Johny Bertels, MSc

Drug Product Development and Supply – Oral Solid Dosage

Janssen Pharmaceutica NV, a Johnson & Johnson company 

The landscape for tablet formulators has undergone significant transformation in the past two decades. Traditional eccentric single-station compression machines, lacking comprehensive process parameter read-outs, have been replaced by compaction simulators that generate extensive datasets.

This discussion will present a case study demonstrating how a compaction simulator can be used to elucidate the root cause of tablet defects. By employing various customized compaction cycles, including the emulation of a rotary press, the study reveals the critical role of applying precompression force. This force proves essential not only in overcoming tablet defects but also in limiting out-die elastic recovery, while simultaneously significantly enhancing tablet strength. Anticipating the next paradigm shift, it is envisioned that a database will integrate systematically gathered process data and material characteristics, allowing for the estimation of tablet attributes through in-silico methods. In this scenario, the necessity for formulation experiments may be reduced.