Targeting inhaled therapy beyond the lungs

Respiration

Volumn 88, Issue 5, 2014, Pages 353-364

  Mortensen, Ninell P ^a   Hickey, Anthony J ^a  

^a RTI INTERNATIONAL   (United States)

Author keywords

Aerosolization; Dissolution rate; Drug delivery; Drug release; Inhaled therapy; Systemic delivery

Indexed keywords

ALCOHOL DEHYDROGENASE; ALDEHYDE OXIDASE; AMINE OXIDASE (COPPER CONTAINING); AZO REDUCTASE; CYTOCHROME P450; DEXTRAN; DIHYDROERGOTAMINE; DIHYDROERGOTAMINE MESILATE; EPOXIDE HYDROLASE; LEUPRORELIN; LOXAPINE; NANOPARTICLE; NITROREDUCTASE; PEPTIDASE; POLYMER; PROSTAGLANDIN SYNTHASE; AEROSOL;

AEROSOL; ARTICLE; BRONCHIOLE; DRUG ABSORPTION; DRUG CLEARANCE; DRUG DEGRADATION; DRUG DELIVERY SYSTEM; DRUG DIFFUSION; DRUG METABOLISM; DRUG SOLUBILITY; ELECTROSTATIC PRECIPITATION; GLUTATHIONE METABOLISM; HUMAN; LUNG; LUNG ALVEOLUS MACROPHAGE; PARTICLE SIZE; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; STATIC ELECTRICITY; ADMINISTRATION AND DOSAGE; INHALATIONAL DRUG ADMINISTRATION; LUNG GAS EXCHANGE; METABOLISM; MUCOCILIARY CLEARANCE; PATHOLOGY; PATHOPHYSIOLOGY; PHARMACOKINETICS; PHYSIOLOGY;

ADMINISTRATION, INHALATION; AEROSOLS; DRUG DELIVERY SYSTEMS; HUMANS; LUNG; MUCOCILIARY CLEARANCE; RESPIRATORY TRANSPORT;

EID: 84918769866     PISSN: 00257931     EISSN: 14230356     Source Type: Journal    
DOI: 10.1159/000367852     Document Type: Article

References (78)

