PAT-tools for process control in pharmaceutical film coating applications

Area of Science:

• Pharmaceutical technology
• Analytical chemistry
• Process analytical technology (PAT)

Background:

• Pharmaceutical coating is crucial for drug delivery and stability.
• Traditional monitoring methods are often time-consuming and labor-intensive.
• The need for real-time process control in pharmaceutical manufacturing is increasing.

Purpose of the Study:

• To review recent advancements in analytical techniques for monitoring pharmaceutical solid dosage form coating.
• To highlight the transition from off-line to on-line/in-line monitoring strategies.
• To discuss the application of spectroscopic and imaging methods for process control.

Main Methods:

• Near-infrared (NIR) spectroscopy
• Raman spectroscopy
• Terahertz pulsed imaging (TPI)
• Image analysis
• On-line and in-line measurement strategies

Main Results:

• Spectroscopic and imaging techniques have advanced for real-time coating monitoring.
• These methods facilitate the shift from off-line to on-line/in-line process analysis.
• Successful application of NIR, Raman, and TPI in monitoring coating uniformity and endpoint detection.

Conclusions:

• Modern analytical techniques offer robust solutions for real-time pharmaceutical coating monitoring.
• On-line/in-line monitoring improves process understanding and control.
• These technologies are key to ensuring consistent pharmaceutical product quality and optimizing manufacturing processes.