Dear GMP colleagues,
I have a question about how to increase tablet hardness without affecting other critical parameters of the tablets. Our problem at the moment is that our CMO in Asia produced the domperidone tablets within the specifications [40-120N], i.e. 50-60N. But when the tablets are tested in an EU-Lab, the result is often round 35N, which means an OOS. We have investigated this problem, but no root cause could be observed. Perhaps there are people in this group who can give me advise how to increase the hardness to a min. of 80N for example? The CMO is not very cooperative in this case as the tablets are within the spec in their site.
Many thanks in advance for your help.