In Vitro Dissolution Testing as a Quality Control Tool

The purpose of the dissolution test often dictates the choice of dissolution media. In principle, dissolution testing should be carried out under physiological conditions if possible, allowing interpretation of dissolution data with respect to the in vivo performance of a drug product. However, strict adherence to the GI environment is not necessary for routine dissolution testing. In fact, as mentioned previously, under the current setting of the pharmaceutical industry, the development of dissolution methods for QC focuses more on discriminatory capability, rugged-ness, and stability. Particularly, as a QC and testing tool, it is critical to develop a dissolution method, which can consistently deliver a reliable test result and also assess drug product quality attributes (e.g., particle size, polymorphic form, or excipients) that are sensitive to formulation and manufacturing changes.

For QC, dissolution tests are developed and optimized to target and assess product attributes by monitoring their effect on the rate and extent to which the drug is released from the formulation. The design of a dissolution test used for QC is therefore often dictated by the physicochemical properties (particularly solubility) of a drug substance and its formulation. The details regarding QC dissolution testing of two solid dosage forms, immediate-release dosage forms and modified-release dosage forms are discussed below. In general, for QC purposes, the use of the simplest dissolution medium is preferred whenever possible, regardless of the dosage form.

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