New treatments for chronic obstructive pulmonary disease and viable formulation/device options for inhalation therapy

Expert Opinion on Drug Delivery

Volumn 6, Issue 8, 2009, Pages 793-811

  Onoue, Satomi ^a   Misaka, Shingen ^a   Kawabata, Yohei ^a   Yamada, Shizuo ^a  

^a UNIVERSITY OF SHIZUOKA   (Japan)

Author keywords

Asthma; Chronic obstructive pulmonary disease; Dry powder inhaler; Inhaler device; Pulmonary delivery

Indexed keywords

ANTIASTHMATIC AGENT; ANTIINFLAMMATORY AGENT; BECLOMETASONE DIPROPIONATE; BETAMETHASONE; BRONCHODILATING AGENT; BUDESONIDE; CICLESONIDE; CORTICOSTEROID; DEXAMETHASONE; FENOTEROL; FLUTICASONE PROPIONATE; FORMOTEROL; IBUDILAST; IPRATROPIUM BROMIDE; ISOPRENALINE; KETOTIFEN; METHYLEPHEDRINE; ORCIPRENALINE; PEMIROLAST; PREDNISOLONE; PROCATEROL; PROTEINASE INHIBITOR; REPIRINAST; SALBUTAMOL; SALMETEROL; THEOPHYLLINE; TIOTROPIUM BROMIDE; TRANILAST; TULOBUTEROL; UNINDEXED DRUG;

AIRWAY; ASTHMA; CHRONIC OBSTRUCTIVE LUNG DISEASE; DISEASE COURSE; DRUG DELIVERY SYSTEM; DRUG EFFECT; DRUG EXPOSURE; DRUG FORMULATION; DRY POWDER; HUMAN; METERED DOSE INHALER; MORBIDITY; MORTALITY; NEBULIZER; PATHOPHYSIOLOGY; REVIEW; TREATMENT OUTCOME;

ADMINISTRATION, INHALATION; AEROSOLS; ANTI-INFLAMMATORY AGENTS; ASTHMA; BRONCHODILATOR AGENTS; DRUG DELIVERY SYSTEMS; EQUIPMENT DESIGN; HUMANS; INFLAMMATION MEDIATORS; METERED DOSE INHALERS; POWDERS; PROTEASE INHIBITORS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RESPIRATORY THERAPY;

EID: 68149168979     PISSN: 17425247     EISSN: None     Source Type: Journal    
DOI: 10.1517/17425240903089310     Document Type: Review

References (115)

