Porcine model to evaluate local tissue tolerability associated with subcutaneous delivery of protein

Journal of Pharmacological and Toxicological Methods

Volumn 67, Issue 3, 2013, Pages 140-147

  Kang, D W ^a   Oh, D A ^a   Fu, G Y ^a   Anderson, J M ^a   Zepeda, M L ^a  

^a Halozyme Therapeutics Inc   (United States)

Author keywords

Infusion; Local tolerability; Methods; Porcine model; Protein delivery; Subcutaneous

Indexed keywords

HUMAN IMMUNOGLOBULIN; RECOMBINANT HYALURONIDASE;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CONTROLLED STUDY; DRUG TOLERABILITY; IN VIVO STUDY; INJECTION SITE; INJECTION SITE ERYTHEMA; INJECTION SITE SWELLING; MALE; MINIPIG; NONHUMAN; QUALITATIVE ANALYSIS; SUBCUTANEOUS DRUG ADMINISTRATION; TISSUE PRESSURE; VISCOELASTICITY;

ABDOMEN; ANIMALS; CELL ADHESION MOLECULES; HUMANS; HYALURONOGLUCOSAMINIDASE; IMMUNOGLOBULIN G; INFUSIONS, SUBCUTANEOUS; MODELS, ANIMAL; RECOMBINANT PROTEINS; SKIN; SUBCUTANEOUS TISSUE; SWINE;

EID: 84875260648     PISSN: 10568719     EISSN: 1873488X     Source Type: Journal    
DOI: 10.1016/j.vascn.2013.01.011     Document Type: Article

References (36)

