Dissolution Concepts and Applications

Addressing Compliance Concerns During Dissolution Method Development, Validation, and Transfer

By Gregory P. Martin and Vivian A. Gray

Dissolution is an important test for pharmaceutical products. Dissolu­tion is the only test that addresses product performance. While most dissolution tests are used for quality control purposes, there are several potential applications for dissolution methods that are vital during the entire product lifecycle. These include activities such as aiding in formulation selection, developing a correlation between in vitro data and in vivo data (IVIVC), or justifying post-approval product changes. Dissolution method development should be linked to the intended purpose of the method. Once method conditions have been established and an understand­ing of method ruggedness generated, the method must be validated. When sufficient data have been generated with the validated method, a specification can be proposed. The product dissolution specifica­tion will ultimately require regulatory approval. Over the lifetime of the method (from development to pro­duction to site transfer to generic product), there are likely to be multiple changes to both the drug prod­uct and the testing laboratory. With each change, the validity of the method may be challenged and must be reestablished.

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