Nondestructive Analysis of Structure and Components of Tablet Coated with Film by the Usage of Terahertz Time-Domain Reflection Spectroscopy

被引:15
|
作者
Takeuchi, Issei [1 ]
Shimakura, Kemmaro [1 ]
Ohtake, Hideyuki [2 ]
Takayanagi, Jun [2 ]
Tomoda, Keishiro [1 ,3 ,4 ]
Nakajima, Takehisa [3 ,4 ]
Terada, Hiroshi [1 ,3 ,4 ]
Makino, Kimiko [1 ,3 ,4 ]
机构
[1] Tokyo Univ Sci, Fac Pharmaceut Sci, Noda, Chiba 2788510, Japan
[2] AISIN SEIKI Co Ltd, Kariya, Aichi 4488650, Japan
[3] Tokyo Univ Sci, Ctr Drug Delivery Res, Noda, Chiba 2788510, Japan
[4] Tokyo Univ Sci, Ctr Phys Pharmaceut, Noda, Chiba 2788510, Japan
关键词
terahertz time-domain reflection spectroscopy; nondestructive analysis of component; bilayer coated tablet; push-pull osmotic pump; analysis; spectroscopy; structure; coating; osmotic pumps; PHARMACEUTICAL MATERIALS; CONTROLLED-RELEASE; VIBRATIONAL-MODES; DRUG TABLET; CRYSTALLINITY; SYSTEMS;
D O I
10.1002/jps.23797
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
Nondestructive analysis of tablet is of great importance from the aspect of productivity and safety. In terahertz (THz) region, however, the analysis of core of coated tablet has not been progressed. In this study, we have measured a flat-surface push-pull osmotic pump tablet, having no orifice, having bilayer core and a coating film layer. The bilayer core was made from the drug layer and the push layer, and acetaminophen was contained in the drug layer as a model drug. To study its structure and components, we have obtained reflection spectra from the drug layer side and the push layer side measurements using THz time-domain reflection spectroscopy (THz-TDRS). From these results, detection of the peak of acetaminophen in the spectrum from the drug layer side measurements was confirmed. We have made ridges approximated toward the peak using a general method of linear regression analysis in both spectra. Two-sample t-test was applied to their gradients, and significant difference between the drug layer and the push layer was shown. These results suggested that THz-TDRS is applicable to the analysis of structure and component of a coated tablet. (c) 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 103:256-261, 2014
引用
收藏
页码:256 / 261
页数:6
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