Challenges associated with the pulmonary delivery of therapeutic dry powders for preclinical testing

KONA Powder and Particle Journal

Volumn 36, Issue , 2019, Pages 129-144

  Price, Dominique N ^a   Kunda, Nitesh K ^a   Muttil, Pavan ^a  

^a UNIVERSITY OF NEW MEXICO   (United States)

Author keywords

Dry powders; Endotracheal; Inhalation devices; Intratracheal; Preclinical models; Pulmonary delivery

Indexed keywords

ANIMALS; ATOMIZERS; DEPOSITION; POWDERS; TARGETED DRUG DELIVERY;

DRY POWDERS; ENDOTRACHEAL; INHALATION DEVICES; INTRATRACHEAL; PULMONARY DELIVERY;

CONTROLLED DRUG DELIVERY;

EID: 85063477115     PISSN: 02884534     EISSN: 21875537     Source Type: Journal    
DOI: 10.14356/kona.2019008     Document Type: Review

References (95)

1. Amirav I., Borojeni A.A.T., Halamish A., Newhouse M.T., Golshahi L., Nasal versus oral aerosol delivery to the “lungs” in infants and toddlers, Pediatric Pulmonology, 50 (2015) 276–283.
2. Anderson P.J., History of aerosol therapy: Liquid nebulization to MDIs to DPIs, Respiratory Care, 50 (2012) 1139–1150.
3. Ari A., Fink J.B., Aerosol therapy in children: challenges and solutions, Expert Review of Respiratory Medicine, 7 (2013) 665–672.
4. Asgharian B., Price O., McClellan G., Corley R., Einstein D.R., Jacob R.E., Harkema J., Carey S.A., Schelegle E., Hyde D., Kimbell J.S., Miller F.J., Development of a rhesus monkey lung geometry model and application to particle deposition in comparison to humans, Inhalation Toxicology, 24 (2012) 869–899.
5. Bäckman P., Adelmann H., Petersson G., Jones C.B., Advances in inhaled technologies: understanding the therapeutic challenge, predicting clinical performance, and designing the optimal inhaled product, Clinical Pharmacology & Therapeutics, 95 (2014) 509–520.
6. Balcombe J.P., Barnard N.D., Sandusky C., Laboratory routines cause animal stress, Journal of the American Association for Laboratory Animal Science, 43,6 (2004) 42–51.
7. Balhara J., Gounni A.S., The alveolar macrophages in asthma: a double-edged sword, Mucosal Immunology, 5 (2012) 605– 609.
8. Behara S.R.B., Worth Longest P., Farkas D.R., Hindle M., Development and comparison of new high-efficiency dry powder inhalers for carrier-free formulations, Journal of Pharmaceutical Sciences, 103 (2014) 465–477.
9. Brewer N.R., Cruise L.J., The respiratory system of the guinea pig: Emphasis on species differences, Journal of the American Association for Laboratory Animal Science, 36,1 (1997) 100–108.
10. Carvalho S.R., Watts A.B., Peters J.I., Williams R.O., Dry Powder Inhalation for Pulmonary Delivery: Recent Advances and Continuing Challenges, John Wiley & Sons, Ltd, Chichester (2015) pp. 35–62.
11. Chan J.G.Y., Wong J., Zhou Q.T., Leung S.S.Y., Chan H.-k., Advances in device and formulation technologies for pulmonary drug delivery, AAPS PharmSciTech, 15 (2014) 882–897.
12. Chung Y.H., Han J.H., Lee Y.-H., A study on subchronic inhalation toxicity of 1-chloropropane, Toxicological Research, 31 (2015) 393–402.
13. Cipolla D., Shekunov B., Blanchard J., Hickey A., Lipid-based carriers for pulmonary products: Preclinical development and case studies in humans, Advanced Drug Delivery Reviews, 75 (2014) 53–80.
14. Cryan S.-A., Sivadas N., Garcia-Contreras L., In vivo animal models for drug delivery across the lung mucosal barrier, Advanced drug delivery reviews, 59 (2007) 1133–1151.
15. de Boer A.H., Hagedoorn P., Hoppentocht M., Buttini F., Grasmeijer F., Frijlink H.W., Dry powder inhalation: past, present and future, Expert Opinion on Drug Delivery, 14 (2017) 499–512.
16. Demoly P., Hagedoorn P., de Boer A.H., Frijlink H.W., The clinical relevance of dry powder inhaler performance for drug delivery, Respiratory Medicine, 108 (2014) 1195–1203.
17. DiBlasi R.M., Clinical controversies in aerosol therapy for infants and children, Respiratory Care, 60 (2015) 894–916.
