A roller compaction process is designed to yield consistent downstream tablet compression, resulting in uniform dissolution and content uniformity.
A successful process produces a granule with consistent particle size distribution, density and porosity control.
However, inconsistencies occur during granulation scale-up due to a change in raw materials or process dynamics.
Collaboration with Patheon demonstrates FBRM at-line to map design space and optimise a series of roller compaction runs while varying vertical/horizontal feed speed, roller compaction force, and mill speed.
Characterising particle distribution allows users to directly link process control parameters to product quality.
By designing a robust process, consistent processing from dry granulation to tablet compression is achieved.
A 19-batch DoE was performed in order to understand processing parameters affecting downstream product quality.
FBRM technology was used to measure and control changes in particle count and dimension.
FBRM is typically inserted in-line in a collection funnel downstream of the Comil and powder flows over the probe tip providing a representative measurement due to measuring in-line or at-line within concentrated particle systems, increasing sample size and providing high sensitivity to fine particles.
In this case, an at-line method was used.
10g of powder was sampled downstream and dispersed in 100g of mineral oil.
Due to concentrated sample size, a representative measurement was achieved.
Sample repeatability was
Mettler Toledo has described how to optimise the roller compaction process using its FBRM particle characterisation.
In roller compaction, particle distribution is recognised as one of the most critical parameters affecting downstream process performance and product quality.