what is the optimal PSD differences between the API and excipients allowed.
what will happen if the API is finer and excipient PSD is 8-10x of API.
will there be segregation to be expected
can the PSD difference impact the content uniformity
Before blending we should ensure both the materials having nearly values of bulk density and PSD.
This matters if process is Direct compression or direct capsule filling, where there are chances of segregation. If API and Excipients PSD difference is more, then can change the manufacturing processes e.g. RMG ,Top Spray , HME Granulation.