18. Dolovich M.B., Ahrens R.C., Hess D.R., Anderson P., Dhand R., Rau J.L., Smaldone G.C., Guyatt G., Device selection and outcomes of aerosol therapy: Evidence-based guidelines, CHEST, 127 (2005) 335–371.
19. Duddu S.P., Sisk S.A., Walter Y.H., Tarara T.E., Trimble K.R., Clark A.R., Eldon M.A., Elton R.C., Pickford M., Hirst P.H., Newman S.P., Weers J.G., Improved lung delivery from a passive dry powder inhaler using an engineered Pulmo-Sphere® powder, Pharmaceutical research, 19 (2002) 689– 695.
20. Duret C., Wauthoz N., Merlos R., Goole J., Maris C., Roland I., Sebti T., Vanderbist F., Amighi K., In vitro and in vivo evaluation of a dry powder endotracheal insufflator device for use in dose-dependent preclinical studies in mice, European journal of pharmaceutics and biopharmaceutics: official journal of Arbeitsgemeinschaft für Pharmaze-Pharmaze-utische Verfahrenstechnik eV, 81 (2012) 627–634. utische
21. Durham P.G., Hanif S.N., Garcia-Contreras L., Young E.F., Braunstein M.S., Hickey A.J., Disposable dosators for pulmonary insufflation of therapeutic agents to small animals, Journal of Visualized Experiments, 121 (2017) e55356. DOI: 10.3791/55356.
22. Edwards D.A., Hanes J., Caponetti G., Hrkach J., Ben-Jebria A., Eskew M.L., Mintzes J., Deaver D., Lotan N., Langer R., Large porous particles for pulmonary drug delivery, Science (New York, NY), 276 (1997) 1868–1871.
23. Effros R.M., Anatomy, development, and physiology of the lungs, GI Motility online, 1 (2006) doi:10.1038/gimo73
24. Fernandes C.A., Vanbever R., Preclinical models for pulmonary drug delivery, Expert Opinion on Drug Delivery, 6 (2009) 1231–1245.
25. Fields M.R., Inhalator, US Patent, (1949) US2470297A.
26. Fink J.B., Rubin B.K., Problems with inhaler use: a call for improved clinician and patient education, Respiratory care, 50 (2005) 1360–1365.
27. Forbes B., Asgharian B., Dailey L.A., Ferguson D., Gerde P., Gumbleton M., Gustavsson L., Hardy C., Hassall D., Jones R., Lock R., Maas J., McGovern T., Pitcairn G.R., Somers G., Wolff R.K., Challenges in inhaled product development and opportunities for open innovation, Advanced Drug Delivery Reviews, 63 (2011) 69–87.
28. Foster W.M., Walters D.M., Longphre M., Macri K., Miller L.M., Methodology for the measurement of mucociliary function in the mouse by scintigraphy, Journal of Applied Physiology, 90 (2001) 1111–1118.
29. Friebel C., Stolte S., Steckel H., Solomon I., Performance of a new single-use disposable dry powder inhaler prototype, Respiratory Drug Delivery, 2 (2010) 517–522.
30. Frijlink H.W., De Boer A.H., Dry powder inhalers for pulmonary drug delivery, Expert Opinion on Drug Delivery, 1 (2004) 67–86.
31. Garcia-Contreras L., Hickey A.J., Aerosol treatment of cystic fibro-sis, Critical Reviews™ in Therapeutic Drug Carrier Systems, 20 (2003) 317–356. DOI: 10.1615/CritRevTherDrugCarrierSyst. v20.i5.10
32. Geller D.E., Weers J., Heuerding S., Development of an inhaled dry-powder formulation of tobramycin using Pulmo-Sphere™ technology, Journal of Aerosol Medicine and Pulmonary Drug Delivery, 24 (2011) 175–182.
33. Ghosh S., Collier A., Inhaled insulins, Postgraduate Medical Journal, 83 (2007) 178–181.
34. Grand View Research, 2016, Digital Dose Inhaler Market Analysis By Product (Metered Dose Inhaler, Dry Powder Inhaler), By Type (Branded Medication, Generics Medica-tion) And Segment Forecasts to 2024, Available at: http://www.grandviewresearch.com/industry-analysis/digital-dose-inhaler-market, accessed 15.02.2018.
35. Guillon A., Montharu J., Vecellio L., Schubnel V., Roseau G., Guillemain J., Diot P., de Monte M., Pulmonary delivery of dry powders to rats: Tolerability limits of an intra-tracheal administration model, International Journal of Pharmaceutics, 434 (2012) 481–487.
36. Haidl P., Heindl S., Siemon K., Bernacka M., Cloes R.M., Inhalation device requirements for patients’ inhalation maneu-vers, Respiratory Medicine, 118 (2016) 65–75.
