Oral inhalation therapy: Meeting the challenge of developing more patient-appropriate devices

Expert Review of Medical Devices

Volumn 6, Issue 2, 2009, Pages 147-155

  Mitchell, Jolyon P ^a   Nagel, Mark W ^a  

^a TRUDELL MEDICAL INTERNATIONAL   (Canada)

Author keywords

Dry powder inhaler; Feedback; Holding chamber; Metered liquid inhaler; Metered dose inhaler; Nebulizer; Patient; Patient interface; Spacer

Indexed keywords

AMIKACIN; ANTINEOPLASTIC AGENT; BECLOMETASONE DIPROPIONATE; BETA ADRENERGIC RECEPTOR STIMULATING AGENT; CORTICOSTEROID; LONG ACTING DRUG; PIRBUTEROL ACETATE; RECOMBINANT HUMAN INSULIN; SALBUTAMOL SULFATE;

AEROSOL; ASTHMA; BACTERIAL PNEUMONIA; CHRONIC OBSTRUCTIVE LUNG DISEASE; COST BENEFIT ANALYSIS; DRUG ADMINISTRATION ROUTE; DRUG DELIVERY SYSTEM; DRUG FORMULATION; EQUIPMENT DESIGN; HUMAN; INHALER; LUNG CANCER; MEDICAL NEBULIZER; METERED DOSE INHALER; NEBULIZER; NONHUMAN; ORAL INHALATIONAL DRUG ADMINISTRATION; PARTICLE SIZE; PATIENT ATTITUDE; POWDER INHALER; PRODUCT DEVELOPMENT; REVIEW; SYSTEMIC THERAPY; ARTIFICIAL VENTILATION; INHALATIONAL DRUG ADMINISTRATION; INSTRUMENTATION;

ADMINISTRATION, INHALATION; HUMANS; NEBULIZERS AND VAPORIZERS; RESPIRATORY THERAPY;

EID: 67449085288     PISSN: 17434440     EISSN: 17452422     Source Type: Journal    
DOI: 10.1586/17434440.6.2.147     Document Type: Review

References (91)

