Recent advances in controlled release pulmonary therapy

Current Drug Delivery

Volumn 6, Issue 4, 2009, Pages 404-414

  Salama, Rania ^a   Traini, Daniela ^a   Chan, Hak Kim ^a   Young, Paul M ^a  

^a UNIVERSITY OF SYDNEY   (Australia)

Author keywords

Biodegradable polymers; Controlled release; Diffusion; In vitro release; In vivo; Particle engineering; Pulmonary inhalation

Indexed keywords

6 CARBOXYFLUORESCEIN; ALBUMIN; ANTIASTHMATIC AGENT; ANTIINFECTIVE AGENT; ANTIOXIDANT; ANTIVIRUS AGENT; BECLOMETASONE DIPROPIONATE; BIOPOLYMER; BRONCHODILATING AGENT; CHITOSAN; CHONDROITIN SULFATE; CIPROFLOXACIN; CROMOGLYCATE DISODIUM; CYTOTOXIC AGENT; DESLORELIN; DRUG CARRIER; EXCIPIENT; FLUTICASONE PROPIONATE; GELATIN; HYALURONIC ACID; HYDROXYPROPYLCELLULOSE; LIPOSOME; METHYLCELLULOSE; POLYGLACTIN; POLYVINYL ALCOHOL; SALBUTAMOL; SOLID LIPID NANOPARTICLE; THEOPHYLLINE; UNINDEXED DRUG; VASOACTIVE INTESTINAL POLYPEPTIDE;

AEROSOL; AIRWAY; BIODEGRADABILITY; CONJUGATE; CONTROLLED RELEASE FORMULATION; DRUG ABSORPTION; DRUG CLEARANCE; DRUG COATING; DRUG PENETRATION; ENCAPSULATION; INFLAMMATION; LIPOSOMAL DELIVERY; LUNG DISEASE; LUNG PARENCHYMA; NONHUMAN; PARTICLE SIZE; PRIORITY JOURNAL; REVIEW; SPRAY DRYING; VISCOSITY;

ADMINISTRATION, INHALATION; ANIMALS; CHEMISTRY, PHARMACEUTICAL; DELAYED-ACTION PREPARATIONS; DRUG DELIVERY SYSTEMS; HUMANS; LUNG; PARTICLE SIZE; PHARMACEUTICAL PREPARATIONS; RESPIRATORY TRACT DISEASES;

EID: 68949114238     PISSN: 15672018     EISSN: None     Source Type: Journal    
DOI: 10.2174/156720109789000546     Document Type: Review

References (143)

1. Bennett, W. D.; Brown, J. S.; Zeman, K. L.; Hu, S.-C.; Scheuch, G.; Sommerer, K. Targeting delivery of aerosols to different lung regions. J. Aerosol Med., 2002, 15, 179-188. (Pubitemid 34827531)
2. Jain, K. K. Drug Delivery systems - An Overview. In Drug Delivery Systems, Jain, K. K., Ed. Humana Press: Totowa. NJ, 2008; Vol. 437, pp 1-50.
3. Byron, P. R. Prediction of drug residence times in regions of the human respiratory tract following aerosol inhalation. J. Pharm. Sci., 1986, 75, 433-438.
4. Smolensky, M. H.; D'Alonzo, G. E.; Kunkel, G.; Barnes, P. J. Daynight patterns in bronchial patency and dyspnea: basis for oncedaily and unequally divided twice-daily theophylline dosing schedules. Chronobiol. Int., 1987, 4, 303-307.
5. Taylor, K. M.; Newton, J. M. Liposomes for controlled delivery of drugs to the lung. Thorax, 1992, 47, 257-259.
6. Zeng, X. M.; Martin, G. P.; Marriott, C. The controlled delivery of drugs to the lung. Int. J. Pharm. 1995, 124, 149-164.
7. Poyner, E. A.; Alpar, H. O.; Almeida, A. J.; Gamble, M. D.; Brown, M. R. W. A comparative study on the pulmonary delivery of tobramycin encapsulated into liposomes and PLA microspheres following intravenous and endotracheal delivery. J. Control. Release, 1995, 35, 41-48.
8. Schreier, H.; Gonzalez-Rothi, R. J.; Stecenko, A. A. Pulmonary delivery of liposomes. J. Control. Release, 1993, 24, 209-223.
9. Gilbert, B. E. Liposomal aerosols in the management of pulmonary infections. J. Aerosol Med., 1996, 9, 111-122.
10. Ruijgrok, E. J.; Vulto, A. G.; Van Etten, E. W. Aerosol delivery of amphotericin B desoxycholate (Fungizone) and liposomal amphotericin B (AmBisome): aerosol characteristics and in-vivo amphotericin B deposition in rats. J. Pharm. Pharmacol., 2000, 52, 619-627.
11. Alvarez, C. A.; Wiederhold, N. P.; McConville, J. T.; Peters, J. I.; Najvar, L. K.; Graybill, J. R.; Coalson, J. J.; Talbert, R. L.; Burgess, D. S.; Bocanegra, R.; Johnston, K. P.; Williams Iii, R. O. Aerosolized nanostructured itraconazole as prophylaxis against invasive pulmonary aspergillosis. J. Infection, 2007, 55, 68-74.
