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Formation of Dispersible Taohong Siwu Tablets

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Tablet diversion strategy based on in-line NIR tablet press feed frame measurements.

Alexander Ryckaert¹, Matthew Cannon², Thomas De Beer³

¹Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium; Pharmaceutical Engineering Research Group (PharmaEng), Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium.

International Journal of Pharmaceutics

|January 12, 2025

Summary

The tablet diversion strategy uses in-line near-infrared (NIR) spectroscopy to monitor blend uniformity in real-time, preventing the diversion of non-compliant tablets and optimizing manufacturing processes.

Keywords:

Near-infrared spectroscopy Process Analytical Technology Residence time distribution Tablet diversion strategy Tableting Tank-in-series

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Area of Science:

Pharmaceutical Manufacturing
Process Analytical Technology (PAT)
Spectroscopy

Background:

Traditional sampling methods for oral solid dose manufacturing are interval-based and less efficient.
Real-time monitoring enhances process understanding and compliance in batch and continuous manufacturing.
Near-infrared (NIR) spectroscopy is a key Process Analytical Technology (PAT) for in-line blend uniformity analysis.

Purpose of the Study:

To evaluate a tablet diversion strategy using in-line NIR measurements for real-time blend uniformity monitoring.
To link in-line blend uniformity data with tablet content uniformity for effective process control.
To predict API content in tablets based on feed frame NIR measurements, minimizing yield loss.

Main Methods:

In-line NIR blend uniformity measurements in the tablet press feed frame.
Off-line Raman tablet content uniformity measurements.
Tank-in-series (TIS) modeling to derive Residence Time Distribution (RTD) between measurement points.
Evaluation of spectral loss impact on PAT sensor auto-correction.

Main Results:

The study successfully predicted API content in tablets using in-line NIR feed frame measurements.
The derived RTD allowed accurate prediction of tablet content from blend uniformity data.
The strategy effectively avoids yield loss by only diverting non-compliant batches.
Spectral loss due to auto-correction was evaluated, identifying conditions for potential deviation detection.

Conclusions:

The tablet diversion strategy, utilizing in-line NIR blend uniformity, is a viable approach for pharmaceutical manufacturing.
This PAT-based strategy enhances real-time monitoring and control, improving process efficiency and compliance.
Diversion failures are highly unlikely under normal operating conditions, ensuring reliable process control.