Application of Process Analytical Technology for Pharmaceutical Coating: Challenges, Pitfalls, and Trends

Area of Science:

• Pharmaceutical manufacturing
• Chemical engineering
• Materials science

Background:

• Coating is a critical step in solid oral dosage form manufacturing.
• Traditionally, coating weight gain is the primary quality indicator.
• Overlooked attributes significantly impact coated product performance.

Purpose of the Study:

• Review analytical techniques for pharmaceutical coating quality assessment.
• Explore the potential of Process Analytical Technology (PAT) as a PAT tool.
• Identify challenges and pitfalls in PAT implementation for coating processes.

Main Methods:

• Literature review of analytical techniques for coating characterization.
• Focus on rapid, non-destructive measurement methods.
• Discussion of PAT principles and applications in coating.

Main Results:

• PAT enables analysis of critical quality attributes beyond weight gain.
• Rapid, non-destructive techniques are crucial for real-time process monitoring.
• Various analytical methods show potential for PAT integration in coating.

Conclusions:

• Adoption of PAT can significantly enhance coating process quality and efficiency.
• Addressing PAT implementation challenges is key to realizing its benefits.
• PAT facilitates a shift towards a Quality by Design (QbD) approach in pharmaceutical coating.