An integrated framework streamlining the manufacturing of high drug loading pharmaceutical tablets

Increasing pipeline volatility and need for shorter development times, creates the need to professionals working in the development of tableted solid dosage forms, within the biopharma industry, to develop appropriate workflows, emphasising at the synergies between functions, which henceforth were working in silos. Breaking the silos and streamlining the synergies between the different functions require the ability to communicate scientifically sound findings in way that facilitates the discussions. This work highlights the workflow developed at UCB, to accelerate the development of Direct Compression (DC). In particular, the workflow makes use of the CrystalGrower platform to identify the most appropriate particle engineering by crystallisation strategies. Based on the CrystalGrower's orientation, small scale experiments were conducted to produce material for characterisation by miniaturised powder characterisation tools. By producing enough samples with appropriate variability in size and shape, and combining their characterisation results with those of material obtained from Technical and GMP campaigns, a good mapping of the relation between particle and powder properties was obtained. Then based on considerations for the industrialisation of crystallisation, one API was selected and the Elegent platform was used to identify formulations suitable for DC with high drug loading. The predictions were tested successfully, on the tablet press. The successful deployment of this workflow in the context of a UCB's NCE development candidate, Minzasolmin, a demanding drug product requiring high drug loading and with an API exhibiting persistent elongated morphology, highlights its potential for use in future CMC development activities.