Gerd Hueffmann reports on a successful upscaling exercise using a compaction simulator
The work discussed here represents a practical example of using a compaction simulator to create scalable compression data for a rotary press.
The task description was as follows: to establish a hardness/ compaction force profile for a pharmaceutical tablet (Olmesartan) in two different prescription strengths, while at the same time providing setting data for a specific rotary press (here a Kilian Synthesis 51D) at a defined speed setting.
The tool used was a compaction simulator tablet press, in this case a Styl’One Evolution from Romaco Kilian.
Tableting requirements
To fulfil all tabletingrequirements, this simulator isfully instrumented to measurecompaction forces (tampingforce, pre- and main compaction force), as well as ejection forces and punch displacement.
Compaction cycles can either be force- or displacement controlled to replicate all commercially available tablet press control systems.
As the task was to simulate a rotary press the simulator was equipped with a force-feed fill shoe.
Most important is the ability of the compaction simulator to replicate the compaction cycle of the rotarypress in question/comparisonat a given operational speed.
For this purpose, unrestrictedcompaction profiles for any rotary press make and model can be created with the help of the compaction simulators’control panel.
A compaction profile typically comprises of the following parameters that are in line with those of the simulated rotary press:
* Die Filling (time)
* Pre-compression (force and de-aeration time)
* Main-compression (force and dwell time)
* Ejection (force)
The trials
The trials were carried out on a Styl’One Evolution simulating a Kilian Synthesis 700 51D with 30rpm. The setting for each punch as well as the results are listed here.
Three tablets were measured for each compression force setting.
Below are the requested parameters from the client:
The tables 2,4 and 6 (LS to check this) provide the setting data for the rotary production press (die filling, pre-compression and main-compression) that will lead to a specific tablet hardness within the permissible specification range for each dosing tablet strength, without the need to establish that data using the production press; a process that would consume large amounts of product and occupy valuable production time.
Based on this data, the user is now in a position to choose the optimal combination of tablet hardness (high enough) and compression – as well as ejection forces (as low as possible to minimise wear on
the machine).
For more information visit www.scientistlive.com/eurolab
Gerd Hueffmann is with Kilian Tableting.