1. Agache P. Subcutis histopathology. Measuring the skin 2004, 401-409. Springer-Verlag, Berlin & Heidelberg. P. Agache, P. Humbert (Eds.).
2. Agache P.G., Monneur C., Leveque J.L., De Rigal J. Mechanical properties and Young's modulus of human skin in vivo. Archives of Dermatological Research 1980, 269(3):221-232.
3. Agache P., Varchon D. Mechanical behavior assessment. Measuring the skin 2006, 446-467. Springer-Verlag, Berlin & Heidelberg. P. Agache, P. Humbert (Eds.).
4. Auckland K., Nicolaysen G. Interstitial fluid volume: Local regulatory mechanisms. Physiological Reviews 1981, 61(3):556-643.
5. Barel A.O., Courage W., Clarys P. Suction chamber method for measurement of skin mechanics: The new digital version of the Cutometer. Handbook of Non-Invasive Methods and the Skin 2006, 583-591. CRC Press, Boca Raton, FL. 2nd ed. J. Serup, G.B.E. Jemec, G.L. Grove (Eds.).
6. Berger M. Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clinical Immunology 2004, 112(1):1-7.
7. Bookbinder L.H., Hofer A., Haller M.F., Zepeda M.L., Keller G.-A., Lim J.E., et al. A recombinant human enzyme for enhanced interstitial transport of therapeutics. Journal of Controlled Release 2006, 114(2):230-241.
8. Brazeau G.A., Cooper B., Svetic K.A., Smith C.L., Gupta P. Current perspectives on pain upon injection of drugs. Journal of Pharmaceutical Sciences 1998, 87(6):667-677.
9. Burch G.E., Sodeman W.A. The estimation of the subcutaneous tissue pressure by direct method. Journal of Clinical Investigation 1937, 16(6):845-850.
10. Dorfman A., Ott M.L. A turbidimetric method for the assay of hyaluronidase. Journal of Biological Chemistry 1948, 172(2):367-375.
11. Frost G.I. Recombinant human hyaluronidase (rHuPH20): An enabling platform for subcutaneous drug and fluid administration. Expert Opinion on Drug Delivery 2007, 4(4):427-440.
12. Gardulf A. Immunoglobulin treatment for primary antibody deficiencies. BioDrugs 2007, 21(2):105-116.
13. Golla S., Madihally S., Robinson R.L., Gasem K.A.M. Quantitative structure-property relationships modeling of skin irritation. Toxicology In Vitro 2009, 23(1):176-184.
14. Gustafson R., Gardulf A., Hansen S., Leibl H., Engl W., Lindén M., et al. Rapid subcutaneous immunoglobulin administration every second week results in high and stable serum immunoglobulin G levels in patients with primary antibody deficiencies. Clinical and Experimental Immunology 2008, 152(2):274-279.
15. Haller M.F. Converting intravenous dosing to subcutaneous dosing with recombinant human hyaluronidase. Pharmaceutical Technology 2007, (http://pharmtech.findpharma.com/pharmtech/Article/Converting-Intravenous-Dosing-to-Subcutaneous-Dosi/ArticleStandard/Article/detail/463578).
16. Hansen S., Gustafson R., Smith C.I.E., Gardulf A. Express subcutaneous IgG infusions: Decreased time of delivery with maintained safety. Clinical Immunology 2002, 104(3):237-241.
17. Heltne J.K., Husby P., Koller M.-E., Lund T. Sampling of interstitial fluid and measurement of colloid osmotic pressure (COPi) in pigs: Evaluation of the wick method. Laboratory Animals 1998, 32(4):439-445.
18. Jorgensen J.T., Romsing J., Rasmussen M., Moller-Sonnergaard J., Vang L., Musaeus L. Pain assessment of subcutaneous injections. The Annals of Pharmacotherapy 1996, 30(7-8):729-732.
19. Katz M.A. Validity of interstitial fluid hydrostatic pressure measurement in hollow porous polyethylene capsules. Microvascular Research 1978, 16(3):316-326.
20. Kawamata S., Ozawa J., Hashimoto M., Kurose T., Shinohara H. Structure of the rat subcutaneous connective tissue in relation to its sliding mechanism. Archives of Histology and Cytology 2003, 66(3):273-279.
21. Klabunde R.E. Exchange function of the microcirculation. Cardiovascular physiology concept 2005, 171-183. Lippincott William & Wilkins, Philadelphia, PA.
22. Knight E., Carne E., Novak B., El-Shanawany T., Williams P., Pickersgill T., et al. Self-administered hyaluronidase-facilitated subcutaneous immunoglobulin home therapy in a patient with primary immunodeficiency. Journal of Clinical Pathology 2010, 63(9):846-847.
23. Mahl J.A., Vogel B.E., Court M., Kolopp M., Roman D., Nogués V. The minipig in dermatotoxicology: Methods and challenges. Experimental and Toxicologic Pathology 2006, 57(5-6):341-345.
24. McDonald T.A., Zepeda M.L., Tomlinson M.J., Bee W.H., Iven I.A. Subcutaneous administration of biotherapeutics: Current experience in animal models. Current Opinion in Molecular Therapeutics 2010, 12(4):461-470.
25. Misbah S., Sturzenegger M.H., Borte M., Shapiro R.S., Wasserman R.L., Berger M., et al. Subcutaneous immunoglobulin: Opportunities and outlook. Clinical and Experimental Immunology 2009, 158(Suppl. 1):51-59.
26. Nedelec B., Correa J.A., Rachelska G., Armour A., LaSalle L. Quantitative measurement of hypertrophic scar: Interrater reliability and concurrent validity. Journal of Burn Care & Research 2008, 29(3):501-511.
27. Nunoya T., Shibuya K., Saitoh T., Yazawa H., Nakamura K., Baba Y., et al. Use of miniature pig for biomedical research, with reference to toxicologic studies. Journal of Toxicologic Pathology 2007, 20:125-132.
28. O'goshi K. Suction chamber method for measurement of skin mechanics: The Cutometer®. Handbook of non-invasive methods and the skin 2006, 579-582. CRC Press, Boca Raton, FL. 2nd ed. J. Serup, G.B.E. Jemec, G.L. Grove (Eds.).
29. Porter C.J.H., Edwards G.A., Charman S.A. Lymphatic transport of proteins after s.c. injection: Implications of animal model selection. Advanced Drug Delivery Reviews 2001, 50(1-2):157-171.
30. Sharp B., Whyte P. The requirements of an injection device: a clinical perspective. Ondrugdelivery.com 2011, June 12-14, 12-14.
31. Starling, E. H. (1896). On the absorption of fluids from the connective tissue spaces. The Journal of Physiology, 19(4), 312-326.
32. Steingrímsdóttir, O. A., Vøllestad, N. K., Røe, C., & Knardahl, S. (2004). Variation in reporting of pain and other subjective health complaints in a working population and limitations of single sample measurements. Pain, 110(1-2), 130-139.
33. Stoker, M. R. (2004). Principles of pressure transducers, resonance, damping and frequency response. Anaesthesia and Intensive Care Medicine, 5(11), 371-375.
34. Supersaxo, A., Hein, W. R., & Steffen, H. (1990). Effect of molecular weight on the lymphatic absorption of water-soluble compounds following subcutaneous administration. Pharmaceutical Research, 7(2), 167-169.
35. Svendsen, O. (2006). The minipig in toxicology. Experimental and Toxicologic Pathology, 57(5-6), 335-339.
36. Wells, H. S., Youman, J. B., & Miller, D. G. (1938). Tissue pressure (intracutaneous, subcutaneous, and intramuscular) as related to venous pressure, capillary filtration, and other factors. Journal of Clinical Investigation, 17(4), 489-499.