Cetus 840®: A New Paradigm for a Modernized Fully Automated Dissolution System

Abstract

Fully automated dissolution test systems have become common throughout the pharmaceutical industry, and they are frequently utilized in laboratories that have a high sample throughput such as stability testing and quality control laboratories. Although these systems were introduced approximately 20 to 30 years ago, very few "new" automated dissolution systems have been introduced in the last 10 years. Thus, there is a unique demand for a novel approach in designing a dissolution system which incorporates many of the technological advances that have been made in the last decade. This case study describes the entire process of creating a novel fully automated dissolution system. The introduction of the Cetus 840® automated micro-sampling dissolution system, developed by Hatch Science® in collaboration with Bristol-Myers Squibb, integrates several new technologies, such as micro-sampling, cameras to record the dissolution test, a robust vessel washing routine, on-line highperformance liquid chromatography, vibration sensor, and a more hydrodynamic sampling system.