1. Pauwels RA, Rabe KF. Burden and clinical features of chronic obstructive pulmonary disease (COPD). Lancet 2004;364:613-620 • A detailed review on history, prevalence, risk factors and clinical features of COPD.
2. Halbert RJ, Natoli JL, Gano A, et al. Global burden of COPD: systematic review and meta-analysis. Eur Respir J 2006;28:523-532 (Pubitemid 44794666)
3. Anto JM, Vermeire P, Vestbo J, et al. Epidemiology of chronic obstructive pulmonary disease. Eur Respir J 2001;17:982-994 (Pubitemid 32600349)
4. Lopez AD, Murray CC. The global burden of disease, 1990-2020. Nat Med 1998;4:1241-1243
5. Barnes PJ. Mediators of chronic obstructive pulmonary disease. Pharmacol Rev 2004;56:515-548 (Pubitemid 39658462)
6. Fitzgerald MF, Fox JC. Emerging trends in the therapy of COPD: novel anti-inflammatory agents in clinical development. Drug Discov Today 2007;12:479-486 •• A review on new medications for COPD.
7. Barnes PJ, Stockley RA. COPD: current therapeutic interventions and future approaches. Eur Respir J 2005;25:1084-1106 (Pubitemid 40823786)
8. Borgstrom L, Asking L, Thorsson L. Idealhalers or realhalers? A comparison of Diskus and Turbuhaler. Int J Clin Pract 2005;59:1488-1495 (Pubitemid 43922640)
9. Taylor K. Pulmonary drug delivery, Churchill Livingstone, Edinburgh, 2002
10. Purewal TS. Formulation of metered dose inhalers, Interpharm, Illinois, 1998
11. Smyth HD, Hickey AJ. Carriers in drug powder delivery: implications for inhalation system design. Am J Drug Deliv 2005;3:117-132
12. Churg A, Cosio M, Wright JL. Mechanisms of cigarette smoke-induced COPD: insights from animal models. Am J Physiol Lung Cell Mol Physiol 2008;294:L612-31
13. Hogg JC, Chu F, Utokaparch S, et al. The nature of small-airway obstruction in chronic obstructive pulmonary disease. N Engl J Med 2004;350:2645-2653 (Pubitemid 38787999)
14. De Boer WI. Cytokines and therapy in COPD: a promising combination? Chest 2002;121:209S-18S
15. Kuwano K. Epithelial cell apoptosis and lung remodeling. Cell Mol Immunol 2007;4:419-429
16. Blease K, Lewis A, Raymon HK. Emerging treatments for asthma. Expert Opin Emerg Drugs 2003;8:71-81
17. Briggs DD. Chronic obstructive pulmonary disease overview: prevalence, pathogenesis, and treatment. J Manag Care Pharm 2004;10:S3-10
18. Jeffery PK. Differences and similarities between chronic obstructive pulmonary disease and asthma. Clin Exp Allergy 1999;29(Suppl 2):14-26 (Pubitemid 29314658)
19. Frode TS, Medeiros YS. The puzzle of asthma treatment: animal models to genetic studies. Curr Pharm Des 2005;11:2515-2524
20. Holgate ST, Polosa R. The mechanisms, diagnosis, and management of severe asthma in adults. Lancet 2006;368:780-793 (Pubitemid 44279056)
21. Nagai H, Teramachi H, Tuchiya T. Recent advances in the development of anti-allergic drugs. Allergol Int 2006;55:35-42
22. Busse WW, Rosenwasser LJ. Mechanisms of asthma. J Allergy Clin Immunol 2003;111:S799-804
23. Hanania NA, Donohue JF. Pharmacologic interventions in chronic obstructive pulmonary disease: bronchodilators. Proc Am Thorac Soc 2007;4:526-534 (Pubitemid 47547847)
24. Tashkin DP, Pearle J, Iezzoni D, et al. Formoterol and tiotropium compared with tiotropium alone for treatment of COPD. COPD 2009;6:17-25
25. Gross NJ, Co E, Skorodin MS. Cholinergic bronchomotor tone in COPD. Estimates of its amount in comparison with that in normal subjects. Chest 1989;96:984-987
26. Vincken W, van Noord JA, Greefhorst AP et al. Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium. Eur Respir J 2002;19:209-216 (Pubitemid 34162819)
