Is relief from diabetes just a breath away...?

Current Drug Delivery

Volumn 6, Issue 2, 2009, Pages 166-173

  Passey, Chaitali ^a   Bhardwaj, Sunny Piyush ^a   Majumdar, Dipak K ^a,b  

^a UNIVERSITY OF DELHI   (India)

^b UNIVERSITY OF MINNESOTA   (United States)

Author keywords

Diabetes; DPI; Exubera ; Inhalation; Insulin; Lung disease

Indexed keywords

RECOMBINANT HUMAN INSULIN;

AEROSOL; CLINICAL TRIAL; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG STABILITY; DRUG TOLERABILITY; HUMAN; INHALER; INSULIN DEPENDENT DIABETES MELLITUS; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; REVIEW; TREATMENT RESPONSE;

ADMINISTRATION, INHALATION; AEROSOLS; BIOLOGICAL AVAILABILITY; CLINICAL TRIALS AS TOPIC; DIABETES MELLITUS; DRUG DELIVERY SYSTEMS; DRUG STABILITY; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; LUNG DISEASES; NEBULIZERS AND VAPORIZERS; SMOKING; TREATMENT OUTCOME;

EID: 66749158032     PISSN: 15672018     EISSN: None     Source Type: Journal    
DOI: 10.2174/156720109787846216     Document Type: Review

References (81)

