Dissolution Profiles of Glibenclamide Tablet Using Flow-Through-Cell Method

Abstract

Operating conditions affecting the dissolution characteristics of glibenclamide were investigated with the flow-through-cell method (the third method of dissolution test in JP XIII). The partition coefficient of glibenclamide between octanol and phosphate buffer (pH 7.4) was observed to be 24.2, thus suggesting the lipophilic nature of glibenclamide. The flow indicator on the apparatus in the flow-through-cell method did not reflect the real flow rate of the dissolution media.The dissolution-time curve (ADT) value increased in line with the decrease in the bead's diameter when the flow rate of the indicator was slow (8 ml/min). On the other hand, the ADT value was hardly affected by the bead's diameter when the flow rate was fast (24 ml/min), however, a wide deviation in the ADT values was seen during such conditions. The operating condition of flow rate and bead's diameter was optimized based on the response surface method. As a result, a flow rate of 14 ml/min and a bead diameter of 0.5 mm were estimated as the optimal conditions to obtain the largest ADT and the smallest deviation in the ADT. When using the fl ow-through-cell method, the operating condition should be optimized based on the nature of pharmaceuticals under test.