Particle Characterization Ensures Consistent Roller Compaction Processes

In roller compaction, particle distribution is recognized as one of the most critical parameters affecting downstream process performance and product quality of the final tablet product. Applying particle characterization during roller compaction directly links process control parameters to product quality.

Roller Compaction Process Optimization using FBRM Particle Characterization
In roller compaction, particle distribution is recognized as one of the most critical parameters affecting downstream process performance and product quality. The particle distribution affects the following unit operations:

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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 in change raw materials or process dynamics. Collaboration with Patheon demonstrates FBRM at-line to map design space and optimize a series of roller compaction runs whilst varying vertical/horizontal feed speed, roller compaction force, and mill speed. Characterizing 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.

Experiment Design
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-line3 in a collection funnel downstream of the Comil and powder flows over the probe tip providing a representative measurement due to measuring in-line4 or at-line5 within concentrated particle systems, increasing sample size and providing high sensitivity to fine particles. In this case, an at-line method was used6. 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 specializes in the area of precision instruments for professional use. METTLER TOLEDO laboratory instruments are used in research, scientific, drug discovery, and quality control labs, amongst many others in the pharmaceutical, chemical, food and cosmetics industries.

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This release was published on openPR.