Moritz Rosch, Friederike Gütter
KORSCH AG, Breitenbachstraße 1, 13509 Berlin

Purpose.
The scale up process for tablet formulations from development scale to production size rotary presses can be very challenging. The development process can be strongly catalyzed by compaction simulators, which allow for a single step scale up of tablet formulations by a concise simulation of the compaction cycles of high throughput production presses. The aim of this study was to assess the feasibility of a single step scale up process with two Tricalcium Citrate placebo formulations.
Methods.
Firstly, the materials were characterized on a STYL’One Evolution compaction simulator. Two Tricalcium citrate qualities named TCC TB and TCC GN were investigated. Tabletability and speed sensitivity of the TCCs were assessed on the simulator to create a compaction recipe to be transferred to the KORSCH X3 rotary press. After successful transfer to the rotary press, an extended performance test with high turret speed was conducted for both excipient qualities.

Results.
During the compaction simulations, both TCC qualities showed linear increases of hardness resulting from main compaction force increase. Simulated turret speed increase caused only slight decrease of tablet hardness. The obtained data enabled a successful scale up and very constant values form tablet sampling throughout the extended performance test on the rotary press.

Conclusions.
Both TCC qualities proved to be very well suited for a single step scale up from compaction simulator to a production rotary press. The concise compaction simulation enabled a swift, material- and time-saving process development.