1. Guyton, A.C.; Hall, J.E. Textbook of Medical Physiology, W.B. Saunders Company: Philadelphia, 1996.
2. Waugh, A.; Grant, A. Anatomy and Physiology in Health and Illness, Churchill Livingstone: London, 2001.
3. Suarez, S.; Hickey, A.J. Drug properties affecting aerosol behavior. Resp. Care., 2000, 45, 652-66.
4. Owens, D.R.; Zinman, B.; Bolli, G. Alternative routes of insulin delivery. Diabet. Med., 2003, 20, 886-98.
5. Newhouse, M.T. Tennis anyone? The lungs as a new court for systemic therapy. CMAJ, 1999, 161, 1287-8.
6. Heinemann, L.; Pfutzner, A.; Heise, T. Alternative routes of administration as an approach to improve insulin therapy: Update on dermal, oral, nasal and pulmonary insulin delivery. Curr. Pharm. Des., 2001, 7, 1327-51.
7. Ghilzai, N.M.K. New developments in insulin delivery. Drug Dev. Ind. Pharm., 2003, 29, 253-65.
8. Skyler, J.S.; Cefalu, W.T.; Kourides, I.A.; Landschulz W.H.; Balagtas, C.C.; Cheng, S.L.; Gelfand, R.A. Efficacy of inhaled human insulin in type 1 diabetes mellitus: A randomized proof-of-concept study. Lancet, 2001, 357, 331-5.
9. Laube, B.L. Treating diabetes with aerosolized insulin. Chest, 2001, 120, 99-106.
10. Schlesinger, R.B. Clearance from the respiratory tract. Fundam. Appl. Toxicol., 1985, 5, 435-50.
11. Carpenter, R.L. Aerosol deposition modeling using ACSL. Drug Chem. Toxicol., 1999, 22, 73-90.
12. O'Doherty, M.J.; Miller R.F. Aerosols for therapy and diagnosis. Eur. J. Nucl. Med., 1993, 20, 1201-13.
13. Gibaldi, M. Biopharmaceutics and Clinical Pharmacokinetics, Lea & Febiger: Philadelphia, 1984.
14. Klonoff, D.C. Inhaled insulin. Diabetes Technol. Ther., 1999, 1, 307-13.
15. Patton, J.S.; Fishburn C.S.; Weers, J.G. The lungs as a portal of entry for systemic drug delivery. Proc. Am. Thorac. Soc., 2004, 1, 338-44.
16. Schou, J. Absorption of drugs from subcutaneous connective tissue. Pharmacol. Rev., 1961, 13, 441-64.
17. Charman, S.A.; McLennan, D.N.; Edwards, G.A.; Porter, C.J.H. Lymphatic absorption is a significant contributor to the subcutaneous bioavailability of insulin in a sheep model. Pharm. Res., 2001, 18, 1620-26.
18. Mandal, T.K. Inhaled insulin for diabetes mellitus. Am. J. Health-Syst. Pharm., 2005, 62, 1359-64.
19. Belmin, J.; Valensi, P. Novel drug delivery systems for insulin: Clinical potential for use in the elderly. Drugs Aging, 2003, 20, 303-12.
20. DeVries, J.H. Mealtime inhaled insulin lowers fasting glucose: A look at possible explanations. Diabetologia, 2005, 48, 2682-83.
21. Cefalu, W.T.; Skyler, J.S.; Kourides, I.A.; Landschulz, W.H.; Balagtas, C.C.; Cheng, S.; Gelfand, R.A. Inhaled human insulin treatment in patients with type 2 diabetes mellitus. Ann. Intern. Med., 2001, 134, 203-07.
22. White, J.R.; Campbell, R.K. Inhaled insulin: An overview. Clin. Diabetes, 2001, 19, 13-16.
23. Gonda, I. Systemic delivery of drugs to humans via inhalation. J. Aerosol Med., 2006, 19, 47-53.
24. Barnett, A.H.; Lange, P.; Dreyer, M.; Serdarevic-Pehar, M. Longterm tolerability of inhaled human insulin (Exubera) in patients with poorly controlled type 2 diabetes. Int. J. Clin. Pract., 2007, 61, 1614-25.
25. Sadrzadeh, N.; Glembourtt, M.J.; Stevenson, C.L. Peptide drug delivery strategies for the treatment of diabetes. J. Pharm. Sci., 2007, 96, 1925-54.
26. Shoyele, S.A.; Slowey, A. Prospects of formulating proteins/peptides as aerosols for pulmonary drug delivery. Int. J. Pharm., 2006, 314, 1-8.
27. White, S.; Bennett, D.B.; Cheu, S.; Conley, P.W.; Guzek, D.B.; Gray, S.; Howard, J.; Malcolmson, R.; Parker, J.M.; Sadrzadeh, N.; Schumacher, J.D.; Seshadri, S.; Sluggett, G.W.; Stevenson, C.L.; Harper, N.J. Exubera: Pharmaceutical development of a novel product for pulmonary insulin delivery. Diabetes Technol. Ther., 2005, 7, 896-906.
28. McMahon, G.T.; Arky, R. A. Inhaled insulin for diabetes mellitus. N. Engl. J. Med., 2007, 356, 497-502.
29. Hermansen, K.; Ronnemma, T.; Petersen, A.H.; Bellaire, S.; Adamson, U. Intensive therapy with inhaled insulin via the AERx insulin diabetes management system: a 12-week proof-of-concept trial in patients with type 2 diabetes. Diabetes Care, 2004, 27, 162-67.
