ABSTRACT

In vitro dissolution is perhaps the most important test method when developing solid dosage forms. Despite the apparent simplicity, it is no trivial matter to develop methods and use them rationally. To be successful, a multidisciplinary approach is needed, involving expertise from the fields of biopharmaceutics, formulation, analytical chemistry, and physical chemistry. Well-designed and accurately performed tests contribute to reducing development times, resource requirements, and the number of in vivo experiments, while ensuring a high quality biopharmaceutical product of benefit for clinical efficacy and safety.