Inhaled insulin: A model for pulmonary systemic absorption?

Revue des Maladies Respiratoires

Volumn 27, Issue 8, 2010, Pages

  Becquemin, M H ^a   Chaumuzeau, J P ^b  

^a PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^b Soc de Pneumol de Langue Francaise   (France)

Author keywords

Insulin; Nebulisation; Pulmonary absorption

Indexed keywords

INSULIN;

BASEMENT MEMBRANE; COUGHING; DOSE RESPONSE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG EFFECT; DRUG FORMULATION; DRUG INDUSTRY; DRUG TRANSPORT; HUMAN; INSULIN RESISTANCE; LUNG ALVEOLUS EPITHELIUM; LUNG CIRCULATION; LUNG DISEASE; MOLECULAR WEIGHT; REVIEW; SMOKING; TRANSCYTOSIS; VASCULAR ENDOTHELIUM;

EID: 78649657055     PISSN: 07618425     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.rmr.2010.04.004     Document Type: Short Survey

References (109)

1. Banting FG, Best CH, Collip JB, Campbell J J R, Fletcher AA. Pancreatic extracts in the treatment of diabetes mellitus: preliminary report. Can Med Assoc J 1922;12:141-6.
2. Radermecker RP, Sélam JL. L'insuline inhalée, nouvelle perspective pour l'insulinothérapie. Rev Med Liege 2005;60:355-60.
3. Von Heubner W, de Jongh SE, Laquer E. Uber inhalation von insulin. Klin Wochenschrift 1924;51:2342-3.
4. Gansslen M. Uber inhalation von insulin. Klin Wochenschrift 1925;4:71.
5. Wigley FM, Londono JH, Scott MD, Wood SH, Shipp JC, Waldman RH. Insulin across respiratory mucosae by aerosol delivery. Diabetes 1971;20:552-6.
6. Gonda I, Byron PR. Perspectives on the biopharmacy of inhalation aerosols. Drug Dev Ind Pharm 1978;4:243-59.
7. Elliot RB, Edgar BW, Pilcher CC, Quested C, McMaster J. Parenteral absorption of insulin from the lung in diabetic children. Aust Paediatr J 1987;23:293-7.
8. Laube BL, Georgopoulos A, Adams GK. Preliminary study of the efficacy of insulin delivered by oral inhalation in diabetic subjects. JAMA 1987;269:2106-9.
9. Adjei A, Gupta PG. Inhalation delivery of therapeutic peptides and proteins. In: Marcel Dekker, editor. New York, 1997, p. 185-266.
10. Lenzer J. Inhaled insulin is approved in Europe and United States. BMJ 2006;332:321.
11. Insulin inhalation-Pfizer Nektar Therapeutics: HMR 4006, inhaled PEG-insulin-Nektar, PEGylated insuIin-Nektar. Drugs RD 2004;5:166-70.
12. Hrkach J, Batycky R, Chen D, Deaver D, Lloyd E, Kovalesky RA, et al. AIR insulin: complete diabetes therapy via inhalation of fast-acting and slow-acting dry powder aerosols. Diabetes 2000;49(Suppl. 1): A9.
13. Zambanini A, Newson RB, Maisey M, Feher MD. Injection related anxiety in insulin-treated diabetes. Diabetes Res Clin Pract 1999;46:239-46.
14. Korytkowski M. When ora1 agents fail: practical barriers to starting insulin. Int J Obesity 2002;26(Suppl. 3): S18-24.
15. Scheen A, Paquot N, Lefèbvre P. Perspectives concernant les voies inhabituelles de l'insuline: les voies orale, rectale et nasale. Ann Endocrinol 1988;49:386-90.
16. Cefalu William T. Concept, strategies, and feasibility of noninvasive insulin delivery. Diabetes Care 2004;27:239-46.
17. Owens DR. New horizons - alternative routes for insulin therapy. Nature Rev Drug Discov 2002;1:529-40.
18. Brange J, Langkjaer L. In protein delivery: physical systems. In: L. M. and Hendren, R. W. (eds Sanders). 1997. p. 343-412.
19. Weibel ER. Morphometry of the human lung. New York: Academic Press; 1963.
