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KMID : 0369820050350030157
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Jorunal of Korean Pharmaceutical Sciences
2005 Volume.35 No. 3 p.157 ~ p.163
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A Formulation Study for the Controlled Release Rate of Diltiazem,HCl using the Multiple Drug Release System
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김학형/Kim HH
오진환/한건/Oh JH/Han K
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Abstract
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The pellets with multiple drug release system (MDRS) of Diltiazem. HCl which consist of immediate drug release layer, drug reservoir layer and controlled release rate membrane, were prepared by using CF-Coater. As main factors for more effective MDRS of Diltiazem. HCl, ethylcellulose was used for the controlling drug release rate, and diethylphthalate was used for plasticizer, respectively. In vitro evaluation study was performed by comparative dissolution test between our test MDRS and reference Diltiazem. HCl preparation. The physical tests were performed using FT-IR and SEM. In vivo evaluation was also performed by observing the behavior of a plasma drug concentration after oral administration. The bioavailability was determined by analyzing the blood sample after oral administration to healthy, male volunteers once a day. As a result, there were no significant differences in bioequivalence parameters (AUC∞,Cmax,t1/2) between two systems. It might be concluded that our MDRS of Diltiazem. HCl could be an alternative delivery system to reference drug preparation.
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KEYWORD
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multiple drug release system, Diltiazem, HCl, pharmaceutical equivalence, bioequivalence
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