ABSTRACT
In the previous chapters we focused on stability testing for strength (potency) and some discrete drug characteristics such as odor, color, and hardness of oral solid dosage form. In practice, it is also important to make sure other characteristics such as dissolution will remain within approved specification limits prior to the drug expiration date. In the pharmaceutical industry in vitro dissolution testing is one of the primary United States Pharmacopeia-National Formulary (USP-NF) tests that is often performed to ensure that a drug product meets the USP-NF standards for identity, strength, purity, stability, and reproducibility. As indicated in Chapter 1, dissolution failure was one of the top 10 reasons for drug recalls in the fiscal year of 2004 (it becomes the top two reasons for drug recalls in the fiscal year of 2005). As a result, dissolution testing at various critical stages of the manufacturing process for in-process controls, at the end of manufacturing process (final product) for quality assurance, and at commercial marketing for stability plays an important role to ensure that the drug product meets the USP-NF standards prior to its expiration date. In addition, after a drug is approved for commercial use, there may be changes with respect to chemistry, manufacturing, and controls. Before the postapproval change formulation can be approved, the Food and Drug Administration (FDA) requires that similarity in dissolution profiles between postchange and prechange formulations be established. In this chapter dissolution testing including the USP-NF dissolution test and stability testing for dissolution profiles are discussed.