20. Stone KC, Mercer RR, Gehr P, Stockstill B, Crapo JD. Allometric relationships of cell numbers and size in the mammalian lung. Am Respir Cell Mol Biol 1992;6:235-43.
21. Shen Z, Zhang Q, Wei S, et al. Proteolytic enzymes as a limitation for pulmonary absorption of insulin: in vitro and in vivo investigations. Int J Pharm 1999;192(2):115-21.
22. Forbes B, Wilson C, Gumbleton M. Temporal dependence of ectopeptidase expression in alveolar epithelial cell culture, applications for the study of peptide absorption. Int J Pharm 1999;180:225-34.
23. Byron PR. Prediction of drug residence times in regions of the human respiratory tract following aerosol inhalation. J Pharm Sci 1986;75:433-9.
24. Patton JS. Mechanisms of macromolecule absorption by the lungs. Adv Drug Deliv Rev 1996;19:3-36.
25. Gorin AB, Stewart PA. DifferentiaI permeability of endothelial and epithelial barriers to albumin flux. J Appl Physiol Respir Environ Exercise Physiol 1979;47:1315-24.
26. Cevc G. Transfersomes, liposomes and other liquid suspensions on the skin: permeation enhancement vesicle penetration and transdermal drug delivery. Crit Rev Ther Drug Carrier Syst 1996;13:257-388.
27. Klonoff DC. Inhaled insulin. Diabetes Technol Ther 1999;1:307-13.
28. Laube BL, Benedict GW, Dobs AS. Time to peak insulin level, relative bioavailability and effect of site deposition of nebulized insulin in patients with non insulin-dependent diabetes mellitus. J Aerosol Med 1998;11:153-73.
29. Marks JD, Luce JM, Lazar NM, Ngao-Sun Wu J, Lipavsky A, Murray JF. Effect of increases in lung volume on clearance of aerosolized solute from human lungs. J Appl Physiol 1985;59:1242-8.
30. Boucher RC, Johnson J, Inoue S, Hulbert W, Hogg JC. The effect of cigarette smoke on the permeability of guinea pig airways. Lab Invest 1980;43:94-100.
31. Pan A, Chan C, Loh MT, Yeo KP, Muchmore D, Silverman B, et al. Effects of smoking (immediate and delayed), abstinence, nicotine replacement therapy and smoking resumption on pulmonary insulin pharmacokinetics and glucodynamics. Diabetes 2004;53: A112.
32. Himmelmann A, Jendle J, Mellen A, Petersen AH, Dahi UL, Wollmer P. The impact of smoking on inhaled insulin. Diabetes Care 2003;26:677-82.
33. Mason GR, Uszler JM, Effros RM, Reid E. Rapidly reversible alterations of pulmonary epithelial permeability induced by smoking. Chest 1983;83:6-11.
34. Henry RR, Mudaliar SR, Howland III WC, Chu N, Kim D, An B, Reinhardt RR. Inhaled insulin using the AERx insulin diabetes management system in healthy and asthmatic subjects. Diabetes Care 2003;26:764-9.
35. Heinemann L, Klappoth W, Rave K, et al. Intra-individual variability of the metabolic effect of inhaled insulin together with an absorption enhancer. Diabetes Care 2000;23:1343-7.
36. Hochman J, Artursson P. Mechanisms of absorption enhancement and tight junction regulation. J Control Release 1994;29:253-67.
37. Yamamoto A, Tanaka H, Okumura S, et al. Evaluation of insulin permeability and effects of absorption enhancers on its permeability by an in vitro pulmonary epithelial system using Xenopus pulmonary membrane. Biol Pharm Bull 2001;24(4):385-9.
38. Kellaway IW, Farr SJ. Liposomes as drug delivery systems to the lung. Adv Drug Deliv Rev 1990;5:149-61.
