It's important for clients to understand how formulation samples react to different press speeds. This provides valuable information to guide scale-up and tech transfer.
De-risking Scale-up
Understanding how development formulations perform with different profiles and at different speeds is important as it allows our clients to decide on which conditions are best to compress tablets. Compression speed can affect tabletability and can be assessed in our laboratory.
One of our clients wanted to de-risk the tech transfer process by carrying out tests to predict the tablet behaviour of a development formulation from one site to another. The formulation contained relatively large amounts of polymer and was being transferred to a new manufacturing site with different presses and unexpected surprises at this scale would have been expensive.
Merlin used the compaction simulator software to generate profiles to the formulation to mimic different presses. The press speeds explored were the Korsch XL100 and a Fette P1090i press simulations, with speeds of 3 RPM and 50 RPM. The test uses only 10s of grams of material compared to kilograms required for full scale comparisons.
Our Case Study Highlights:
- Understanding how speed and profile can affect a formulation is important to decide which conditions to use.
- We can de-risk tech transfer by carrying out tests to predict behaviour of formulations at different sites.
- Only 10g of material was used compared to kilograms used in full-scale manufacture.
- We saved the client time and money by finding potential scale-up issues before they occur in production.
- The information was perfectly placed to help our client make informed decisions on scale-up.
Reassurance
The aim was to check for adverse elasticity and scale-up risks for their powder blend as compression speed and dwell time changes. One of the Korsch simulations gave a dwell time in the target range the client was looking for, which allowed them to compare directly with the Fette high speed simulation tablets. By running tabletability tests, we will have saved our clients time and money by finding potential scale-up issues such as capping and laminating before they occur in production.
During the projects we generated information on the tabletability, compactibility, compressibility and the ejection force. The results were reported and sent to the scientists in charge of the projects. This information is perfectly placed to help our clients make informed decisions on scale-up with their material.
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