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Original Research

Enabling faster subcutaneous delivery of larger volume, high viscosity fluids

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Pages 1165-1176 | Received 14 Jul 2022, Accepted 19 Aug 2022, Published online: 02 Sep 2022

References

  • Bittner B, Richter W, Schmidt J. Subcutaneous administration of biotherapeutics: an overview of current challenges and opportunities. BioDrugs. 2018 Oct;32(5):425–440.
  • Pivot X, Gligorov J, Muller V, et al. Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study. Lancet Oncol. 2013 Sep;14(10):962–970.
  • Stoner KL, Harder H, Fallowfield LJ, et al. Intravenous versus subcutaneous drug administration. Which do patients prefer? A systematic review. Patient. 2014 Jul 12. DOI:10.1007/s40271-014-0075-y.
  • Stewart D, Aucoin JS, Crosbie T, et al. Update on the subcutaneous administration of rituximab in Canadian cancer centres. Curr Oncol. 2020 Apr;27(2):113–116.
  • Usmani SZ, Mateos MV, Hungria V, et al. Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results. J Cancer Res Clin Oncol. 2021 Feb;147(2):619–631.
  • Overton PM, Shalet N, Somers F, et al. Patient preferences for subcutaneous versus intravenous administration of treatment for chronic immune system disorders: a systematic review. Patient Prefer Adherence. 2021;15:811–834.
  • Jin JF, Zhu LL, Chen M, et al. The optimal choice of medication administration route regarding intravenous, intramuscular, and subcutaneous injection. Patient Prefer Adherence. 2015;9:923–942.
  • Mateos MV, Nahi H, Legiec W, et al. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020 May;7(5):e370–e380.
  • Schreiber S, Ben-Horin S, Leszczyszyn J, et al. Randomized controlled trial: subcutaneous vs intravenous infliximab CT-P13 maintenance in inflammatory Bowel disease. Gastroenterology. 2021 Jun;160(7):2340–2353.
  • Salar A, Avivi I, Bittner B, et al. Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study. J Clin Oncol. 2014 Jun 10;32(17):1782–1791.
  • Marcucci G, Silverman L, Eller M, et al. Bioavailability of azacitidine subcutaneous versus intravenous in patients with the myelodysplastic syndromes. J Clin Pharmacol. 2005 May;45(5):597–602.
  • Merz M, Salwender H, Haenel M, et al. Subcutaneous versus intravenous bortezomib in two different induction therapies for newly diagnosed multiple myeloma: an interim analysis from the prospective GMMG-MM5 trial. Haematologica. 2015 Jul;100(7):964–969.
  • Stohl W, Schwarting A, Okada M, et al. Efficacy and safety of subcutaneous belimumab in systemic lupus erythematosus: a fifty-two-week randomized, double-blind, placebo-controlled study. Arthritis Rheumatol. 2017 May;69(5):1016–1027.
  • Badkar AV, Gandhi RB, Davis SP, et al. Subcutaneous delivery of high-dose/volume biologics: current status and prospect for future advancements. Drug Des Devel Ther. 2021;15:159–170.
  • Collins DS, Sanchez-Felix M, Badkar AV, et al. Accelerating the development of novel technologies and tools for the subcutaneous delivery of biotherapeutics. J Control Release. 2020 May 10;321:475–482.
  • Tornero Molina J, Lopez Robledillo JC, Casamira Ruiz N. Potential benefits of the self-administration of subcutaneous methotrexate with autoinjector devices for patients: a review. Drug Healthc Patient Saf. 2021;13:81–94.
  • Asche CV, Shane-McWhorter L, Raparla S. Health economics and compliance of vials/syringes versus pen devices: a review of the evidence. Diabetes Technol Ther. 2010 Jun;12(Suppl 1):S101–8.
  • Berteau C, Filipe-Santos O, Wang T, et al. Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance. Med Devices (Auckl). 2015;8:473–484.
  • Dias C, Abosaleem B, Crispino C, et al. Tolerability of high-volume subcutaneous injections of a viscous placebo buffer: a randomized, crossover study in healthy subjects. AAPS PharmSciTech. 2015 Oct;16(5):1101–1107.
  • Woodley WD, Morel DR, Sutter DE, et al. Clinical evaluation of large volume subcutaneous injection tissue effects, pain, and acceptability in healthy adults. Clin Transl Sci. 2022 Jan;15(1):92–104.
  • Woodley WD, Yue W, Morel DR, et al. Clinical evaluation of an investigational 5 mL wearable injector in healthy human subjects. Clin Transl Sci. 2021 May;14(3):859–869.
  • Heise T, Nosek L, Dellweg S, et al. Impact of injection speed and volume on perceived pain during subcutaneous injections into the abdomen and thigh: a single-centre, randomized controlled trial. Diabetes Obes Metab. 2014 Oct;16(10):971–976.
  • Zijlstra E, Jahnke J, Fischer A, et al. Impact of injection speed, volume, and site on pain sensation. J Diabetes Sci Technol. 2018 Jan;12(1):163–168.
  • Doughty DV, Clawson CZ, Lambert W, et al. Understanding subcutaneous tissue pressure for engineering injection devices for large-volume protein delivery. J Pharm Sci. 2016 Jul;105(7):2105–2113.
  • Collins DS, Kourtis LC, Thyagarajapuram NR, et al. Optimizing the bioavailability of subcutaneously administered biotherapeutics through mechanochemical drivers. Pharm Res. 2017 Oct;34(10):2000–2011.
  • Sequeira JAD, Santos AC, Serra J, et al. Subcutaneous delivery of biotherapeutics: challenges at the injection site. Expert Opin Drug Deliv. 2019 Feb;16(2):143–151.
