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논문 상세정보

다중약물방출시스템을 이용한 염산딜티아젬의 방출속도 조절에 관한 연구

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

Abstract

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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참고문헌 (9)

  1. The pharmacopeia of the United States, 26th Rev., the United States pharmacopeial convention, Inc., Rockville, MD, USA, 2355-2356, 2003 
  2. S.W. Lee, S.H. Kam, J.W. Hong, K.S. Choi, E.S. Park and S.C. Chi, Effect of poloxamer content on dissolution of diltiazem hydrochloride from core pellets. J. Kor. Pharm. Sci., 32(4), 305-311 (2002) 
  3. FDA guidance for industry, SUPAC-MR: modified release solid oral dosage forms; scale-up and post approval changes; chemistry, manufacturing and controls; In vitro dissolution testing and in vivo bioequivalence documentation, September, 32-33 (1997) 
  4. P.C. Wu, Y.B. Huang, J.I. Chang, M.J. Tsai and Y.H. Tsai, Preparation and evaluation of sustained release microspheres of potassium chloride prepared with ethylcellulose, Int. J. Pharm., 260, 115-121 (2003) 
  5. Y.H, Lee, K.B. Shim, M.H. Lee and S.K. Kim, HPLC determination of diltiazem and deacetyldiltiazem in rat plasma, J. Kor. Pharm. Sci., 22(4),317-321 (1992) 
  6. The pharmacopeia of the Japan, 14th rev. Hirakawa, Tokyo, C674-C677 (2001) 
  7. B.S. Rao and K.Y.R. Murthy, Studies on rifampicin release from ethylcellulose coated nonpareil beads, Int. J. Pharm., 231,97-106 (2002) 
  8. M. Choi, C.S. Kang, B.K. Choi, C.H. Hong and K.S. Kim, In vitro/in vivo correlation of sustained release diltiazem, J. Kor. Pharm. Sci., 32(4), 321-325 (2002) 
  9. H. Kim and R. Fassibi, A ternary polymeric matrix system for controlled drug delivery of highly soluble drug with high drug loading: diltiazem hydrochloride, J. Kor. Pharm. Sci., 31(1), 19-25 (2001) 

이 논문을 인용한 문헌 (1)

  1. Lee, Gye-Won ; Kim, Hak-Hyung ; Ryu, Sung-Kyun 2008. "Preparation and Dissolution Characteristics of Sustained Release Pellets Containing Isosorbide Dinitrate" 藥劑學會誌 = Journal of Korean pharmaceutical sciences, 38(6): 381~385 

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