A New Method for Disintegration Studies of Rapid Disintegrating Tablet
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概要
- 論文の詳細を見る
The aim of this study was to develop a simple and suitable disintegration method specific for rapid disintegrating tablets (RDTs). The new disintegration method that we propose employs a rotary shaft to exert mechanical pressure on the RDT. To assess our method, we manufactured several placebo RDTs and exposed them to severe storage conditions (60℃/75%RH for 1 week) in order to obtain RDTs with a wide range of disintegration times. These placebo RDTs were utilized to compare the disintegration times obtained by several methods, including the proposed method. As expected, the disintegration time of the placebo RDTs in human sensory test varied widely. The disintegration times determined by the conventional disintegration test were in good correlation to those in human sensory test, but the slope was far from 1 (0.241). There was no correlation between the disintegration time of RDTs in human sensory test and those determined by the conventional dissolution test. In contrast, we acquired good correlation between the disintegration times obtained with the new method and those in human sensory test, and the slope was very close to 1 (0.858). We attribute this to the use of mechanical stress in the new method, similar to that the RDT is subject to in the oral cavity. We therefore concluded that the proposed method was suitable for the measurement of the disintegration time of RDTs. This new method might provide a valuable approach for the establishment of the official disintegration test for RDTs in the future.
- 公益社団法人日本薬学会の論文
- 2004-06-01
著者
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Kato Yoshihisa
School Of Pharmaceutical Science University Of Shizuoka
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NARAZAKI Ryuichi
Formulation Research Laboratory, Kawashima, Eisai Co., Ltd.,
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HARADA Tsutomu
Formulation Research Laboratories, Kawashima Research, Eisai Co., Ltd.
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OHWAKI Takayuki
Formulation Research Laboratories, Kawashima Research, Eisai Co., Ltd.
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Kato Y
Yoshitomi Pharmaceutical Industries Ltd. Fukuoka Jpn
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Kato Yoshiteru
Formulation Research Lab. Kawashima Industrial Park Eisai
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TAKAMI Norishige
Formulation Research Lab., Kawashima Industrial Park, Eisai
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Ohwaki T
Formulation Research Laboratories Kawashima Research Eisai Co. Ltd.
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Takami Norishige
Formulation Research Lab. Kawashima Industrial Park Eisai
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Narazaki R
Formulation Research Laboratories Kawashima Research Eisai Co. Ltd.
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Narazaki Ryuichi
Formulation Research Laboratory Kawashima Eisai Co. Ltd.
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Narazaki Ryuichi
Formulation Research Laboratories, Kawashima Research, Eisai Co., Ltd.
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