Newer devices and improved formulations of inhaled insulin

Bibliography

• Diabetes Fact Sheet. Available from: http://www.who.int/mediacentre/factsheets/fs312/en/ [ Last accessed 6 June 2014]
   Google Scholar
• National Diabetes Statistics Report. 2014. Available from: http://www.cdc.gov/diabetes/pubs/statsreport14.htm [Last accessed 13 June 2014]
   Google Scholar
• IDF Diabtes Atlas. Available from: http://www.idf.org/sites/default/files/EN_6E_Atlas_Full_0.pdf [Last accessed 6 June 2014]
   Google Scholar
• Krentz AJ, Bailey CJ. Oral antidiabetic agents: current role in type 2 diabetes mellitus. Drugs 2005;65:385-411
   PubMed Web of Science ®Google Scholar
• Hampp C, Borders-Hemphill V, Moeny DG, Wysowski DK. Use of antidiabetic drugs in the U.S., 2003-2012. Diabetes Care 2014;37:1367-74
   PubMed Web of Science ®Google Scholar
• Wallia A, Molitch ME. Insulin therapy for type 2 diabetes mellitus. JAMA 2014;311:2315-25
   PubMed Web of Science ®Google Scholar
• Flood T. Advances in insulin delivery systems and devices: beyond the vial and syringe. Insulin 2006;1:99-108
   Google Scholar
• Fry A. Insulin delivery device technology 2012: where are we after 90 years? J Diabetes Sci Technol 2012;6:947-53
   PubMedGoogle Scholar
• Khafagy el S, Morishita M, Onuki Y, Takayama K. Current challenges in non-invasive insulin delivery systems: a comparative review. Adv Drug Deliv Rev 2007;59:1521-46
   PubMed Web of Science ®Google Scholar
• Lassmann-Vague V, Raccah D. Alternatives routes of insulin delivery. Diabetes Metab 2006;32:513-22
   PubMed Web of Science ®Google Scholar
• Sermet-Gaudelus I, Le Cocguic Y, Ferroni A, et al. Nebulized antibiotics in cystic fibrosis. Paediatr Drugs 2002;4:455-67
   PubMedGoogle Scholar
• Sung JC, Pulliam BL, Edwards DA. Nanoparticles for drug delivery to the lungs. Trends Biotechnol 2007;25:563-70
   PubMed Web of Science ®Google Scholar
• Patton JS, Platz RM. Penetration Enhancement for Polypeptides through Epithelia. D. Routes of Delivery - Case-Studies. 2. Pulmonary Delivery of Peptides and Proteins for Systemic Action. Adv Drug Deliver Rev 1992;8:179-96
   Web of Science ®Google Scholar
• Patton JS, Bukar JG, Eldon MA. Clinical pharmacokinetics and pharmacodynamics of inhaled insulin. Clin Pharmacokinet 2004;43:781-801
   PubMed Web of Science ®Google Scholar
• Heinemann L. New ways of insulin delivery. Int J Clin Pract 2010;29-40
   PubMedGoogle Scholar
• Renukuntla J, Vadlapudi AD, Patel A, et al. Approaches for enhancing oral bioavailability of peptides and proteins. Int J Pharm 2013;447:75-93
   PubMed Web of Science ®Google Scholar
• Patton JS. Mechanisms of macromolecule absorption by the lungs. Adv Drug Deliver Rev 1996;19:3-36
   Web of Science ®Google Scholar
• Byron PR. Prediction of drug residence times in regions of the human respiratory tract following aerosol inhalation. J Pharm Sci 1986;75:433-8
   PubMed Web of Science ®Google Scholar
• Martonen TB, Katz IM. Deposition patterns of aerosolized drugs within human lungs: effects of ventilatory parameters. Pharm Res 1993;10:871-8
   PubMed Web of Science ®Google Scholar
• Weibel ER. Morphometry of the human lung: the state of the art after two decades. Bull Eur Physiopathol Respir 1979;15:999-1013
   PubMedGoogle Scholar
• Newman SP, Agnew JE, Pavia D, Clarke SW. Inhaled aerosols: lung deposition and clinical applications. Clin Phys Physiol Meas 1982;3:1-20
   PubMedGoogle Scholar
• Labiris NR, Dolovich MB. Pulmonary drug delivery. Part I: physiological factors affecting therapeutic effectiveness of aerosolized medications. Br J Clin Pharmacol 2003;56:588-99
   PubMed Web of Science ®Google Scholar
• Ferron GA. Aerosol properties and lung deposition. Eur Respir J 1994;7:1392-4
   PubMed Web of Science ®Google Scholar
