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Continuous direct compression of a commercially batch-manufactured tablet formulation with two different processing

Jenna Lyytikäinen¹, Pawel Stasiak², Tomáš Kubelka²

¹School of Pharmacy, PromisLab, University of Eastern Finland, Kuopio, Finland.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V

|April 7, 2024

Summary

This summary is machine-generated.

Continuous direct compression manufacturing offers improved tablet quality and efficiency. This study identified API micro-agglomerates as a cause for content uniformity issues, solvable by adding a mill to the process line.

Keywords:

Blending Pharmaceutical continuous manufacturing Process parameters Tablet compaction Twin screw feeding

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Area of Science:

Pharmaceutical Manufacturing
Chemical Engineering
Process Optimization

Background:

Transitioning from batch to continuous manufacturing enhances pharmaceutical production quality and efficiency.
Continuous process design necessitates optimization studies for robustness, similar to batch processes.

Purpose of the Study:

To evaluate continuous direct compression manufacturing for a commercial tablet product.
To identify and address challenges in maintaining tablet quality, specifically API content and uniformity.

Main Methods:

Two continuous direct compression lines were used to process a commercial tablet formulation.
Tablet properties were assessed across various process parameter settings.
Root cause analysis was performed for content uniformity deviations.

Main Results:

Most tablet quality properties were maintained within limits without extensive parameter optimization.
Content uniformity issues were linked to API micro-agglomerates, not tablet weight variability.
Incorporating a mill between blenders resolved content uniformity challenges.

Conclusions:

Continuous direct compression is a viable manufacturing approach for the tested tablet product.
Addressing API micro-agglomerates through process modification (milling) is crucial for content uniformity.
Promising results were achieved, with many tablet properties meeting limits pre-optimization.