Impact of different MCC grades on processability and dissolution of IR tablet

Antagonists of G protein-coupled receptors are evaluated for treatment of inflammatory diseases.¹ Immediate release (IR) tablets with such an antagonist should be manufactured for clinical trials with different dosage strengths. First runs with an existing IR formulation revealed slight filming during roller compaction and relevant filming and sticking during subsequent compression. Increase in the level of extragranular lubricant did not reliably avoid filming.
The purpose of this study was to evaluate if change of the approximately 30% filler MCC with ~50 µm mean particle size against MCC qualities with different particle size could avoid that issues.