Design and Evaluation of a Novel Bio-Mimicking In Vitro Dissolution Test Apparatus for Floating Drug Delivery Systems

The aim of the present study was to design a new biorelevant dissolution test apparatus for evaluating floating drug delivery systems. The gastric fluid secretion rate, volume of gastric fluid present in the stomach, and gastric emptying from the pylorus opening were taken into consideration. The material of construction was borosilicate glass. In vitro dissolution testing of pharmaceutical dosage forms is performed for quality control purposes and to establish in vitro–in vivo correlations (IVIVC). Compendial in vitro dissolution test apparatus are poor predictors of the in vivo performance of a floating drug delivery system (FDDS). The drawbacks associated with compendial and noncompendial dissolution test apparatus were rectified in the present study. A magnetic stir bar provided agitation of the dissolution medium for uniform mixing. The phenomenon of gastric emptying was mimicked by a special assembly attached at the bottom of the glass apparatus. The drug release study was conducted with USP Apparatus 2 (paddle) and an apparatus designed for a commercial floating product. The experiments were run at 37 ± 0.5 °C and a stirring speed of 75 rpm. Analysis of the data was performed by comparing drug release profiles using the similarity factor f2 as a tool for the assessment of dissolution. In vivo performance was predicted using a convolution technique.