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Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality

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Integrated Continuous Wet Granulation and Drying: Process Evaluation and Comparison with Batch Processing.

Seth P Forster¹, Erin Dippold¹, Abbe Haser²

¹Merck & Co., Inc., West Point, PA 19486, USA.

|September 28, 2023

Summary

This summary is machine-generated.

Continuous manufacturing in pharmaceuticals is advancing. New equipment for continuous wet granulation and drying shows promise, producing high-quality granules comparable to traditional batch methods.

Keywords:

continuous drying continuous granulation continuous manufacturing pharmaceutical pharmaceutical manufacturing wet granulation

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Area of Science:

Pharmaceutical Manufacturing
Chemical Engineering
Materials Science

Background:

The pharmaceutical industry is shifting from batch to continuous manufacturing.
Wet granulation presents unique challenges for continuous processing due to equipment limitations.
Limited options exist for continuous granule drying.

Purpose of the Study:

To describe the process space of novel continuous wet granulation and drying equipment.
To compare granules produced by this new equipment with traditional batch methods.
To evaluate the effectiveness and quality of continuous wet granulation and drying.

Main Methods:

Utilized pilot and commercial scale equipment combining a twin-screw wet granulator and a horizontal vibratory fluid-bed dryer.
Characterized the process space of the continuous equipment.
Compared granule properties produced by continuous and batch (high-shear and fluid-bed) wet granulation processes.

Main Results:

The novel equipment effectively granulated and dried across various formulations.
Granules produced demonstrated comparable or improved quality to those from batch processes.
The equipment demonstrated a viable process space for continuous wet granulation and drying.

Conclusions:

The developed twin-screw granulator and vibratory fluid-bed dryer system is effective for continuous wet granulation and drying.
This technology offers a viable alternative to traditional batch wet granulation, producing high-quality granules.
The findings support the transition of wet granulation processes to continuous manufacturing.