12. Behr, J.; Zimmermann, G.; Baumgartner, R.; Leuchte, H.; Neurohr, C.; Brand, P.; Herpich, C.; Sommerer, K.; Seitz, J.; Menges, G.; Tillmanns, S.; Keller, M. Lung Deposition of a Liposomal Cyclosporine A Inhalation Solution in Patients after Lung Transplantation. J. Aerosol Med. Pulm. Drug Deliv., 2009, 22, 1-9.
13. Gonda, I. Inhalation therapy with recombinant human deoxyribonuclease I. Adv. Drug Deliv. Rev., 1996, 19, 37-46. (Pubitemid 26167853)
14. Fiel, S. B.; Fuchs, H. J.; Johnson, C.; Gonda, I.; Clark, A. R. Comparison of three jet nebulizer aerosol delivery systems used to administer recombinant human DNase I to patients with cystic fibrosis. Chest, 1995, 108, 153-156.
15. Clark, A. R.; Wolff, R. K.; Eldon, M. A.; Dwivedi, S. K.; Anthony, W. The application of pulmonary inhalation technology to drug discovery. In Annual Reports in Medicinal Chemistry; Academic Press: 2006; Vol. 41, pp. 383-393.
16. Bivas-Benita, M.; Ottenhoff, T. H. M.; Junginger, H. E.; Borchard, G. Pulmonary DNA vaccination: Concepts, possibilities and perspectives. J. Control. Release, 2005, 107, 1-29. (Pubitemid 41253699)
17. Chan, H.-K.; Young, P. M.; Traini, D.; Coates, M. Dry powder inhalers: challenges and goals for next generation therapies; This article describes the latest developments in dry powder inhaler (DPI) systems, including the nature and production of active pharmaceutical ingredient particles, formulation considerations for powder blends, and recent developments in DPI devices.(Cover story). Pharm. Technol. Eur., 2007, 19, 19(16).
18. Damms, B.; Bains, W. The cost of delivering drugs without needles. Nat. Biotechnol., 1995, 13, 1438-1440.
19. Patton, J. S.; Bukar, J.; Nagarajan, S. Inhaled insulin. Adv. Drug Deliv. Rev., 1999, 35, 235-247.
20. Uchenna Agu, R.; Ikechukwu Ugwoke, M.; Armand, M.; Kinget, R.; Verbeke, N. The lung as a route for systemic delivery of therapeutic proteins and peptides. Resp. Res., 2001, 2, 198-209. (Pubitemid 34187927)
21. Ward, E. M.; Woodhouse, A.; Mather, L. E.; Farr, S. J.; Okikawa, J. K.; Lloyd, P.; Schuster, J. A.; Rubsamen, R. M. Morphine pharmacokinetics after pulmonary administration from a novel aerosol delivery system. Clin. Pharmacol. Ther., 1997, 62, 596-609.
22. Pritchard, J. N. The influence of lung deposition on clinical response. J. Aerosol Med., 2001, 14, S19-S26.
23. Lee, P. I.; Good, W. R. Controlled-release technology: pharmaceutical application. ACS: Washington, DC, 1987.
24. Rosoff, M. Controlled release of drugs: polymers and aggregate systems: VCH Publishers: New York, N.Y., Weinheim, Germany, 1989.
25. French, D. L.; Edwards, D. A.; Niven, R. W. The influence of formulation on emission, deaggregation and deposition of dry powders for inhalation. J. Aerosol Sci., 1996, 27, 769-783.
26. Ticehurst, M. D.; Basford, P. A.; Dallman, C. I.; Lukas, T. M.; Marshall, P. V.; Nichols, G.; Smith, D. Characterisation of the influence of micronisation on the crystallinity and physical stability of revatropate hydrobromide. Int. J. Pharm., 2000, 193, 247-259.
27. Young, P. M.; Cocconi, D.; Colombo, P.; Bettini, R.; Price, R.; Steele, D. F.; Tobyn, M. J. Characterization of a surface modified dry powder inhalation carrier prepared by "particle smoothing". J. Pharm. Pharmacol., 2002, 54, 1339-1344.
28. Martonen, T. B. Mathematical model for the selective deposition of inhaled pharmaceuticals. J. Pharm. Sci., 1993, 82, 1191-1199.
29. Labiris, N. R.; Dolovich, M. B. Pulmonary drug delivery. Part I: Physiological factors affecting therapeutic effectiveness of aerosolized medications. Br. J. Clin. Pharmacol., 2003, 56, 588-599.
30. Stone, K. C.; Mercer, R. R.; Gehr, P.; Stockstill, B.; Crapo, J. D. Allometric relationship of cell numbers and size in the mammalian lung. Am. J. Respir. Cell Mol. Biol., 1992, 6, 235-243.
31. Hickey, A. J.; Thompson, D. C. Physiology of the Airways. In Pharmaceutica Inhalation Aerosol Technology; Hickey, A. J., Ed. Marcel Dekker, Inc.: 1992; Vol. 54, pp 1-27.
