27 September 2022
The dissolution test is a key test parameter for assessing the performance of solid and semi-solid dosage forms in both drug development and quality control.
In part 1 of this article, we gave you a summary of the test's purpose and the apparatuses according to the European Pharmacopoeia. In part 2, we provided an overview of the requirements laid down in dissolution guidances and associated documents. Part 3 now deals with automation in dissolution testing.
Dissolution testing is very work and time-intensive. The test consists of several steps:
Depending on the dosage form, the entire test can take a long time. For this reason, automation of the test can be helpful. Dissolution systems with varying degrees of automation are available from different manufacturers.
With regard to the degree of automation, a distinction can be made between semi-automatic and fully automatic dissolution systems. In fully automated dissolution systems, all steps are automated. In semi-automatic systems, sample collection is typically automated, as this is a particularly work-intensive step.
The following variants can be used:
fully automated systems with online analytics
Automation in dissolution testing offers a number of advantages. These include:
However, the advantages mentioned are also counterbalanced by some disadvantages that need to be taken into account when making a decision: