Being able to check the consistency of batches of powder is important as the suitability of a material is often governed by several factors including cost, supply chain, availability, and regulation.
We work at different stages of the life cycle of a product, to check how consistent new batches are compared to earlier examples. This is especially important if a new supplier is being considered or API manufactured from a different synthetic route.
Merlin help by generating compactibility and compressibility results on batches from different years or different campaigns. Measuring the characteristics of the batch will help limit and understand any risks that may occur during manufacture of the final product.
Excipients are one of the ingredients that may be tested for batch-to-batch consistency, this is due to excipients having an impact on the characteristics such as tablet strength. If the quality of powder between batches of excipients starts to change, there can be issues with the final product, so materials need to be closely monitored to check for any changes in characteristics which can cause bigger issues in manufacture. Excipients are important for the function and processibility of formulations. If there are issues with consistency, then there will be significant impacts on the quality and the business.
We work with several companies to generate data to give them the key functional information of their powders. We produce this data by using as little as 20g of the material to assess the key functional properties such as yield pressure, compressibility, compatibility, tabletability and true density.
Our Case Study Highlights:
One client requested us to test their excipient samples to see if there had been any changes in the characteristics of the powder. We assessed the functional characteristics that would make their material a good excipient of choice. We did this by understanding the compaction properties of the excipient by completing a range of tests such as Heckel analysis which helps calculate the average yield pressure of the excipient and calculating the SRS (Strain Rate Sensitivity) which gives an indication of deformation characteristics of the excipient. For this client, we also ran tests to understand the strength of the excipient over a range of forces. The tabletability data that was generated by this provides “fingerprints” for assessment of each batch of excipient tested across the working range. It shows the impact of process variables that may affect the material’s performance.
The results from these tests showed the batch of excipients were similar to the previous batches that were sent to use for testing last year. The client will be able to complete the manufacture of the product with the new material, having checked for possible issues in quality.
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