Performance characterization of spring actuated autoinjector devices for Emgality and Aimovig

References

• Collins DS, Kourtis LC, Thyagarajapuram NR, et al. Optimizing the bioavailability of subcutaneously administered biotherapeutics through mechanochemical drivers. Pharm Res. 2017;34(10):2000–2011. Springer New York LLC.
   PubMed Web of Science ®Google Scholar
• Jones GB, Collins DS, Harrison MW, et al. Subcutaneous drug delivery: an evolving enterprise. Sci Transl Med. 2017;9(405):eaaf9166.
   PubMed Web of Science ®Google Scholar
• Veilleux JC, Shepherd JE. Pressure and stress transients in autoinjector devices. Drug Deliv Transl Res. 2018;8(5):1238–1253.
   PubMed Web of Science ®Google Scholar
• Cilurzo F, Selmin F, Minghetti P, et al. Injectability evaluation: an open issue. AAPS PharmSciTech. 2011;12(2):604–609.
   PubMed Web of Science ®Google Scholar
• Burckbuchler V, Mekhloufi G, Giteau AP, et al. Rheological and syringeability properties of highly concentrated human polyclonal immunoglobulin solutions. Eur J Pharm Biopharm. 2010;76(3):351–356.
   PubMed Web of Science ®Google Scholar
• Randolph TW, Schiltz E, Sederstrom D, et al. Do not drop: mechanical shock in vials causes cavitation, protein aggregation, and particle formation. J Pharm. Sci. 2015;104(2):602–611.
   PubMed Web of Science ®Google Scholar
• Dammerman R, Mead J. User acceptance of a prefilled auto‐injector device for erenumab in patients with migraine. 61st Annual Science Meet American Headache Society. Philadelphia, PA: Pennsylvania Convention Center; 2019. p. P266LB.
   Google Scholar
• Stauffer VL, Sides R, Lanteri-Minet M, et al. Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies. Patient Prefer Adher. 2018;12:1785–1795.
   Web of Science ®Google Scholar
• Guerlain S, Hugine A, Wang L. A comparison of 4 epinephrine autoinjector delivery systems: usability and patient preference. Ann Allergy Asthma Immunol. 2010;104(2):172–177.
   Web of Science ®Google Scholar
• Hey-Hadavi J, Pleil A, Deeb LC, et al. Ease of use and preference for a new disposable self-injection pen compared with a reusable pen for administering recombinant human growth hormone: A multicenter, 2-Month, single-arm, open-label clinical trial in patient-caregiver dyads. Clin Ther. 2010;32(12):2036–2047.
   Google Scholar
• Xiao X, Li W, Clawson C, et al. Evaluation of performance, acceptance, and compliance of an auto-injector in healthy and rheumatoid arthritic subjects measured by a motion capture system. Patient Prefer Adher. 2018;12:515–526.
   Web of Science ®Google Scholar
• Schneider AE, Lange J. Pen devices for self-injection: contrasting measured injection force with users’ perceived ease of injection. Expert Opin Drug Deliv. 2018;15(2):115–125.
   PubMed Web of Science ®Google Scholar
• Brand-Schieber E, Munjal S, Kumar R, et al. Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients. Med Devices. 2016;9:131–137.
   Google Scholar
• French DL, Collins JJ. Advances in parenteral injection devices and aids. In Nema S, Ludwig JD, editors. Pharmaceutical dosage forms-parenteral medications. Boca Raton, FL: CRC Press; 2016. p. 85–99.
   Google Scholar
• Thompson I, Lange J. Pen and autoinjector drug delivery devices. In Sterile product development. New York, NY: Springer; 2013. p. 331–356.
   Google Scholar
• Eli Lilly and Company. Highlights of prescribing information for Emgality. 2019. Available from: https://pi.lilly.com/us/emgality-uspi.pdf
   Google Scholar
• Amgen Inc. Highlights of prescribing information for Aimovig. 2019. Available from: https://www.pi.amgen.com/∼/media/amgen/repositorysites/pi-amgen-com/aimovig/aimovig_pi_hcp_english.ashx
   Google Scholar
• McGill R, Tukey JW, Larsen WA. Variations of box plots. Am Stat. 1978;32(1):12–16.
   Web of Science ®Google Scholar
• Velleman PF, Hoaglin DC. Applications, basics, and computing of exploratory data analysis. Pacific Grove, CA: Duxbury Press; 1981.
   Google Scholar
• Kutner MH. Applied linear statistical models. 5th ed. In Nachtsheim C, Neter J, Li W, editors;. New York, NY: McGraw-Hill/Irwin; 2005.
   Google Scholar
• Frew AJ. What are the “ideal” features of an adrenaline (epinephrine) auto-injector in the treatment of anaphylaxis? Eur J Allergy Clin Immunol. 2011;66(1):15–24.
   Google Scholar
• Watt RP, Khatri H, Dibble ARG. Injectability as a function of viscosity and dosing materials for subcutaneous administration. Int J Pharm. 2019;554:376–386.
   PubMed Web of Science ®Google Scholar
• Van Der Burg T. Injection force of SoloSTAR compared with other disposable insulin pen devices at constant volume flow rates. J Diabetes Sci Technol. 2011;5(1):150–155.
   PubMedGoogle Scholar
• Clarke A, Spollett G. Dose accuracy and injection force dynamics of a novel disposable insulin pen. Expert Opin Drug Deliv. 2007;4(2):165–174.
   PubMed Web of Science ®Google Scholar
• Ignaut DA, Opincar M, Lenox S. FlexPen and KwikPen prefilled insulin devices: a laboratory evaluation of ergonomic and injection force characteristics. J Diabetes Sci Technol. 2008;2(3):533–537.
   PubMedGoogle Scholar
• Simons FER, Gu X, Simons KJ. Epinephrine absorption in adults: intramuscular versus subcutaneous injection. J Allergy Clin Immunol. 2001;108(5):871–873.
   Web of Science ®Google Scholar
• Dreborg S, Kim L, Tsai G, et al. Epinephrine auto-injector needle lengths: can both subcutaneous and periosteal/intraosseous injection be avoided? Ann Allergy Asthma Immunol. 2018;120(6):648–653.e1.
   Web of Science ®Google Scholar
• Van Mulder TJS, de Koeijer M, Theeten H, et al. High frequency ultrasound to assess skin thickness in healthy adults. Vaccine. 2017;35(14):1810–1815.
   PubMed Web of Science ®Google Scholar
• Derraik JGB, Rademaker M, Cutfield WS, et al. Effects of age, gender, BMI, and anatomical site on skin thickness in children and adults with diabetes. PLOS One. 2014;9(1):e86637.
   PubMed Web of Science ®Google Scholar
• Hirsch L, Byron K, Gibney M. Intramuscular risk at insulin injection sites-measurement of the distance from skin to muscle and rationale for shorter-length needles for subcutaneous insulin therapy. Diabetes Technol Ther. 2014;16(12):867–873.
   Web of Science ®Google Scholar
• Gibney MA, Arce CH, Byron KJ, et al. Skin and subcutaneous adipose layer thickness in adults with diabetes at sites used for insulin injections: implications for needle length recommendations. Curr Med Res Opin. 2010;26(6):1519–1530.
   Web of Science ®Google Scholar