Dissolution Test: Causes of Understated Results and their Elimination (Review)

Understated results of the pharmacopoeial Dissolution test are often encountered in practice. Elimination of this problem is not an easy task. This review considers possible causes of obtaining underestimated data during the development, validation, and use of drug Dissolution test methods. Four groups of factors that can potentially lead to understates results of the Dissolution test are discussed in detail, including (1) factors related to the analytical method, dissolution tester performance, and data collection; (2) factors associated with the dissolution medium; (3) factors related to the properties of the drug substance; and (4) technological factors. Recommendations for eliminating understated results of the Dissolution test are given.