The Case for Apex Vessels

Abstract

Apex vessels are an important element of the dissolution scientist’s toolbox and are frequently used in pharmaceutical drug product development settings. However, their use in development has not translated widely into use in the final approved QC method. This article aims to demonstrate the significant benefit of the apex vessel relative to the standard vessel in overcoming coning for formulations which contain dense insoluble excipients. Industrial case studies outline the benefits imparted 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 dissolution bath manufacturers, an interlaboratory study was performed across 11 partners which demonstrated minimal differences in dissolution performance between partners when a controlled protocol was executed