39. Patton JS, Platz RM. Pulmonary delivery of peptides and proteins for systemic action. Adv Drug Deliv Rev 1992;8:179-96.
40. Patton JS. Deep-lung delivery therapeutic proteins. Chemtech 1997;27(12):34-8.
41. Maestranda LD, Quattrin T. Clinical evaluation of inhaled insulin. Adv Drug Deliv Rev 2006;58:1061-75.
42. Patton JS, Bukar JG, Eldon MA. Clinical pharmacokinetics and pharmacodynamics of inhaled insulin. Clin Pharmacokinet 2004;43:781-801.
43. Rave K, Bott S, Heinemann L, Sha S, Becker HA, Willavize SA, et al. Time-action profile of inhaled insulin in comparison with subcutaneously injected insulin lispro and regular human insulin. Diabetes Care 2005;28:1077-82.
44. Sakagami M. Insulin deposition in the lung following oral inhalation in humans; a meta-analysis of its pharmacokinetics. Clin Pharmacokinet 2004;43:539-52.
45. Kohler D, Schluter KJ, Kerp L, et al. Nicht radioactives verfahren zur messung der lungenpermeabilitat: inhalation von insulin. Atemw Lungenkrkh 1987;13:230-2.
46. Brunner GA, Balent B, Ellmerer M, Schaupp L, Siebenhofer A, Jendle JH, et al. Dose-response relation of liquid aerosol inhaled insulin in type 1 diabetic patients. Diabetologia 2001;44:305-8.
47. Kim D, Mudaliar S, Plodkowski R, et al. Dose-response relationships of inhaled and subcutaneous insulin in type 2 diabetic patients (abstract). Diabetes 2002;51(Suppl. 2): A47.
48. Quattrin T, Bélanger A, Nancy JV, Bohannon N J V, Schwartz SL, for the Exubera Phase III Study Group. Efficacy and safety of inhaled insulin (Exubera) compared with subcutaneously insulin therapy in patients with type 1 diabetes. Diabetes Care 2004;27:2622-7.
49. Hollander PA, Blonde L, Rowe R, Mehta AE, Milburn JL, Hershon KS, et al. Efficacy and safety of inhaled insulin (Exubera) compared with subcutaneous insulin therapy in patients with type 2 diabetes. Diabetes Care 2004;27:2356-62.
50. Cefalu WT, Skyler JS, Kourides IA, Landschuls WH, Balagtas CC, Cheng S-L, et al. Inhaled human insulin treatment in patients with type 2 diabetes mellitus. Ann Intern Med 2001;134:203-7.
51. Henry RR, Mudaliar S, Chu N, Kim D, Annstrong D, Davis TT, et al. Young and elderly type 2 diabetie patients inhaling insulin with the AERx Insulin Diabetes Management System: a pharmacokinetic and pharmacodynamic comparison. J Clin Pharmacol 2003;43:1228-34.
52. Ceglia L, et al. Meta-analysis: efficacy and safety of inhaled insulin therapy with diabetes mellitus. Ann Int 2006;145:665-75.
53. Selam JL. Inhaled insulin for the treatment of diabetes: projects and devices. Expert Opin Pharmacother 2004;4:1373-7.
54. Gonda I. Systemic delivery of drugs to humans via inhalation. J Aerosol Med 2006;19:47-53.
55. Owens DR, Zinman B, Bolli G. Alternative routes of insulin delivery. Diabet Med 2003;20:886-98.
56. Skyler JS. Pulmonary insulin update. Diabetes Technol Ther 2005;7:834-9.
57. Patton JS. Unlocking the opportunity of tight glycaemic control. Innovative delivery of insulin via the lung. Diabetes Obes Metab 2005;7(Suppl. 1): S5-8.
58. Maggi L, Bruni R, Conte U. Influence of the moisture on the performance of a new dry powder inhaler. Int J Pharmaceutics 1999;177:83-91. (Pubitemid 29067429)
59. Corne J, Gillespie D, Roberts D, Younes M. Effect of inspiratory flow rate in intubated ventilated patients. Am J Resp Crit Care Med 1997;156:304-8.
