Formulation Approach for Nicorandil Pulsatile Release Tablet
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概要
- 論文の詳細を見る
The purpose of this study was to obtain a nicorandil pulsatile release tablet that has a well-regulated release lag time. When nicorandil is used as an antiangina drug, administration time control is important. A pulsatile release tablet is one of the effective approaches to modified release to reduce daily administration frequency. In this study, a pulsatile release tablet of nicorandil was formulated by fumaric acid dry coating around the core tablet including nicorandil. The model tablets, which had different content ratios of excipients in the dry-coating layer, were characterized by a dissolution test. The results showed that the release lag time was generated with fast release profiles. Various lag time controls of tablets were achieved, from 60 to 310 min on average, by variation of outer layer composition. From an analysis of the relation between lag times and outer layer composition, the key ingredient for prolongation of lag time was found to be fumaric acid. To analyze the lag time generation mechanism, water penetration for tablet was measured. The results indicated that the penetration depth was proportionate to the square root of time and the lag time formation mechanism was simple water penetration through the matrix of fumaric acid to the tablet core. The results also showed that the Washburn equation could be used to design the lag time of the pulsatile release tablet in this study. In conclusion, novel release control technology using fumaric acid was appropriate to obtain a nicorandil pulsatile release tablet that has well regulated lag time.
- 公益社団法人日本薬学会の論文
- 2008-04-01
著者
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MAEDA Hiroyuki
Department of Molecular and Internal Medicine, Graduate School of Biomedical Sciences, Hiroshima Uni
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Terada Katsuhide
Department Of Pharmaceutics Faculty Of Pharmaceutical Sciences Toho University
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Terada Katsuhide
Department Of Pharmaceuticals Faculty Of Pharmaceutical Science Toho University
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OGAWA Yutaka
Formulation Technology Research Department, Chugai Pharmaceutical Co., Ltd.
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ISHIYAMA Masato
CMC Coordination and Planning Department, Chugai Pharmaceutical Co., Ltd.
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HIRAYAMA Tomoaki
Formulation Technology Research Department, Chugai Pharmaceutical Co., Ltd.
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Ishiyama Masato
Cmc Coordination And Planning Department Chugai Pharmaceutical Co. Ltd.
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Hirayama Tomoaki
Formulation Technology Research Department Chugai Pharmaceutical Co. Ltd.
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Ogawa Yutaka
Formulation Technology Research Department Chugai Pharmaceutical Co. Ltd.
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Maeda Hiroyuki
Department Of Civil And Environmental Engineering Faculty Of Engineering National University Corpora
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Maeda Hiroyuki
Department Of Pharmaceuticals Faculty Of Pharmaceutical Science Toho University:formulation Technolo
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MAEDA Hiroyuki
Department of Chemistry, Materials Engineering, Kansai University
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MAEDA Hiroyuki
Departhents of Biochemistry and Surgery, Fukui Medical School
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