Customer Credentials
– Choosing the best punch format despite API shortage
Situation at first contact
An international pharmaceutical company wanted to establish a new product. During development, they observed that the formulation was very sensitive to changes in the punch format. As the API was expensive and rare, they were looking for a partner who could perform trials in small scale to save both, material and punches.
Our Approach
Step 1 – Analyzing the Status Quo
During the initial discussions, it became clear that the customer had already decided on several punch formats to be tested. And that the data which led to the statement of the sensitivity to the punch format was very opaque. It was largely based on empirical and somewhat unstructured observations. Additionally, the available amount of API was indeed very limited, and the customer was happy for every gram that did not have to be used.
Step 2 – Developing a Trial Plan
Based on the previous results and the limitations given by the customer, we developed a trial plan to generate the required information and samples while minimizing the use of resources. Central components of the test plan were a compaction simulator that only requires one pair of punches and a step-by-step procedure for the trials.
Step 3 – Tableting Trials
During the tableting trials the advantages of the step-by-step approach became already evident. Some formats actually showed a higher tendency to tablet defects. Thanks to the elaborated trial plan and the sequential analysis of the results, some tests could be saved.
Results
Based on our trials the customer had a sound basis for deciding on the tooling for the next development batches which should be performed on a rotary tablet press as soon as the API was available again.
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