Browse > Article
http://dx.doi.org/10.4333/KPS.2002.32.2.095

Formulation of sustained-release matrix tablets of nifedipine  

Cui, Yu (College of Pharmacy, Sungkyunkwan University)
Kim, Seung-Su (College of Pharmacy, Sungkyunkwan University)
Park, Eun-Seok (College of Pharmacy, Sungkyunkwan University)
Chi, Sang-Cheol (College of Pharmacy, Sungkyunkwan University)
Publication Information
Journal of Pharmaceutical Investigation / v.32, no.2, 2002 , pp. 95-101 More about this Journal
Abstract
Matrix tablets of nifedipine (NP) were prepared with Eudragit, diluent (lactose or Ca. phosphate) and Mg. stearate employing two different preparation methods (wet granulation and direct compression) to develop its sustained-release dosage forms. The effects of various formulation factors on the dissolution rate of the drug were investigated. Dissolution test was studied in pH 6.8 phosphate buffer containing 1% sodium lauryl sulfate using the paddle method. Formulation factors were the type and content of Eudragit, the type of diluent and the tablet preparation method. The optimum formula of NP matrix tablet, which resulted in a similar dissolution profile to that from Adalat Oros used as a reference, was 30 mg NP, 10% Eudragit RS, 2% Mg. stearate and an adequate quantity of lactose to yield 500 mg weight using the wet granulation method.
Keywords
Nifedipine; Sustained-release; Matrix tablet; Dissolution;
Citations & Related Records
연도 인용수 순위
  • Reference
1 N. Kohri, K. Miyazaki, T. Arita, H. Shimono, A. Nomura and H. Yasuda, Release characteristics of nifedipine sustained-release granules in vitro and in healthy subjects, Chem. Pharm. Bull., 35, 2504-2509 (1987)   DOI   ScienceOn
2 L.A. Syed, Nifedipine, Analytical Profiles of Drug Substances, 18, 221-288 (1989)
3 C.H. Kleinbloesem, P. Brummelen, J.A. Linde, P.J. Voogd and D.D. Breimer, Nifedipine: Kinetics and dynamics in healthy subjects, Clin. Pharmacol. Ther., 35, 742-749 (1984)   DOI   ScienceOn
4 D. Murdoch and R.N. Brogden, Sustained release nifedipine formulations, Drugs, 41, 737-779 (1991)   DOI   ScienceOn
5 G. Yan, H. Li, R. Zhang and D. Ding, Preparation and evaluation of a sustained-release formulation of nifedipine HPMC tablets, Drug Dev. Ind. Pharm., 26, 681-686 (2000)   DOI   ScienceOn
6 S.E. Leucuta, The kinetics of nifedipine release from porous hydrophilic matrices and the pharmacokinetics in man, Die Pharmazie, 43, 845-848 (1988)
7 K. Tateshita, S. Sugawara, T. Imai and M. Otagiri, Prepara- tion and evaluation of a controlled-release formulation of nifedipine using alginate gel beads, Bio. Pharm. Bull., 16, 420-424 (1993)   DOI   ScienceOn
8 T. Chandy and C.P. Sharma, Chitosan beads and granules for oral sustained delivery of nifedipine: in vitro studies, Biomaterials, 13, 949-952 (1992)   DOI   ScienceOn
9 G.J. Filipovic, L.M. Becirevic, N. Skalko and I. Jalsenjak, Chitosan microsheres of nifedipine and nifedipine-cyclo- dextrin inclusion complexes, Int. J. Pharm., 135, 183-190 (1996)   DOI   ScienceOn
10 S.E. Leucuta, Controlled release of nifedipine from gelatin microspheres and microcapsules: in vitro kinetics and pharmacokinetics in man, J. Microencapsul., 7, 209-217 (1990)   DOI
11 A. Barkai, Y.V. Pathak and S. Benita, Polyacrylate (Eudragit retard) microspheres for oral controlled release of nifedipine. I. Formulation design and process optimization, Drug Dev. Ind. Pharm., 16, 2057-2075 (1990)   DOI
12 K.P.R. Chowdary and S.G. Girija, Eudragit microcapsules of nifedipine and its dispersions in HPMC-MCC : Physicochemi- cal characterization and drug release studies, Drug Dev. Ind. Pharm., 23, 325-330 (1997)   DOI   ScienceOn
13 W.H. Chuo, T.R. Tsai, S.H. Hsu and T.M. Cham, Preparation and in-vitro evaluation of nifedipine loaded albumin micro- spheres cross-linked by different glutaraldehyde concentra- tions, Int. J. Pharm., 144, 241-245 (1996)   DOI   ScienceOn
14 L. Maggi, M.L. Torre, P. Giunchedi and U. Conte, Suprami- cellar solutions of sodium dodecyl sulphate as dissolution media to study the in vitro release characteristics of sustained-release formulations containing an insoluble drug: nifedipine, Int. J. Pharm., 135, 73-79 (1996)   DOI   ScienceOn
15 F. Carli, G. Capone, I. Colombo, L. Magarotto and A. Motta, Surface and transport properties of acrylic polymers influen- cing drug release from porous matrices, Int. J. Pharm., 21, 317-329 (1984)   DOI   ScienceOn
16 Z. Wang, T. Horikawa, F. Hirayama and K. Uekama, Design and in vitro evaluation of a modified-release oral dosage form of nifedipine by hybriation of hydroxypropyl-beta-cyclodextrin and hydroxypropylcellulose, J. Pharm. Pharmacol., 45, 942-946 (1993)   DOI   ScienceOn
17 J.W. Moore and H.H. Flanner, Mathematical comparison of dissolution profiles, Pharm. Tech., 20, 64-74 (1996)
18 P.R.P. Vera and V. Banu, Sustained release of theophylline from Eudragit RLPO and RSPO tablets, Drug Dev. Ind. Pharm., 22, 1243-1247 (1996)   DOI   ScienceOn
19 R. Bodmeier, X. Guo, R.E. Sarabia and P.F. Skultety, The influence of buffer species and strength on diltiazem HCl release from beads coated with the aqueous cationic polymer dispersions, Eudragit RS, RL 30D, Pharm. Res., 13, 52-56 (1996)   DOI   ScienceOn
20 M.R. Jenquin, S.M. Liebowitz, R.E. Sarabia and J.W. Mc- Ginity, Physical and chemical factors influencing the release of drugs from acrylic resin films, J. Pharm. Sci., 79, 811-816 (1990)   DOI