32. Armstrong, D. J.; Elliott, P. N.; Ford, J. L.; Gadsdon, D.; McCarthy, G. P.; Rostron, C.; Worsley, M. D. Poly-(D,L-lactic acid) microspheres incorporating histological dyes for intrapulmonary histopathological investigations. J. Pharm. Pharmacol., 1996, 48, 258-262.
33. Müller, R. H.; Maaen, S.; Weyhers, H.; Specht, F.; Lucks, J. S. Cytotoxicity of magnetite-loaded polylactide, polylactide/glycolide particles and solid lipid nanoparticles. Int. J. Pharm., 1996, 138, 85-94. (Pubitemid 26241925)
34. Sivadas, N.; O'Rourke, D.; Tobin, A.; Buckley, V.; Ramtoola, Z.; Kelly, J. G.; Hickey, A. J.; Cryan, S.-A. A comparative study of a range of polymeric microspheres as potential carriers for the inhalation of proteins. Int. J. Pharm., 2008, 358, 159-167.
35. Sharma, A.; Sharma, U. S. Liposomes in drug delivery: Progress and limitations. Int. J. Pharm., 1997, 154, 123-140. (Pubitemid 27351317)
36. Abra, R. M.; Mihalko, P. J.; Schreier, H. The effect of lipid composition upon the encapsulation and in vitro leakage of metaproterenol sulfate from 0.2 μm diameter, extruded, multilamellar liposomes. J. Control. Release, 1990, 14, 71-78. (Pubitemid 20305842)
37. Allen, T. M. Liposomal drug formulations: rationale for development and what we can expect for the future. Drugs, 1998, 56, 747-756.
38. Alton, E.; Stern, M.; Farley, R.; Jaffe, A.; Chadwick, S. L.; Phillips, J.; Davies, J.; Smith, S. N.; Browning, J.; Davies, M. G.; Hodson, M. E.; Durham, S. R.; Li, D.; Jeffery, P. K.; Scallan, M.; Balfour, R.; Eastman, S. J.; Cheng, S. H.; Smith, A. E.; Meeker, D.; Geddes, D. M. Cationic lipid-mediated CFTR gene transfer to the lungs and nose of patients with cystic fibrosis: a double-blind placebo- controlled trial. Lancet, 1999, 353, 947-954.
39. Niven, R.; Pearlman, R.; Wedeking, T.; Mackeigan, J.; Noker, P.; Simpson-Herren, L.; Smith, J. G. Biodistribution of radiolabeled lipid-DNA complexes and DNA in mice. J. Pharm. Sci., 1998, 87, 1292-1299. (Pubitemid 28514130)
40. Smith, P. L. Peptide delivery via the pulmonary route: a valid approach for local and systemic delivery. J. Control. Release, 1997, 46, 99-106.
41. Labiris, N. R.; Dolovich, M. B. Pulmonary drug delivery. Part II: The role of inhalant delivery devices and drug formulations in therapeutic effectiveness of aerosolized medications. Br. J. Clin. Pharmacol., 2003, 56, 600-612. (Pubitemid 37491711)
42. Thomas, D. A.; Myers, M. A.; Wichert, B.; Schreier, H.; Gonzalez- Rothi, R. J. Acute effects of liposome aerosol inhalation on pulmonary function in healthy human volunteers. Chest, 1991, 99, 1268-1270.
43. Debs, R. J.; Straubinger, R. M.; Brunette, E. N.; Lin, J. M.; Montgomery, A. B.; Friend, D. S.; Papahadjopoulas, D. P. Selective enhancement of pentamidine uptake in the lung by aerosolization and delivery in liposomes. Am. Rev. Respir. Dis., 1987, 135, 731-737.
44. Byron, P. R.; Phillips, E. M. Absorption, Clearance, and Dissolution in the Lung. In Respiratory Drug Delivery; Byron, P. R., Ed. CRS Press, Inc.: Boca Raton, Florida, 1990; pp 107-141.
45. Stark, B.; Andreae, F.; Mosgoeller, W.; Edetsberger, M.; Gaubitzer, E.; Koehler, G.; Prassl, R. Liposomal vasoactive intestinal peptide for lung application: Protection from proteolytic degradation. Eur. J. Pharm. Biopharm., 2008, 70, 153-164.
46. Chono, S.; Tanino, T.; Seki, T.; Morimoto, K. Efficient drug targeting to rat alveolar macrophages by pulmonary administration of ciprofloxacin incorporated into mannosylated liposomes for treatment of respiratory intracellular parasitic infections. J. Control. Release, 2008, 127, 50-58.
47. Wong, J. P.; Yang, H. M.; Blasetti, K. L.; Schnell, G.; Conley, J.; Schofield, L. N. Liposome delivery of ciprofloxacin against intracellular Francisella tularensis infection. J. Control. Release, 2003, 92, 265-273.
48. Bhavane, R.; Karathanasis, E.; Annapragada, A. V. Agglomerated vesicle technology: a new class of particles for controlled and modulated pulmonary drug delivery. J. Control. Release, 2003, 93, 15-28.