27. Barnes PJ. Theophylline for COPD. Thorax 2006;61:742-744
28. Johnson M. Corticosteroids: potential beta2-agonist and anticholinergic interactions in chronic obstructive pulmonary disease. Proc Am Thorac Soc 2005;2:320-5; discussion 40-41 (Pubitemid 41566943)
29. Caramori G, Adcock I. Pharmacology of airway inflammation in asthma and COPD. Pulm Pharmacol Ther 2003;16:247-277 (Pubitemid 36870860)
30. Barnes PJ. Corticosteroid resistance in airway disease. Proc Am Thorac Soc 2004;1:264-268
31. Cazzola M, Matera MG, Lotvall J. Ultra long-acting beta 2-agonists in development for asthma and chronic obstructive pulmonary disease. Expert Opin Investig Drugs 2005;14:775-783 (Pubitemid 41030946)
32. Fitzgerald MF, Fox JC. Emerging trends in the therapy of COPD: bronchodilators as mono- and combination therapies. Drug Discov Today 2007;12:472-478 (Pubitemid 46795590)
33. Matera MG, Cazzola M. Ultra-long-acting beta2-adrenoceptor agonists: an emerging therapeutic option for asthma and COPD? Drugs 2007;67:503-515
34. Onoue S, Yamada S, Yajima T. Bioactive analogues and drug delivery systems of vasoactive intestinal peptide (VIP) for the treatment of asthma/COPD. Peptides 2007;28:1640-1650 (Pubitemid 47361420)
35. Said SI. Vasoactive intestinal polypeptide and asthma [editorial]. N Engl J Med 1989;320:1271-1273 (Pubitemid 19128125)
36. Donnelly LE, Rogers DF. Therapy for chronic obstructive pulmonary disease in the 21st century. Drugs 2003;63:1973-1998 • A review on new therapeutic strategies of COPD treatment.
37. Gueders MM, Foidart JM, Noel A, et al. Matrix metalloproteinases (MMPs) and tissue inhibitors of MMPs in the respiratory tract: potential implications in asthma and other lung diseases. Eur J Pharmacol 2006;533:133-144 (Pubitemid 43340010)
38. Hu J, Van den Steen PE, Sang QX, et al. Matrix metalloproteinase inhibitors as therapy for inflammatory and vascular diseases. Nat Rev Drug Discov 2007;6:480-498 (Pubitemid 47064570)
39. Barnes PJ. New treatments for COPD. Nat Rev Drug Discov 2002;1:437-446
40. Barnes PJ. Emerging pharmacotherapies for COPD. Chest 2008;134:1278-1286 •• A detailed review on current and new medications for COPD.
41. Rennard SI. Antiinflammatory therapies other than corticosteroids. Proc Am Thorac Soc 2004;1:282-287
42. Cheng J, Grande JP. Cyclic nucleotide phosphodiesterase (PDE) inhibitors: novel therapeutic agents for progressive renal disease. Exp Biol Med (Maywood) 2007;232:38-51 (Pubitemid 46089939)
43. Spina D. PDE4 inhibitors: current status. Br J Pharmacol 2008;155:308-315 • A detailed review on the current status of PDE4 inhibitors for the treatment of asthma and COPD.
44. Hasko G, Linden J, Cronstein B, et al. Adenosine receptors: therapeutic aspects for inflammatory and immune diseases. Nat Rev Drug Discov 2008;7:759-770
45. Stockley RA. Neutrophils and the pathogenesis of COPD. Chest 2002;121:151S-5S
46. Adcock IM, Chung KF, Caramori G, et al. Kinase inhibitors and airway inflammation. Eur J Pharmacol 2006;533:118-132
47. Gonsiorek W, Fan X, Hesk D, et al. Pharmacological characterization of Sch527123, a potent allosteric CXCR1/CXCR2 antagonist. J Pharmacol Exp Ther 2007;322:477-485
48. Dugo L, Marzocco S, Mazzon E, et al. Effects of GW274150, a novel and selective inhibitor of iNOS activity, in acute lung inflammation. Br J Pharmacol 2004;141:979-987 (Pubitemid 38510081)
49. Hansel TT, Kharitonov SA, Donnelly LE, et al. A selective inhibitor of inducible nitric oxide synthase inhibits exhaled breath nitric oxide in healthy volunteers and asthmatics. FASEB J 2003;17:1298-1300
