ABSTRACT
The main goal of quality testing of dosage forms is the assurance of better safety in their use by patients. Therefore the purpose of the dosage form quality testing is to minimize or eliminate the risk of marketing an unsafe product, guaranteeing the efficacy of the product, and guaranteeing that the product will meet regulatory requirements. Extended-release dosage forms, i.e., the preparations designed to permit longer dosage intervals of short-acting drugs, must meet the same requirements as other dosage forms. Besides specification of the drug content in the dosage form, the other important factors are the timed drug release pattern as well as the time course of the drug plasma level after dosage-form application. The only fully satisfactory criterion allowing for objective evaluation of extended-release dosage form quality is in vivo absorption testing, which shows how long after a dosage-form administration effective drug plasma level is maintained.
