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KMID : 0369820080380060381
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Jorunal of Korean Pharmaceutical Sciences
2008 Volume.38 No. 6 p.381 ~ p.385
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Preparation and Dissolution Characteristics of Sustained Release Pellets Containing Isosorbide Dinitrate
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Lee Gye-Won
Kim Hak-Hyung
Ryu Sung-Kyun
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Abstract
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Isosorbide dinitrate is an oral assiatant therapy agent of angina pectoris, myocardial infarction and congestive heart failure. The objective of this study was to formulate sustained release containing isosorbide dinitrate and assess their formulation variables. Pellets were prepared by fluid bed process and consist of drug layer and membrane layer. The pellets were coated with ethylcellulose along with 5 ~ 15% of plasticizer such as triacetin and diethyl butylrate. In vitro evaluation study was performed by comparative dissolution test between test and reference isosorbide dinitrate preparation. We could prepare sustained pellets of isosorbide dinitrate by fluid bed process which were reduced process time and had high
content. The pellet coated with 1% ethylcellulose and triacetin(15%) had a similar dissolution behavior compare to reference isosorbide dinitrate preparation controlling initial dissolution and those of dissolution at 30 min were 17.25 and 17.09%, respectively. Difference factor and similarity factor were 0 ~ 15 and 50 ~ 100 and there was no significant difference in bioequivalence between formulations. It might be concluded that our sustained release pellet of isosorbide dinitrate could be an alternatively delivery system to reference drug preparation.
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KEYWORD
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Isosorbide dinitrate, side spray method, ethylcellulose, difference factor, similarity factor, plasticizer
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