50. Barnes PJ. Cytokine modulators as novel therapies for airway disease. Eur Respir J 2001;18:67s-77s
51. Newman SP. Dry powder inhalers for optimal drug delivery. Expert Opin Biol Ther 2004;4:23-33 •• A review on the development of DPI device and formulation technology.
52. Onoue S, Hashimoto N, Yamada S. Dry powder inhalation systems for pulmonary delivery of therapeutic peptides and proteins. Expert Opin Ther Patents 2008;18:429-442 (Pubitemid 351618752)
53. van der Palen J, Klein JJ, van Herwaarden CL et al. Multiple inhalers confuse asthma patients. Eur Respir J 1999;14:1034-1037
54. Rau JL. Practical problems with aerosol therapy in COPD. Respir Care 2006;51:158-172 • A detailed review on problems of inhalation systems.
55. Corden ZM, Bosley CM, Rees PJ, et al. Home nebulized therapy for patients with COPD: patient compliance with treatment and its relation to quality of life. Chest 1997;112:1278-1282
56. Fink JB, Rubin BK. Problems with inhaler use: a call for improved clinician and patient education. Respir Care 2005;50:1360-74; discussion 74-75
57. Geller DE. Comparing clinical features of the nebulizer, metered-dose inhaler, and dry powder inhaler. Respir Care 2005;50:1313-21; discussion 21-22
58. Pickering H, Pitcairn GR, Hirst PH, et al. Regional lung deposition of a technetium 99m-labeled formulation of mometasone furoate administered by hydrofluoroalkane 227 metered-dose inhaler. Clin Ther 2000;22:1483-1493 (Pubitemid 32056086)
59. Kohler D. Novolizer: the new technology for the management of asthma therapy. Curr Opin Pulm Med 2003;9(Suppl 1):S11-6 (Pubitemid 36741330)
60. Atkins PJ. Dry powder inhalers: an overview. Respir Care 2005;50:1304-12; discussion 12
61. Dhand R. Inhalation therapy with metered-dose inhalers and dry powder inhalers in mechanically ventilated patients. Respir Care 2005;50:1331-4; discussion 44-45
62. Newman SP. Therapeutic aerosols, Butterworths, London, 1984
63. Bell JH, Hartley PS, Cox JS. Dry powder aerosols. I. A new powder inhalation device. J Pharm Sci 1971;60:1559-1564
64. Dahl R, Backer V, Ollgaard B, et al. Assessment of patient performance of the HandiHaler compared with the metered dose inhaler four weeks after instruction. Respir Med 2003;97:1126-1133 (Pubitemid 37185116)
65. Frijlink HW, De Boer AH. Dry powder inhalers for pulmonary drug delivery. Expert Opin Drug Deliv 2004;1:67-86 • A review on concepts, devices and formulations of DPI.
66. Ikegami K, Kawashima Y, Takeuchi H, et al. Improved inhalation behavior of steroid KSR-592 in vitro with Jethaler by polymorphic transformation to needle-like crystals (beta-form). Pharm Res 2002;19:1439-1445 (Pubitemid 35266547)
67. Agu RU, Ugwoke MI, Armand M, et al. The lung as a route for systemic delivery of therapeutic proteins and peptides. Respir Res 2001;2:198-209 (Pubitemid 34187927)
68. Pover GM, Langdon CG, Jones SR, et al. Evaluation of a breath operated powder inhaler. J Int Med Res 1988;16:201-203
69. Villax P, Brito V, Steckel H. Development and performance of a new simple dry powder inhaler operating at low airflow eates, Davis Horwood International, Raleigh, NC, 2002
70. Han R, Papadopoulos G, Greenspan B. Investigation of powder dispersion inside a SPIROS dry powder inhaler using particle image velocimetry. Powd Technol 2002;125:266-278 (Pubitemid 34518455)
71. Parry-Billings M, Boyes R, Clisby L, et al. Design, development and performance of a multidose dry powder inhaler. Pharm Technol 2000;12:38-45 (Pubitemid 30098596)