49. Zalipsky, S. Synthesis of an end-group functionalized polyethylene glycol-lipid conjugate for preparation of polymer-grafted liposomes. Bioconjug. Chem., 1993, 4, 296-299.
50. Karathanasis, E.; Ayyagari, A. L.; Bhavane, R.; Bellamkonda, R. V.; Annapragada, A. V. Preparation of in vivo cleavable agglomerated liposomes suitable for modulated pulmonary drug delivery. J. Control. Release, 2005, 103, 159-175.
51. Darwis, Y.; Kellaway, I. W. Nebulisation of rehydrated freeze-dried beclomethasone dipropionate liposomes. Int. J. Pharm., 2001, 215, 113-121.
52. Kellaway, I. W.; Farr, S. J. Liposomes as drug delivery systems to the lung. Adv. Drug Deliv. Rev., 1990, 5, 149-161. (Pubitemid 20333021)
53. Cook, R. O.; Pannu, R. K.; Kellaway, I. W. Novel sustained release microspheres for pulmonary drug delivery. J. Control. Release, 2005, 104, 79-90. (Pubitemid 40615237)
54. Taylor, K. M. G.; Taylor, G.; Kellaway, I. W.; Stevens, J. The stability of liposomes to nebulisation. Int. J. Pharm., 1990, 58, 57-61.
55. Cortesi, R.; Esposito, E.; Luca, G.; Nastruzzi, C. Production of lipospheres as carriers for bioactive compounds. Biomaterials, 2002, 23, 2283-2294. (Pubitemid 34234829)
56. Jaspart, S.; Bertholet, P.; Piel, G.; Dogné, J.-M.; Delattre, L.; Evrard, B. Solid lipid microparticles as a sustained release system for pulmonary drug delivery. Eur. J. Pharm. Biopharm., 2007, 65, 47-56. (Pubitemid 44827691)
57. Sanna, V.; Kirschvink, N.; Gustin, P.; Gavini, E.; Roland, I.; Delattre, L.; Evrard, B. Preparation and in vivo toxicity study of solid lipid microparticles as carrier for pulmonary administration. AAPS PharmSciTech, 2004, 5, Article 27.
58. Evora, C.; Soriano, I.; Rogers, R. A.; Shakesheff, K. M.; Hanes, J.; Langer, R. Relating the phagocytosis of microparticles by alveolar macrophages to surface chemistry: the effect of 1,2- dipalmitoylphosphatidylcholine. J. Control. Release, 1998, 51, 143-152. (Pubitemid 28252865)
59. Grenha, A.; Remuñán-López, C.; Carvalho, E. L. S.; Seijo, B. Microspheres containing lipid/chitosan nanoparticles complexes for pulmonary delivery of therapeutic proteins. Eur. J. Pharm. Biopharm., 2008, 69, 83-93.
60. Shoyele, S. A. Controlling the Release of Proteins/Peptides via the Pulmonary Route. In Drug Delivery Systems; Jain, K. K., Ed.; Humana Press: Totowa, NJ, 2008; Vol. 437, pp 141-148.
61. Schanker, L. S.; Mitchell, E. W.; Brown, R. A., Jr. Species comparison of drug absorption from the lung after aerosol inhalation or intratracheal injection. Drug Metab. Dispos., 1986, 14, 79-88.
62. 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, 1997, 276, 1868-1872. (Pubitemid 27443665)
63. Koushik, K.; Kompella, U. Preparation of large porous deslorelin- PLGA microparticles with reduced residual solvent and cellular up take using a supercritical carbon dioxide process. Pharm. Res., 2004, 21, 524-535.
64. Yamamoto, H.; Hoshina, W.; Kurashima, H.; Takeuchi, H.; Kawashima, Y.; Yokoyama, T.; Tsujimoto, H. Engineering of poly(DL-lactic- co-glycolic acid) nanocomposite particles for dry powder inhalation dosage forms of insulin with the spray-fluidized bed granulating system. Adv. Powder Technol., 2007, 18, 215-228. (Pubitemid 47181968)
65. Yang, Y.; Bajaj, N.; Xu, P.; Ohn, K.; Tsifansky, M. D.; Yeo, Y. Development of highly porous large PLGA microparticles for pulmonary drug delivery. Biomaterials. 2009, 30, 1947-1953.
66. Kim, H. K.; Chung, H. J.; Park, T. G. Biodegradable polymeric microspheres with "open/closed" pores for sustained release of human growth hormone. J. Control. Release, 2006, 112, 167-174.
67. Wang, J.; Chua, K. M.; Wang, C.-H. Stabilization and encapsulation of human immunoglobulin G into biodegradable microspheres. J. Colloid Interf. Sci., 2004, 271, 92-101. (Pubitemid 38147608)
68. Wang, J.; Ben-Jebria, A.; Edwards, D. A. Inhalation of estradiol for sustained systemic delivery. J. Aerosol Med., 1999, 12, 27-36.
69. Vanbever, R.; Mintzes, J. D.; Wang, J.; Nice, J.; Chen, D.; Batycky, R.; Langer, R.; Edwards, D. A. Formulation and Physical Characterization of Large Porous Particles for Inhalation. Pharm. Res., 1999, 16, 1735-1742.
