Development of a Rapid Process Monitoring Method for Dry-Coated Tableting Process by Using Near-Infrared Spectroscopy

被引：2

作者：

Ito, Masatomo ^{[1
,2
]}

Suzuki, Tatsuya ^{[2
]}

Wakiyama, Naoki ^{[2
]}

Teramoto, Hiroshi ^{[3
]}

Yonemochi, Etsuo ^{[1
,4
]}

Terada, Katsuhide ^{[1
,4
]}

机构：

[1] Japan Soc Pharmaceut Machinery & Engn, PAT Comm, Chiyoda Ku, Tokyo 1010046, Japan

[2] Daiichi Sankyo Co Ltd, Formulat Technol Res Labs, Hiratsuka, Kanagawa 2540014, Japan

[3] NIRECO Corp, OE Div, Tokyo 1928522, Japan

[4] Toho Univ, Fac Pharmaceut Sci, Chiba 2748510, Japan

来源：

CHEMICAL & PHARMACEUTICAL BULLETIN | 2011年 / 59卷 / 07期

关键词：

transmittance near-infrared spectroscopy; dry-coated tablet; core misalignment; caffeine anhydrate; partial least squares regression; principal component regression; CAFFEINE ANHYDRATE; REFLECTANCE; NIR;

D O I：

10.1248/cpb.59.868

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

A nondestructive transmittance near-infrared (NIR) method for detecting off-centered cores in dry-coated (DC) tablets was developed as a monitoring system in the DC tableting process. Caffeine anhydrate was used as a core active pharmaceutical ingredient (API), and DC tablets were made by the direct compression method. NIR spectra were obtained from these intact DC tablets using the transmittance method. The reference assay was performed with H PLC. Calibration models were generated by partial least squares (PLS) regression and principal component regression (PCR) utilizing external validations. Hierarchical cluster analysis (HCA) of the results confirmed that NIR spectroscopy correctly detected off-centered cores in DC tablets. We formulated and used the Centering Index (CI) to evaluate the precision of core alignment and generated an NIR calibration model that could correctly predict this index. The principal component (PC) 1 loading vector of the final calibration model indicated that it could specifically detect the misalignment of tablet cores. The model also had good linearity and accuracy. The CIs of unknown sample tablets predicted by the final calibration model and those calculated through the HPLC analysis were closely parallel with each other. These results demonstrate the validity of the final calibration model and the utility of the transmittance NIR spectroscopic method developed in this study as a monitoring system in DC tableting process.

引用

页码：868 / 873

页数：6