1. O'Callaghan C, Nerbrink O, Vidgen MT. The history of inhaled drug therapy. In: Drug Delivery to the Lung. Bisgaard H, O'Callaghan C, Smadlone G (Eds). Marcel Dekker, NY, USA, 1-20 (2002).
2. Anderson PJ. History of aerosol therapy: liquid nebulization to MDIs to DPIs. Respir. Care 50(9), 1139-1150 (2005).
3. Thiel GC. From Suzie's question to CFC-free: an inventor's perspective on forty years of MDI development and regulation. In: Respiratory Drug Delivery-V. Dalby RN, Byron PR, Farr SJ (Eds). Interpharm Press, IL, USA, 115-123 (1996).
4. International Standards Organization. ISO 20072 (DIS (2)). Aerosol Drug Delivery Device Design Verification: Requirements and Test Methods. ISO Geneva, Switzerland (2008).
5. Becker A, Lemière C, Bérubé D et al. Summary of recommendations from the Canadian Asthma Consensus Guidelines, 2003, and Canadian Pediatric Asthma Consensus Guidelines. CMAJ 173(6 Suppl.), S1-S56 (2003).
6. O'Donnell DE, Aaron S, Bourbeau J et al. State of the art compendium: Canadian Thoracic Society recommendations for the management of chronic obstructive pulmonary disease. Can. Respir. J. 11 (Suppl. B), B7-B59 (2004).
7. Flume PA, O'Sullivan BP, Robinson KA et al. Cystic fibrosis pulmonary guidelines: chronic medications for maintenance of lung health. Am. J. Resp. Crit. Care Med. 176, 957-969 (2007).
8. Dolovich MB, MacIntyre NR, Andersen PJ. Consensus statement: aerosols and delivery devices. Respir. Care 45(6), 589-596 (2000).
9. Hickey AJ. Inhalation Aerosols: Physical and Biological Basis for Therapy. Informa Healthcare, NY, USA (2007).
10. Bisgaard H, O'Callaghan C, Smaldone GC. Drug Delivery to the Lungs. Marcel Dekker, NY, USA (2002).
11. Hess DR. Nebulizers - principles and performance. Respir. Care 45(6), 609-622 (2000).
12. Fink JB. Metered-dose inhalers, dry powder inhalers, and transitions. Respir. Care 45(6), 623-635 (2000).
13. Newman SP. Principles of metered-dose inhaler design. Respir. Care 50(9), 1177-1190 (2005).
14. Rubin BK, Fink JB. Optimizing aerosol delivery by pressurized metered-dose inhalers. Respir. Care 50(9), 1191-1200 (2005).
15. Atkins PJ. Dry powder inhalers: an overview. Respir. Care 50(10), 1304-1312 (2005).
16. Berlinski A, Waldrep JC. Four hours of continuous albuterol nebulization. Chest 114(3), 847-853 (1998).
17. O'Callaghan C, Wright P. The metered dose inhaler. In: Drug Delivery to the Lung. Bisgaard H, O'Callaghan C, Smaldone GC (Eds). Marcel Dekker, NY, USA, 337-370 (2002).
18. Knoch M, Wunderlich E. In-vitro assessment of a new efficient nebulizer system for continuous operation. In: Respiratory Drug Delivery-IV. Byron PR, Dalby RN, Farr SJ (Eds). Interpharm Press, IL, USA, 265-271 (1994).
19. Devadason SG, Everard ML, Linto JM. Comparison of drug delivery from conventional versus "venturi" nebulizers. Eur. Respir. J. 10(11), 2479-2483 (1997)
20. Bell JH, Hartley PS, Cox JS. Dry powder aerosols I. A new powder inhalation device. J. Pharm. Sci. 60(10), 1559-1564 (1971).
21. Wetterlin KIL. Design and function of Turbohaler. In: A New Concept in Inhalation Therapy. Newman SP, Morén F, Crompton GK (Eds). Medicom, London, UK (1987).
22. Telko MJ, Hickey AJ. Dry powder inhaler formulation. Respir. Care 50(9), 1209-1227 (2005).
23. Cougele MB, Padhi BK, Jinkurkar KA et al. Development of dry powder inhalers. Recent Pat. Drug Deliv. Formul. 1, 11-21 (2007).
24. Edwards DA, Hanes J, Caponetti G et al. Large porous particles for pulmonary drug delivery. Science 276, 1868-1871 (1997).
25. Bot AL, Tarara TE, Smith DJ et al. Novel lipid based hollow porous microparticles as a platform for immunoglobulin delivery to the respiratory tract. Pharm. Res. 17, 275-283 (2000).
26. Ostrander KD, Hovey DC, Knapp DA et al. Potential delivery of advantages of spray-dried nanocrystal colloidal budesonide with the Clickhaler. In: Respiratory Drug Delivery-VII. Dalby RN, Byron PR, Farr SJ, Peart J (Eds). Serentec Press, NC, USA, 447-449 (2000).