70. Ben-Jebria, A.; Chen, D.; Eskew, M. L.; Vanbever, R.; Langer, R.; Edwards, D. A. Large Porous Particles for Sustained Protection from Carbachol-Induced Bronchoconstriction in Guinea Pigs. Pharm. Res., 1999, 16, 555-561.
71. Kompella, U. B.; Koushik, K. Preparation of Drug Delivery Systems Using Supercritical Fluid Technology. Crit. Rev. Ther. Drug, 2001, 18, 173-199. (Pubitemid 32378147)
72. Dunne, M.; Corrigan, O. I.; Ramtoola, Z. Influence of particle size and dissolution conditions on the degradation properties of polylactide- co-glycolide particles. Biomaterials. 2000, 21, 1659-1668. (Pubitemid 30347308)
73. Batycky, R. P.; Hanes, J.; Langer, R.; Edwards, D. A. A theoretical model of erosion and macromolecular drug release from biodegrading microspheres. J. Pharm. Sci., 1997, 86, 1464-1477. (Pubitemid 28018331)
74. Salama, R.; Hoe, S.; Chan, H.-K.; Traini, D.; Young, P. M. Preparation and characterisation of controlled release co-spray dried drug-polymer microparticles for inhalation 1: Influence of polymer concentration on physical and in vitro characteristics. Eur. J. Pharm. Biopharm., 2008, 69, 486-495.
75. Salama, R. O.; Daniela, T.; Chan, H.-K.; Sung, A.; Ammit, A. J.; Young, P. M. Preparation and evaluation of controlled release microparticles for respiratory protein therapy. J. Pharm. Sci., 2009, DOI:10.1002/jps.21653
76. Salama, R. O.; Traini, D.; Chan, H.-K.; Young, P. M. Preparation and characterisation of controlled release co-spray dried drug-polymer microparticles for inhalation 2: Evaluation of in vitro release profiling methodologies for controlled release respiratory aerosols. Eur. J. Pharm. Biopharm., 2008, 70, 145-152.
77. Liao, Y. H.; Brown, M. B.; Jones, S. A.; Nazir, T.; Martin, G. P. The effects of polyvinyl alcohol on the in vitro stability and delivery of spray-dried protein particles from surfactant-free HFA 134a-based pressurised metered dose inhalers. Int. J. Pharm., 2005, 304, 29-39.
78. Li, F. Q.; Hu, J. H.; Lu, B.; Yao, H.; Zhang, W. G. Ciprofloxacin-loaded bovine serum albumin microspheres: preparation and drug-release in vitro. J. Microencapsul., 2001, 18, 825-829.
79. Codrons, V.; Vanderbist, F.; Verbeeck, R. K.; Arras, M.; Lison, D.; Préat, V.; Vanbever, R. Systemic delivery of parathyroid hormone (1-34) using inhalation dry powders in rats. J. Pharm. Sci., 2003, 92, 938-950. (Pubitemid 36523439)
80. Bosquillon, C.; Lombry, C.; Préat, V.; Vanbever, R. Influence of formulation excipients and physical characteristics of inhalation dry powders on their aerosolization performance. J. Control. Release, 2001, 70, 329-339. (Pubitemid 32155456)
81. Zeng, X. M.; Martin, G. P.; Marriott, C. Preparation and In-Vitro Evaluation of Tetrandrine-Entrapped Albumin Microspheres As An Inhaled Drug-Delivery System. Eur. J. Pharm. Sci., 1995, 3, 87-93.
82. Kwon, M. J.; Bae, J. H.; Kim, J. J.; Na, K.; Lee, E. S. Long acting porous microparticle for pulmonary protein delivery. Int. J. Pharm., 2007, 333, 5-9.
83. Asada, M.; Takahashi, H.; Okamoto, H.; Tanino, H.; Danjo, K. Theophylline particle design using chitosan by the spray drying. Int. J. Pharm., 2004, 270, 167-174. (Pubitemid 38077097)
84. Huang, Y. C.; Yeh, M. K.; Cheng, S. N.; Chiang, C. H. The characteristics of betamethasone-loaded chitosan microparticles by spray-drying method. J. Microencapsul., 2003, 20, 459-472. (Pubitemid 36805892)
85. Sakagami, M.; Kinoshita, W.; Sakon, K.; Sato, J.-i.; Makino, Y. Mucoadhesive beclomethasone microspheres for powder inhalation: their pharmacokinetics and pharmacodynamics evaluation. J. Control. Release, 2002, 80, 207-218.
86. Smith, J.; Wood, E.; Dornish, M. Effect of chitosan on epithelial cell tight junctions. Pharm. Res., 2004, 21, 43-49. (Pubitemid 38122290)
87. Yamamoto, H.; Kuno, Y.; Sugimoto, S.; Takeuchi, H.; Kawashima, Y. Surface-modified PLGA nanosphere with chitosan improved pulmonary delivery of calcitonin by mucoadhesion and opening of the intercellular tight junctions. J. Control. Release, 2005, 102, 373-381. (Pubitemid 40093760)
88. Learoyd, T. P.; Burrows, J. L.; French, E.; Seville, P. C. Modified release of beclometasone dipropionate from chitosan-based spray-dried respirable powders. Powder Technol., 2008, 187, 231-238.