30. nd; Heinemann, L; Batycky, R.P.; Muchmore, D.B. Dose response of inhaled dry-powder insulin and dose equivalence to subcutaneous insulin lispro. Diabetes Care, 2005, 28, 2400-05.
31. Hancock, B.C.; Shamblin, S.L.; Zografi, G. Molecular mobility of amorphous pharmaceutical solids below their glass transition temperatures. Pharm. Res., 1995, 12, 799-806.
32. Franks, F.; Hartley, R.H.M.; Mathias, S.F. Materials science and the production of shelf-stable biologicals. Pharm. Technol. Int., 1991, 3, 24-34.
33. Lechuga-Ballesteros, D.; Kuo, M.; Liang, Y.; Malcolmson, R.; Miller, D.; Sekulic, S.; Seshadri, S.; Stults, C.; Tan, T.; Joshi, V.; Zhen, C.; Williams, L.; Bennett, D. The physical stability of insulin powder for inhalation. AAPS J., 2004, 6.
34. [34] Pikal, M.J.; Rigsbee, D.R. The stability of insulin in crystalline and amorphous solids: observation of greater stability for the amorphous form. Pharm. Res., 1997, 14, 1379-87.
35. Wright, J. Overview of protein formulation and delivery. Clin. Res. Reg. Affairs., 2001, 18, 215-18.
36. Harper, N.J.; Gray, S.; De Groot, J.; Parker, J.M.; Sadrzadeh, N.; Schuler, C.; Schumacher, J.D.; Seshadri, S.; Smith, A.E.; Steeno, G.S.; Stevenson, C.L.; Taniere, R.; Wang, M.; Bennett, D.B. The design and performance of the Exubera pulmonary insulin delivery system. Diabetes Technol. Ther., 2007, 9, S-16-27.
37. You, Y.; Zhao, M.; Liu, G.; Tang, X. Physical characteristics and aerosolization performance of insulin dry powders for inhalation prepared by a spray-drying method. J. Pharm. Pharmacol., 2007, 59, 927-34.
38. McCarthy A.A. New approaches to diabetes disease control, insulin delivery, and monitoring. Chem. Biol., 2004, 11, 1597-8.
39. Li, S.; Schoneich, C.; Borchardt, R.T. Protein characterization and quality control. Chemical instability of protein pharmaceuticals: Mechanisms of oxidation and strategies for stabilization. Biotechnol. Bioeng., 1995, 48, 490-500.
40. Lechuga-Ballesteros, D.; Charan, C.; Stults, C.L.; Stevenson, C.L.; Miller, D.P.; Vehring, R.; Tep, V.; Kuo, M.C. Trileucine improves aerosol performance and stability of spray-dried powders for inhalation. J. Pharm. Sci., 2008, 97, 287-302.
41. Edwards, D.A.; Ben-Jebria, A.; Langer, R. Recent advances in pulmonary drug delivery using large, porous inhaled particles. J. Appl. Physiol., 1998, 85, 379-85.
42. Patton, J.S.; Bukar, J.G.; Eldon, M.A. Clinical pharmacokinetics and pharmacodynamics of inhaled insulin. Clin. Pharmacokinet., 2004, 43, 781-801.
43. Groneberg, D.A.; Witt, C.; Wagner, U.; Chung, K.F.; Fischer, A. Fundamentals of pulmonary drug delivery. Respir. Med., 2003, 97, 382-7.
44. Amidon, G.L.; Lee, H.J. Absorption of peptide and peptidomimetic drug. Annu. Rev. Pharmacol. Toxicol., 1994, 34, 321-41.
45. Ganderton, D. General factors influencing drug delivery to the lung. Respir. Med. 1997, 91, 13-16.
46. Patton, J.S. Deep-lung delivery of therapeutic proteins. Chemtech, 1997, 27, 34-38.
47. Laube, B.L.; Benedict, G.W.; Dobs, A.S. The lung as an alternative route of delivery for insulin in controlling post-prandial glucose levels in patients with diabetes. Chest, 1998, 114, 1734-39.
48. Dolovich, M; Ruffin, R.E.; Roberts, R; Newhouse, M.T. Optimal delivery of aerosols from metered dose inhalers. Chest, 1981, 80, 911-15.
49. Pedersen, S.; Mortensen, S. Use of different inhalation devices in children. Lung, 1990, 168, 653-57.
50. Batenburg, J.J. Surfactant phospholipids-synthesis and storage. Am. J. Physiol., 1992, 262, L367-85.
51. Miyamura, K.; Malhotra, R.; Hoppe, H.J.; Reid, K.B.; Phizackerley, P.J.; Macpherson, P.; Lopez Bernal, A. Surfactant proteins A (SP-A) and D (SP-D): levels in human amniotic fluid and localization in the fetal membranes. Biochim. Biophys. Acta, 1994, 1210, 303-07.
52. 99mTc-DTPA: Effects of surfactant depletion by lung lavage. J. Appl. Physiol., 1987, 62, 1611-14.
53. 99mTc-DTPA: Effects of surfactant depletion in rabbits. Clin. Physiol., 1986, 6, 85-89.
54. Griese, M. Pulmonary surfactant in health and human lung diseases: State of the art. Eur. Respir. J., 1999, 13, 1455-76.
55. Jeffrey, P.K. The origins of secretions in the lower respiratory tract. Eur. J. Respir. Dis. Suppl., 1987, 153, 34-42.
