Techniques - tablet testing and dissolution

Dissolution testing is a critical test for measuring the performance of solid dosage drug products, principally tablets, capsules and pellets. The technique measures the change in stability of the product and is used to establish in-vitro, in-vivo correlations for some. The new Cetus Micro Dissolution Tester will improve data by enabling more frequent sampling without media replacement or needing to use complex algorithms for data correction.

UV is still the main method used to analyse the endpoint of dissolution tests. The use of fully or semi automated systems based on the Agilent 8453 UV-Visible Spectrometer, is a powerful tool for the dissolution laboratory Using a four bath Agilent 8453 UV-Visible Spectrometer system linked to four Distek 6100 Dissolution Baths as shown in the schematic below, it is possible to complete, analyse and report over 30 dissolutions per day.

Omicron has extensive experience in set -up, qualification and maintenance of these systems. For support of compliance with the requirements for electronic records and signatures (21 CFR Part 11), the dissolution-testing mode can be combined with the Security Pack for UV-Visible ChemStations.

Omicron has recently introduced new piston pump technology options, which seamlessly integrate with all Agilent 8453 systems, for systems when peristaltic pumps are not suitable.