89. Learoyd, T. P.; Burrows, J. L.; French, E.; Seville, P. C. Chitosan-based spray-dried respirable powders for sustained delivery of terbutaline sulfate. Eur. J. Pharm. Biopharm., 2008, 68, 224-234.
90. McConville, J. T.; Patel, N.; Ditchburn, N.; Tobyn, M. J.; Staniforth, J. N.; Woodcock, P. Use of a novel modified TSI for the evaluation of controlled-release aerosol formulations. I. Drug Dev. Ind. Pharm., 2000, 26, 1191-1198. (Pubitemid 30807505)
91. Ho, D. H.; Wang, C. Y.; Lin, J. R.; Brown, N.; Newman, R. A.; Krakoff, I. H. Polyethylene glycol-L-asparaginase and L-asparaginase studies in rabbits. Drug Met. Dispos., 1988, 16, 27-29.
92. Garcia-Contreras, L.; Morçöl, T.; Bell, S. J. D.; Hickey, A. J. Evaluation of Novel Particles as Pulmonary Delivery Systems for Insulin in Rats. AAPS PharmSci., 2003, 5, Article 9. (Pubitemid 38097485)
93. Yamamoto, A.; Yamada, K.; Muramatsu, H.; Nishinaka, A.; Okumura, S.; Okada, N.; Fujita, T.; Muranishi, S. Control of pulmonary absorption of water-soluble compounds by various viscous vehicles. Int. J. Pharm., 2004, 282, 141-149. (Pubitemid 39178491)
94. Yamada, K.; Kamada, N.; Odomi, M.; Okada, N.; Nabe, T.; Fujita, T.; Kohno, S.; Yamamoto, A. Carrageenans can regulate the pulmonary absorption of antiasthmatic drugs and their retention in the rat lung tissues without any membrane damage. Int. J. Pharm., 2005, 293, 63-72. (Pubitemid 40381081)
95. BP-2008; British Pharmacopoeia 2008. In Electronic Resource ed.; TSO; The Stationery Office Limited: 2008.
96. USP31-NF26; United States Pharmacopeia and National Formulary. 26th ed.; United States Pharmacopia Convention INC: Rockville, MD, 2007.
97. Newman, S. P.; Pitcairn, G. R.; Hirst, P. H.; Rankin, L. Radionuclide imaging technologies and their use in evaluating asthma drug deposition in the lungs. Adv. Drug Deliv. Rev., 2003, 55, 851-867. (Pubitemid 36776797)
98. Derendorf, H.; Hochhaus, G.; Meibohm, B.; Möllmann, H.; Barth, J. Pharmacokinetics and pharmacodynamics of inhaled corticosteroids. J. Allergy Clin. Immun., 1998, 101, S440-S446.
99. Patton, J. S.; Bukar, J. G.; Eldon, M. A. Clinical Pharmacokinetics and Pharmacodynamics of Inhaled Insulin. Clin. Pharmacokinet., 2004, 43, 781-801. (Pubitemid 39382220)
100. Widdicombe, J. H. Regulation of the depth and composition of airway surface liquid. J. Anat., 2002, 201, 313-318. (Pubitemid 35244050)
101. Davies, N. M.; Feddah, M. I. R. A novel method for assessing dissolution of aerosol inhaler products. Int. J. Pharm., 2003, 255, 175-187.
102. Ungaro, F.; d'Emmanuele di Villa Bianca, R.; Giovino, C.; Miro, A.; Sorrentino, R.; Quaglia, F.; La Rotonda, M. I. Insulin-loaded PLGA/cyclodextrin large porous particles with improved aerosolization properties: In vivo deposition and hypoglycaemic activity after delivery to rat lungs. J. Control. Release, 2009, 135, 25-34.
103. Kalkwarf, D. R.; Sikov, M. R.; Smith, L.; Gordon, R. Release of progesterone from polyethylene devices in vitro and in experimental animals. Contraception. 1972, 6, 423-431.
104. Alhusban, F. A.; Seville, P. C. Carbomer-modified spray-dried respirable powders for pulmonary delivery of salbutamol sulphate. J. Microencapsul., 2008, 1-12.
105. Shaw, L. R.; Irwin, W. J.; Grattan, T. J.; Conway, B. R. The Development of a Modified Dissolution Method Suitable for Investigating Powder Mixtures. Drug Dev. Ind. Pharm., 2002, 28, 1147-1153.
106. Beyssac, E.; Lavigne, J. Dissolution Study of Active Pharmaceutical Ingredients Using the Flow Through Apparatus USP 4. Dissolution Technol., 2005, 12, 23-25.
107. Kauffman, J. S. Qualification and Validation of USP Apparatus 4. Dissolution Technol., 2005, 12, 41-43.
108. Lameiro, M. H.; Lopes, A.; Martins, L. O.; Alves, P. M.; Melo, E. Incorporation of a model protein into chitosan-bile salt microparticles. Int. J. Pharm., 2006, 312, 119-130.
