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Biorelevant in vitro dissolution is a useful technique for qualitative forecasting of the in vivo behavior of a formulation. A biorelevant dissolution medium for simvastatin was developed with a lower concentration of surfactant (0.1% sodium lauryl sulfate, SLS) in the medium as compared with the 0.5% SLS concentration stated in the USP monograph. The slower dissolution rate of simvastatin tablets in 0.1% SLS relative to a self-emulsifying formulation of simvastatin correlated with the enhanced bioavailability of the self-emulsifying formulation in albino rats.

A Discriminatory and Biorelevant Dissolution Test Method for Simvastatin Drug Products