Real time release testing of tablet content and content uniformity

Area of Science:

• Pharmaceutical Manufacturing
• Process Analytical Technology (PAT)

Background:

• Tablet content and content uniformity are critical quality attributes (CQAs) in pharmaceutical manufacturing.
• Current control strategies often rely on end-product testing, delaying release and hindering process optimization.

Purpose of the Study:

• To present a commercial control strategy for tablet content and content uniformity.
• To enable real-time release for these critical quality attributes focused on the compression unit operation.

Main Methods:

• Process understanding and control through compaction force and tablet weight monitoring.
• At-line testing of tablet content using near-infrared (NIR) spectroscopy.
• Application of a parametric tolerance interval test (PTIT) for acceptance criteria.

Main Results:

• Demonstrated achievement of quality standards for content and content uniformity across ten commercial-scale batches.
• The control strategy effectively managed tablet quality during compression.

Conclusions:

• The proposed control strategy, integrating process understanding and PAT tools like NIR, enables real-time release for tablet content and uniformity.
• This approach enhances manufacturing efficiency and ensures consistent product quality.