Monitoring microsphere coating processes using PAT tools in a bench scale fluid bed

Area of Science:

• Pharmaceutical Technology
• Process Analytical Technology (PAT)
• Materials Science

Background:

• Medication adherence in pediatric patients is often hindered by taste and irritation.
• Microsphere coatings with reverse enteric polymers can mask taste and ensure targeted drug release.
• Developing robust monitoring methods for coating processes is crucial for consistent drug delivery and patient compliance.

Purpose of the Study:

• To evaluate the in-line performance of Process Analytical Technology (PAT) tools for monitoring microsphere coating processes.
• To assess the predictive capability of Raman spectroscopy, near-infrared spectroscopy, and focused beam reflectance measurements for coating barrier performance.
• To investigate the potential of PAT tools for real-time process monitoring and quality control in microsphere manufacturing.

Main Methods:

• Utilized Raman spectroscopy, near-infrared spectroscopy, and focused beam reflectance measurements for in-line monitoring.
• Integrated PAT tool data with process parameters and raw material attributes.
• Employed multiblock partial least squares (MBPLS) for a combined-data approach to predict coating performance.
• Evaluated the ability of PAT tools to detect process variations, such as spray rate changes.

Main Results:

• Raman spectroscopy exhibited superior predictive performance for the microsphere coating process.
• Raman spectroscopy successfully monitored the coating process and detected discrepancies like spray rate variations.
• PAT tools, particularly Raman spectroscopy, demonstrated the ability to differentiate batches with significant differences in in-vitro dissolution.
• The study confirmed the potential of PAT for ensuring consistent coating performance and enhancing patient compliance.

Conclusions:

• Raman spectroscopy is a highly effective PAT tool for real-time monitoring of microsphere coating processes.
• Implementing Raman spectroscopy can ensure consistent coating quality, which is critical for pediatric medication adherence.
• PAT tools offer a valuable approach for quality control and process optimization in pharmaceutical manufacturing.