• Swift DL. Aerosols and humidity therapy. Generation and respiratory deposition of therapeutic aerosols. Am Rev Respir Dis 1980;122:71-7
   PubMed Web of Science ®Google Scholar
• Groneberg DA, Witt C, Wagner U, et al. Fundamentals of pulmonary drug delivery. Respir Med 2003;97:382-7
   PubMed Web of Science ®Google Scholar
• Patton JS, Byron PR. Inhaling medicines: delivering drugs to the body through the lungs. Nat Rev Drug Discov 2007;6:67-74
   PubMed Web of Science ®Google Scholar
• Insulin Basics. Available from: http://www.diabetes.org/living-with-diabetes/treatment-and-care/medication/insulin/insulin-basics.html [Last accessed 15 May 2014]
   Google Scholar
• Owens DR. New horizons--alternative routes for insulin therapy. Nat Rev Drug Discov 2002;1:529-40
   PubMed Web of Science ®Google Scholar
• Colledge NR, Walker BR, Ralston S, Davidson S. Davidson’s principles and practice of medicine. 22nd edition. Churchill Livingstone/Elsevier; Edinburgh; New York: 2010
   Google Scholar
• Laqueur E, Grevenstuk A. Über die Wirkung Intratrachealer Zuführung von Insulin. Klin Wochenschr 1924;3:1273-4
   Google Scholar
• Heubner W, de Jongh SE, Laquer E. Über inhalation von insulin. Klin Wochenschr 1925;3:2342-3
   Google Scholar
• Gänsslen M. Über inhalation von insulin. Klin Wochenschr 1925;4:71
   Google Scholar
• Wigley FW, Londono JH, Wood SH, et al. Insulin across respiratory mucosae by aerosol delivery. Diabetes 1971;20:552-6
   PubMed Web of Science ®Google Scholar
• Hickey AJ. Back to the future: inhaled drug products. J Pharm Sci 2013;102:1165-72
   PubMed Web of Science ®Google Scholar
• Heise T, Brugger A, Cook C, et al. PROMAXX inhaled insulin: safe and efficacious administration with a commercially available dry powder inhaler. Diabetes Obes Metab 2009;11:455-9
   PubMed Web of Science ®Google Scholar
• Mannkind Corporation. Available from: http://www.mannkindcorp.com/product-pipeline-diabetes-afrezza.htm [Last accessed 15 May 2014]
   Google Scholar
• US FDA News Release: FDA approves Afrezza to treat diabetes. Available from: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm403122.htm [Last accessed 27 June 2014]
   Google Scholar
• Dance Biopharm Inc. Available from: http://dancebiopharm.com/ [Last accessed 13 November 2014]
   Google Scholar
• Mendivil CO, Teeter JG, Finch GL, et al. Trough insulin levels in bronchoalveolar lavage following inhaled human insulin (Exubera) in patients with diabetes mellitus. Diabetes Technol Ther 2012;14:50-8
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Cefalu WT, Hollander PA, et al. Two-year pulmonary safety and efficacy of inhaled human insulin (Exubera) in adult patients with type 2 diabetes. Diabetes Care 2008;31:1723-8
   PubMed Web of Science ®Google Scholar
• Skyler JS, Jovanovic L, Klioze S, et al. Inhaled Human Insulin Type 1 Diabetes Study G. Two-year safety and efficacy of inhaled human insulin (Exubera) in adult patients with type 1 diabetes. Diabetes Care 2007;30:579-85
   PubMed Web of Science ®Google Scholar
• Davis SN. The role of inhaled insulin in the treatment of type 2 diabetes. J Diabetes Complications 2008;22:420-9
   PubMed Web of Science ®Google Scholar
• US FDA News Release: FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of Diabetes. Available from: http://www.fda.gov/newsevents/newsroom/pressannouncements/2006/ucm108585.htm [Last accessed 13 November 2014]
   Google Scholar
• Rave KM, Nosek L, de la Pena A, et al. Dose response of inhaled dry-powder insulin and dose equivalence to subcutaneous insulin lispro. Diabetes Care 2005;28:2400-5
   PubMed Web of Science ®Google Scholar
• Weiss SR, Cheng SL, Kourides IA, Inhaled Insulin Phase IISG. Inhaled insulin provides improved glycemic control in patients with type 2 diabetes mellitus inadequately controlled with oral agents: a randomized controlled trial. Arch Intern Med 2003;163:2277-82
