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Nov 30, 2021

Stimuli to the Revision Process: The Case for Apex Vessels Stimuli articles do not necessarily reflect the policies of the USPC or the USP Council of Experts

Abstract

Apex vessels (previously known as PEAK vessels) are an important element of the dissoluton scientst’s toolbox and are frequently used in pharmaceutcal drug product development setngs. However, their use in development has not translated widely into use in the final approved quality control (QC) method. This Stmuli artcle aims to demonstrate the significant benefit of the apex vessel relatve to the standard vessel in overcoming coning for formulatons that contain dense insoluble excipients. Industrial case studies outline the benefits obtained by the apex vessel such as improved clinical relevance, more robust and discriminatory methods, and streamlined in vitro bridging strategies. Furthermore, to understand the impact of apex vessels produced by different dissoluton bath manufacturers, an interlaboratory study was performed across 11 partners, which demonstrated minimal differences in dissoluton performance between partners when a controlled protocol was executed. This was supplemented by a comparison between the different manufacturer designs using a computatonal fluid dynamic model, which showed no significant differences between manufacturers. This led to a manufacturer proposed specifcaton for an apex vessel alongside a qualifcaton procedure for the use of the vessels. It is the authors’ intent by publishing this artcle that it will stmulate discussion leading to greater acceptance of the apex vessel such that it will be considered for a more prominent inclusion in future pharmacopeial chapters such as the US Pharmacopeia (USP) chapter The Dissoluton Procedure: Development And Validaton and ultmately inclusion into the USP chapter Dissoluton and other harmonized pharmacopoeia as an alternative vessel to the standard 1-L vessel to be used when scientifically justified.

By James Mann, Michael Cohen, Andreas Abend, Carrie Coutant, Lee Ashworth and Robert Shaw

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