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Review Article

Identifying a predictive relationship between maximal flow rate and viscosity for subcutaneous administration of macromolecules with recombinant human hyaluronidase PH20 in a miniature pig model

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Article: 2252999 | Received 29 May 2023, Accepted 27 Jul 2023, Published online: 13 Sep 2023

References

  • Amgen Inc. (2021). Highlights of Prescribing Information. REPATHA (evolcumab) injection, for subcutaneous use. https://www.pi.amgen.com/∼/media/amgen/repositorysites/pi-amgen-com/repatha/repatha_pi_hcp_english.pdf [last accessed 23 March 2022].
  • Bittner B, Locke KW, Maneval DC, et al. (2022). ENHANZE® drug delivery technology. Oxford (UK): S. Karger Publishers Ltd.
  • Bittner B, Richter W, Schmidt J. (2018). Subcutaneous administration of biotherapeutics: an overview of current challenges and opportunities. BioDrugs 32:1–11. doi:10.1007/s40259-018-0295-0.
  • Bookbinder LH, Hofer A, Haller MF, et al. (2006). A recombinant human enzyme for enhanced interstitial transport of therapeutics. J Control Release 114:230–41. doi:10.1016/j.jconrel.2006.05.027.
  • Buhren BA, Schrumpf H, Hoff NP, et al. (2016). Hyaluronidase: from clinical applications to molecular and cellular mechanisms. Eur J Med Res 21:5. doi:10.1186/s40001-016-0201-5.
  • Burcombe R, Chan S, Simcock R, et al. (2013). Subcutaneous trastuzumab (Herceptin®): a UK time and motion study in comparison with intravenous formulation for the treatment of patients with HER2-positive early breast cancer. Adv Breast Cancer Res 02:133–40. doi:10.4236/abcr.2013.24022.
  • Cowman MK, Lee HG, Schwertfeger KL, et al. (2015). The content and size of hyaluronan in biological fluids and tissues. Front Immunol 6:261. doi:10.3389/fimmu.2015.00261.
  • De Cock E, Kritikou P, Sandoval M, et al. (2016a). Time savings with rituximab subcutaneous injection versus rituximab intravenous infusion: a time and motion study in eight countries. PLoS One 11:e0157957. doi:10.1371/journal.pone.0157957.
  • De Cock E, Pivot X, Hauser N, et al. (2016b). A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Med 5:389–97. doi:10.1002/cam4.573.
  • Dicker KT, Gurski LA, Pradhan-Bhatt S, et al. (2014). Hyaluronan: a simple polysaccharide with diverse biological functions. Acta Biomater 10:1558–70. doi:10.1016/j.actbio.2013.12.019.
  • DuFort CC, DelGiorno KE, Carlson MA, et al. (2016). Interstitial pressure in pancreatic ductal adenocarcinoma is dominated by a gel-fluid phase. Biophys J 110:2106–19. doi:10.1016/j.bpj.2016.03.040.
  • Dychter SS, Gold DA, Haller MF. (2012). Subcutaneous drug delivery: a route to increased safety, patient satisfaction, and reduced costs. J Infus Nurs 35:154–60. doi:10.1097/NAN.0b013e31824d2271.
  • Finnigan N, Roberts J, Mercer J, Jones SA. (2018). Home infusion with Elosulfase alpha (VimizimR) in a UK Paediatric setting. Mol Genet Metab Rep 14:15–8. doi:10.1016/j.ymgmr.2017.10.012.
  • Frost GI. (2007). Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv 4:427–40. doi:10.1517/17425247.4.4.427.
  • Garidel P, Kuhn AB, Schafer LV, et al. (2017). High-concentration protein formulations: how high is high? Eur J Pharm Biopharm 119:353–60. doi:10.1016/j.ejpb.2017.06.029.
  • Genentech Inc. (2020). Highlights of Prescribing Information. PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, for subcutaneous use. https://www.gene.com/download/pdf/phesgo_prescribing.pdf [last accessed 23 March 2022].
  • Genentech Inc. (2021). Highlights of Prescribing Information RITUXAN HYCELA® (rituximab and hyaluronidase human) injection, for subcutaneous use. https://www.gene.com/download/pdf/rituxan_hycela_prescribing.pdf [last accessed 23 March 2022].
  • Halozyme, Inc. (2016). Highlights of Prescribing Information. HYLENEX recombinant (hyaluronidase human injection) for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, retrobulbar use, for soft tissue use and for subcutaneous use. https://hylenex.com/downloads/approved-uspi-lbl301feb2016.pdf [last accessed 23 March 2022].
  • Hanna KS, Segal EM, Barlow A, Barlow B. (2021). Clinical strategies for optimizing infusion center care through a pandemic. J Oncol Pharm Pract 27:165–79. doi:10.1177/1078155220960211.
