(673a) Exploring the Effects of Equipment Operational Defects on the Dissolution Performance in USP Apparatus 1

Dissolution methods remain an important quality control tool for ensuring the safety and efficacy of tablets and capsules in the pharmaceutical industry. The quality of the drug product is ensured through the comparison of dissolution profiles over the course of time. Despite the use of standardized equipment and protocols, systematic differences in dissolution profiles sometimes arise between different apparatus of the same USP type. These differences may also arise inconsistently depending on operating variables such as shaft rpm. Delays from uncovering the culprit of these differences can produce serious costs when bringing new formulations to market. In this work, we examine how operational variation such as vibrations and wobble in a shaft manifest in differences in dissolution profiles by influencing the fluid mechanics. Specifically, this work investigates the USP Apparatus 1. We utilize computational fluid dynamics (CFD) modeling to quantify the effects of these defects on local turbulence characteristics. Standard dissolution equations could then be used to explore the sensitivity of dissolution profiles, thereby establishing a link between the observed dissolution performance and the underlying fluid mechanics. The results of this work are expected to provide a rational basis for the discrepancies observed by dissolution practitioners.

Disclosure: Authors are employees of AbbVie and may own AbbVie stock. AbbVie sponsored and funded the study; contributed to the design; participated in the collection, analysis, and interpretation of data, and in writing, reviewing, and approval of the final publication