37. Harrison L.I., Novak C.C., Needham M.J., Ratner P., Comparative pulmonary function and pharmacokinetics of flutica-sone propionate and salmeterol xinafoate delivered by two dry powder inhalers to patients with asthma, Journal of Aerosol Medicine and Pulmonary Drug Delivery, 24 (2011) 245–252.
38. Hasegawa-Baba Y., Kubota H., Takata A., Miyagawa M., Intratracheal instillation methods and the distribution of administered material in the lung of the rat, Journal of Toxicologic Pathology, 27 (2014) 197–204.
39. Hickey A.J., Back to the future: Inhaled drug products, Journal of Pharmaceutical Sciences, 102 (2013) 1165–1172.
40. Hickey A.J., Complexity in pharmaceutical powders for inhalation: A perspective, KONA Powder and Particle Journal, 35 (2018) 3–13.
41. Hildebrandt I.J., Su H., Weber W.A., Newport D.F., Cherry S.R., Rooney W., Pratte J.F., Junnarkar S., Stoll S., Master Z., Purschke M., Park S.J., Southekal S., Kriplani A., Krishnamoorthy S., Maramraju S., O’Connor P., Radeka V., Vaska P., Villanueva A., Yu B., Gershenson D.M., Kundra V., Lopez-Berestein G., Lutgendorf S.K., Cole S.W., Sood A.K., Anesthesia and other considerations for in vivo imaging of small animals, ILAR Journal, 49 (2008) 17–26.
42. Hoppentocht M., Hagedoorn P., Frijlink H.W., de Boer A.H., Technological and practical challenges of dry powder inhalers and formulations, Advanced Drug Delivery Reviews, 75 (2014a) 18–31.
43. Hoppentocht M., Hoste C., Hagedoorn P., Frijlink H.W.W., de Boer A.H.H., In vitro evaluation of the DP-4M PennCen-tury insufflator, European Journal of Pharmaceutics and Biopharmaceutics, 88 (2014b) 153–159.
44. Horváth A., Balásházy I., Tomisa G., Farkas Á., Significance of breath-hold time in dry powder aerosol drug therapy of COPD patients, European Journal of Pharmaceutical Sciences, 104 (2017) 145–149.
45. Hoskins M., Afrezza Updates: Upcoming TV Ads and Possibly ‘The Uber of Diabetes’?, February 2017, Available at: http://www.healthline.com/diabetesmine/afrezza-updates-february-2017#1 (Accessed: 28 June 2017).
46. Hou S., Wu J., Li X., Shu H., Practical, regulatory and clinical considerations for development of inhalation drug products, Asian Journal of Pharmaceutical Sciences, 10 (2015) 490– 500.
47. Hoyt Jr R.F., Hawkins J.V., St Clair M.B., Kennett M.J., Mouse Physiology, in: Fox J.G., Barthold S.W., Davisson M.T. et al. (Eds.), Academic Press, Burlington, 2007, pp. 23–90, ISBN: 9780123694577.
48. Ibrahim M., Verma R., Garcia-Contreras L., Inhalation drug delivery devices: technology update, Medical Devices (Auckland, NZ), 8 (2015) 131–139.
49. Islam N., Cleary M.J., Developing an efficient and reliable dry powder inhaler for pulmonary drug delivery – A review for multidisciplinary researchers, Medical Engineering & Physics, 34 (2012) 409–427.
50. Kaur J., Muttil P., Verma R.K., Kumar K., Yadav A.B., Sharma R., Misra A., A hand-held apparatus for “nose-only” exposure of mice to inhalable microparticles as a dry powder inhalation targeting lung and airway macrophages, European Journal of Pharmaceutical Sciences, 34 (2008) 56–65.
51. Kleinstreuer C., Zhang Z., Donohue J.F., Targeted drug-aerosol delivery in the human respiratory system, Annual Review of Biomedical Engineering, 10 (2008) 195–220.
52. Kuehl P.J., Anderson T.L., Candelaria G., Gershman B., Harlin K., Hesterman J.Y., Holmes T., Hoppin J., Lackas C., Norenberg J.P., Yu H., McDonald J.D., Regional particle size dependent deposition of inhaled aerosols in rats and mice, Inhalation Toxicology, 24 (2012) 27–35.
53. Kunda N.K., Hautmann J., Godoy S.E., Marshik P., Chand R., Krishna S., Muttil P., A novel approach to study the pMDI plume using an infrared camera and to evaluate the aerodynamic properties after varying the time between actuations, International Journal of Pharmaceutics, 526:1 (2017) 41–49.
