Lymphatic transport and catabolism of therapeutic proteins after subcutaneous administration to rats and dogs

Drug Metabolism and Disposition

Volumn 40, Issue 5, 2012, Pages 952-962

  Wang, Weirong ^a,b   Chen, Nancy ^a   Shen, Xiaolan ^a   Cunningham, Paul ^a   Fauty, Scott ^a   Michel, Kimberly ^a   Wang, Bo ^a   Hong, Xuening ^a   Adreani, Christine ^a   Nunes, Christian N ^a   Johnson, Chris V ^a   Yin, Kuo Chang ^a   Groff, Michelle ^a   Zou, Yan ^a   Liu, Liming ^a   Hamuro, Lora ^a   Prueksaritanont, Thomayant ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

CONTINUOUS ERYTHROPOIESIS RECEPTOR ACTIVATOR; RECOMBINANT ERYTHROPOIETIN;

ANIMAL CELL; ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; CANNULATION; CATABOLISM; CONTROLLED STUDY; DOG; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DEGRADATION; DRUG DISTRIBUTION; DRUG METABOLISM; DRUG STABILITY; DRUG TRANSPORT; LYMPH VESSEL; LYMPHATIC SYSTEM; MALE; MAXIMUM PLASMA CONCENTRATION; NONHUMAN; PHYSICAL ACTIVITY; PRIORITY JOURNAL; RADIOACTIVITY; RAT; SUBCUTANEOUS ABSORPTION;

ABSORPTION; ADIPOSE TISSUE; ANIMALS; BIOLOGICAL AVAILABILITY; BIOLOGICAL TRANSPORT; DOGS; DRUG DISCOVERY; ELECTROPHORESIS, POLYACRYLAMIDE GEL; ERYTHROPOIETIN; INJECTIONS, SUBCUTANEOUS; LYMPH NODES; LYMPHATIC SYSTEM; MALE; MOTOR ACTIVITY; POLYETHYLENE GLYCOLS; RATS; RATS, SPRAGUE-DAWLEY; RECOMBINANT PROTEINS; SPECIES SPECIFICITY; TIME FACTORS; TISSUE DISTRIBUTION;

ANIMALIA; CANIS FAMILIARIS; OVIS ARIES; RATTUS;

EID: 84859926954     PISSN: 00909556     EISSN: 1521009X     Source Type: Journal    
DOI: 10.1124/dmd.111.043604     Document Type: Article

References (40)

