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

Abstract
This study leverages Fourier Transform Near-Infrared (FT-NIR) spectroscopy to monitor the coating process of pharmaceutical tablets using PVA-based TiO2-free films, with talc and iron oxides as opacifiers. By employing a combination of multivariate analytical techniques to evaluate the correlation between film coating progression and film thickness. Assessment of coating thickness for different coating levels was performed by optical microscopy.
Highlights
- TiO2-free film coating optimization is challenging in the pharmaceutical industry
- NIR offers a precise and exact method for film coating thickness determination
- MVA methods allow a knowledge-based approach to determine film chemical signals
- Both film thickness and a* can be used as calibration techniques with high accuracy
Additionally, using colorimetric analysis by scanner method, the color progression for different coating levels was evaluated and expressed as the a* value from CIELAB color space. The coordinate value a* showed predictable changes with the progression of the coating process and film thickness values, indicating its utility as a robust reference method for quality control and process optimization. The predictive capability of the OPLS models, validated against measured film thickness and the a* value, demonstrated low prediction errors and confirmed the models’ effectiveness in distinguishing coating levels and accurately predicting film coating progression.
The OPLS model used knowledge-based peaks of interest, which were further confirmed by loading and coefficient plots. The study demonstrated that film thickness, as a destructive, and a* value from CIELAB color space, as a non-destructive reference method for coating progression could be used during a controlled pharmaceutical coating process for product quality assessment and pharmaceutical process endpoint determination.
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Materials
Core composition: Cellulose, Microcrystalline (Avicel PH 102, Du Pont, USA), Dibasic Calcium Phosphate anhydrous (Di-CAFOS A 60 Budenheim; Germany), Copovidone (Kollidon VA 64 BASF, Germany), Croscarmellose sodium (Ac-Di-Sol; Du Pont), Silica, Colloidal anhydrous (Aerosil 200; Evonik, Germany), Magnesium Stearate (FACI S.p.A. -Carascp GE -Italy).
Film coating system: PVA-based TiO2-free film coating (Opadry TF®; proprietary formula containing partially hydrolyzed Polyvinyl alcohol (PVA), talc, PEG 3350, and iron oxides yellow, red; Colorcon Inc, UK)
Filip Gorachinov, Monika Koviloska, Katerina Tnokovska, Ana Atanasova, Packa Antovksa, Jelena Lazova, Nikola Geskovski, FT-NIR models for predicting film quality parameters in titanium dioxide-free tablet coatings, European Journal of Pharmaceutical Sciences, 2024, 106992, ISSN 0928-0987, https://doi.org/10.1016/j.ejps.2024.106992.
Read also our introduction article on Talc here:
