Needle-free nasal delivery of glucagon for treatment of diabetes-related severe hypoglycemia: toxicology of polypropylene resin used in delivery device

References

• International Diabetes Federation. Diabetes: facts and figures. Available from: https://www.idf.org/worlddiabetesday/toolkit/gp/facts-figures [last accessed 8 Jun 2015]
   Google Scholar
• Pontiroli AE. Intranasal glucagon: a promising approach for treatment of severe hypoglycemia. J Diabetes Sci Technol 2015;9:38–43
   PubMedGoogle Scholar
• Ford W, Self WH, Slovis C, McNaughton CD. Diabetes in the emergency department and hospital: acute care of diabetes patients. Curr Emerg Hosp Med Rep 2013;1:1–9
   PubMedGoogle Scholar
• Harris G, Diment A, Sulway M, Wilkinson M. Glucagon administration – underevaluated and undertaught. Pract Diabetes Int 2001;18:22–25
   Google Scholar
• Pontiroli AE, Alberetto M, Pozza G. Intranasal glucagon raises blood glucose concentrations in healthy volunteers. Br Med J (Clin Res Ed) 1983;287:462–463
   PubMed Web of Science ®Google Scholar
• Slama G, Alamowitch C, Desplanque N, et al. A new non-invasive method for treating insulin-reaction: intranasal lyophylized glucagon. Diabetologia 1990;33:671–674
   PubMed Web of Science ®Google Scholar
• Teshima D, Yamauchi A, Makino K, et al. Nasal glucagon delivery using microcrystalline cellulose in healthy volunteers. Int J Pharm 2002;233:61–66
   PubMed Web of Science ®Google Scholar
• Freychet L, Rizkalla SW, Desplanque N, et al. Effect of intranasal glucagon on blood glucose levels in healthy subjects and hypoglycaemic patients with insulin-dependent diabetes. Lancet 1988;1:1364–1366
   PubMed Web of Science ®Google Scholar
• Pontiroli AE, Calderara A, Pajetta E, et al. Intranasal glucagon as remedy for hypoglycemia. Studies in healthy subjects and type I diabetic patients. Diabetes Care 1989;12:604–608
   PubMed Web of Science ®Google Scholar
• Slama G, Reach G, Cahane M, et al. Intranasal glucagon in the treatment of hypoglycaemic attacks in children: experience at a summer camp. Diabetologia 1992;35:398
   PubMed Web of Science ®Google Scholar
• Rosenfalck AM, Bendtson I, Jørgensen S, Binder C. Nasal glucagon in the treatment of hypoglycaemia in type 1 (insulin-dependent) diabetic patients. Diabetes Res Clin Pract 1992;17:43–50
   PubMed Web of Science ®Google Scholar
• Stenninger E, Åman J. Intranasal glucagon treatment relieves hypoglycaemia in children with type 1 (insulin-dependent) diabetes mellitus. Diabetologia 1993;36:931–935
   PubMed Web of Science ®Google Scholar
• Hvidberg A, Djurup R, Hilsted J. Glucose recovery after intranasal glucagon during hypoglycaemia in man. Eur J Clin Pharmacol 1994;46:15–17
   PubMed Web of Science ®Google Scholar
• Boido A, Ceriani V, Pontiroli AE. Glucagon for hypoglycemic episodes in insulin-treated diabetic patients: a systematic review and meta-analysis with a comparison of glucagon with dextrose and of different glucagon formulations. Acta Diabetol 2015;52:405–412
   PubMed Web of Science ®Google Scholar
• Yanai O, Pilpel D, Harman I, et al. IDDM patients’ opinions on the use of Glucagon Emergency Kit in severe episodes of hypoglycemia. Pract Diabetes Int 1997;14:40–42
   Google Scholar
• Labiris NR, Dolovich MB. Pulmonary drug delivery. Part I: physiological factors affecting therapeutic effectiveness of aerosolized medications. Br J Clin Pharmacol 2003;56:588–599
   PubMed Web of Science ®Google Scholar
• FDA Guidance, Use of International Standard ISO-10993. “Biological Evaluation of Medical Devices Part-1. Evaluation and Testing” Draft Guidance for Industry and Food and Drug Administration Staff. Available from: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm348890.pdf [last accessed 20 Apr 2015]
   Google Scholar
• ANSI/AAMI/ISO 10993-1:2009/(R)2013. Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. Available from: https://my.aami.org/store/detail.aspx?id = 1099301 [last accessed 20 Apr 2015]
   Google Scholar
• ANSI/AAMI/ISO 10993-5:2009/(R)2014. Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity. Available from: http://my.aami.org/store/detail.aspx?id = 1099305 [last accessed 20 Apr 2015]
   Google Scholar
• ANSI/AAMI/ISO 10993-12:2012. Biological evaluation of medical devices – Part 12: Sample preparation and reference materials. Available from: http://www.iso.org/iso/catalogue_detail.htm?csnumber = 53468 [last accessed 20 Apr 2015]
   Google Scholar
• ANSI/AAMI/ISO 10993-10:2010/(R)2014. Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization. Available from: http://www.iso.org/iso/catalogue_detail?csnumber = 40884 [last accessed 20 Apr 2015]
   Google Scholar
• Draize JH. “Dermal Toxicity” in “Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics”. Austin (TX): Association of Food and Drug Officials of the United States; 1959:46–59
   Google Scholar
• Cariou B, Fontaine P, Eschwege E, et al. Frequency and predictors of confirmed hypoglycaemia in type 1 and insulin-treated type 2 diabetes mellitus patients in a real-life setting: results from the DIALOG study. Diabetes Metab 2015;41:116–125
   PubMed Web of Science ®Google Scholar
• Edridge CL, Dunkley AJ, Bodicoat DH, et al. Prevalence and incidence of hypoglycaemia in 532,542 people with type 2 diabetes on oral therapies and insulin: a systematic review and meta-analysis of population based studies. PLoS One 2015;10:e0126427
   PubMed Web of Science ®Google Scholar
• Liatis S, Mylona M, Kalopita S, et al. Hypoglycaemia requiring medical assistance in patients with diabetes: a prospective multicentre survey in tertiary hospitals. Diabetes Metab 2015;41:126–131
   PubMed Web of Science ®Google Scholar
• Lagast H, Tomenson J, Stringer DA. Polypropylene production and colorectal cancer: a review of the epidemiological evidence. Occup Med (Lond) 1995;45:69–74
   PubMed Web of Science ®Google Scholar
• Atis S, Tutluoglu B, Levent E, et al. The respiratory effects of occupational polypropylene flock exposure. Eur Respir J 2005;25:110–117
   PubMed Web of Science ®Google Scholar
• Hesterberg TW, McConnell EE, Miller WC, et al. Pulmonary toxicity of inhaled polypropylene fibers in rats. Fundam Appl Toxicol 1992;19:358–366
   PubMedGoogle Scholar