Overview of Workshop: In Vitro Dissolution of Immediate Release Dosage Forms: Development of in Vivo Relevance and Quality Control Issues

Abstract

Scientists from industry, academia, and the regulatory agencies met to discuss the role of dissolution tests with immediate release dosage forms. Dissolution is clearly important in formulation development and can provide evidence for later use in quality control. Regulatory agencies also need such information in assessing “change” in manufacture to decide when in vivo information would be required. The workshop examined the limitations of dissolution as a surrogate for in vivo testing. As well as calibration and specification issues, a major challenge is to provide tests for highly water insoluble drugs in which formulation is used to enhance bioavailability. General specifications are difficult and case-by-case consideration is often required.