; D013607:Tablets; D013997:Time Factors
D013607:Tablets; D002740:Chlorothiazide