Buchanan B R, Baxter M A, Chen T S, Qin X Z, Robinson P A
Analytical Methods & Support, Merck and Co., Inc., West Point, Pennsylvania 19486, USA.
Pharm Res. 1996 Apr;13(4):616-21. 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.
提供一种在新包衣技术研发过程中快速筛选片剂的方法。
采用近红外（NIR）反射光谱法对由包裹活性药物核心的药物活性成分组成的片剂进行定量分析。获得了240片单片在1100 - 2500 nm范围内的漫反射近红外扫描结果。采用高效液相色谱法（HPLC）作为参考方法。
定性的主成分分析和定量结果均表明近红外法与高效液相色谱法之间具有高度一致性。近红外分析是非侵入性的，并且允许对片剂进行后续测试。使用近红外分析确定药物包衣中所含药物活性成分的含量与目标值的偏差在±4%以内。利用该技术在不到一个月的时间内分析了400多个样品，从而实现了一种新包衣技术的优化。
近红外分析能够更快且更经济地评估新药薄膜包衣制造工艺的效率。由于近红外方法是非侵入性的，与色谱法不同，片剂可用于进一步分析。
