Customer Credentials – Roller Compaction Trials with Oxygen-reduced Environment
Situation at first contact
An international pharmaceutical company contacted us because they wanted to perform some roller compaction trials to optimize one of their existing formulations and test different granulates on a rotary tablet press. The difficulty was the low ignition properties of the API which made it necessary to work in an oxygen-reduced environment during the milling phase in roller compaction.
Our Approach
Step 1 – Preparation of an Oxygen-reduced Environment for the Roller Compactor
To be able to carry out the necessary trials with a reasonable amount of formulation we decided to create an oxygen-reduced environment for the whole compactor. Before the trials both, the material and the roller compactor were flushed with nitrogen. During the trials a slight overpressure with nitrogen was realized inside the roller compactor. The challenge was to compensate the pressure during the runs and to avoid a backflow of air into the system. Therefore, we decided for continuous liners which could collapse at the inlet and expand at the outlet. The surplus nitrogen that escaped from the material during compaction was discharged via an overpressure filter.
Step 2 – Performing the Trials
Although the handling was unfamiliar and more complex, the roller compaction trials could be performed as planned. The oxygen concentration during the trials was below 5%. Enough granulate at different settings could be collected for the rotary tablet press tests which were also successful.
Results
Even without a fully implemented solution, it was possible to create an oxygen-reduced environment for test purposes. The complex handling is no solution for production but allowed to obtain the necessary data for further development.
Planning roller compaction trials under special conditions?
Let’s talk about your challenge – get in touch now for expert support in pharmaceutical formulation development.
📩 Interested? Contact us via www.solids-development.com or email us directly at contact@solids-development.com.
Let’s talk about your challenge – get in touch now for expert support in pharmaceutical formulation development.
📩 Interested? Contact us via www.solids-development.com or email us directly at contact@solids-development.com.