Customer Credentials – Stability issues in tablet production
Situation at first contact
An international pharmaceutical company contacted us because they had stability issues with an important product. So far the produced tablet batches were still in-spec, but getting closer to the limits. To identify the root cause and find a solution, we were asked to set up an approach and action plan.
Our Approach
Step 1 – Understanding the situation and preparing an action plan
At the beginning, we had several meetings with the customer to understand the situation. We discussed the limits for finding solutions by changing ingredients or adapting the current FBG process, e.g. to dry granulation. During those meeting we already evaluated initial ideas on cause and possible solutions. At the end of this first step, we developed a comprehensive concept containing several work packages. The first work packages focused on the identification of the root cause.
Step 2 – Understanding the root cause
The results of the first work package showed clearly that the root cause was related to moisture. Based on this finding, we updated our approach for the next work packages and started investigating the process. We performed several trials at a controlled relative humidity of 10 – 15%. For example, we analyzed the moisture within the ingredients themselves and also tested the impact of drying the ingredients before processing. We also divided the FBG process into a multi step process in order to better control the humidification of the critical ingredient.
Results
We could define an adapted process to produce stable granules already before finalizing all planed trials. To save time and money, the process was verified by a final technical stability test in our lab. This allowed the customer to adapt his process in production scale.
Finally, it was possible to find a solution for the current production process. A change to a completely different production process like dry granulation or bi-layer tableting was not necessary.
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