Development and Internal Validation of an In Vitro-in Vivo Correlation for a Hydrophilic Metoprolol Tartrate Extended Release Tablet Formulation

被引:0
作者
Natalie D. Eddington
Patrick Marroum
Ramana Uppoor
Ajaz Hussain
Larry Augsburger
机构
[1] University of Maryland at Baltimore,Pharmacokinetics Biopharmaceutics Laboratory
[2] University of Maryland at Baltimore,Department of Pharmaceutical Sciences, School of Pharmacy
[3] Food and Drug Administration,undefined
[4] Office of Pharmaceutical Sciences,undefined
来源
Pharmaceutical Research | 1998年 / 15卷
关键词
convolution; metoprolol; validation; dissolution; prediction errors;
D O I
暂无
中图分类号
学科分类号
摘要
Purpose. To develop and validate internally an in vitro-in vivo correlation (IVIVC) for a hydrophilic matrix extended release metoprolol tablet.
引用
收藏
页码:466 / 473
页数:7
相关论文
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[1]  
Skelly J. P.(1990)Report of the workshop on in-vitro and in-vivo testing and correlation for oral controlled/modified-release dosage forms J. Pharm. Sci. 79 849-854
[2]  
Amidon G. L.(1985)Comparison of two slow-release formulations of metoprolol with conventional metoprolol and atenolol in hypertensive patients Br. J. Clin. Pharmacol. 20 387-391
[3]  
Barr W. H.(1993)Steady-state bioavailability and day-to-day variability of a multiple unit (CR/ZOK) and a single-unit (OROS) delivery system of metoprolol after once-daily dosing Pharm. Res. 10 28-34
[4]  
Benet L. Z.(1988)Design of a new multiple-unit controlled-release formulation of metoprolol-CR Eur. J. Clin. Pharmacol. 33 S3-S7
[5]  
Carter J. E.(1995)A theoretical basis for a biopharmaceutical drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability Pharm. Res. 12 413-420
[6]  
Robinson J. R.(1997)Evaluation of Pharmaceutical Dev. Tech. 29 11-24
[7]  
Shah V. P.(1989) Release Rate and Euro. J. Clin. Pharmacol. 1989 315-318
[8]  
Yacobi A.(1996) Absorption characteristics of Four Metoprolol Tartrate Immediate Release Tablet Formulations Pharm. Tech. 6 64-74
[9]  
Silas J. H.(1981)Determination of dextromethorphan metabolizer phenotype in healthy volunteers Clin. Pharmacokin. 6 429-453
[10]  
Freestone S.(1981)Mathematical comparison of curves with an emphasis on dissolution profiles J. Pharmacokinet. Biopharm. 9 503-512