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A Material-process-equipment Integrated Design Method For Accelerating The Process Development Of Twin-screw Wet Granulation.

Home
A Material-process-equipment Integrated Design Method For Accelerating The Process Development Of Twin-screw Wet Granulation.

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A Material-Process-Equipment Integrated Design Method for Accelerating the Process Development of Twin-Screw Wet

Liping Chen^1,2,3, Wuzhen Qi^1,3, Juntao Xie^1,3

¹Department of Chinese Medicine Informatics, Beijing University of Chinese Medicine, Beijing 100029, China.

Pharmaceuticals (Basel, Switzerland)

|June 26, 2026

View abstract on PubMed

Summary

This summary is machine-generated.

A new integrated design methodology accelerates twin-screw wet granulation (TSWG) process development for botanical drugs. This approach optimizes screw configurations and process parameters, ensuring consistent granule quality and efficient manufacturing.

Keywords:

3D printing critical screw parameters equivalent formulation material-process-equipment integrated design twin-screw wet granulation

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Area of Science:

Pharmaceutical Technology
Chemical Engineering
Continuous Manufacturing

Background:

Twin-screw wet granulation (TSWG) offers operational flexibility and consistent quality in continuous manufacturing.
TSWG process development requires integrating material properties, screw design, and process parameters.
Botanical drug products present unique challenges for granulation process development.

Purpose of the Study:

To accelerate twin-screw wet granulation (TSWG) process development using a material-process-equipment integrated design (MPEID) methodology.
To apply the MPEID methodology to the TSWG process of Guizhi Fuling capsules, a botanical drug.
To optimize critical screw parameters (CSPs) and critical process parameters (CPPs) for enhanced granule quality.

Main Methods:

An equivalent formulation was designed to reduce trial costs.
3D printing was utilized to create customized screw elements, varying stagger angle (SA) and thickness (thick).
A two-step design of experiment (DOE) identified critical screw parameters (CSPs) and critical process parameters (CPPs).

Main Results:

Stagger angle (SA) and thickness (thick) were identified as critical screw parameters (CSPs).
The liquid-to-solid ratio was identified as the critical process parameter (CPP).
Optimal TSWG conditions resulted in low torque operation and granules with superior flowability and consistent particle size distribution, comparable to commercial products.

Conclusions:

The material-process-equipment integrated design (MPEID) methodology is feasible for TSWG process development.
This approach enables efficient and cost-effective development of TSWG processes for botanical drugs.
The optimized process yielded Guizhi Fuling capsules with dissolution profiles similar to commercial products.