We have been working with a client that came to Merlin for expert advice on assessing their formulation that is to be scaled up from lab to production.
The primary objective of this testing was to assess if changing the excipients in the formulation would make a significant improvement to the flow properties. We recommended two tests that would be beneficial for the client to get the data they required.
Firstly, Shear cell testing was conducted to assess the flow properties. Using a Schulze shear cell, we were able to compare the formulation with different excipients. Secondly, a roller compaction simulation was used to compress the material, to see if the changes in excipients have a significant effect on the ribbon quality.
The formulation had experience of being made at a relatively low batch size and we expected that it would need to be transferred to high-speed presses for manufacture. The samples were lubricated at Merlin to avoid the risk of over blending during transport from the client’s lab. We compressed the final blend at high speed to mimic the effects of full-scale production conditions, to confirm that the compressibility is not significantly affected by speed or highlight potential risks for tabletting.
Our Case Study Highlights:
Using our compaction simulator, we assessed the formulation and the results showed that all the formulation blends had acceptable strength, even at the extreme fast speed. There were some differences between the blends which moved the formulation into both positive and negative directions, depending upon the parameter looked at.
The biggest compaction issue was with high adhesion force as many tablets had extreme ejection forces. The flow results revealed that flow did not achieve >10 FFC and therefore would be moderate to high risk for die filling.
From our investigations, we gave further insight into possible issues and suggested improvements that could help during scale-up. We completed the project with tight time constraints as the client needed to make formulation decisions quickly.
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