   PubMed Web of Science ®Google Scholar
• Hollander PA, Blonde L, Rowe R, et al. Efficacy and safety of inhaled insulin (exubera) compared with subcutaneous insulin therapy in patients with type 2 diabetes: results of a 6-month, randomized, comparative trial. Diabetes Care 2004;27:2356-62
   PubMed Web of Science ®Google Scholar
• Profit L. Exubera((R)) (inhaled insulin): an evidence-based review of its effectiveness in the management of diabetes. Core Evid 2005;1:89-101
   PubMedGoogle Scholar
• Cefalu WT, Skyler JS, Kourides IA, et al. Inhaled human insulin treatment in patients with type 2 diabetes mellitus. Ann Intern Med 2001;134:203-7
   PubMed Web of Science ®Google Scholar
• DeFronzo RA, Bergenstal RM, Cefalu WT, et al. Efficacy of inhaled insulin in patients with type 2 diabetes not controlled with diet and exercise: a 12-week, randomized, comparative trial. Diabetes Care 2005;28:1922-8
   PubMed Web of Science ®Google Scholar
• Fineberg SE, Kawabata T, Finco-Kent D, et al. Antibody response to inhaled insulin in patients with type 1 or type 2 diabetes. An analysis of initial phase II and III inhaled insulin (Exubera) trials and a two-year extension trial. J Clin Endocrinol Metab 2005;90:3287-94
   PubMed Web of Science ®Google Scholar
• Heise T, Bott S, Tusek C, et al. The effect of insulin antibodies on the metabolic action of inhaled and subcutaneous insulin: a prospective randomized pharmacodynamic study. Diabetes Care 2005;28:2161-9
   PubMed Web of Science ®Google Scholar
• DeLong M, Wright J, Dawson M, et al. Dose delivery characteristics of the AIR pulmonary delivery system over a range of inspiratory flow rates. J Aerosol Med 2005;18:452-9
   PubMedGoogle Scholar
• Rosenstock J, Nakano M, Silverman BL, et al. Comparison of standard (self-directed) versus intensive patient training for the human insulin inhalation powder (HIIP) delivery system in patients with type 2 diabetes: efficacy, safety, and training measures. Diabetes Technol Ther 2007;9:80-8
   PubMed Web of Science ®Google Scholar
• Garg S, Rosenstock J, Silverman BL, et al. Efficacy and safety of preprandial human insulin inhalation powder versus injectable insulin in patients with type 1 diabetes. Diabetologia 2006;49:891-9
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Eliaschewitz FG, Heilmann CR, et al. Comparison of prandial AIR inhaled insulin alone to intensified insulin glargine alone and to AIR insulin plus intensified insulin glargine in patients with type 2 diabetes previously treated with once-daily insulin glargine. Diabetes Technol Ther 2009;11(Suppl 2):S63-73
   Google Scholar
• Ang E, Lawrence MK, Heilmann CR, et al. Safety and efficacy of AIR inhaled insulin compared with subcutaneous insulin in patients having diabetes and asthma: a 12-month, randomized, noninferiority trial. Diabetes Technol Ther 2009;11(Suppl 2):S35-44
   Google Scholar
• Gross JL, Nakano M, Colon-Vega G, et al. Initiation of prandial insulin therapy with AIR inhaled insulin or insulin lispro in patients with type 2 diabetes: a randomized noninferiority trial. Diabetes Technol Ther 2009;11(Suppl 2):S27-34
   PubMedGoogle Scholar
• Thipphawong J, Otulana B, Clauson P, et al. Pulmonary insulin administration using the AERx insulin diabetes system. Diabetes Technol Ther 2002;4:499-504
   PubMedGoogle Scholar
• Wollmer P, Pieber TR, Gall MA, Brunton S. Delivering needle-free insulin using AERx iDMS (insulin diabetes management system) technology. Diabetes Technol Ther 2007;9(Suppl 1):S57-64
   PubMedGoogle Scholar
• Brunner GA, Balent B, Ellmerer M, et al. Dose-response relation of liquid aerosol inhaled insulin in type I diabetic patients. Diabetologia 2001;44:305-8
   PubMed Web of Science ®Google Scholar
