Kirsch J D, Drennen J K
Duquesne University, Graduate School of Pharmaceutical Sciences, Division of Pharmaceutics, Pittsburgh, PA 15282, USA.
J Pharm Biomed Anal. 1995 Sep;13(10):1273-81. doi: 10.1016/0731-7085(95)01562-y.
Near-infrared (near-IR) spectroscopy was used in the determination of three parameters of theophylline tablets film-coated with ethylcellulose. Spectra of individual intact tablets were collected on two near-IR spectrometers: a grating-based spectrometer, and an acousto-optic tunable filter spectrometer. Calibrations were developed for the prediction of the time to 50% dissolution (t50%) of theophylline for tablets of varying coat thickness, for the determination of the thickness of the ethylcellulose coat applied, and for the prediction of the hardness of coated tablets. Principal component analysis was performed on the spectra prior to calibration development. The standard errors of calibration (SEC) and prediction (SEP) for determination of dissolution rates were 2.8 and 6.6 min, respectively. The SEC for the coating thickness calibration was 0.0002 inches, with an SEP of 0.00024 inches, and the SEC and SEP for the determination of tablet hardness were 0.54 and 0.62 kilopons, respectively.
近红外（near-IR）光谱法用于测定乙基纤维素薄膜包衣的茶碱片的三个参数。在两台近红外光谱仪上收集单个完整片剂的光谱：一台基于光栅的光谱仪和一台声光可调滤光片光谱仪。针对不同包衣厚度的片剂，建立了预测茶碱50%溶解时间（t50%）的校准模型，用于测定所施加的乙基纤维素包衣的厚度，以及预测包衣片剂的硬度。在校准模型建立之前，对光谱进行了主成分分析。测定溶解速率的校准标准误差（SEC）和预测标准误差（SEP）分别为2.8分钟和6.6分钟。包衣厚度校准的SEC为0.0002英寸，SEP为0.00024英寸，测定片剂硬度的SEC和SEP分别为0.54千磅和0.62千磅。
