Conclusions

Dissolution testing is critical to the drug product development and production. It is routinely used in QC as well as research and development. The objective of dissolution testing in QC is to assure batch to batch consistency and detect manufacturing deviations. In research and development, dissolution testing is used to evaluate the performance of new formulations by measuring the rate of drug release from dosage forms, examining the stability of these formulations, and assessing formulation changes. More importantly, dissolution testing is employed to provide some predictive estimates of the drug release under physiological conditions by establishing IVIVCs. For QC, dissolution tests are developed and optimized to target and assess specific product properties (e.g., particle size and excipient composition) by monitoring their effects 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, dependent on the drug substance physicochemical properties (e.g., solubility) and formulation principles (e.g., extended-release dosage forms). On the other hand, in addition to the physicochemical properties of the drug substance and formulation characteristics, physiological factors also play an important role in the design of biorelevant dissolution methods, since these methods are developed mainly to simulate relevant conditions where the drug is being released from the formulation in the GI tract. Although progress has been made in developing dissolution media that reflect gastric (e.g., SGF) and intestinal conditions (e.g., FaSSIF), developing dissolution methods, which reflect all physiological parameters (e.g., motility pattern and transit times) that may influence the drug release behavior in the GI tract, remains as a significant challenge.

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