Development of a method for the determination of caffeine anhydrate in various designed intact tables by near-infrared spectroscopy: A comparison between reflectance and transmittance technique

被引:33
作者
Ito, Masatomo [1 ]
Suzuki, Tatsuya [1 ]
Yada, Shuichi [1 ]
Kusai, Akira [1 ]
Nakagami, Hiroaki [1 ]
Yonemochi, Etsuo [2 ]
Terada, Katsuhide [2 ]
机构
[1] Daiichi Sankyo Co Ltd, Formulat Tech Res Labs, Hiratsuka, Kanagawa 2540014, Japan
[2] Toho Univ, Sch Pharmaceut Sci, Chiba 2748510, Japan
关键词
reflectance near-infrared spectroscopy; transmittance near-infrared spectroscopy; partial least-squares; tablet design; caffeine anhydrate;
D O I
10.1016/j.jpba.2008.03.033
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
Using near-infrared (NIR) spectroscopy, an assay method which is not affected by such elements of tablet design as thickness, shape, embossing and scored line was developed. Tablets containing caffeine anhydrate were prepared by direct compression at various compression force levels using different shaped punches. NIR spectra were obtained from these intact tablets using the reflectance and transmittance techniques. A reference assay was performed by high-performance liquid chromatography (HPLC). Calibration models were generated by the partial least-squares (PLS) regression. Changes in the tablet thickness, shape, embossing and scored line caused NIR spectral changes in different ways, depending on the technique used. As a result, noticeable errors in drug content prediction occurred using calibration models generated according to the conventional method. On the other hand, when the various tablet design elements which caused the NIR spectral changes were included in the model, the prediction of the drug content in the tablets was scarcely affected by those elements when using either of the techniques. A comparison of these techniques resulted in higher predictability under the tablet design variations using the transmittance technique with preferable linearity and accuracy. This is probably attributed to the transmittance spectra which sensitively reflect the differences in tablet thickness or shape as a result of obtaining information inside the tablets. (C) 2008 Elsevier B.V. All rights reserved.
引用
收藏
页码:819 / 827
页数:9
相关论文
共 39 条
[1]   Characterizing mixing and lubrication in the Bohle Bin blender [J].
Arratia, PE ;
Duong, NH ;
Muzzio, FJ ;
Godbole, P ;
Lange, A ;
Reynolds, S .
POWDER TECHNOLOGY, 2006, 161 (03) :202-208
[2]   Quantitative in-line monitoring of powder blending by near infrared reflection spectroscopy [J].
Berntsson, O ;
Danielsson, LG ;
Lagerholm, B ;
Folestad, S .
POWDER TECHNOLOGY, 2002, 123 (2-3) :185-193
[3]   Content uniformity and tablet hardness testing of intact pharmaceutical tablets by near infrared spectroscopy -: A contribution to process analytical technologies [J].
Blanco, M ;
Alcalá, M .
ANALYTICA CHIMICA ACTA, 2006, 557 (1-2) :353-359
[4]   A process analytical technology approach based on near infrared spectroscopy:: Tablet hardness, content uniformity, and dissolution test measurements of intact tablets [J].
Blanco, Marcelo ;
Alcala, Manel ;
Gonzalez, Josep M. ;
Torrasz, Ester .
JOURNAL OF PHARMACEUTICAL SCIENCES, 2006, 95 (10) :2137-2144
[5]   Modeling and monitoring of polymorphic transformations during the drying phase of wet granulation [J].
Davis, TD ;
Peck, GE ;
Stowell, JG ;
Morris, KR ;
Byrn, SR .
PHARMACEUTICAL RESEARCH, 2004, 21 (05) :860-866
[6]   A homogeneity study using NIR spectroscopy: Tracking magnesium stearate in Bohle bin-blender [J].
Duong, NH ;
Arratia, P ;
Muzzio, F ;
Lange, A ;
Timmermans, J ;
Reynolds, S .
DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 2003, 29 (06) :679-687
[7]   Evaluation of risk and benefit in the implementation of near-infrared spectroscopy for monitoring of lubricant mixing [J].
El Hagrasy, Arwa S. ;
Chang, Shih-Ying ;
Kiang, San .
PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, 2006, 11 (03) :303-312
[8]   A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending. Part III: Quantitative near-infrared calibration for prediction of blend homogeneity and characterization of powder mixing kinetics [J].
El-Hagrasy, AS ;
Drennen, JK .
JOURNAL OF PHARMACEUTICAL SCIENCES, 2006, 95 (02) :422-434
[9]   A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending: Part II: Qualitative near-infrared models for prediction of blend homogeneity [J].
El-Hagrasy, AS ;
Delgado-Lopez, M ;
Drennen, JK .
JOURNAL OF PHARMACEUTICAL SCIENCES, 2006, 95 (02) :407-421
[10]   A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending. Part I: D-optimal design for characterization of powder mixing and preliminary spectral data evaluation [J].
El-Hagrasy, AS ;
D'Amico, F ;
Drennen, JK .
JOURNAL OF PHARMACEUTICAL SCIENCES, 2006, 95 (02) :392-406