Tabletting and compaction simulation

Tabletting

Tablets are the most commonly used dosage form as their convenience of administration, accurate dosing, ease of manufacturing and excellent stability make them attractive to patients as well as manufacturers. As a result, tablets account for more than 80% of all pharmaceutical preparations.

Time and cost efficiency, flexibility, quality and environmental impact during manufacturing of oral solid dosage forms are important advantages of continuous manufacturing technologies. Therefore, the pharmaceutical industry is showing high interest in these technologies.

Laboratory of Pharmaceutical Technology focuses mainly on the implementation and optimization of a tableting process in a continuous direct compression line. Therefore, the lab is equipped with an altered Modul™-P for R&D purposes.

Ongoing work investigates the influence of raw material and blend properties on the die-filling and tabletability during continuous manufacturing. Residence time distributions in the feedframe and influence of different process parameters are being studied.

In addition, the influence of feeding and blending during continuous direct compression on the tablet content uniformity is evaluated.

Compaction simulation

The upscaling of the compaction process between early R&D and production can be time-consuming and costly, resulting in a long time-to-market and shorter commercial lifecycles. Due to the limited availability and high price of a new API during early drug development phases, compaction simulators proved highly valuable as the dwell time and punch speed can be set accurately to mimic bottom and upper punch movement on a rotary tablet press.

The Styl’One Evolution compaction simulator (Medelpharm, Beynost, France) is a small-scale tableting instrument developed to mimic high speed tableting on a rotary tablet press while producing single tablets using 1 punch pair. Moreover, it is equipped with a feedframe to simultaneously evaluate tabletability and die filling during high speed tableting. Additionally, it can be equipped with a system for external lubrication to facilitate scale-up of formulations requiring this technology.

The Laboratory of Pharmaceutical Technology focuses mainly on:

• Evaluation of the external lubrication system on the compaction simulator
• Evaluation of the correlation between the tableting process and tablet quality of tablets produced on the Styl’One Evolution tableting instrument and Modul™ P rotary tablet press in function of formulation properties.
• Evaluation of formulation and process parameters on the compactability, compressibility and tabletability of granules and extrudates