ABSTRACT

The release of the drug substance from the solid dosage form has a major impact on how

fast a drug will be absorbed. In certain instances, as is the case with modified release

formulations the rate limiting step in the appearance of the drug in the systemic circu-

lation is its release from the formulation. Due to the critical role that dissolution plays in

the bioavailability of the drug, in vitro dissolution can serve as a relevant predictor of the

in vivo performance of the drug product.