Development and internal validation of an in vitro-in vivo correlation for a hydrophilic metoprolol tartrate extended release tablet formulation

Pharmaceutical Research

Volumn 15, Issue 3, 1998, Pages 466-473

  Eddington, Natalie D ^a,b   Marroum, Patrick ^c   Uppoor, Ramana ^c   Hussain, Ajaz ^c   Augsburger, Larry ^b  

^a UNIVERSITY OF MARYLAND   (United States)

^b UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

^c CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Convolution; Dissolution; Metoprolol; Prediction errors; Validation

Indexed keywords

DEXTROMETHORPHAN; HYDROXYPROPYLMETHYLCELLULOSE; METOPROLOL TARTRATE;

ADULT; APPARATUS; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; DATA ANALYSIS; DIET RESTRICTION; DISSOLUTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DETERMINATION; FEMALE; FLUORESCENCE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; HUMAN TISSUE; IN VITRO STUDY; MALE; METHODOLOGY; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PH; PRIORITY JOURNAL; PROGNOSIS; SOLID PHASE EXTRACTION; SPECTROPHOTOMETRY; SUSTAINED RELEASE PREPARATION;

ADRENERGIC BETA-ANTAGONISTS; ADULT; ANTIHYPERTENSIVE AGENTS; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MALE; METOPROLOL; MIDDLE AGED; MODELS, STATISTICAL; REPRODUCIBILITY OF RESULTS; SOLUBILITY; TABLETS;

EID: 0031900490     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1011988601696     Document Type: Article

References (16)

1. "In Vitro In Vivo Evaluation of Dosage Forms" United States Pharmacopeia XXIII chapter 1088, United States Pharmacopeial Convention, Incorporated, Rockville, Maryland, pp. 1927-1929,
2. J. P. Skelly, G. L. Amidon, W. H. Barr, L. Z. Benet, J. E. Carter, J. R. Robinson, V. P. Shah, and A. Yacobi. 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 (1990).
3. Guidance for the Industry: Extended Release Solid Oral Dosage Forms: Development, Evaluation and Application of In Vitro/In Vivo Correlations. U. S. Department of Health, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), September, 26, 1997.
4. J. H. Silas, S. Freestone, M. S. Lennard, and L. E. Ramsay. Comparison of two slow-release formulations of metoprolol with conventional metoprolol and atenolol in hypertensive patients. Br. J. Clin. Pharmacol. 20:387-391 (1985).
5. A. Sandberg, B. Abrahamsson, A. Svenheden, B. Olofsson, and R. Bergstrand. 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 (1993).
6. A. Sandberg, G. Ragnarsson, U. E. Jonsson, and J. Sjörgren. Design of a new multiple-unit controlled-release formulation of metoprolol-CR. Eur. J. Clin. Pharmacol. 33: Supp S3-S7 (1988).
7. G. Amidon, H. Lennernas, V. P. Shah, and J. R. Crison. 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 (1995).
8. G. S. Rekhi, N. D. Eddington, M. J. Fossler, P. Schwartz P., L. J. Lesko, and L. L. Augsburger. Evaluation of In Vitro Release Rate and In Vivo Absorption characteristics of Four Metoprolol Tartrate Immediate Release Tablet Formulations. Pharmaceutical Dev. Tech. 29:11-24 (1997).
9. R. V. Nellore, G. S. Rekhi, A. S. Hussain, L. G. Tillman, and L. L. Augsburger. Development of Metoprolol Tartrate Extended-Release Matrix Tablet formulations for Regulatory Consideration. J. Controlled Release (in press).
10. Modified Release Solid Oral Dosage Form Guidance: Scale-up and Postapproval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation. U. S. Department of Health, Food and Drug Administration. Center for Drug Evaluation and Research (CDER), September, 26, 1997.
11. M. Hildebrand, W. Seifert, and A. Reichenberger. Determination of dextromethorphan metabolizer phenotype in healthy volunteers. Euro. J. Clin. Pharmacol. 1989:315-318 (1989).
12. B. Mistry, J. Leslie, and N. D. Eddington. A sensitive assay of metoprolol and its major metabolite, α-hydroxy metoprolol in human plasma and determination of dextromethorphan and its metabolite in urine with high performance liquid chromatography and fluorometric detection. J. Pharmaceut. Biomed. Anal. (in press).
13. J. W. Moore and H. H. Flanner. Mathematical comparison of curves with an emphasis on dissolution profiles. Pharm. Tech. 6:64-74 (1996).
14. N. H. G. Holford and L. B. Sheiner. Understanding the dose-effect relationship: clinical application of pharmacokinetic-pharmacodynamic models. Clin. Pharmacokin. 6:429-453 (1981).
15. L. B. Sheiner and S. Beal. Some suggestions for measuring predictive performance. J. Pharmacokinet. Biopharm. 9:503-512 (1981).
16. J. P. Skelly, G. A. Van Buskirk, H. M. Arbit, G. L. Amidon, L. L. Augsburger, W. H. Barr, S. Berge, J. Clevenger, S. Dighe, M. Fawzi, D. Fox, M. A. Gonzalez, V. A. Gray, C. Hoiberg, L. J. Lesson, L. Lesko, H. Malinowski, P. R. Nixon, D. M. Pearce, G. Peck, S. Porter, J. Robinson, D. R. Savello, P. Schwartz, J. B. Schwartz, V. P. Shah, R. Shangraw, F. Theeuwes, and T. Wheatley. Workshop II Report. Scaleup of oral extended-release dosage forms Pharm. Res. 10:1800-1805 (1993).