Abstract

In vitro dissolution testing should discriminate between the impact of excipients on release profile of Biopharmaceutics Classification System class 2 drugs. Among the four batches of carvedilol solid dispersion tablets, SDT-2-L containing 30% w/w mannitol and 2.5% w/w L-hydroxypropyl cellulose LH-11 exhibited  least mean dissolution time in gastric buffer (pH = 1.2) and phosphate buffer (pH = 6.8). However, inter-batch differences in release parameters from phosphate buffer were usually higher and also statistically significant at p < 0.05. Drug release from an individual formulation exhibited different kinetics in two media. Therefore, improper selection of dissolution medium may fail to discriminate between product performances.

Key words: Solid dispersion tablet, dissolution efficiency, mean dissolution time.