We have been working over the last few months with a client who has been experiencing issues with tabletting manufacture of a marketed product.
Our client's key requirement was to collect data on the API and the granules to find out why the manufacturing issues were happening, and what they could do to help improve the strength of the current formulation.
The problems were linked to poor compression strength during production, and we were asked to investigate the tablet compression at slow and fast speeds, using Heckel, tabletability, compressibility and compactibility testing. Due to the materials already being a commercial product, there is little room for change to the formulation apart from process settings.
We had already been told that the client's tablets had difficulty consistently achieving the target disintegration times and they were also friable and prone to capping. The client had run internal trials, and the problem required further information.
Following our investigation, we were able to give further insights into the cause of the manufacturing issues and suggest improvements which could be made within the limitations of the manufacturing licence.
Our Case Study Highlights:
To investigate the problem, we used embossed tooling. It was important for us to replicate the production process to see exactly what was happening during manufacturing and we used the exact tooling being used by the client and all settings were sent by the client to enable us to replicate their production press.
We looked at the compressibility of the formulation at two speeds. A fast speed which allows us to replicate production conditions and a slow speed to understand how speeds effects compressibility. This tabletability test allows us to identify if there are any warning signs which would indicate where the problem is, and to look for the optimum compressibility range to see if the client's production is in the right range for tabletting.
Using our Compaction Simulator, we were able to find the issues the client has been experiencing and we could see that the strength was struggling to find the range which would be expected for tabletting, which is 1.7MPa. We witnessed capping and lamination during the testing which was also seen during the client's manufacture.
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