60. White S, Bennett DB, Cheu S, Conley PW, Guzek DB, Gray S, et al. Exubera: pharmaceutical development of a novel product for pulmonary delivery of insulin. Diabetes Techno Ther 2005;7(6):896-906.
61. Skyler JS, Cefalu WT, Kourides IA, Landschulz WH, Balagtas CC, Cheng S-L, et al. Efficacy of inhaled human insulin in type 1 diabetes mellitus: a randomised proof-concept study. Lancet 2001;357:331-5.
62. Skyler JS, Weinstock RS, Raskin P, Yale J-F, Barrett E, Gerich E, et al. Use of inhaled insulin in a basal/bolus insulin regimen in type 1 diabetic subjects. Diabetes Care 2005;28:1630-5.
63. Heise T, Bott S, Tuser C, Stephan J-A, Kawabata T, Finco-Kent D, et al. The effect of insulin antibodies on the metabolic action of inhaled and subcutaneous insulin. Diabetes Care 2005;28:2161-9.
64. Rosenstock J, Zinman B, Murphy LJ, Clement SC, Moore P, Bowerind C, et al. Inhaled insulin improves glycemic control when substitutes for or added to oral combination therapy in type 2 diabetes. Ann Intern Med 2005;143:549-58.
65. Weiss SR, Cheng S-L, Kourides IA, Gelfand RA, Landschulz WH, for the Inhaled Insulin Phase II Study Group. Inhaled insulin provides improved glycemic control in patients with type 2 diabetes mellitus inadequately controlled with oral agents. Arch Intern Med 2003;163(19):2277-82.
66. Defronzo RA, Bergenstal RM, Cefalu WT, Pullman J, Lerman S, Bode BW, et al. Efficacy of inhaled insulin in patients with type 2 diabetes not controlled with diet and exercise. Diabetes Care 2005;28:1922-8.
67. Freemantle N, Blonde L, Duhot D, Hompesch M, Eggertsen R, Hobbs F D R, et al. Availability of inhaled insulin promotes greater perceived acceptance of insulin therapy in patients with type 2 diabetes. Diabetes Care 2005;28(2):427-28.
68. Rosenstock Julio, Cappelleri Joseph C, Bolinder Björn, Gerber Robert A. Patient satisfaction and glycemic control after 1 year with inhaled insulin (Exubera) in patients with type 1 or type 2 diabetes. Diabetes Care 2007;27:1318-23.
69. Pfutzner A, Mann SE, Steiner SS. Techno-sphere/Insulin: a new approach for effective delivery of human insulin via the pulmonary route. Diabetes Technol Ther 2002;4:589-94.
70. Rave KM, Heise T, Pfutzner A, Steiner S, Heinemann L. Results of a dose-response study with a new pulmonary insulin formulation and inhaler. Diabetes 2000;49(Suppl. 1): A7.
71. Steiner S, Pfutzner A, Wilson BR, Harzer O, Heinemann L, Rave K. Technosphere/Insulin: proof of concept study with a new insulin formulation for pulmonary delivery. Exp Clin Endocrinol Diabetes 2002;110:17-21.
72. Tarun K, Mandal. Inhaled insulin for diabetes mellitus. Am J Health-Syst Pharm 2005;62(13):1359-64.
73. Cryan S-A. Carrier-based strategies for targeting protein and peptide drugs to the lungs. AAPS Journal 2005;07(01):E20-41.
74. Edwards DA, Hanes J, Caponetti G, Hrkach J, Ben-Jebria A, Eskew ML, et al. Large porous particles for pulmonary drug delivery. Science 1997;276:1868-71. (Pubitemid 27443665)
75. Edwards DA, Ben-Jerbria A, Eskew ML, Langer R. Recent advances in pulmonary drug delivery using large, porous inhaled particles. J Appl Physiol 1998;85:379-85.
76. Garg S, Rosenstock J, Muchmore DB, De La Pena A, Sun B, Silverman B. The safety and efficacy of human insulin inhalation powder (HIIP) versus injectable insulin in patients with type 1 diabetes (T1D). Program and abstracts of the European Association for the Study of Diabetes 41st Annual Meeting September 12-15, 2005; Athens, Greece. Abstract 75.