72. Dahl R, Creemers JP, Van Noord J, et al. Comparable efficacy and tolerability of formoterol (Foradil) administered via a novel multi-dose dry powder inhaler (Certihaler) or the Aerolizer dry powder inhaler in patients with persistent asthma. Respiration 2004;71:126-133 (Pubitemid 38529166)
73. Wetterlin K. Turbuhaler: a new powder inhaler for administration of drugs to the airways. Pharm Res 1988;5:506-508
74. Fan B, Yang T, Keaton D. Application of computer modeling in the design and development of the new mometasone furoate dry powder inhaler (F-dpi) nozzle. Serentec Press, Raleigh, 2000
75. Meakin BJ, Ganderton D, Panza I, et al. The effect of flow rate on drug delivery from the Pulvinal, a high-resistance dry powder inhaler. J Aerosol Med 1998;11:143-152 (Pubitemid 28485302)
76. Keating GM, Faulds D. Airmax: a multi-dose dry powder inhaler. Drugs 2002;62:1887-95; discussion 96-97
77. de Boer AH, Gjaltema D, Hagedoorn P, et al. Comparative in vitro performance evaluation of the Novopulmon 200 Novolizer and Budesonid-ratiopharm Jethaler: two novel budesonide dry powder inhalers. Pharmazie 2004;59:692-699 (Pubitemid 39281007)
78. Seppala OR, Aalto E, Annila I, et al. The efficacy of a new salbutamol metered-dose powder inhaler in comparison with two other inhaler devices. Respir Med 2001;95:949-953 (Pubitemid 34013542)
79. Rau JL. The inhalation of drugs: advantages and problems. Respir Care 2005;50:367-382
80. Byron PR. Aerosol formulation, generation, and delivery using non-metered and metered systems, CRC Press, Inc., Boca Raton, FL, 1990
81. Suarez S, Hickey AJ. Drug properties affecting aerosol behavior. Respir Care 2000;45:652-666 (Pubitemid 30484805)
82. 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 • A review on physiological factors affecting therapeutic effectiveness of inhaled drug therapy.
83. Chrystyn H. Is total particle dose more important than particle distribution? Respir Med 1997;91:(Suppl A):17-19
84. Telko MJ, Hickey AJ. Dry powder inhaler formulation. Respir Care 2005;50:1209-1227 • A detailed review on the development of DPI formulations and characterization strategies.
85. Thibert R, Parry-Billings M, Shott M. Clickhaler dry powder inhaler: focussed in vitro proof of principle evaluation of a new chemical entity for asthma. Int J Pharm 2002;239:149-156 (Pubitemid 34615804)
86. de Boer AH, Hagedoorn P, Gjaltema D, et al. Air classifier technology (ACT) in dry powder inhalation Part 4. Performance of air classifier technology in the Novolizer multi-dose dry powder inhaler. Int J Pharm 2006;310:81-89 (Pubitemid 43287970)
87. Endo K, Amikawa S, Matsumoto A, et al. Erythritol-based dry powder of glucagon for pulmonary administration. Int J Pharm 2005;290:63-71 (Pubitemid 40139045)
88. Louey MD, Stewart PJ. Particle interactions involved in aerosol dispersion of ternary interactive mixtures. Pharm Res 2002;19:1524-1531
89. Larhrib H, Martin GP, Marriott C, et al. The influence of carrier and drug morphology on drug delivery from dry powder formulations. Int J Pharm 2003;257:283-296 (Pubitemid 36507054)
90. Chan HK, Clark A, Gonda I, et al. Spray dried powders and powder blends of recombinant human deoxyribonuclease (rhDNase) for aerosol delivery. Pharm Res 1997;14:431-437 (Pubitemid 27205000)
91. Staniforth JN. Pre-formulation aspects of dry powder aerosols, Interpharm Press, Buffalo Grove, 1996
92. Patton JS. Deep-lung delivery of therapeutic proteins. Chemtech 1997;27:34-38
93. Edwards DA, Hanes J, Caponetti G, et al. Large porous particles for pulmonary drug delivery. Science 1997;276:1868-1871 (Pubitemid 27443665)
