Browse > Article
http://dx.doi.org/10.4333/KPS.2005.35.3.157

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

Kim, Hak-Hyung (Central R&D Center, Kolmar Korea Inc.)
Oh, Jin-Hwan (Central R&D Center, Kolmar Korea Inc.)
Han, Kun (College of Pharmacy, Chungbuk National University)
Publication Information
Journal of Pharmaceutical Investigation / v.35, no.3, 2005 , pp. 157-163 More about this Journal
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.
Keywords
multiple drug release system; Diltiazem.HCl; pharmaceutical equivalence; bioequivalence;
Citations & Related Records
Times Cited By KSCI : 2  (Citation Analysis)
연도 인용수 순위
1 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)
2 The pharmacopeia of the United States, 26th Rev., the United States pharmacopeial convention, Inc., Rockville, MD, USA, 2355-2356, 2003
3 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)
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)   DOI   ScienceOn
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)   DOI   ScienceOn
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)