Comparative Dissolution Studies of Marketed Tablets of Telmisartan in Biorelevant Media

In vitro dissolution studies constitute the mainstay for evaluation of any oral dosage form and more so for a poorly water soluble drugs. Selection of appropriate dissolution medium is critical for these studies as it could have an impact on in vitro - in vivo correlations. Biorelevant media simulate the in vivo conditions in fasting and fed state and are being investigated as novel dissolution media. Telmisartan is a BCS class II drug exhibiting solubility and dissolution rate limited bioavailability. In the present study 03 marketed brands of TEL tablets were subjected to in vitro dissolution studies in biorelevant media. The results were compared with tablets prepared using binary and ternary solid dispersions of TEL with poloxamer 188 and TPGS. The marketed and formulated products displayed widely different release profiles in fasting and fed state simulated intestinal fluid. The results indicated the need to develop dissolution studies and media which will facilitate in vitro in vivo correlation studies. Key Words: Telmisartan, fasting state simulated intestinal fluid, fed state simulated intestinal fluid