論文

査読有り
2017年6月

Non-destructive prediction of enteric coating layer thickness and drug dissolution rate by near-infrared spectroscopy and X-ray computed tomography

INTERNATIONAL JOURNAL OF PHARMACEUTICS
  • Aoi Ariyasu
  • ,
  • Yusuke Hattori
  • ,
  • Makoto Otsuka

525
1
開始ページ
282
終了ページ
290
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1016/j.ijpharm.2017.04.017
出版者・発行元
ELSEVIER SCIENCE BV

The coating layer thickness of enteric-coated tablets is a key factor that determines the drug dissolution rate from the tablet. Near-infrared spectroscopy (NIRS) enables non-destructive and quick measurement of the coating layer thickness, and thus allows the investigation of the relation between enteric coating layer thickness and drug dissolution rate. Two marketed products of aspirin enteric-coated tablets were used in this study, and the correlation between the predicted coating layer thickness and the obtained drug dissolution rate was investigated. Our results showed correlation for one product; the drug dissolution rate decreased with the increase in enteric coating layer thickness, whereas, there was no correlation for the other product. Additional examination of the distribution of coating layer thickness by X-ray computed tomography (CT) showed homogenous distribution of coating layer thickness for the former product, whereas the latter product exhibited heterogeneous distribution within the tablet, as well as inconsistent trend in the thickness distribution between the tablets. It was suggested that this heterogeneity and inconsistent trend in layer thickness distribution contributed to the absence of correlation between the layer thickness of the face and side regions of the tablets, which resulted in the loss of correlation between the coating layer thickness and drug dissolution rate. Therefore, the predictability of drug dissolution rate from enteric-coated tablets depended on the homogeneity of the coating layer thickness. In addition, the importance of micro analysis, X-ray CT in this study, was suggested even if the macro analysis, NIRS in this study, are finally applied for the measurement. (C) 2017 Elsevier B.V. All rights reserved.

リンク情報
DOI
https://doi.org/10.1016/j.ijpharm.2017.04.017
Web of Science
https://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=JSTA_CEL&SrcApp=J_Gate_JST&DestLinkType=FullRecord&KeyUT=WOS:000401112300029&DestApp=WOS_CPL
ID情報
  • DOI : 10.1016/j.ijpharm.2017.04.017
  • ISSN : 0378-5173
  • eISSN : 1873-3476
  • Web of Science ID : WOS:000401112300029

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