Building Up to a Bright Future

ABSTRACT

Dissolution testing is an integral part of pharmaceutical development, providing drug companies with the analytical ability to determine the efficacy, bioequivalence, and bioavailability of the active drug substance, as well as control quality, stability, and consistency of the final drug product. [...]there is also a shift in focus to more novel and personalized dosage forms that is happening within the bio/pharma industry, requiring modifications to many different areas of drug development and manufacturing, including dissolution testing, Spisak added. Novel formulations can pose challenges when using standard apparatus;nanoparticles, for example, are not necessarily sufficiently separated from the dissolution medium with standard techniques. [...]modification of the instrumentation, such as that found in Agilent's NanoDis system, is required to ensure an accurate prediction of in-vivo performance of the drug product can be made.