Development and validation of a higher-throughput equilibrium dialysis assay for plasma protein binding

Journal of Laboratory Automation

Volumn 16, Issue 1, 2011, Pages 56-67

  van Liempd, Sebastiaan ^a   Morrison, Denise ^a   Sysmans, Leen ^a   Nelis, Paul ^a   Mortishire Smith, Russell ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

Automation; Binding; Dialysis; LC MS MS; Plasma protein; Rapid equilibrium; Robotics

Indexed keywords

AUTOMATION; BINS; BIOCHEMISTRY; DIALYSIS; DRUG PRODUCTS; PROTEINS; ROBOTICS;

BINDING; EQUILIBRATION TIME; EQUILIBRIUM DIALYSIS; LC-MS/MS; PLASMA PROTEIN; PLASMA PROTEIN BINDING; QUANTITATIVE BIO-ANALYSIS; RAPID EQUILIBRIUM;

DIALYSIS MEMBRANES;

ATENOLOL; CLOZAPINE; FLUCONAZOLE; NAPROXEN; PLASMA PROTEIN; PROPRANOLOL; VERAPAMIL; WARFARIN;

ARTICLE; CONTROLLED STUDY; EQUILIBRIUM DIALYSIS; HIGH THROUGHPUT SCREENING; HUMAN; INTERMETHOD COMPARISON; LABORATORY AUTOMATION; MALE; NONHUMAN; PLASMA PROTEIN BINDING; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; PROTEIN CONTENT; PROTEIN DETERMINATION; QUANTITATIVE ANALYSIS; ROBOTICS; VALIDATION STUDY;

EID: 79955007487     PISSN: 22110682     EISSN: 22110690     Source Type: Journal    
DOI: 10.1016/j.jala.2010.06.002     Document Type: Article

References (18)

1. Trainor, G. L. The importance of plasma protein binding in drug discovery. Expert Opin. Drug Discov. 2007, 2, 51-64.
2. Anderson, G. D. Pregnancy-induced changes in pharmacokinetics: a mechanistic-based approach. Clin. Pharmacokinet. 2005, 44, 989-1008.
3. Zamacona, M. K.; Suarez, E.; Aguilera, L.; Rodriguez, S.; Aguirre, C.; Calvo, R. Serum protein binding of propofol in critically ill patients. Acta Anaesthesiol. Scand. 1997, 41, 1267-1272.
4. Sinha, V. K.; De Buck, S. S.; Fenu, L. A.; Smit, J. W.; Nijsen, M.; Gilissen, R. A.; Van Peer, A.; Lavrijsen, K.; Mackie, C. E. Predicting oral clearance in humans: how close can we get with allometry?. Clin. Pharmacokinet. 2008, 47, 35-45.
5. Barre, J.; Chamouard, J. M.; Houin, G.; Tillement, J. P. Equilibrium dialysis, ultrafiltration, and ultracentrifugation compared for determining the plasma-protein-binding characteristics of valproic acid. Clin. Chem. 1985, 31, 60-64.
6. Kurz, H.; Trunk, H.; Weitz, B. Evaluation of methods to determine protein-binding of drugs. Equilibrium dialysis, ultrafiltration, ultracentrifugation, gel filtration. Arzneimittelforschung 1977, 27, 1373-1380.
7. Wan, H.; Rehngren, M. High-throughput screening of protein binding by equilibrium dialysis combined with liquid chromatography and mass spectrometry. J. Chromatogr. A 2006, 1102, 125-134.
8. Waters, N. J.; Jones, R.; Williams, G.; Sohal, B. Validation of a rapid equilibrium dialysis approach for the measurement of plasma protein binding. J. Pharm. Sci. 2008, 97, 4586-4595.
9. Goodman, L. S.; Gilman, A. G.; Hardman, J. G.; Limbird, L. E. Goodman & Gilman's the Pharmacological Basis of Therapeutics. 11th ed. New York: McGraw-Hill, Health Professions Division; 2001.
10. Kochansky, C. J.; McMasters, D. R.; Lu, P.; Koeplinger, K. A.; Kerr, H. H.; Shou, M.; Korzekwa, K. R. Impact of pH on plasma protein binding in equilibrium dialysis. Mol. Pharm. 2008, 5, 438-448.
11. Noble, J. E.; Bailey, M. J. Quantitation of protein. Methods Enzymol. 2009, 463, 73-95.
12. Shah, V. P. The history of bioanalytical method validation and regulation: evolution of a guidance document on bioanalytical methods validation. AAPS J. 2007, 9, E43-E47.
13. McGinnity, D. F.; Collington, J.; Austin, R. P.; Riley, R. J. Evaluation of human pharmacokinetics, therapeutic dose and exposure predictions using marketed oral drugs. Curr. Drug Metab. 2007, 8, 463-479.
14. Yamazaki, K.; Kanaoka, M. Computational prediction of the plasma protein-binding percent of diverse pharmaceutical compounds. J. Pharm. Sci. 2004, 93, 1480-1494.
15. Arredondo, G.; Suarez, E.; Calvo, R.; Vazquez, J. A.; Garcia-Sanchez, J.; Martinez-Jorda, R. Serum protein binding of itraconazole and fluconazole in patients with diabetes mellitus. J. Antimicrob. Chemother. 1999, 43, 305-307.
16. Fung, E. N.; Chen, Y. H.; Lau, Y. Y. Semi-automatic high-throughput determination of plasma protein binding using a 96-well plate filtrate assembly and fast liquid chromatography-tandem mass spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2003, 795, 187-194.
17. Kariv, I.; Cao, H.; Oldenburg, K. R. Development of a high throughput equilibrium dialysis method. J. Pharm. Sci. 2001, 90, 580-587.
18. Banker, M. J.; Clark, T. H.; Williams, J. A. Development and validation of a 96-well equilibrium dialysis apparatus for measuring plasma protein binding. J. Pharm. Sci. 2003, 92, 967-974.