Dissolution Method Troubleshooting: An Industry Perspective

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 are given to highlight errors related to equipment, method, materials, measurement, people, and the environment. Best practices for building method understanding and avoiding the exemplified issues are discussed. Case studies highlight 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. Investing in analyst training programs, understanding the capabilities of your equipment portfolio, and using well-designed studies for robustness and ruggedness will reduce dissolution method investigations and improve compliance and productivity during the method lifecycle.