Thein vitro development of extended-release solid oral dosage forms

Abstract
A system is described for developing extended-release products, based upon predicting or simulating the entire plasma level-time curve to be expected from the administration of a controlled-release oral dosage form. Termed “biorelevant dissolution,” it employs the product's in vitrodissolution behavior and the drug's pharmacokinetic parameters in conjunction with a classical pharmacokinetic model. The basic system is described along with some pertinent examples.