Keynote abstract
Drugabsorption from a solid dosage form after oral administration depends on the release of the drug substance from the drug product, the dissolution or solubilisation of the drug under physiological conditions, and the permeability across the gastrointestinal tract. Dissolution test has been extensively used as a quality control toolfor drug products. In vitrodissolution may be relevant to the prediction of in vivo performance. Based on this general consideration, in vitro dissolution tests for immediate release solid oral dosage forms, are used to (1) asses the batch to batch quality of a drug product, (2) guide development of new formulations, (3) ensure continuing product quality and performanceafter certain changes in the formulation, the manufacturing process, the site of manufacture, and the scale-up of the manufacturing process.
Dissolution test serves as a surrogate end pointfor bioequivalence test and the comparison of dissolution profilecan be usedto assurebioequivalence without the necessity of an in vivo study. In vitro dissolution test can also be used to waive for lower strengths of immediate release and extended release drug products under certain conditions (doseproportional formulationand similar release mechanism). In addition, according to the Biopharmaceutics Classification System (BCS), immediate release drug products with high solubility/high permeability and rapidly dissolving properties can be considered as biowaivers. On the other hand, the dissolution test is important in terms of the revealingofin vitro/in vivo correlation (IVIVC).