54. Kunda N.K., Somavarapu S., Gordon S.B., Hutcheon G.A., Saleem I.Y., Nanocarriers targeting dendritic cells for pulmonary vaccine delivery, Pharmaceutical Research, 30 (2013) 325–341.
55. Labiris N.R., Dolovich M.B., Pulmonary drug delivery. Part I: Physiological factors affecting therapeutic effectiveness of aerosolized medications, British Journal of Clinical Pharmacology, 56 (2003) 588–599.
56. Lakatos H.F., Burgess H.A., Thatcher T.H., Redonnet M.R., Hernady E., Williams J.P., Sime P.J., Oropharyngeal aspiration of a silica suspension produces a superior model of silicosis in the mouse when compared to intratracheal instillation, Experimental Lung Research, 32 (2006) 181– 199.
57. Lightfoot J.T., Bamman M.M., Booth F.W., Translation goes both ways: The power of reverse translation from human trials into animal models, Translational Journal of the American College of Sports Medicine, 2 (2017) 29–31.
58. Lombry C., Marteleur A., Arras M., Lison D., Louahed J., Renauld J.-C., Préat V., Vanbever R., Local and systemic immune responses to intratracheal instillation of antigen and DNA vaccines in mice, Pharmaceutical Research, 21 (2004) 127–135.
59. Longest P.W., Son Y.-J., Holbrook L., Hindle M., Aerodynamic factors responsible for the deaggregation of carrier-free drug powders to form micrometer and submicrometer aerosols, Pharmaceutical Research, 30 (2013) 1608–1627.
60. Mack G.S., Pfizer dumps Exubera, Nature Biotechnology, 25 (2007) 1331–1332.
61. McGregor K., Principles of anaesthesia for term neonates, Anaesthesia & Intensive Care Medicine, 18 (2017) 75–78.
62. Nahar K., Gupta N., Gauvin R., Absar S., Patel B., Gupta V., Khademhosseini A., Ahsan F., In vitro, in vivo and ex vivo models for studying particle deposition and drug absorption of inhaled pharmaceuticals, European Journal of Pharmaceutical Sciences, 49 (2013) 805–818.
63. Newman S.P., Principles of metered-dose inhaler design, Respiratory Care, 50 (2005) 1177–1190.
64. Patil J., Sarasija S., Pulmonary drug delivery strategies: A concise, systematic review, Lung India, 29 (2012) 44–49.
65. Patton J.S., Byron P.R., Inhaling medicines: delivering drugs to the body through the lungs, Nature Reviews Drug Discovery, 6 (2007) 67–74.
66. Phalen R.F., Mendez L.B., Dosimetry considerations for animal aerosol inhalation studies, Biomarkers: biochemical indicators of exposure, response, and susceptibility to chemicals, 14 Suppl 1 (2009) 63–66.
67. Phalen R.F., Oldham M.J., Wolff R.K., The relevance of animal models for aerosol studies, Journal of Aerosol Medicine and Pulmonary Drug Delivery, 21 (2008) 113–124.
68. Price D.N., Stromberg L.R., Kunda N.K., Muttil P., In vivo pulmonary delivery and magnetic-targeting of dry powder nano-in-microparticles, Molecular Pharmaceutics, 14:12 (2017) 4741–4750.
69. Purser D.A., Similarities and differences between animal species in relation to the effect of irritants, in: Stec A., Hull R. (Eds.), CRC Press, Florida, 2010, pp. 75–83, ISBN: 9781845698072.
70. Rubin B.K., Williams R.W., Emerging aerosol drug delivery strategies: From bench to clinic, Advanced Drug Delivery Reviews, 75 (2014) 141–148.
71. Sacchetti M., Van Oort M.M., Spray drying and supercritical fluid particle generation techniques in inhalation aerosols, in: Anthony J.H. (Ed.), Informa Healthcare, New York, 2007, pp. 307–346.
72. Sakagami M., Systemic delivery of biotherapeutics through the lung: opportunities and challenges for improved lung absorption, Therapeutic Delivery, 4 (2013) 1511–1525, DOI: 10.4155/tde.13.119.
73. Saluja V., Amorij J.P., Kapteyn J.C., de Boer A.H., Frijlink H.W., Hinrichs W.L.J., A comparison between spray drying and spray freeze drying to produce an influenza subunit vaccine powder for inhalation, Journal of Controlled Release, 144 (2010) 127–133.