27. Chan HK. Dry Powder aerosol delivery systems: current and future research directions. J. Aerosol Med. 19(1), 21-27 (2006).
28. Virchow JC, Crompton GK, Dal Negro R et al. Importance of inhaler devices in the management of airway disease. Respir. Med. 102(1), 10-19 (2008).
29. Tezky T, Holquist C. Misadministration of capsules for inhalation. Drug Topics 4, 48 (2005).
30. Knoch M, Keller M. The customised electronic nebulizer: a new category of liquid aerosol drug delivery systems. Expert Opin. Drug Deliv. 2(2), 377-390 (2005).
31. Dhand R. Nebulizers that use a vibrating mesh or plate with multiple apertures to generate aerosol. Respir. Care 47(12), 1406-1416 (2002).
32. Newman S, Gee-Turner A. The Omron Micro-Air vibration mesh technology nebulizer, a 21st Century approach to inhalation therapy. J. Appl. Ther. Res. 5, 29-33 (2005).
33. Hochrainer D, Hölz H, Kreher C et al. Comparison of the aerosol velocity and spray duration of Respimat® Softmist™ inhaler and pressurized metered dose inhalers. J. Aerosol Med. 18(3), 273-282 (2005).
34. Crompton GK, Barnes PJ, Broeders M et al. The need to improve inhalation technique in Europe: a report from the Aerosol Drug Management Improvement Team. Respir. Med. 100(9), 1479-1494 (2006).
35. Newman SP. Improving drug metering to the lung: making the patient the most important factor. In: Respiratory Drug Delivery-2006. Dalby RN, Byron PR, Peart J, Suman JD, Farr SJ (Eds). Davis Horwood International Publishing, IL, USA, 1-12 (2006).
36. Leach C. Enhanced drug delivery through reformulating MDIs with HFA propellants - drug deposition and its effect on preclinical and clinical programs. In: Respiratory Drug Delivery-V. Dalby RN, Byron PR, Farr SJ (Eds). Interpharm Press Inc., IL, USA, 133-144 (1996).
37. Melani AS, Zancetta D, Barbato N et al. Inhalation technique and variables associated with misuse of conventional metered-dose inhalers and newer dry powder inhalers in experienced adults. Ann. Allergy Asthma Immunol. 93(5), 439-446 (2004).
38. Barnes P, Virchow JC, Sanchis J et al. Asthma management: important issues. Eur. Respir. Rev. 14(97), 147-151 (2005).
39. Corr D, Dolovich M, McCormack D et al. Design and characteristics of a portable breath actuated, particle size selective medical aerosol inhaler. J. Aerosol Sci. 13(1), 1-7 (1982).
40. Bisgaard H, Anhøj J, Wildhaber JH. Spacer devices. In: Drug Delivery to the Lung. Bisgaard H, O'Callaghan C, Smaldone GC (Eds). Marcel Dekker, NY, USA, 389-420 (2002).
41. Dolovich MB, Ahrens RC, Hess DR et al. Device selection and outcomes of aerosol therapy: evidence-based guidelines. Chest 127(1), 335-371 (2005).
42. Mitchell JP, Nagel MW. Valved holding chambers (VHCs) for use with pressurized metered-dose inhalers (pMDIs): a review of causes of inconsistent medication delivery. Prim. Care Respir. J. 16(4), 207-214 (2007).
43. Mitchell J, Avvakoumova V, MacKay H et al. Substantial in vitro equivalence exists for anti-static and non-static versions of the same valved holding chamber (VHC) family provided pre-washing of the non-static version is undertaken to mitigate electrostatic charge. In: Drug Delivery to the Lungs-19. The Aerosol Society, Edinburgh, UK (2008).
44. Dolovich MB. In my opinion - interview with the expert. Pediatric Asthma, Allerg. Immunol. 17, 292-300 (2004).
45. Canadian Medical Association. Canadian asthma consensus report, 1999. CMAJ 161(11 Suppl.), S1-S62 (1999).
46. Morton RW, Mitchell JP. Design of facemasks for delivery of aerosol-based medication via pressurized metered dose inhaler with valved holding chamber: key issues that affect performance. J. Aerosol Med. 20(S1), S29-S45 (2007).
47. Nagel MW, Avvakoumova V, MacKay H et al. Medication delivery via infant and child valved holding chambers (VHCs) with facemask is aided with inhalation flow indicator. Eur. Respir. J. 32(S52), S3497 (2008).