  • Kinnunen HM, Mrsny RJ. Improving the outcomes of biopharmaceutical delivery via the subcutaneous route by understanding the chemical, physical and physiological properties of the subcutaneous injection site. J Control Release. 2014 May 28;182:22–32.
  • Weinhold T, Del Zotto M, Rochat J, et al. Improving the safety of disposable auto-injection devices: a systematic review of use errors. AAPS Open. 2018 Oct 18;4(1):7.
  • Schneider A, Mueller P, Jordi C, et al. Hold the device against the skin: the impact of injection duration on user’s force for handheld autoinjectors. Expert Opin Drug Deliv. 2020 Feb;17(2):225–236.
  • Zhang Q, Fassihi MA, Fassihi R. Delivery considerations of highly viscous polymeric fluids mimicking concentrated biopharmaceuticals: assessment of injectability via measurement of total work done “WT.” AAPS PharmSciTech. 2018 May;19(4):1520–1528.
  • Allmendinger A, Fischer S, Huwyler J, et al. Rheological characterization and injection forces of concentrated protein formulations: an alternative predictive model for non-Newtonian solutions. Eur J Pharm Biopharm. 2014 Jul;87(2):318–328.
  • Roberts BC, Rini C, Klug R, et al. Novel cannula design improves large volume auto-injection rates for high viscosity solutions. Drug Deliv. 2022 Dec;29(1):43–51.
  • Swindle MM, Makin A, Herron AJ, et al. Swine as models in biomedical research and toxicology testing. Vet Pathol. 2012 Mar;49(2):344–356.
  • Laurent PE, Pettis R, Easterbrook W, et al. Evaluating new hypodermic and intradermal injection devices. Med Device Technol. 2006 Mar;17(2):16–19.
  • OECD. Guidelines for the testing of chemicals, section 4, test no. 404: acute dermal irritation/corrosion. Paris France: OECD Publishing; 2015.
  • Kang DW, Oh DA, Fu GY, et al. Porcine model to evaluate local tissue tolerability associated with subcutaneous delivery of protein. J Pharmacol Toxicol Methods. 2013 May-Jun;67(3):140–147.
  • Agresti A. Categorical data analysis. 2nd ed. Hoboken, New Jersey: John Wiley & Sons, Inc. (Wiley Series in Probability and Statistics); 2002.
  • Allmendinger A, Fischer S. Tissue resistance during large-volume injections in subcutaneous tissue of minipigs. Pharm Res. 2020 Sep 4;37(10):184.
  • Shahriar M, Rewanwar A, Rohilla P, et al. Understanding the effect of counterpressure buildup during syringe injections. Int J Pharm. 2021 Jun 1;602:120530.
  • Watt RP, Khatri H, Dibble ARG. Injectability as a function of viscosity and dosing materials for subcutaneous administration. Int J Pharm. 2019 Jan 10;554:376–386.
  • Yildiz A, Lenau TA. In vitro simulation of tissue back-pressure for pen injectors and auto-injectors. J Pharm Sci. 2019 Aug;108(8):2685–2689.
  • Usach I, Martinez R, Festini T, et al. Subcutaneous injection of drugs: literature review of factors influencing pain sensation at the injection site. Adv Ther. 2019 Nov;36(11):2986–2996.
  • St Clair-Jones A, Prignano F, Goncalves J, et al. Understanding and minimising injection-site pain following subcutaneous administration of biologics: a narrative review. Rheumatol Ther. 2020 Dec;7(4):741–757.
  • Gradel AKJ, Porsgaard T, Lykkesfeldt J, et al. Factors affecting the absorption of subcutaneously administered insulin: effect on variability. J Diabetes Res. 2018;2018:1205121.
  • Shi GH, Connor RJ, Collins DS, et al. Subcutaneous injection performance in yucatan miniature pigs with and without human hyaluronidase and auto-injector tolerability in humans. AAPS PharmSciTech. 2021 Jan 6;22(1):39.
  • Rini C, Roberts BC, Morel D, et al. Evaluating the impact of human factors and pen needle design on insulin pen injection. J Diabetes Sci Technol. 2019 May;13(3):533–545.
  • Wang W. Tolerability of hypertonic injectables. Int J Pharm. 2015 Jul 25;490(1–2):308–315.
  • Shi GH, Pisupati K, Parker JG, et al. Subcutaneous injection site pain of formulation matrices. Pharm Res. 2021 May;38(5):779–793.
  • Graham S, Weinman J, Auyeung V. Identifying potentially modifiable factors associated with treatment non-adherence in paediatric growth hormone deficiency: a systematic review. Horm Res Paediatr. 2018;90(4):221–227.
  • Bolge SC, Goren A, Tandon N. Reasons for discontinuation of subcutaneous biologic therapy in the treatment of rheumatoid arthritis: a patient perspective. Patient Prefer Adherence. 2015;9:121–131.
  • Salaffi F, Di Carlo M, Farah S, et al. Adherence to subcutaneous anti-TNFalpha agents in patients with rheumatoid arthritis is largely influenced by pain and skin sensations at the injection site. Int J Rheum Dis. 2020 Apr;23(4):480–487.
  • Chabra S, Gill BJ, Gallo G, et al. Ixekizumab citrate-free formulation: results from two clinical trials. Adv Ther. 2022 Jun;39(6):2862–2872.
  • Thomaidou E, Ramot Y. Injection site reactions with the use of biological agents. Dermatol Ther. 2019 Mar;32(2):e12817.
  • Ionova Y, Wilson L, Mallela KMG. Biologic excipients: importance of clinical awareness of inactive ingredients. PLoS One. 2020;15(6):e0235076.
  • Yoshida T, Otaki Y, Katsuyama N, et al. New Adalimumab formulation associated with less injection site pain and improved motivation for treatment. Mod Rheumatol. 2019 Nov;29(6):949–953.