Use of near-infrared spectroscopy to evaluate an active in a film coated tablet

• Published in: Pharmaceutical research Vol. 13; no. 4; pp. 616 - 621
• Main Authors: BUCHANAN, B. R, BAXTER, M. A, CHEN, T.-S, XUE-ZHI QIN, ROBINSON, P. A
• Format: Journal Article
• Language: English
• Published: New York, NY Springer 01-04-1996
• Subjects: Analysis; Biological and medical sciences; Calibration; Chromatography, High Pressure Liquid; General pharmacology; Least-Squares Analysis; Linear Models; Medical sciences; Pharmacology. Drug treatments; Quality Control; Reference Standards; Reproducibility of Results; Spectrophotometry, Infrared; Tablets, Enteric-Coated - analysis; Tablets, Enteric-Coated - chemistry; Drug; Near infrared spectrometry; Pharmaceutical technology; Quality control; Dosage form; Coating; Coated tablet; Quantitative analysis; Thin film; Production process
• ISSN: 0724-8741; 1573-904X
• DOI: 10.1023/A:1016014625418

To provide a method to rapidly screen tablets in the development of new coating technology.
Near-Infrared (NIR) reflectance spectroscopy was used to quantitatively analyze tablets which were composed of a drug active encasing an active drug core. Diffuse reflectance NIR scans of 240 individual tablets over the range of 1100-2500 nm were obtained. High Performance Liquid Chromatography (HPLC) was used as the reference method.
Both qualitative, Principal Component Analysis, and quantitative results showed a strong agreement between the NIR and HPLC methods. The NIR analysis was non-invasive and allowed subsequent testing of the tablets. The contents of the drug active contained in a drug coating was determined to +/- 4% of the target value using NIR analysis. Over 400 samples were analyzed in less than a month utilizing this technique which allowed the optimization of a new coating technology.
NIR analysis allowed the evaluation of the efficiency of a new drug film coating manufacturing process more quickly and inexpensively. Because the Near-Infrared method was non-invasive the tablets were available for further analysis unlike the chromatography method.