Preparation and Evaluation of Nicardipine Hydrochloride Sustained Release Dosage Form

碩士 === 高雄醫學大學 === 藥學研究所 === 90 === Controlled release may be defined as a technique by which drug are made available to a target at a rate and duration to produce a desirable therapeutic effect. Among the advantages of this technique are to achieve rapid onset and then maintain therapeuti...

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Bibliographic Details
Main Authors: Chia-Hung Sung, 宋嘉鴻
Other Authors: Yi-Hung Tsai
Format: Others
Language:zh-TW
Published: 2002
Online Access:http://ndltd.ncl.edu.tw/handle/37384242568638005980
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Summary:碩士 === 高雄醫學大學 === 藥學研究所 === 90 === Controlled release may be defined as a technique by which drug are made available to a target at a rate and duration to produce a desirable therapeutic effect. Among the advantages of this technique are to achieve rapid onset and then maintain therapeutic drug level, to reduce dosing frequency, fluctuation in drug level, total amount of drug used and inconvenience to patient and also increase patient compliance. In the study solid dispersion with solvent method was applied with Eudragit RS 100 and Eudragit RL 100 as carriers to prepare nicardipine solid dispersion system and study thephysicochemical properties and dissolution of the solid dispersion system. The result showed that the system of drug/Eudragit RS 100=1/5 retarded its drug release in the medium of pH=1.2 and the dissolution profile was similar to that of Perdipine. However, nicardipine could not release form the system mentioned above in the medium of pH=6.8 until organic acids and enterosoluble materials were added. The dissolution profiles of all formulations including Perdipine were evaluated with f1 and f2 fit factors. It was found that dissolution profiles of two self-made formulations (drug/Eudragit RS 100/HP-55=2/3.5/1.5) and (drug/Eudragit RS 100/HP-55=1/3.5/1.5) were the same as Perdipine. According the result of in vitro dissolution study, two formulations (drug/Eudragit RS 100/HP-55=1/3/2 and drug/Eudragit RS 100/HP-55=1.5/3.5/1.5) were chose to in vivo study and compared with Perdipine. Cmax, Tmax and AUC of both formulations were significant with that of Perdipine (p<0.05, t test). It suggested that there was no relationship between in vitro and in vivo result for both formulations.