56. Becker, R. H.; Sha, S; Frick, A.D.; Fountaine, R.J. The effect of smoking cessation and subsequent resumption on absorption of inhaled insulin. Diabetes Care, 2006, 29, 277-82.
57. Himmelmann, A.; Jendle, J.; Mellen, A.; Petersen, A.H.; Dahl, U.L.; Wollmer, P. The impact of smoking on inhaled insulin. Diabetes Care, 2003, 26, 677-82.
58. Rave, K.; de la Pena, A.; Tibaldi, F.S.; Zhang, L.; Silverman, B.; Hausmann, M.; Heinemann, L.; Muchmore, D.B. AIR inhaled insulin in subjects with chronic obstructive pulmonary disease: pharmacokinetics, glucodynamics, safety, and tolerability. Diabetes Care, 2007, 30, 1777-82.
59. rd; Chu, N.; Kim, D.; An, B.; Reinhardt, R.R. Inhaled insulin using the AERx insulin diabetes management system in healthy and asthmatic subjects. Diabetes Care, 2003, 26, 764-69.
60. Wolzt, M.; de la Pena, A.; Berclaz, P.; Tibaldi, F.S.; Gates, J.R.; Muchmore, D.B. AIR inhaled insulin versus subcutaneous insulin: pharmacokinetics, glucodynamics, and pulmonary function in asthma. Diabetes Care, 2008, 31, 735-40.
61. Mudaliar, S.S.; Henry, R.R. Inhaled insulin in patients with asthma and chronic obstructive pulmonary disease. Diabetes Technol. Ther., 2007, 9, S-83-92.
62. ® iDMS (insulin diabetes management system) technology. Diabetes Technol Ther., 2007, 9, S-57-64.
63. Agu, R.U.; Ugwoke, M.I.; Armand, M.; Kinget, R.; Verbeke,N. The lung as a route for systemic delivery of therapeutic proteins and peptides. Respir. Res., 2001, 2, 198-209.
64. Schatz, H. Inhaled insulin and the dream of a needle free insulin application. Exp. Clin. Endocrinol. Diabetes, 2004, 112, 285-87.
65. Fineberg, S.E.; Kawabata, T.T.; Krasner, A.S.; Fineberg, N.S. Insulin antibodies with pulmonary delivery of insulin. Diabetes Technol. Ther., 2007, 9, S-102-10.
66. Muchmore, D.B.; Gates, J.R. Inhaled insulin delivery-where are we now? Diabetes Obes. Metab., 2006, 8, 634-42.
67. Heise, T.; Bott, S.; Tusek, C.; Stephan, J.; Kawabata, T.; Finco-Kent, D.; Liu, C.; Krasner, A. The effect of insulin antibodies on the metabolic action of inhaled and subcutaneous insulin: a prospective randomized pharmacodynamic study. Diabetes Care, 2005, 28, 2161-69.
68. Johansson, F.; Hjertberg, E.; Eirefelt, S.; Tronde, A.; Hultkvist Bengtsson, U. Mechanisms for absorption enhancement of inhaled insulin by sodium taurocholate. Eur. J. Pharm. Sci., 2002, 17, 63-71.
69. Banga, A.K. Therapeutic Peptides and Proteins, Technomic Publishing Company: Lancaster, 1995.
70. [70] Zinman, B. The Physiologic replacement of insulin. An elusive goal. N. Engl. J. Med., 1989, 321, 363-70.
71. th 2008, No.: 3353.
72. Yoshioka, K.I.K.; Laube, B.L.; Benedict, G.W.; Dobs, A.S. Pulmonary administration of insulin as aerosol. Chest, 1999, 116, 581-82.
73. Lenzer, J. Inhaled insulin is approved in Europe and United States. BMJ, 2006, 332, 321.
74. Quattrin, T.; Belanger, A.; Bohannon, N.J.; Schwartz, S.L. Exubera phase III study group. Efficacy and safety of inhaled insulin (Exubera) compared with subcutaneous insulin therapy in patients with type 1 diabetes: Results of a 6-month, randomized, comparative trial. Diabetes Care, 2004, 27, 2622-27.
75. Skyler, J.S.; Weinstock, R.S.; Raskin, P.; Yale, J.F.; Barrett, E.; Gerich, J.E.; Gerstein, H.C. Use of inhaled insulin in a basal/bolus insulin regimen in type 1 diabetic subjects: A 6-month randomized, comparative trial. Diabetes Care, 2005, 28, 1630-35.
76. Hollander, P.A.; Blonde, L.; Rowe, R.; Mehta, A.E.; Milburn, J.L.; Hershon, K.S.; Chiasson, J.L.; Levin, S.R. 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.
77. th Sept, 2005;49.
78. Charlesworth, B. Approval of inhaled insulin in Europe and United States. BMJ, 2006, 332, 730.
79. Newman, S.P. Scintigraphic assessment of therapeutic aerosols. Crit. Rev. Ther. Drug Carrier Syst., 1993, 10, 65-109.
80. Davis, S.S. Delivery of peptide and non-peptide drugs through the respiratory tract. Pharm. Sci. Technol. Today, 1999, 2, 450-56.
81. Hollander, P.A. Evolution of a pulmonary insulin delivery system (Exubera) for patients with diabetes. Med. Gen. Med., 2007, 9, 45.