Layla Hassan ^a, René Jensen ^a, Lasse I Blaabjerg ^a
aNovo Nordisk A/S, Novo Nordisk Park 2, 2760 Maaloev, Denmark

The aim of this study was to investigate the feasibility of the MedelPharm Styl’One Evolution and Frewitt FlexMill-Lab OW-1 to mimic the Gerteis Mini-Polygran as a material sparring approach for method development. Microcrystalline cellulose (MCC) and dicalcium phosphate dihydrate (DCPD) were chosen to represent soft and hard materials, respectively. Ribbons were characterized by solid fraction and granules were characterized by size distribution, flowability, bulk and tapped density. Furthermore, tablets produced from the respective granules were characterized by solid fraction and tensile strength.
The study showed that the solid fraction of riblets produced by the use of the Styl’One Evolution and ribbons produced by the Mini-Polygran were similar in the specific compaction force range 1-12 kN/cm for both MCC and DCPD, which indicates that the compaction simulator adequately mimics the material compaction of the roller-compactor at a specific correction factor Kp of 1. Additionally, the size distribution, flowability, bulk and tapped density of granules produced by the FlexMill-Lab and the Mini-Polygran were similar, which indicate that the oscillating mill adequately mimics the mill in the roller-compactor when using similar gap.
Finally, the solid fraction and tensile strength of tablets produced from the respective granules were similar independent of the use of MCC or DCPD, which indicate that the method is feasible for both soft and hard materials. In conclusion, the use of a compaction simulator and an oscillating mill in combination adequality mimics the roller-compactor, which ultimately can save large amounts of material during method development.