109. Wang, L. Y.; Gu, Y. H.; Su, Z. G.; Ma, G. H. Preparation and improvement of release behavior of chitosan microspheres containing insulin. Int. J. Pharm., 2006, 311, 187-195. (Pubitemid 43319218)
110. Forbes, B.; Ehrhardt, C. Human respiratory epithelial cell culture for drug delivery applications. Eur. J. Pharm. Biopharm., 2005, 60, 193-205. (Pubitemid 40804561)
111. Grainger, C. I.; Greenwell, L. L.; Martin, G. P.; Forbes, B. The permeability of large molecular weight solutes following particle delivery to air-interfaced cells that model the respiratory mucosa. Eur. J. Pharm. Biopharm., 2009, 71, 318-324.
112. Grenha, A.; Grainger, C. I.; Dailey, L. A.; Seijo, B.; Martin, G. P.; Remuñán-López, C.; Forbes, B. Chitosan nanoparticles are compatible with respiratory epithelial cells in vitro. Eur. J. Pharm. Sci., 2007, 31, 73-84. (Pubitemid 46660576)
113. Pang, Y.; Sakagami, M.; Byron, P. R. The pharmacokinetics of pulmonary insulin in the in vitro isolated perfused rat lung: Implications of metabolism and regional deposition. Eur. J. Pharm. Sci., 2005, 25, 369-378.
114. Sakagami, M. In vivo, in vitro and ex vivo models to assess pulmonary absorption and disposition of inhaled therapeutics for systemic delivery. Adv. Drug Deliv. Rev., 2006, 58, 1030-1060. (Pubitemid 44712023)
115. Cryan, S.-A.; Sivadas, N.; Garcia-Contreras, L. In vivo animal models for drug delivery across the lung mucosal barrier. Adv. Drug Deliv. Rev., 2007, 59, 1133-1151. (Pubitemid 47628783)
116. Enna, S. J.; Schanker, L. S. Absorption of drugs from rat lung. Am. J. Physiol, 1972, 223, 1227-1231.
117. Pettis, R. J.; Hall, I.; Costa, D.; Hickey, A. J. Aerosol Delivery of Muramyl Dipeptide to Rodent Lungs. AAPS J., 2003, 2, Article 25.
118. Brain, J. D.; Knudson, D. E.; Sorokin, S. P.; Davis, M. A. Pulmonary distribution of particles given by intratracheal instillation or by aerosol inhalation. Environ. Res., 1976, 11, 13-33.
119. Sakagami, M.; Kinoshita, W.; Sakon, K.; Makino, Y. Fractional contribution of lung, nasal and gastrointestinal absorption to the systemic level following nose-only aerosol exposure in rats: A case study of 3.7-μm fluorescein aerosols. Arch. Toxicol., 2003, 77, 321-329.(Pubitemid 36819262)
120. McConville, J. T.; Williams, R. O.; Carvalho, T. C.; Iberg, A. N.; Johnston, K. P.; Talbert, R. L.; Burgess, D.; Peters, J. I. Design and evaluation of a restraint-free small animal inhalation dosing chamber. Drug Dev. Ind. Pharm., 2005, 31, 35-42.
121. Prime, D.; Atkins, P. J.; Slater, A.; Sumby, B. Review of dry powder inhalers. Adv. Drug Deliv. Rev., 1997, 26, 51-58.
122. Smith, I. J.; Parry-Billings, M. The inhalers of the future? A review of dry powder devices on the market today. Pulm. Pharmacol. Ther., 2003, 16, 79-95. (Pubitemid 36372063)
123. Islam, N.; Gladki, E. Dry powder inhalers (DPIs) - A review of device reliability and innovation. Int. J. Pharm., 2008, 360, 1-11.
124. Dellamary, L.; Smith, D. J.; Bloom, A.; Bot, S.; Guo, G. R.; Deshmuk, H.; Costello, M.; Bot, A. Rational design of solid aerosols for immunoglobulin delivery by modulation of aerodynamic and release characteristics. J. Control Release, 2004, 95, 489-500. (Pubitemid 38340499)
125. Underwood, S. L.; Lingham, D.; Pearson, J.; Raeburn, D. A novel technique for the administration of bronchodilator drugs formulated as dry powders to the anaesthetized guinea pig. J. Pharmacol. Method., 1991, 26, 203-210.
126. Komada, F.; Iwakawa, S.; Yamamoto, N.; Sakakibara, H.; Okumura, K. Intratracheal delivery of peptide and protein agents: Absorption from solution and dry powder by rat lung. J. Pharm. Sci., 1994, 83, 863-867. (Pubitemid 24233766)
127. Kawashima, Y.; Serigano, T.; Hino, T.; Yamamoto, H.; Takeuchi, H. Surface-modified antiasthmatic dry powder aerosols inhaled intratracheally reduce the pharmacologically effective dose. Pharm. Res., 1998, 15, 1753-1759 (Pubitemid 28524588)
128. Okamoto, H.; Aoki, M.; Danjo, K. A novel apparatus for rat in vivo evaluation of dry powder formulations for pulmonary administration. J. Pharm. Sci., 2000, 89, 1028-1035. (Pubitemid 30692819)
129. Sakr, F. M. A new approach for insulin delivery via the pulmonary route: Design and pharmacokinetics in non-diabetic rabbits. Int. J. Pharm., 1992, 86, 1-7.