77. Muchmore DB, Nosek L, De La Pena A, et al. Dose response of human insulin inhalation powder (HIIP) and dose equivalence to subcutaneous (SC) insulin lispro. Program and abstracts of the European Association for the Study of Diabetes 41st Annual Meeting September 12-15, 2005; Athens, Greece. Abstract 818.
78. Gonda I, Shuster J, Rubasamen R, et al. Inhalation delivery systems with compliance and disease management capabilities. J Contr Rel 1998;53:269-74.
79. Farr SJ, McElduff A, Mather LE, Okikawa J, Ward ME, Gonda I, et al. Pulmonary insulin administration using the AERxTM system: physiological and physiochemical factors influencing insulin effectiveness in healthy fasting subjects. Diabetes Technol Ther 2000;2:185-97.
80. Farr SJ, Warren SJ, Lloyd P, Okikawa JK, Schuster JA, Rowe AM, et al. Comparison of in vitro and in vivo efficiencies of a novel unit-dose aerosol generator and a pressurised metered dose inhaler. Int J Pharmacol 2000;198:63-70.
81. Sangwan S, Agosti JM, Bave LA, Otulana BA, Morishige RJ, Cipolla DC, et al. Aerosolized protein delivery in asthma: gamma camera analysis of regional deposition and perfusion. J Aerosol Med 2001;14:185-95.
82. Cramer JA, Okikawa J, Bellaire S, Clauson P. Compliance with inhaled insulin using the AERx IDMS insulin diabetes management system. Diabetes Technol Ther 2004;6(6):800-7.
83. Hermansen K, Ronnemaa T, Petersen AH, Bellaire S, Adamson U. Intensive therapy with inhaled insulin via the AERx insulin diabetes management system: a 12-week proof-ofconcept trial in patients with type 2 diabetes. Diabetes Care 2004;27(1):162-7.
84. Adamson U, Ronnemaa T, Petersen AH, Hermansen K. Inhaled human insulin via the AERx iDMS insulin diabetes management system in combination with NPH insulin offers the same metabolic control as intensive subcutaneous therapy: a proof of concept trial in type 2 diabetic patients. Diabetologia 2002;45(Suppl. 2): A255-6.
85. McElduff A, Clauson P, Uy C, Kam P, Mather LE. Pulmonary absorption profiles of insulin during and after an upper respiratory tract infection in healthy volunteers using the AERx insulin diabetes management system: an open labelled crossover study in healthy volunteers (Abstract). Diabetes 2002;51(Suppl. 2): A107.
86. Henry R, Mudaliar S, Howland HI, Chu N, Kim D, An B, et al. Pulmonary delivery of insulin using the AERxTM insulin diabetes management system in healthy and asthmatic subjects. Diabetologia 2001;44(Suppl. 1): A5.
87. Mellen A, Himmelmann A, Jendle J, Wollmer P. Pharmacokinetics and intra-patient variability of inhaled insulin in healthy smokers and non-smokers. Diabetes 2001;50(Suppl. 2): A126.
88. Fishman RS, Guinta D, Chambers F, Quintana R, Shapiro DA:. Insulin administration via the AerodoseTM inhaler: comparison to subcutaneously injected insulin. Diabetes 2000;49(Suppl. 1): A9.
89. Heinemann L, Kapitza C, Heise T, Shapiro DA, Gopalakrishnan V, Fishman RS. Impact of particle size and aerosolization time on the metabolic effect of an inhaled insulin aerosol. Diabetologia 2001;44(Suppl. 1): A5.
