A Formulation Study for the Controled Release Rate of Diltiazem. HCl using the Multiple Drug Release System

다중약물방출시스템을 이용한 염산딜티아젬의 방출속도 조절에 관한 연구

  • 김학형 ((주)한국콜마 기술연구원) ;
  • 오진환 ((주)한국콜마 기술연구원) ;
  • 한건 (충북대학교 약학대학 약제학실)
  • Published : 2005.06.20


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 $(AUC_{\infty},\;C_{max},\;t_{1/2})$ 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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