• Kohler D. Aerosols for systemic treatment. Lung 1990;168:677-84
   PubMed Web of Science ®Google Scholar
• Henry RR, Mudaliar SR, Howland WCIII, et al. Inhaled insulin using the AERx Insulin Diabetes Management System in healthy and asthmatic subjects. Diabetes Care 2003;26:764-9
   PubMed Web of Science ®Google Scholar
• McElduff A, Mather LE, Kam PC, Clauson P. Influence of acute upper respiratory tract infection on the absorption of inhaled insulin using the AERx insulin Diabetes Management System. Br J Clin Pharmacol 2005;59:546-51
   PubMed Web of Science ®Google Scholar
• Potocka E, Cassidy JP, Haworth P, et al. Pharmacokinetic characterization of the novel pulmonary delivery excipient fumaryl diketopiperazine. J Diabetes Sci Technol 2010;4:1164-73
   PubMedGoogle Scholar
• Richardson PC, Boss AH. Technosphere insulin technology. Diabetes Technol Ther 2007;9(Suppl 1):S65-72
   PubMedGoogle Scholar
• Angelo R, Rousseau K, Grant M, et al. Technosphere insulin: defining the role of Technosphere particles at the cellular level. J Diabetes Sci Technol 2009;3:545-54
   PubMedGoogle Scholar
• Pfutzner A, Mann AE, Steiner SS. Technosphere/Insulin – a new approach for effective delivery of human insulin via the pulmonary route. Diabetes Technol Ther 2002;4:589-94
   PubMedGoogle Scholar
• Dance Biopharm Announces Encouraging Clinical Data for Adagio™. – Inhalable Insulin Product Candidate for Diabetes. Available from: http://www.prnewswire.com/news-releases/dance-biopharm-announces-encouraging-clinical-data-for-adagio---inhalable-insulin-product-candidate-for-diabetes-219384281.html [Last accessed 13 November 2014]
   Google Scholar
• Rave K, Heise T, Heinemann L, Boss AH. Inhaled Technosphere insulin in comparison to subcutaneous regular human insulin: time action profile and variability in subjects with type 2 diabetes. J Diabetes Sci Technol 2008;2:205-12
   PubMedGoogle Scholar
• Owens DR, Zinman B, Bolli G. Alternative routes of insulin delivery. Diabet Med 2003;20:886-98
   PubMed Web of Science ®Google Scholar
• Al-Qadi S, Grenha A, Carrion-Recio D, et al. Microencapsulated chitosan nanoparticles for pulmonary protein delivery: in vivo evaluation of insulin-loaded formulations. J Control Release 2012;157:383-90
   PubMed Web of Science ®Google Scholar
• Patel LN, Wang J, Kim KJ, et al. Conjugation with cationic cell-penetrating peptide increases pulmonary absorption of insulin. Mol Pharm 2009;6:492-503
   PubMed Web of Science ®Google Scholar
• Li HY, Birchall J. Chitosan-modified dry powder formulations for pulmonary gene delivery. Pharm Res 2006;23:941-50
   PubMed Web of Science ®Google Scholar
• Amancha KP, Balkundi S, Lvov Y, Hussain A. Pulmonary sustained release of insulin from microparticles composed of polyelectrolyte layer-by-layer assembly. Int J Pharm 2014;466:96-108
   PubMed Web of Science ®Google Scholar
• Kamei N, Nielsen EJ, Khafagy el S, Takeda-Morishita M. Noninvasive insulin delivery: the great potential of cell-penetrating peptides. Ther Deliv 2013;4:315-26
   PubMedGoogle Scholar
• Sakagami M. Systemic delivery of biotherapeutics through the lung: opportunities and challenges for improved lung absorption. Ther Deliv 2013;4:1511-25
   PubMedGoogle Scholar
• Huang YY, Wang CH. Pulmonary delivery of insulin by liposomal carriers. J Control Release 2006;113:9-14
   PubMed Web of Science ®Google Scholar
• Rave K, Nosek L, Heinemann L, et al. Inhaled micronized crystalline human insulin using a dry powder inhaler: dose-response and time-action profiles. Diabet Med 2004;21:763-8
   PubMed Web of Science ®Google Scholar
• Muchmore DB, Silverman B, De La Pena A, Tobian J. The AIR inhaled insulin system: system components and pharmacokinetic/glucodynamic data. Diabetes Technol Ther 2007;9(Suppl 1):S41-7
   Google Scholar