1. Bensadoun A and Weinstein D (1976) Assay of proteins in the presence of interfering materials. Anal Biochem 70:241-250.
2. Bocci V, Muscettola M, Grasso G, Magyar Z, Naldini A, and Szabo G (1986) The lymphatic route. 1) Albumin and hyaluronidase modify the normal distribution of interferon in lymph and plasma. Experientia 42:432-433.
3. Bocci V, Pessina GP, Paulesu L, and Nicoletti C (1988) The lymphatic route. VI. Distribution of recombinant interferon-α2 in rabbit and pig plasma and lymph. J Biol Response Mod 7:390-400.
4. Chan CC, Ng EH, Chan MM, Tang OS, Lau EY, Yeung WS, and Ho PC (2003) Bioavailability of hCG after intramuscular or subcutaneous injection in obese and non-obese women. Hum Reprod 18:2294-2297. (Pubitemid 37427806)
5. Charman SA, Segrave AM, Edwards GA, and Porter CJ (2000) Systemic availability and lymphatic transport of human growth hormone administered by subcutaneous injection. J Pharm Sci 89:168-177. (Pubitemid 30120797)
6. Davis CB and Bugelski PJ (1998) Subcutaneous bioavailability of a PRIMATIZED IgG1 anti-human CD4 monoclonal antibody is dose dependent in transgenic mice bearing human CD4. Drug Deliv 5:95-100. (Pubitemid 28313918)
7. Downey HF, Durgam P, Williams AG Jr, Rajmane A, King HH, and Stoll ST (2008) Lymph flow in the thoracic duct of conscious dogs during lymphatic pump treatment, exercise, and expansion of extracellular fluid volume. Lymphat Res Biol 6:3-13. (Pubitemid 351440564)
8. Fishbane S, Pannier A, Liogier X, Jordan P, Dougherty FC, and Reigner B (2007) Pharmacokinetic and pharmacodynamic properties of methoxy polyethylene glycol-epoetin beta are unaffected by the site of subcutaneous administration. J Clin Pharmacol 47:1390-1397. (Pubitemid 47624598)
9. Gonzalez SF, Kuligowski MP, Pitcher LA, Roozendaal R, and Carroll MC (2010) The role of innate immunity in B cell acquisition of antigen within LNs. Adv Immunol 106:1-19.
10. Ionac M (2003) One technique, two approaches, and results: thoracic duct cannulation in small laboratory animals. Microsurgery 23:239-245.
11. Kagan L, Gershkovich P, Mendelman A, Amsili S, Ezov N, and Hoffman A (2007) The role of the lymphatic system in subcutaneous absorption of macromolecules in the rat model. Eur J Pharm Biopharm 67:759-765. (Pubitemid 47576609)
12. Kagan L, Turner MR, Balu-Iyer SV, and Mager DE (2012) Subcutaneous absorption of monoclonal antibodies: role of dose, site of injection, and injection volume on rituximab pharmacokinetics in rats. Pharm Res 29:490-499.
13. Kakkar T, Sung C, Gibiansky L, Vu T, Narayanan A, Lin SL, Vincent M, Banfield C, Colbert A, Hoofring S, et al. (2011) Population PK and IgE pharmacodynamic analysis of a fully human monoclonal antibody against IL4 receptor. Pharm Res 28:2530-2542.
14. Kaminskas LM, Kota J, McLeod VM, Kelly BD, Karellas P, and Porter CJ (2009) PEGylation of polylysine dendrimers improves absorption and lymphatic targeting following SC administration in rats. J Control Release 140:108-116.
15. Kojima K, Takahashi T, and Nakanishi Y (1988) Lymphatic transport of recombinant human tumor necrosis factor in rats. J Pharmacobiodyn 11:700-706. (Pubitemid 18268044)
16. Kota J, Machavaram KK, McLennan DN, Edwards GA, Porter CJ, and Charman SA (2007) Lymphatic absorption of subcutaneously administered proteins: influence of different injection sites on the absorption of darbepoetin alfa using a sheep model. Drug Metab Dispos 35:2211-2217. (Pubitemid 350146207)
17. Lee DS and Hashim SA (1966) A new catheter system for cannulation of thoracic duct of the rat. J Appl Physiol 21:1887-1888.
18. Lee VH (1988) Enzymatic barriers to peptide and protein absorption. Crit Rev Ther Drug Carrier Syst 5:69-97.
19. Lin JH (2009) Pharmacokinetics of biotech drugs: peptides, proteins and monoclonal antibodies. Curr Drug Metab 10:661-691.
20. Mahmood I (2004) Interspecies scaling of protein drugs: prediction of clearance from animals to humans. J Pharm Sci 93:177-185.
21. Macdougall IC (2005) CERA (continuous erythropoietin receptor activator): a new erythropoiesis- stimulating agent for the treatment of anemia. Curr Hematol Rep 4:436-440.
22. Macdougall IC, Jones JM, Robinson MI, Miles JB, Coles GA, and Williams JD (1991) Subcutaneous erythropoietin therapy: comparison of three different sites of injection. Contrib Nephrol 88:152-158.
23. Magnusson BM, Walters KA, and Roberts MS (2001) Veterinary drug delivery: potential for skin penetration enhancement. Adv Drug Deliv Rev 50:205-227. (Pubitemid 32735457)
24. McDonald TA, Zepeda ML, Tomlinson MJ, Bee WH, and Ivens IA (2010) Subcutaneous administration of biotherapeutics: current experience in animal models. Curr Opin Mol Ther 12:461-470.
25. McLennan DN, Porter CJ, Edwards GA, Heatherington AC, Martin SW, and Charman SA (2006) The absorption of darbepoetin alfa occurs predominantly via the lymphatics following sub-cutaneous administration to sheep. Pharm Res 23:2060-2066.
26. Mordenti J, Chen SA,Moore JA, Ferraiolo BL, and Green JD (1991) Interspecies scaling of clearance and volume of distribution data for five therapeutic proteins. Pharm Res 8:1351-1359.
27. Mrsny RJ and Daugherty AL (2009) Proteins and Peptides: Pharmacokinetic, Pharmacodynamic, and Metabolic Outcomes, pp 80-105, Informa Healthcare, New York.
28. Nett JH, Gomathinayagam S, Hamilton SR, Gong B, Davidson RC, Du M, Hopkins D, Mitchell T, Mallem MR, Nylen A, et al. (2012) Optimization of erythropoietin production with controlled glycosylation-PEGylated erythropoietin produced in glycoengineered Pichia pastoris. J Biotechnol 157:198-206.
29. Olsson-Gisleskog P, Jacqmin P, and Perez-Ruixo JJ (2007) Population pharmacokinetics meta-analysis of recombinant human erythropoietin in healthy subjects. Clin Pharmacokinet 46:159-173. (Pubitemid 46193059)
30. Porter CJ and Charman SA (2000) Lymphatic transport of proteins after subcutaneous administration. J Pharm Sci 89:297-310. (Pubitemid 30152431)
31. Porter CJ, Edwards GA, and Charman SA (2001) Lymphatic transport of proteins after s.c. injection: implications of animal model selection. Adv Drug Deliv Rev 50:157-171. (Pubitemid 32727281)
32. Ryan TJ (1995) Lymphatics and adipose tissue. Clin Dermatol 13:493-498.
33. Schreihofer AM, Hair CD, and Stepp DW (2005) Reduced plasma volume and mesenteric vascular reactivity in obese Zucker rats. Am J Physiol Regul Integr Comp Physiol 288:R253-R261. (Pubitemid 40023937)
34. Silva M, Poo J, Wagner F, Jackson M, Cutler D, Grace M, Bordens R, Cullen C, Harvey J, and Laughlin M (2006) A randomised trial to compare the pharmacokinetic, pharmacodynamic, and antiviral effects of peginterferon alfa-2b and peginterferon alfa-2a in patients with chronic hepatitis C (COMPARE). J Hepatol 45:204-213.
35. Supersaxo A, Hein WR, and Steffen H (1990) Effect of molecular weight on the lymphatic absorption of water-soluble compounds following subcutaneous administration. Pharm Res 7:167-169. (Pubitemid 20208069)
36. Swartz MA (2001) The physiology of the lymphatic system. Adv Drug Deliv Rev 50:3-20. (Pubitemid 32727274)
37. Tang L, Persky AM, Hochhaus G, and Meibohm B (2004) Pharmacokinetic aspects of biotechnology products. J Pharm Sci 93:2184-2204. (Pubitemid 39129617)
38. Tilney NL (1971) Patterns of lymphatic drainage in the adult laboratory rat. J Anat 109:369-383.
39. 125I]- labeled therapeutic proteins: application in protein drug development beyond oncology. J Pharm Sci 99:1028-1045.
40. Wang W and Prueksaritanont T (2010) Prediction of human clearance of therapeutic proteins: simple allometric scaling method revisited. Biopharm Drug Dispos 31:253-263.