94. Bot AI, Tarara TE, Smith DJ, et al. Novel lipid-based hollow-porous microparticles as a platform for immunoglobulin delivery to the respiratory tract. Pharm Res 2000;17:275-283
95. Blair J, Mao L, Hodgers E. Modification of the pulmonary absorption of cyclosporin using SoliDose technology, Serentec Press, Raleigh, 2000
96. Wilson BR, Grant MI, Steiner SS, et al. Technospheres for pulmonary and nasal applications, Davis Horwood, Raleigh, 2002
97. Mandal TK. Inhaled insulin for diabetes mellitus. Am J Health Syst Pharm 2005;62:1359-1364
98. Li HY, Birchall J. Chitosan-modified dry powder formulations for pulmonary gene delivery. Pharm Res 2006;23:941-950 (Pubitemid 43781402)
99. Shahiwala A, Misra A. A preliminary pharmacokinetic study of liposomal leuprolide dry powder inhaler: a technical note. AAPS PharmSciTech 2005;6:E482-6
100. Pandey R, Sharma S, Khuller GK. Nebulization of liposome encapsulated antitubercular drugs in guinea pigs. Int J Antimicrob Agents 2004;24:93-94 (Pubitemid 38844571)
101. Vyas SP, Kannan ME, Jain S, et al. Design of liposomal aerosols for improved delivery of rifampicin to alveolar macrophages. Int J Pharm 2004;269:37-49 (Pubitemid 38035210)
102. Ostrander KD, Hovey DC, Knapp DA, et al. Potential delivery of advantages of spray-dried nanocrystal colloidal budesonide with Clickhaler, Serentec Press, Raleigh, 2000
103. Wollmer P, Backstrom K, Zhao H, et al. Surface active agents as enhancers of alveolar absorption. Pharm Res 2000;17:38-41 (Pubitemid 30121097)
104. Khuller GK, Kapur M, Sharma S. Liposome technology for drug delivery against mycobacterial infections. Curr Pharm Des 2004;10:3263-3274 (Pubitemid 39276614)
105. Sivadas N, O'Rourke D, Tobin A, et al. A comparative study of a range of polymeric microspheres as potential carriers for the inhalation of proteins. Int J Pharm 2008;358:159-167
106. Jain RA. The manufacturing techniques of various drug loaded biodegradable poly(lactide-co-glycolide) (PLGA) devices. Biomaterials 2000;21:2475-2490
107. O'Hara P, Hickey AJ. Respirable PLGA microspheres containing rifampicin for the treatment of tuberculosis: manufacture and characterization. Pharm Res 2000;17:955-961 (Pubitemid 30736598)
108. Pandey R, Khuller GK. Polymer based drug delivery systems for mycobacterial infections. Curr Drug Deliv 2004;1:195-201
109. Rao GC, Kumar MS, Mathivanan N, et al. Nanosuspensions as the most promising approach in nanoparticulate drug delivery systems. Pharmazie 2004;59:5-9 (Pubitemid 38129292)
110. Jacobs C, Muller RH. Production and characterization of a budesonide nanosuspension for pulmonary administration. Pharm Res 2002;19:189-194 (Pubitemid 34165405)
111. Daviskas E, Anderson SD, Gonda I, et al. Changes in mucociliary clearance during and after isocapnic hyperventilation in asthmatic and healthy subjects. Eur Respir J 1995;8:742-751
112. Dolovich MB, Jordana M, Newhouse MT. Methodologic considerations in mucociliary clearance and lung epithelial absorption measurements. Eur J Nucl Med 1987;13(Suppl):S45-52 (Pubitemid 17111830)
113. Smaldone GC, Foster WM, O'Riordan TG, et al. Regional impairment of mucociliary clearance in chronic obstructive pulmonary disease. Chest 1993;103:1390-1396 (Pubitemid 23145590)
114. Matilainen L, Jarvinen K, Toropainen T, et al. In vitro evaluation of the effect of cyclodextrin complexation on pulmonary deposition of a peptide, cyclosporin A. Int J Pharm 2006;318:41-48
115. Onoue S, Sato H, Kawabata Y, et al. In vitro and in vivo characterization on amorphous solid dispersion of cyclosporine A for inhalation therapy. J Control Release. In press