Use of near-infrared spectroscopy to evaluate an active in a film coated tablet.
OBJECTIVE
To provide a method to rapidly screen tablets in the development of new coating technology.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Buchanan
B R
BR
Analytical Methods & Support, Merck and Co., Inc., West Point, Pennsylvania 19486, USA.
Baxter
M A
MA
Chen
T S
TS
Qin
X Z
XZ
Robinson
P A
PA
D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D016018:Least-Squares Analysis; D016014:Linear Models; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D013055:Spectrophotometry, Infrared; D013608:Tablets, Enteric-Coated / Q000032:analysis* / Q000737:chemistry
D013608:Tablets, Enteric-Coated