74. Scheuch G., Kohlhaeufl M.J., Brand P., Siekmeier R., Clinical perspectives on pulmonary systemic and macromolecular delivery, Advanced Drug Delivery Reviews, 58 (2006) 996–1008.
75. Schreider J.P., Raabe O.G., Anatomy of the nasal-pharyngeal airway of experimental animals, The Anatomical Record, 200 (1981) 195–205.
76. Scichilone N., Asthma control: the right inhaler for the right patient, Advances in Therapy, 32 (2015) 285–292.
77. Selvam P., McNair D., Truman R., Smyth H.D.C., A novel dry powder inhaler: Effect of device design on dispersion performance, International Journal of Pharmaceutics, 401 (2010) 1–6.
78. Shaji J., Shaikh M., Current development in the evaluation methods of pulmonary drug delivery system, Indian Journal of Pharmaceutical Sciences, 78 (2016) 294–306, DOI: 10.4172/pharmaceutical-sciences.1000118.
79. Smutney C.C., Grant M., Kinsey P.S., Device factors affecting pulmonary delivery of dry powders, Therapeutic Delivery, 4 (2013) 939–949.
80. Society of Toxicology report, Recommendations for the conduct of acute inhalation limit tests, Toxicological Sciences, 18 (1992) 321–327. DOI: 10.1016/0272-0590(92)90130-A.
81. Stein S.W., Thiel C.G., The history of therapeutic aerosols: A chronological review, Journal of Aerosol Medicine and Pulmonary Drug Delivery, 30 (2017) 20–41.
82. Stone K.C., Mercer R.R., Gehr P., Stockstill B., Crapo J.D., Allometric relationships of cell numbers and size in the mammalian lung, American Journal of Respiratory Cell and Molecular Biology, 6 (1992) 235–243.
83. Storti C., Le Noci V., Sommariva M., Tagliabue E., Balsari A., Sfondrini L., Aerosol delivery in the treatment of lung cancer, Current Cancer Drug Targets, 15 (2015) 604–612.
84. Tashkin D., A review of nebulized drug delivery in COPD, International Journal of Chronic Obstructive Pulmonary Disease, Volume 11 (2016) 2585–2596.
85. Telko M.J., Hickey A.J., Dry powder inhaler formulation, Respiratory Care, 50 (2005) 1209–1227.
86. Tonnis W.F., Bagerman M., Weij M., Sjollema J., Frijlink H.W., Hinrichs W.L.J., de Boer A.H., A novel aerosol generator for homogenous distribution of powder over the lungs after pulmonary administration to small laboratory animals, European Journal of Pharmaceutics and Biopharmaceutics, 88 (2014) 1056–1063.
87. Vehring R., Pharmaceutical particle engineering via spray drying, Pharmaceutical Research, 25 (2008) 999–1022. DOI: 10.1007/s11095-007-9475-1
88. Walters E.B., Panda K., Bankson J.A., Brown E., Cody D.D., Improved method of in vivo respiratory-gated micro-CT imaging, Physics in Medicine and Biology, 49 (2004) 4163– 4172.
89. Weers J.G., Clark A.R., Challoner P., High dose inhaled powder delivery: challenges and techniques, Respiratory Drug Delivery IX, 1 (2004) 281–288.
90. Wehling M., Assessing the translatability of drug projects: what needs to be scored to predict success?, Nature Reviews Drug Discovery, 8 (2009) 541–546.
91. Weibel E.R., Geometric and dimensional airway models of conductive, transitory and respiratory zones of the human lung, in: Weibel E.R. (Ed.), Morphometry of the Human Lung, Springer Berlin Heidelberg, Berlin, 1963, pp. 136–142, ISBN 978-1-4832-0076-7.
92. Wong B.A., Inhalation exposure systems: design, methods and operation, Toxicologic Pathology, 35 (2007) 3–14.
93. Yang M.Y., Chan J.G.Y., Chan H.-K., Pulmonary drug delivery by powder aerosols, Journal of Controlled Release, 193 (2014) 228–240.
94. Yi J., Chen B.T., Schwegler-Berry D., Frazer D., Castranova V., McBride C., Knuckles T.L., Stapleton P.A., Minarchick V.C., Nurkiewicz T.R., Whole-body nanoparticle aerosol inhalation exposures, Journal of visualized experiments: JoVE, (2013) e50263. DOI: 10.3791/50263
95. Zhou Q., Tang P., Leung S.S.Y., Chan J.G.Y., Chan H.-K., Emerging inhalation aerosol devices and strategies: Where are we headed?, Advanced Drug Delivery Reviews, 75 (2014) 3–17.