Dissolution testing stands as a cornerstone in formulation development, quality assurance, bioequivalence assessment,) in vitro-in vivo correlation, and scale-up and post approval changes. The USP 2 Paddle Apparatus is the mostly used in dissolution testing. In tandem with dissolution advancements, a United States Pharmacopeia (USP) stimuli article was published on apex vessels in 2021. Apex vessels are dissolution vessels with a convex bottom that have gained interest due to improved hydrodynamics and reduced the accumulation of trapped drug product in formulation at the bottom of the vessel during dissolution testing. The article proposed paddle heights specifications when using apex vessels. It is highlighted in the article that while the FDA has previously accepted data from dissolution testing with apex vessels, these uses in drug applications are quite rare likely due to the lack of compendial acknowledgement and agreed upon qualification methods for dissolution systems with apex vessels. USP recommends performance verification testing (PVT) in addition to mechanical calibration as the performance qualification of a dissolution assembly. Questions remain on how the commonly adjusted mechanical parameters would affect the PVT results of a paddle apparatus using apex vessels. This study aimed to bridge the gap by evaluating the fluctuation of PVT results within the mechanical calibration margins of three commonly adjusted parameters and their impact on the rate of dissolution for new DPVS – Prednisone tablets in deaerated water in apex vessels. Standard vessels were also used as comparison and control. All configurations within specified parameters for standard vessels fell within PVT acceptance criteria, but the higher rate of dissolution in apex vessels fell beyond the acceptable range of tablet dissolution. We therefore recommend a new PVT or DPVS-Prednisone tablet for the qualification of USP Apparatus 2 fitted with apex vessels for performance verification.
Learning Objectives:
Upon completion, participants will be able to understand mechanical calibration does not satisfy the performance qualification component of a dissolution apparatus.
Upon completion, participants will be able to describe the difference between a standard dissolution vessel and an apex vessel, and paddle apparatus with apex vessels would need new PVT.
Upon completion, participants will be able to understand if a performance verification testing (PVT) fails, the PVT result does not inform what adjustment(s) should be made to the apparatus.
