IQ Webinar: The Case for Apex Vessels
Presented by Dissolution Working Group / Sponsored by Analytical Leadership Group
Apex vessels (previously known as PEAK® vessels) are an important element of the dissolution scientist’s toolbox and are frequently used in drug product development. However, their use in development has not translated widely into use in the final approved QC method. This webinar aims to demonstrate the significant benefit of the apex vessel relative to the standard vessel in overcoming coning for formulations that contain dense insoluble excipients. Industrial case studies will be presented which outline the benefits of 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 will be presented, which demonstrated minimal differences in dissolution performance between partners when a controlled protocol was executed. This was supplemented by a comparison between the different manufacturer designs using a computational fluid dynamic (CFD) model, which showed no significant differences between manufacturers. This led to a manufacturer proposed specification for an apex vessel alongside a qualification procedure for the use of the vessels.
The case studies, interlaboratory study, CFD modelling and proposed specification and qualification procedure were submitted as stimuli article to the USP Pharmacopeial Forum and it is the authors intent by publishing this article that it will stimulate discussion leading to greater acceptance of the apex vessel such that it will be considered for a more prominent inclusion in future pharmacopoeia chapters. The webinar will provide an overview of the stimuli article and is timed to coincide with the articles publication.
Xi Shao, Abbvie
Gavin Reynolds/Rob Shaw/James Mann, AstraZeneca
Xujin Lu, Bristol-Myers Squibb
Beverly Nickerson, Pfizer