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Validation of a continuous granulation process using a twin-screw extruder.

B Van Melkebeke¹, C Vervaet, J P Remon

¹Laboratory of Pharmaceutical Technology, Ghent University, Harelbekestraat 72, B-9000 Ghent, Belgium.

International Journal of Pharmaceutics

|February 26, 2008

Summary

Twin-screw granulation screw configuration impacts granule properties and tablet disintegration. Continuous twin-screw granulation is a robust process, achieving good mixing efficiency regardless of tracer addition or granule size.

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Area of Science:

Pharmaceutical Technology
Chemical Engineering
Materials Science

Background:

Particle size enlargement is crucial for pharmaceutical formulation.
Twin-screw granulation offers precise control over granule properties.

Purpose of the Study:

Investigate the effect of screw configuration on twin-screw granulation.
Evaluate granule quality, tablet properties, and mixing efficiency.
Determine the robustness of continuous twin-screw granulation.

Main Methods:

Utilized twin-screw granulation with varied screw configurations (mixing zones, kneading blocks).
Assessed granule properties (oversized agglomerates, yield, friability).
Evaluated tablet properties (disintegration time) and mixing efficiency using different tracers.

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Main Results:

Screw configuration significantly influenced yield, oversized agglomerates, and granule friability.
An extra conveying element at the screw end and kneading block staggering angle were key factors.
Tablet disintegration time was faster with an extra conveying element.
Good mixing efficiency was achieved irrespective of tracer addition method, solubility, granulation time, or granule size.

Conclusions:

Screw configuration is a critical parameter in twin-screw granulation.
Continuous twin-screw granulation demonstrates robustness and process control.
This technique is suitable for producing consistent granules with desirable properties.