130. Adjei, A.; Doyle, R.; Pratt, M.; Finley, R.; Johnson, E. Bioavailability of leuprolide following intratracheal administration to beagle dogs. Int. J. Pharm., 1990, 61, 135-144. (Pubitemid 20201614)
131. Colthorpe, P.; Farr, S. J.; Taylor, G.; Smith, l. J.; Wyatt, D. The pharmacokinetics of pulmonary-delivered insulin: a comparison of intratracheal and aerosol administration to the rabbit. Pharm. Res., 1992, 9, 764-768.
132. Bitonti, A. J.; Dumont, J. A.; Low, S. C.; Peters, R. T.; Kropp, K. E.; Palombella, V. J.; Stattel, J. M.; Lu, Y.; Tan, C. A.; Song, J. J.; Garcia, A. M.; Simister, N. E.; Spiekermann, G. M.; Lencer, W. I.; Blumberg, R. S. Pulmonary delivery of an erythropoietin Fc fusion protein in non-human primates through an immunoglobulin transport pathway. Proc. Natl. Acad. Sci., 2004, 101, 9763-9768.
133. Byron, P. R.; Clark, A. R. Drug absorption from inhalation aerosols administered by positive-pressure ventilation I: Administration of a characterized, solid disodium fluorescein aerosol under a controlled respiratory regime to the beagle dog. J. Phram. Sci., 1985, 74, 934-938. (Pubitemid 15014133)
134. Schreier, H.; McNicol, K. J.; Bennett, D. B.; Teitelbaum, Z.; Derendorf, H. Pharmacokinetics of detirelix following intratracheal instillation and aerosol inhalation in the unanesthetized awake sheep. Pharm. Res., 1994, 11, 1056-1059. (Pubitemid 24227655)
135. Jansen, M.; Darby, I.; Abribat, T.; Dubreuil, P.; Ferdinandi, E. S.; Hardy, J. G. Pulmonary delivery of TH9507, a growth hormone releasing factor analogue, in the dog. Int. J. Pharm., 2004, 276, 75-81.
136. Nerbrink, O.; Fagerström, P.-O.; Wendel, T.; Eirefelt, S.; Källén, A.; Marchner, H.; Dahlbäck, M. A novel dry powder aerosol delivery system for real time measurement of the inhaled dose to large animals (Dogs). Aerosol Sci. Tech., 1997, 27, 147-161. (Pubitemid 27327923)
137. Grainger, C. I.; Alcock, R.; Gard, T. G.; Quirk, A. V.; van Amerongen, G.; de Swart, R. L.; Hardy, J. G. Administration of an insulin powder to the lungs of cynomolgus monkeys using a Penn Century insufflator. Int. J. Pharm., 2004, 269, 523-527.
138. Evgenov, O. V.; Kohane, D. S.; Bloch, K. D.; Stasch, J.-P.; Volpato, G. P.; Bellas, E.; Evgenov, N. V.; Buys, E. S.; Gnoth, M. J.; Graveline, A. R.; Liu, R.; Hess, D. R.; Langer, R.; Zapol, W. M. Inhaled agonists of soluble guanylate cyclase induce selective pulmonary vasodilation. Am. J. Resp. Crit. Care, 2007, 176, 1138-1145.
139. Murakami, K.; Bjertnaes, L. J.; Schmalstieg, F. C.; McGuire, R.; Cox, R. A.; Hawkins, H. K.; Herndon, D. N.; Traber, L. D.; Traber, D. L. A novel animal model of sepsis after acute lung injury in sheep. Crit. Care Med., 2002, 30, 2083-2090.
140. Begin, R.; Rola-Pleszczynski, M.; Sirois, P.; Masse, S.; Nadeau, D.; Bureau, M. A. Sequential analysis of the bronchoalveolar milieu in conscious sheep. J. Appl. Physiol. 1981, 50, 665-671.
141. Bischof, R. J.; Snibson, K.; Shaw, R.; Meeusen, E. N. T. Induction of allergic inflammation in the lungs of sensitized sheep after local challenge with house dust mite. Clin. Exp. Allergy., 2003, 33, 367-375.
142. Abraham, W. M. Modeling of asthma, COPD and cystic fibrosis in sheep. Pulm. Pharmacol. Ther., 2008, 21, 743-754.
143. Salama, R. O.; Ladd, L. A.; Traini, D.; Chan, H.-K.; Young, P. M. In formulation, characterisation and in vitro - in vivo evaluation of spray dried pulmonary microparticles in an ovine animal model, respiratory drug delivery (RDD), Scottsdale, Arizona, 2008; Dalby, R. N.; Byron, P. R.; Peart, J.; Suman, J. D.; Farr, S. J.; Young, P. M., Eds. Scottsdale, Arizona, 2008; pp 923-926.