Comparison of In Vitro Phosphate-Binding Studies of Sevelamer Carbonate Using Incubator Shaker and USP Dissolution Apparatus II

In the case of most phosphate-binding agents, in vitro phosphate-binding studies are essential for establishing bioequivalence between generic and reference drug formulations. Traditionally, an incubator shaker is used to conduct phosphate-binding studies, but this method is limited by manual sample collection and associated variability. This study aims to evaluate an automatic sampling method using a dissolution tester as an alternative to incubator shakers. Kinetic phosphate-binding studies of sevelamer carbonate tablets (test and reference formulations) were performed using an incubator shaker and USP dissolution apparatus 2. The results from both methods were compared. Though both formulations were equivalent in terms of the phosphate-binding capacity in both methods, the automatic sampling method using the dissolution apparatus had less variability than the manual sampling method using the incubator shaker. Thus, the dissolution apparatus is preferred for bioequivalence and interchangeability studies of sevelamer carbonate tablets.