Kirsch J D, Drennen J K
Duquesne University, Graduate School of Pharmaceutical Sciences, Division of Pharmaceutics, Pittsburgh, Pennsylvania 15282, USA.
Pharm Res. 1996 Feb;13(2):234-7. doi: 10.1023/a:1016039014090.
The purpose of this study was to investigate the potential of near-infrared (near-IR) spectroscopy for non-destructive at-line determination of the amount of polymer coat applied to tablet cores in a Wurster column.
The effects of coating composition on the near-IR spectroscopic determination of ethylcellulose (Aquacoat ECD-30) or hydroxypropylmethylcellulose (HPMC)-based (Spectrablend) coating were evaluated, as were the performance of several chemometric techniques.
Tablets were coated with up to 30% ethylcellulose or 22% HPMC, and samples were pulled at regular intervals during each coating run. Near-IR reflectance spectra of the intact tablets were then collected. The spectra were preprocessed by multiplicative scatter correction (MSC) or second derivative (D2) calculations, and calibrations developed using either principal components (PCs) or multiple spectral wavelengths. The near-IR method provided predictions of film applied with standard errors of 1.07% w/w or less.
Near-IR spectroscopy can be profitably employed in a rapid and non-destructive determination of the amount of polymer film applied to tablets, and offers a simple means to monitor the film coating process.
本研究旨在探讨近红外（near-IR）光谱法用于无损在线测定在Wurster柱中施加于片芯上的聚合物包衣量的潜力。
评估了包衣组成对基于乙基纤维素（Aquacoat ECD-30）或羟丙基甲基纤维素（HPMC）（Spectrablend）包衣的近红外光谱测定的影响，以及几种化学计量学技术的性能。
片剂用高达30%的乙基纤维素或22%的HPMC进行包衣，并且在每次包衣过程中定期取样。然后收集完整片剂的近红外反射光谱。光谱通过多元散射校正（MSC）或二阶导数（D2）计算进行预处理，并使用主成分（PCs）或多个光谱波长建立校准模型。近红外方法对包衣膜的预测标准误差为1.07% w/w或更低。
近红外光谱法可有效地用于快速无损测定施加于片剂上的聚合物膜的量，并提供一种监测包衣过程的简单方法。