  • Hunter J. (2008). Subcutaneous injection technique. Nurs Stand 22:41–4. doi:10.7748/ns2008.01.22.21.41.c6418.
  • Kang DW, Jadin L, Nekoroski T, et al. (2012). Recombinant human hyaluronidase PH20 (rHuPH20) facilitates subcutaneous infusions of large volumes of immunoglobulin in a swine model. Drug Deliv Transl Res 2:254–64. doi:10.1007/s13346-012-0065-3.
  • Knowles SP, Printz MA, Kang DW, et al. (2021). Safety of recombinant human hyaluronidase PH20 for subcutaneous drug delivery. Expert Opin Drug Deliv 18:1673–85. doi:10.1080/17425247.2021.1981286.
  • Laurent TC. (1972). The ultrastructure and physical-chemical properties of interstitial connective tissue. Pflugers Arch 336:Suppl:21–42. doi:10.1007/BF00586226.
  • Locke KW, Maneval DC, LaBarre MJ. (2019). ENHANZE® drug delivery technology: a novel approach to subcutaneous administration using recombinant human hyaluronidase PH20. Drug Deliv 26:98–106. doi:10.1080/10717544.2018.1551442.
  • Mahl JA, Vogel BE, Court M, et al. (2006). The minipig in dermatotoxicology: methods and challenges. Exp Toxicol Pathol 57:341–5. doi:10.1016/j.etp.2006.03.004.
  • McDonald TA, Zepeda ML, Tomlinson MJ, et al. (2010). Subcutaneous administration of biotherapeutics: current experience in animal models. Curr Opin Mol Ther 12:461–70.
  • Pivot X, Gligorov J, Muller V, et al. (2014). Patients’ preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study. Ann Oncol 25:1979–87. doi:10.1093/annonc/mdu364.
  • Polinski JM, Kowal MK, Gagnon M, et al. (2017). Home infusion: safe, clinically effective, patient preferred, and cost saving. Healthc (Amst) 5:68–80. doi:10.1016/j.hjdsi.2016.04.004.
  • Rummel M, Kim TM, Aversa F, et al. (2017). Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol 28:836–42. doi:10.1093/annonc/mdw685.
  • Shi GH, Connor RJ, Collins DS, Kang DW. (2021). Subcutaneous injection performance in yucatan miniature pigs with and without human hyaluronidase and auto-injector tolerability in humans. AAPS PharmSciTech 22:39. doi:10.1208/s12249-020-01880-0.
  • Supersaxo A, Hein WR, Steffen H. (1990). Effect of molecular weight on the lymphatic absorption of water-soluble compounds following subcutaneous administration. Pharm Res 7:167–9. doi:10.1023/a:1015880819328.
  • U.S. Food and Drug Administration. (2019). Highlights of Prescribing Information. HERCEPTIN HYLECTA™ (trastuzumab and hyaluronidase-oysk) injection, for subcutaneous use. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761106s000lbl.pdf [last accessed 23 March 2022].
  • U.S. Food and Drug Administration. (2014). Highlights of Prescribing Information. HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Solution, for subcutaneous use. https://www.fda.gov/media/89844/download [last accessed 23 March 2022].
  • U.S. Food and Drug Administration. (2020a). Highlights of Prescribing Information. DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) injection, for subcutaneous use. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf
  • U.S. Food and Drug Administration. (2020b). FDA approves breast cancer treatment that can be administered at home by health care professional. https://www.fda.gov/news-events/press-announcements/fda-approves-breast-cancer-treatment-can-be-administered-home-health-care-professional [last accessed 23 March 2022].
  • van den Bemt BJF, Gettings L, Domanska B, et al. (2019). A portfolio of biologic self-injection devices in rheumatology: how patient involvement in device design can improve treatment experience. Drug Deliv 26:384–92. doi:10.1080/10717544.2019.1587043.
  • Wasserman RL. (2014). Overview of recombinant human hyaluronidase-facilitated subcutaneous infusion of IgG in primary immunodeficiencies. Immunotherapy 6:553–67. doi:10.2217/imt.14.34.
  • Wright J, Jones G. (2017). Developing the subcutaneous drug delivery route. Med Res Arch 5. doi:10.18103/mra.v5i12.1652.
  • Wynne C, Harvey V, Schwabe C, et al. (2013). Comparison of subcutaneous and intravenous administration of trastuzumab: a phase I/Ib trial in healthy male volunteers and patients with HER2-positive breast cancer. J Clin Pharmacol 53:192–201. doi:10.1177/0091270012436560.