Fast, Predictive Analytical Method Generation for Forced Drug Degradation Studies

Now, with the ReactArray workstation, formulation chemists can generate much more data, more quickly, by performing controlled drug degradation assays in parallel.

The product range includes both manual and automated reaction racks to support parallel stressing studies. Drugs can be challenged with multiple combinations of heat, acid, base, oxidation and humidity stressing. The on-line HPLC analyses degradation products in real time to rapidly generate a predictive analytical method.

Forced degradation studies are widely used in the pharmaceutical industry for proactive investigation of stability, degradation pathways and products, and for development of stability-indicating assays. Such knowledge of chemical behavior can be used to improve pharmaceutical development, formulation development, manufacturing and packaging. Forced degradation studies should be performed prior to implementation of stability studies to assure analytical methods are stability indicating. There is increasing need to perform these studies earlier in development and to employ high throughput technology to improve their efficiency. The introduction of ReactArray instrumentation and software makes this achievable for chemists in a wide range of pharmaceutical laboratories.

ReactArray drug stressing systems are also invaluable for excipient compatibility testing, rapidly identifying those that have no effect or retard the active ingredient degradation. ‘Peak Tracker’, a unique software feature even monitors the amount of drug and adjusts conditions to help achieve a desirable degree of degradation.

ReactArray workstations have been developed through collaboration between Anachem and chemists within the pharmaceutical industry to provide a proven and robust concept that meets the demand for high throughput reaction screening and optimization. Today there are over 200 systems in use worldwide.