48. Velsor-Friedrich B, Vlasses F, Moberly J et al. Talking with teems about asthma management. J. School Nursing 20(3), 140-148 (2004).
49. Everard ML. Inhaler devices in infants and children: challenges and solutions. J. Aerosol Med. 17(2), 186-195 (2004).
50. Purewal TS. Formulation of metered dose inhalers. In: Metered Dose Inhaler Technology. Purewal TS, Grant DJW (Eds),.Interpharm Press, IL, USA, 9-65 (1998).
51. Holt S, Holt A, Weatherall M et al. Metered dose inhalers: a need for dose counters. Respirology 10, 105-106 (2005).
52. Ogren RA, Baldwin JL, Simon RA. How patients determine when to replace their metered-dose inhalers. Ann. Allergy Asthma Immunol. 75, 485-489 (1995).
53. Fink JB, Rubin BK. Problems with inhaler use: a call for improved clinician and patient education. Respir. Care 50(10), 1360-1375 (2005).
54. Sander N, Fusco-Walker SJ, Harder JM et al. Dose counting and the use of pressurized metered-dose inhalers: running on empty. Ann. Allergy Asthma Immunol. 97(1), 34-38 (2006).
55. Purkins G. Retrofitting of dose counters to pMDIs. In: Respiratory Drug Delivery Europe - 2007. Dalby RN, Byron PR, Peart J, Suman JD (Eds). Davis International Healthcare Publishing, IL, USA, 221-224 (2007).
56. Scarrott P. An application of quality by design (QBD) and process analytical technology (PAT) to the development of force-driven dose counters for pressurized metered dose inhalers. In: Drug Delivery to the Lungs-19. The Aerosol Society, Edinburgh, UK, Part A, 10-13 (2008).
57. Rau JL. Practical problems with aerosol therapy in COPD. Respir. Care 51(2), 158-172 (2006).
58. Richter K. Successful use of systems in asthmatic patients: key parameters. Respir. Med. 98, S22-S27 (2004).
59. DeGroot JS, Gray S, Wang M et al. Exubera insulin pulmonary inhaler: a comparison of aerosol performance following simulated long-term use and real-time patient use. In: Respiratory Drug Delivery-2006. Byron PR, Dalby RN, Peart J, Suman JD, Farr SJ (Eds). Davis International Healthcare Publishing, IL, USA, 713-716 (2006).
60. Japsen B. Inhaled insulin's cost may take breath away. Chicago Tribune, 2nd February (2006).
61. Berenson A. Pfizer Drug for diabetes is lagging. NY Times, 10 April (2007).
62. Mitchell JP, Nagel MW, Bates SL, Doyle CC. In-vitro performance of a breath-actuated nebulizer for the delivery of methacholine chloride. Respir. Care, 48(1), 46-51 (2003).
63. Denyer J, Nikander K. Halolite™: a novel liquid drug aerosol system. In: Respiratory Drug Delivery-VI. Dalby RN, Byron PR, Farr SJ (Eds). Interpharm Press, IL, USA, 311-314 (1996).
64. Denyer J, Nikander K, Smith NJ. Adaptive aerosol delivery (AAD) technology. Expert Opin. Drug Deliv. 1(1), 165-176 (2004).
65. Scheuch G, Brand P, Müllinger T et al. Regional drug targeting within the lungs by controlled inhalation with the AKITA system. In: Respiratory Drug Delivery-VIII. Dalby RN, Byron PR, Peart J, Farr SJ (Eds). Davis Horwood Int. Publishing, NC, USA, 471-473 (2002).
66. Borgshulte M, Germer M, Hug M et al. Means to optimize drug delivery from a novel electronic inhaler. In: Respiratory Drug Delivery-IX. Dalby RN, Byron PR, Peart J, Suman JD, Farr SJ (Eds). Davis Horwood Int. Publishing, IL, USA, 605-608 (2004).
67. Schuster J, Rubsamen R, Lloyd P et al. The AERx™ aerosol delivery system. Pharm. Res. 14, 354-357 (1997).
68. Luyt C-E, Clavel M, Guntupalli K et al. NKTR-061(inhaled amikacin) BID achieves high epithelial lining fluid concentrations in pneumonic portions of lung. Poster 516. Presented at: American Thoracic Society International Conference. Toronto, Ontario, Canada, 16-21 May, 2008.
69. Thiphawong J, Otulana B, Clauson P et al. Pulmonary insulin administration using the AERx® insulin diabetes system. Diabetes Technol. Therapeut. 4, 499-504 (2002).
