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Biorelevant Dissolution Studies of Pioglitazone Hcl Immediate Release Tablets and the Determination of an In Vitro In Vivo Correlation

Agatonovic-Kustrin S, Morton DW, Ragini Singh, Baboota S and Talegaonkar S

In vitro dissolution testing using biorelevant dissolution media was used to the predict food effects on the absorption of Pioglitazone from immediate release tablets.Dissolution testing was carried out in three dissolution media: hydrochloric acid solution at pH 1.2, in simulated gastric fluid to simulate the gastric fasted state,and in pasteurized milk to simulate the gastric fed state. In order to validate these results, in vivo studies were conducted on young Wistar rats under fed and fasted conditions. The in vivo studies showed that food delays the onset of action of the drug significantly. The compendial dissolution test in hydrochloride solution at pH 1.2 was not able to predict the food effect. However, the biorelevant dissolution test in simulated gastric fluids predicted correctly that the release of Pioglitazone would be slower in the fed state than in the fasted state. The results demonstrate good correlation between in vitro drug release and in vivo drug absorption using the biorelevant dissolution test method.