Abstract
OBJECTIVE To prepare a twice daily sustained release pellets of Metoprolol Tartrate with blends of Eudragit RS 30D and Eudragit RL 30D as sustained coating material and optimize the coating formulation with central composite design-response surface methodology.METHODS Drug release from the coated pellets after 1,4 and 8 h were used as responses and central composite design-response surface methodology was applied to optimize sustained coating formulation,namely Eudragit RS 30D/Eudragit RL 30D ratio in sustained coating material and polymer load(weight gain),which were based on single factor tests.RESULTS Using similarity factor(F2),the dissolution profiles of three batches were found to be similar with the expected target profile.CONCLUSION Central composite design-response surface methodology can be applied to optimize the coating formulation for Metoprolol Tartrate sustained release pellets and the models developed in this study are proved to be predictable and feasible.
Key words
metoprolol tartrate /
Eudragit RS 30D /
Eudragit RL 30D /
sustained release pellets /
central composite design-response surface methodology
{{custom_keyword}} /
Cite this article
Download Citations
HUNG Jin;GO Chun-sheng;SHN Li;MEI Xing-guo.
Optimization of Coating Formulation of Sustained Release Pellets of Metoprolol Tartrate by Central Composite Design-Response Surface Methodology [J]. Chinese Pharmaceutical Journal, 2007, 42(07): 512-515
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
References
[1］SOLIMAN M， KHAN M. Optimization and characterization of controlled release multi-particulate beads coated with starch acetate[J］.Int J Pharm，2005，294(1-2)： 89-101.
[2］QUARTERMAN C， KENDALL M. Plasma levels and negative chronotropic effect of metoprolol following single doses of a conventional and sustained-release formulation[J］.Europ J Clin Pharmacol，1979，15 (11)：97-103.
[3］SCHULTZ P， KLEINEBUDDE P. A new mutiparticulate delayed release system. Part I： Dissolution properties and release mechanism[J］.J Controlled Release，1997， 47 (9)：181-189.
[4］KRAMAR A， VRECER F. Statistical optimization of diclofenac sustained release pellets coated with polymethacrylic films[J］. Int J Pharm，2003，256 (10)：43-52.
[5］ALKHATIB H S，SAKR A.Optimization of methacrylic acid ester copolymers blends as controlled release coatings using response surface methodology[J］.Pharm Dev Tech，2003， 8：87-96.
[6］WU W，CUI G H. Application of central composite design-response surface methodology in pharmaceutical area[J］.Foreign Med Sci Pharm（国外医学药学分册），2000，27(5)：292-298.
[7］LIU G L，WEN L Q，HAO X H，et al. Optimization of ambroxol hydrochloride sustained release tablets by Central Composite Design[J］.Chin Hosp Pharm J（中国医院药学杂志），2004，24（6）：321-323.
[8］HAMED E， SAKR A. Application of multiple response optimization technique to extended release formulations design[J］.J Controlled Release，2001， 73： 326-338.
[9］WU Y J，SHA X Y，FANG X L，et al. Optimization of the intranasal powders of Panax Notoginseng Saponins by the central composite design-response surface methodology[J］.Chin Trandit Pat Med（中成药），2005，27（1）：10-15.
{{custom_fnGroup.title_en}}
Footnotes
{{custom_fn.content}}
