In vitro protein binding of liraglutide in human plasma determined by reiterated stepwise equilibrium dialysis

Journal of Pharmaceutical Sciences

Volumn 102, Issue 8, 2013, Pages 2882-2888

  Plum, Anne ^a   Jensen, Lisbeth Bjerring ^a   Kristensen, Jesper Bøggild ^a  

^a NOVO NORDISK A S   (Denmark)

Author keywords

Acylated peptides; Equilibrium dialysis; Human serum albumin; in vitro method; Insulin detemir; Liraglutide; Plasma proteins; Protein binding; Type 2 diabetes mellitus

Indexed keywords

HUMAN SERUM ALBUMIN; LIRAGLUTIDE; OROSOMUCOID;

ARTICLE; DILUTION; DRUG BINDING; ENZYME LINKED IMMUNOSORBENT ASSAY; EQUILIBRIUM DIALYSIS; FEMALE; HUMAN; IN VITRO STUDY; MALE; PLASMA PROTEIN BINDING; REPRODUCIBILITY;

EID: 84881030553     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23648     Document Type: Article

References (21)

1. Baggio LL, Drucker DJ. 2007. Biology of incretins: GLP-1 and GIP. Gastroenterology 132:2131-2157.
2. Aaboe K, Krarup T, Madsbad S, Holst JJ. 2008. GLP-1: Physiological effects and potential therapeutic applications. Diabetes Obes Metab 10:994-1003.
3. Mentlein R, Gallwitz B, Schmidt WE. 1993. Dipeptidyl-peptidase IV hydrolyses gastric inhibitory polypeptide, glucagon-like peptide-1(7-36)amide, peptide histidine methionine and is responsible for their degradation in human serum. Eur J Biochem 214:829-835.
4. Gutniak MK, Linde B, Holst JJ, Efendić S. 1994. Subcutaneous injection of the incretin hormone glucagon-like peptide 1 abolishes postprandial glycemia in NIDDM. Diabetes Care 17:1039-1044.
5. Knudsen LB, Nielsen PF, Huusfeldt PO, Johansen NL, Madsen K, Pedersen FZ, Thøgersen H, Wilken M, Agersø H. 2000. Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration. J Med Chem 43:1664-1669.
6. Victoza® (liraglutide). Summary of product characteristics. Novo Nordisk. 2012. Accessed May 28, 2013, at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001026/WC500050017.pdf.
7. Guyton AC, Hall JE. 2011. Textbook of medical physiology. 12th ed. Philadelphia: Saunders Elsevier.
8. Busher JT. 1990. Serum albumin and globulin. In Clinical methods: The history, physical, and laboratory examinations; Walker HK, Hall WD, Hurst JW, Ed. 3rd ed. Boston: Butterworths. [Chapter #101.]
9. Shimoda M, Kokue E, Hayama T, Vree TB. 1989. Effect of albumin distribution. A simulation analysis of the effect of altered albumin distribution on the apparent volume of distribution and apparent rate constant of drugs. Pharm World Sci 11:87-91.
10. Barré J, Chamouard JM, Houin G, Tillement JP. 1985. Equilibrium dialysis, ultrafiltration, and ultracentrifugation compared for determining the plasma-protein-binding characteristics of valproic acid. Clin Chem 31:60-64.
11. Plum A, Larsen PS, Larsen UD, Kristensen JB, Jansen JA. 1999. Determination of in vitro plasma protein binding of insulin aspart and insulin detemir by equilibrium dialysis. Diabetologia 42(Suppl 1):A236 [abstract #886].
12. Flint A, Nazzal K, Jagielski P, Hindsberger C, Zdravkovic M. 2010. Influence of hepatic impairment on pharmacokinetics of the human GLP-1 analogue, liraglutide. Br J Clin Pharmacol 70:807-814.
13. Kristensen JB, Pedersen ML, Larsen UD, Martiny L, Hansen LB, Foged C. 2003. [I-125], [I-127]-and [C-14]-labelling of the GLP-1-(7-37) derivative NN2211. J Labelled Comp Radiopharm 46:499-510.
14. Krebs HA, Henseleit K. 1932. Untersuchungen über die Harnstoffbildung im Tierkörper. Z Physiol Chem 210:33-66.
15. Agersø H, Jensen LB, Elbrond B, Rolan P, Zdravkovic M. 2002. The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men. Diabetologia 45:195-202.
16. Burtis CA, Ashwood MD. 1999. Tietz textbook of clinical chemistry. 3rd ed. Oxford: Elsevier Health Sciences.
17. Ritchie RF, Palomaki GE, Neveux LM, Navolotskaia O, Ledue TB, Craig WY. 2000. Reference distributions for the positive acute phase serum proteins, alpha1-acid glycoprotein (orosomucoid), alpha1-antitrypsin, and haptoglobin: A practical, simple, and clinically relevant approach in a large cohort. J Clin Lab Anal 14:284-292.
18. Turner MW, Hulme B. 1970. The plasma proteins: An introduction. London: Pitman Medical & Scientific Publishing Company, Ltd.
19. Kremer JMH, Wilting J, Janssen LHM. 1988. Drug binding to human alpha-1-acid glycoprotein in health and disease. Pharmacol Rev 40:1-47.
20. Jacobsen LV, Hindsberger C, Robson R, Zdravkovic M. 2009. Effect of renal impairment on the pharmacokinetics of the GLP-1 analogue liraglutide. Br J Clin Pharmacol 68:898-905.
21. Kolterman OG, Kim DD, Shen L, Ruggles JA, Nielsen LL, Fineman MS, Baron AD. 2005. Pharmacokinetics, pharmacodynamics, and safety of exenatide in patients with type 2 diabetes mellitus. Am J Health Syst Pharm 62:173-181.