70. Keller M, Bitterle E, Tservistas M et al. Cyclosporine A: investigation on formulation independent toxicity in a calu-3 cell culture model and characterization of aerosols generated by the eFLOW® electronic nebulizer. In: Respiratory Drug Delivery-2006. Dalby RN, Byron PR, Peart J, Suman JD, Farr SJ (Eds). Davis Horwood Int. Publishing, IL, USA, 605-608 (2006).
71. Tronde A, Baran G, Eirefelt S et al. Miniaturized nebulization catheters: a new approach for delivery of defined aerosol doses to the rat lung. J. Aerosol Med. 15(3), 283-286 (2002).
72. Finlay JB, Mitchell JP, Baran G et al. Delivery of medication as large particles at the carina of an in vitro lung model is effective using a nebulizing catheter. In: Drug Delivery to the Lungs-16. The Aerosol Society, London, UK, 34-37 (2005).
73. Nambiar MP, Wright BS, Rezk PE et al. Development of a microinstillation model of inhalation exposure to assess lung injury following exposure to toxic chemicals and nerve agents in guinea pigs. Toxicol. Mechanisms Methods 16, 295-306 (2006).
74. Selting K, Waldrep JC, Reinero C et al. Feasibility and safety of targeted cisplatin delivery to a select lung lobe in dogs via the AeroProbe® intracorporeal nebulizing catheter. J. Aerosol Med. Pulm. Drug Deliv. 21(3), 255-268 (2008).
75. Köping-Höggård M, Issa M M, Köhler T et al. A miniaturized nebulization catheter for improved gene delivery to the mouse lung. J. Gene Med. 7(9), 1215-1222 (2005).
76. Koehler DR, Frndova H, Leung K et al. Aerosol delivery of an enhanced helper-dependent adenovirus formulation to rabbit lung using an intratracheal catheter. J. Gene Med. 7(11), 1409-1420 (2005).
77. Islam N, Gladki E. Dry powder inhalers (DPIs): a review of device reliability and innovation. Int. J. Pharm. 360, 1-11 (2008).
78. Clark A. Pulmonary delivery technology: recent advances and potential for the new millennium. In: Pharmaceutical Inhalation Aerosol Technology. AJ Hickey (Ed.). Marcel Dekker, NY, USA, 571-592 (2004).
79. Keller M, Gallem T, Stangl R et al. Requirements on formulations and nebulizer design: features to improve pulmonary drug delivery in pre-school children, toddlers and infants. In: Drug Delivery to the Lungs-17. The Aerosol Society, Edinburgh, UK, 10-13 (2006).
80. Richardson PC, Boss AH. Technosphere® insulin technology. Diabetes Technol. Therapeut. 9, S65-S72 (2007).
81. Patton JS, Byron PR. Inhaling medicines: delivering drugs to the body through the lungs. Nature Rev. Drug Discovery 6(1), 67-74 (2007).
82. Rand CS. Patient adherence with COPD therapy. Eur. Respir. Rev. 14(96), 97-101 (2005).
83. Everard, ML. Trying to deliver aerosols to upset children is a thankless task. Arch. Dis. Child. 82, 428 (1995).
84. Everard, ML. Role of inhaler competence and contrivance in 'difficult asthma'. Paediatr. Respir. Rev. 4(2), 135-142 (2003).
85. Postma DS, Sevette C, Martinat Y et al. Treatment of asthma by the inhaled corticosteroid ciclesonide given either in the morning or evening. Eur. Respir. J. 17(6), 1083-1088 (2001).
86. Mansfield LE. The future of the long-acting β-adrenergic bronchodilators in the treatment of asthma. Allergy Asthma Proc. 29(2), 103-108 (2008).
87. Sachs A. Knocking down disease: new uses of RNAi might transform all of its possibilities into realities. Drug Discovery and Development, 33-35 (2008).
88. Gabizon AA. Pegylated liposomal doxorubicin: metamorphosis of an old drug into a new form of chemotherapy. Cancer Invest. 19(4), 424-436 (2001).
89. Torchilin VP, Lukyanov AN. Peptide and protein drug delivery to and into tumors: challenges and solutions. Drug Discovery Today 8, 259-266 (2003).
90. Möschwitzer J, Müller RH. Drug nanocrystals: the universal formulation approach for poorly soluble drugs. In: Nanoparticulate Drug Delivery Systems. Thassu D, Deleers M, Pathak Y (Eds). Informa Healthcare USA Inc., NY, USA, 71-88 (2007).
91. Chan C, Valle-Leutri F, Clark J. Self-titrated aerosolized liposome-encapsulated fentanyl results in rapid onset and sustained analgesia following ACL knee surgery. Anesthesiology 101, A77 (2004).