Mueller-Zsigmondy, Martin, Mann, James, Hermans, Andre, Contrella, Nathan, Nickerson, Beverly, Coutant, Carrie A., Jede, Christian, Kao, Shangming, Kou, Dawen, Scheubel, Emmanuel, Winge, Fredrik, Milsmann, Johanna and Zaborenko, Nikolay (2022) Dissolution Method Troubleshooting: An Industry Perspective. Dissolution technologies, 29 (4). pp. 190-203. ISSN 1521298X

Abstract

Quality control dissolution testing represents a key product performance test for solid oral dosage forms and is the most likely QC test to result in laboratory investigations because of the relatively complex relationship between the dissolution performance, the drug product properties, and the systems necessary to measure the quality attribute. The Dissolution Working Group of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) has pooled our collective knowledge to outline some common ways that dissolution methods can fail. Examples and case studies have been highlighted focusing on errors of equipment, method, materials, measurement, people, and the environment, while providing best practices for building method understanding and avoiding the exemplified issues. The case studies have highlighted the importance of buffer preparation, potential impact of contamination of the dissolution medium, additive-induced degradation, risks in the use of automation, differences between dissolution systems, and the effect of filter selection. By applying the learnings in this article and investing in analyst training programs, understanding the capabilities of your equipment portfolio, and well-designed robustness and ruggedness studies will reduce dissolution method investigations and improve compliance and productivity during the method lifecycle.

Item Type:	Article
Keywords:	Dissolution, Troubleshooting, Method Issues
Date Deposited:	21 Feb 2023 00:45
Last Modified:	21 Feb 2023 00:45
URI:	https://oak.novartis.com/id/eprint/47927