90. Perera AD, Kapitza C, Nosek L, Heinemann L, Shapiro DA, Fishman TC, et al. Reproducibility of inhaled and subcutaneous insulin in type 2 diabetic patients. Diabetologia 2001;44(Suppl. 1): A212.
91. Perera AD, Kapitza C, Nosek L, Fishman RS, Shapiro DA, Heise T, et al. Absorption and metabolic effect of inhaled insulin: intrapatient variability after inhalation via the Aerodose insulin inhaler in patients with type 2 diabetes. Diabetes Care 2002;25:2276-81.
92. Kim D, Mudallar S, Chinnapongse S, Chu N, et al. Doseresponse relationships of inhaled insulin delivered via the aerodose insulin inhaler and subcutaneously injected insulin in patients with type 2 diabetes. Diabetes Care 2003;26(10):2842-7.
93. Hausmann M, Dellweg S, Heinemann L, Buchwald A, Heise T. Add-on therapy with Kos inhaled insulin is as efficacious as add-on therapy with Lantus in poorly controlled type 2 diabetic patients treated with sulfonylureas or metformin. Program and abstracts of the European Association for the Study of Diabetes 41st Annual Meeting September 12-15, 2005; Athens, Greece. Abstract 817.
94. Hsia C C W, Raskin P. The diabetic lung: relevance of alveolar microangiopathy for use of inhaled insulin. Am Journal Med 2005;118:205-11.
95. Kida K, Utsuyama M, Takizawa T, Thurlbeck WM. Changes in lung morphologic features and elasticity cause by streptozotocin-induced diabetes mellitus in growing rats. Am Rev Respir Dis 1983;128:125-31.
96. Popov D, Simionescu M. Alterations of lung structure in experimental diabetes, and diabetes associated with hyperlipidaemia in hamsters. Eur Respir J 1997;10:1850-8.
97. Sandler M, Bunn AB, Stewart RI. Pulmonary function in young insulin-dependent diabetic subjects. Chest 1986;90:670-5.
98. Ramirez LC, Dal Nogare A, Hsia C C W, et al. Relationship between diabetes control and pulmonary function in insulin dependent diabetes mellitus. Am J Med 1991;91:371-6.
99. Skyler J, for the Exubera Phase II Study Group. Sustained long-term efficacy and safety of inhaled insulin during 4 years continuous therapy. Diabetes 2004;53: A115.
100. Fineberg SE, Kawabata T, Finco-Kent D, Liu C, Krasner A. Antibody response to inhaled insulin in patients type 1 or 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.
101. Odegard PS, Capoccia KL. Inhaled insulin: Exubera. Ann Pharmacother 2005;39:843-53.
102. Kennedy VB. Drug rivals to vie for share of inhaled-insulin market. In: Vol. 2005, www.investors.com. 2005.
103. Haire-Joshu D, Glasgow R, Tibbs T. Smoking and Diabetes. Diabetes Care 1999;22:1887-98.
104. Sayani AP, Chien YW. Systemic delivery of peptides and proteins across absorptive mucosae. Crit Rev Ther Drug Carrier Syst 1996;13(1-2): 85-184.
105. Gerber RA, Cappelleri JC, Kourides IA, Gelfand RA. Treatment satisfaction with inhaled insulin in patients with type 1 diabetes mellitus: a randomized controlled trial. Diabetes Care 2001;24:1556-9.
106. Cappelleri JC, Cefalu WT, Rosenstock J, Kourides IA, Gerber RA. Treatment satisfaction in type 2 diabetes: a comparison between an inhaled insulin regimen and a subcutaneous insulin regimen. Clin Ther 2002;24:552-64.
107. Editorial. Patient choice stops at inhaled insulin. Lancet 2006;367:1372.
108. Mayor S. Inhaled insulin no longer recommended as routine diabetes treatment. BMJ 2006;333:14.
109. Odegard PS, Capoccia KL. Inhaled Insulin: Exubera. Ann Pharmacother 2005;39(5):843-53.