FT-NIR models for predicting film quality parameters in titanium dioxide-free tablet coatings

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Materials Science

Background:

• Pharmaceutical tablet coating is crucial for drug delivery and stability.
• Monitoring coating thickness and color is essential for quality control.
• Traditional methods for monitoring coating can be destructive or time-consuming.

Purpose of the Study:

• To investigate the use of FT-NIR spectroscopy for monitoring pharmaceutical tablet coating.
• To correlate FT-NIR data with film thickness and color changes.
• To establish a non-destructive method for quality control and process endpoint determination.

Main Methods:

• Fourier Transform Near-Infrared (FT-NIR) spectroscopy was employed.
• Multivariate analytical techniques, including OPLS models, were utilized.
• Film thickness was assessed by optical microscopy (destructive).
• Color progression was evaluated using CIELAB a* values (non-destructive).

Main Results:

• FT-NIR spectroscopy successfully correlated with film thickness and coating progression.
• The CIELAB a* value demonstrated predictable changes with coating levels.
• OPLS models showed low prediction errors, validating their effectiveness.
• Non-destructive a* value serves as a reliable indicator of coating progression.

Conclusions:

• FT-NIR spectroscopy is a viable tool for monitoring pharmaceutical tablet coating processes.
• The CIELAB a* value offers a robust, non-destructive method for quality control.
• This approach enables accurate product quality assessment and process endpoint determination.