Roles of Dissolution Testing

Dissolution testing plays many key roles in the development and production of solid dosage forms. At the early stage of the drug research and development (Phases 0 and 1), dissolution testing is used for active pharmaceutical ingredient

(API) characterization and formulation screening. It is also employed to develop and evaluate the performance of new formulations by examining drug release from dosage forms, evaluating the stability of these formulations, monitoring and assessing the formulation consistency and changes.

In addition to the use of dissolution testing in formulation optimization, process development and scale up during Phases II and III, appropriate dissolution methods are developed to obtain an in vitro-in vivo correlation (IVIVC) and other biorelevant information that will guide bioavailability and/or bioequivalence assessment of drug products.

For the release of drug products, dissolution testing serves as an important QC tool which is used to verify manufacturing and product consistency. It is also employed to evaluate the quality of the product during its shelf life, as well as to assess postapproval changes and examine the need for bioequivalence studies (FDA, 1997c).

Because of the diverse roles of dissolution testing in drug development and manufacturing, it is often preferable to develop a single dissolution test that can evaluate product quality and consistency, as well as predict in vivo performance. However, developing such a dissolution method remains a significant challenge. Under most circumstances, this goal is not achievable since dissolution tests used for QC and in vivo drug product performance assessment have very contrasting characteristics, which is discussed below. Under the current industry setting, the design of dissolution testing used for QC is primarily based upon the selection of discriminatory media, apparatus, and conditions that can be used routinely for QC purposes. Nevertheless, there is an increasing demand for the development of biorelevant dissolution methods that can provide some predictive estimates of the drug release with respect to the in vivo drug product performance. The remaining chapter will be devoted to the review of dissolution methods that are currently employed for QC and bioavailability assessment, as well as the discussion of scientific and regulatory issues associated with these two kinds of dissolution methods. Meanwhile, the significance of the BCS is also emphasized in relation to its use in the design of biorelevant testing.

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