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Evaluation of Various Dissolution Media for Predicting the in vivo Performance of BCS Class II Drug

Manju Nagpal, Pankaj Rakha, Gitika Dhingra and Sunil Gupta

The in vitro dissolution profile of BCS class II drug in biorelevant; compendial media was compared and the potential of different media was determined in predicting in vivo profile. The solubility of weakly acidic drug, naproxen was determined in various media (Compendial- water, SGFSP, SIFSP and Biorelevant- SGFSPSLS, FaSSIF and FeSSIF), to calculate D/S values in different media. The dissolution of naproxen was studied using USP apparatus II in both; compendial and biorelevant media. Hixson-Crowell model was applied to determine drug release kinetics. The in vivo profile was predicted from in vitro dissolution data using modified form of model proposed by Nicolaides in 2001. Dissolution of naproxen from tablet formulation was found to be governed by pH of dissolution media. The similarity factor value indicated higher dissolution of naproxen at higher pH value (SIFSP and FaSSIF). The in vivo profiles predicted that using in vitro dissolution of naproxen supported delayed absorption in the presence of food. The biorelevant media are therefore better at discriminating in vitro release characteristics for forecasting in vivo performance of poorly soluble drugs.