ABSTRACT
In today’s pharmaceutical industry, dissolution testing is a valuable qualitative tool that provides key information about the biological availability and/or equivalency as well as the batch-to-batch consistency of a drug. Therefore, a properly designed dissolution test is essential for the biopharmaceutical characterization and batch-to-batch control of the drug product. During drug development, dissolution testing is used to select appropriate formulations for in vivo testing, guide formulation development activities, and assess stability of the drug product under various packaging and storage requirements. For the dissolution test to be a useful drug
characterization tool, the methodology needs to be able to discriminate between different degrees of product performance and thus, the collection of a multi-time point dissolution profile is useful. At present, almost all solid oral dosage forms require dissolution testing as a quality control check before a product is introduced into the market place. For the dissolution test to be a useful quality control tool, the methodology should be simple, reliable and reproducible, and ideally be able to discriminate between different degrees of product performance (1).