1. FDA: FDA approves Afrezza to treat diabetes.2014.http://www.fda.gov/newsevents/newsroom/ pressannouncements/ucm403122.htm.
2. Hickey AJ: Back to the future: Inhaled drug products.J Pharm Sci 2013; 102: 1165-1172.
3. Olsson B, et al: Pulmonary drug metabolism, clearance and absorption; in Smyth HDC, Hickey AJ (eds): Controlled Pulmonary Drug Delivery.Berlin, Springer, 2012, pp 21-50.
4. Soferman R, et al: Effects of inhaled corticosteroids and inhaled cromolyn sodium on urinary growth hormone excretion in asthmatic children.Pediatr Pulmonol 1998; 26: 339-343.
5. Walvoord EC, et al: Inhaled growth hormone (GH) compared with subcutaneous GH in children with GH deficiency: Pharmacokinetics, pharmacodynamics, and safety.J Clin Endocrinol Metab 2009; 94: 2052-2059.
6. Nelson HS, et al: Short-term safety of somatropin inhalation powder in adults with mild to moderate asthma.Allergy Asthma Proc 2009; 30: 325-332.
7. Byron PR, Patton JS: Drug delivery via the respiratory tract.J Aerosol Med 1994; 7: 49-75.
8. Heise T, et al: PROMAXX inhaled insulin: Safe and efficacious administration with a commercially available dry powder inhaler.Diabetes Obes Metab 2009; 11: 455-459.
9. Mastrandrea LD: Inhaled insulin: overview of a novel route of insulin administration.Vasc Health Risk Manag 2010; 6: 47-58.
10. Mastrandrea LD, Quattrin T: Clinical evaluation of inhaled insulin.Adv Drug Deliv Rev 2006; 58: 1061-1075.
11. Patton JS, Bukar JG, Eldon MA: Clinical pharmacokinetics and pharmacodynamics of inhaled insulin.Clin Pharmacokinet 2004; 43: 781-801.
12. White NH, et al: Efficacy and safety of inhaled human insulin (Exubera) compared to subcutaneous insulin in children ages 6 to 11 years with type 1 diabetes mellitus: results of a 3-month, randomized, parallel trial.J Pediatr Endocrinol Metab 2008; 21: 555-568.
13. White S, et al: EXUBERA: Pharmaceutical development of a novel product for pulmonary delivery of insulin.Diabetes Technol Ther 2005; 7: 896-906.
14. Telko MJ, Hickey AJ: Dry powder inhaler formulation.Respir Care 2005; 50: 1209-1227.
15. Hofmann W: Modelling inhaled particle deposition in the human lung-a review.J Aerosol Sci 2011; 42: 693-724.
16. Patton JS, Byron PR: Inhaling medicines: delivering drugs to the body through the lungs.Nat Rev Drug Discov 2007; 6: 67-74.
17. Misra A, et al: Inhaled drug therapy for treatment of tuberculosis.Tuberculosis (Edinb) 2011; 91: 71-81.
18. Hickey AJ, Misra A, Fourie PB: Dry powder antibiotic aerosol product development: Inhaled therapy for tuberculosis.J Pharm Sci 2013; 102: 3900-3907.
19. Eixarch H, et al: Drug delivery to the lung: Permeability and physicochemical characteristics of drugs as the basis for a pulmonary biopharmaceutical classification system (pBCS).J Epithelial Biol Pharmacol 2010; 3: 1-14.
20. Pillai G, et al: Generation of concentrated aerosols for inhalation studies.J Aerosol Sci 1994; 25: 10.
21. Parra SC, et al: Zonal distribution of alveolar macrophages, type II pneumonocytes, and alveolar septal connective tissue gaps in adult human lungs.Am Rev Respir Dis 1986; 133: 908-912.
22. Stone KC, et al: Allometric relationships of cell numbers and size in the mammalian lung.Am J Respir Cell Mol Biol 1992; 6: 235-243.
23. Lombry C, et al: Alveolar macrophages are a primary barrier to pulmonary absorption of macromolecules.Am J Physiol Lung Cell Mol Physiol 2004; 286:L1002-L1008.
24. Suarez S, et al: Airways delivery of rifampicin microparticles for the treatment of tuberculosis.J Antimicrob Chemother 2001; 48: 431-434.
25. Suarez S, et al: Respirable PLGA microspheres containing rifampicin for the treatment of tuberculosis: Screening in an infectious disease model.Pharm Res 2001; 18: 1315-1319.
26. Fishman AP: The volume of blood in the lungs.Circulation 1966; 33: 835-838.
27. Lewis ML, et al: Determinants of pulmonary blood volume.J Clin Invest 1970; 49: 170-182.
28. Dock DS, et al: The pulmonary blood volume in man.J Clin Invest 1961; 40: 317-328.
29. Ma J, Bhat M, Rojanasakul Y: Drug metabolism and enzyme kinetics in the lung; in Hickey AJ (ed): Inhalation Aerosols.New York, Dekker, 1996.
30. 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.
31. Upton RN, Doolette DJ: Kinetic aspects of drug disposition in the lungs.Clin Exp Pharmacol Physiol 1999; 26: 381-391.
32. Krishna DR, Klotz U: Extrahepatic metabolism of drugs in humans.Clin Pharmacokinet 1994; 26: 144-160.
33. Dahl AR, Lewis JL: Respiratory tract uptake of inhalants and metabolism of xenobiotics.Annu Rev Pharmacol Toxicol 1993; 33: 383-407.
34. Somers GI, et al: A comparison of the expression and metabolizing activities of phase I and II enzymes in freshly isolated human lung parenchymal cells and cryopreserved human hepatocytes.Drug Metab Dispos 2007; 35: 1797-1805.
35. Dharmadhikari AS, et al: Phase I, single-dose, dose-escalating study of inhaled dry powder capreomycin: A new approach to therapy of drug-resistant tuberculosis.Antimicrob Agents Chemother 2013; 57: 2613-2619.
36. Lorenz J, et al: Drug metabolism in man and its relationship to that in three rodent species: Monooxygenase, epoxide hydrolase, and glutathione S-transferase activities in subcellular fractions of lung and liver.Biochem Med 1984; 32: 43-56.
37. Sidorowicz W, et al: Cleavage of the Arg1-Pro2 bond of bradykinin by a human lung peptidase: Isolation, characterization, and inhibition by several beta-lactam antibiotics.Proc Soc Exp Biol Med 1984; 175: 503-509.
38. Ekstrom L, Johansson M, Rane A: Tissue distribution and relative gene expression of UDP-glucuronosyltransferases (2B7, 2B15, 2B17) in the human fetus.Drug Metab Dispos 2013; 41: 291-295.
39. Kurogi K, et al: Sulfation of opioid drugs by human cytosolic sulfotransferases: Metabolic labeling study and enzymatic analysis.Eur J Pharm Sci 2014; 62C:40-48.
40. Leclerc J, et al: Xenobiotic metabolism and disposition in human lung: Transcript profiling in non-tumoral and tumoral tissues.Biochimie 2011; 93: 1012-1027.
41. Carvalho TC, Peters JI, Williams RO 3rd: Influence of particle size on regional lung deposition-what evidence is there? Int J Pharm 2011; 406: 1-10.
42. Goodman DE, et al: The influence of age, diagnosis, and gender on proper use of metered-dose inhalers.Am J Respir Crit Care Med 1994; 150: 1256-1261.
43. Edwards DA, et al: Large porous particles for pulmonary drug delivery.Science 1997; 276: 1868-1871.
44. Swift DL: Generation and respiratory deposition of therapeutic aerosols.Am Rev Respir Dis 1980; 122: 71-77.
45. Vroman L: Effect of adsorbed proteins on wettability of hydrophilic and hydrophobic solids.Nature 1962; 196: 476-477.
46. Vroman L, et al: Interaction of high molecular-weight kininogen, factor-XII, and fibrinogen in plasma at interfaces.Blood 1980; 55: 156-159.
47. Cedervall T, et al: Understanding the nanoparticle-protein corona using methods to quantify exchange rates and affinities of proteins for nanoparticles.Proc Natl Acad Sci USA 2007; 104: 2050-2055.
48. Lundqvist M, et al: Nanoparticle size and surface properties determine the protein corona with possible implications for biological impacts.Proc Natl Acad Sci USA 2008; 105: 14265-14270.
49. Aggarwal P, et al: Nanoparticle interaction with plasma proteins as it relates to particle biodistribution, biocompatibility and therapeutic efficacy.Adv Drug Deliv Rev 2009; 61: 428-437.
50. Mortensen NP, et al: Dynamic development of the protein corona on silica nanoparticles: composition and role in toxicity.Nanoscale 2013; 5: 6372-6380.
51. Hickey AJ: Summary of common approaches to pharmaceutical aerosol administration; in Hickey AJ (ed): Pharmaceutical Inhalation Aerosol Technology, ed 2.New York, Dekker, 2004.
52. Hickey AJ: Pulmonary drug delivery-pharmaceutical chemistry and aerosol technology; in Wang B, Siahaan T, Soltero RA (eds): Drug Delivery: Principles and Applications.New York, Wiley, 2004.
53. Hickey AJ: Methods of aerosol particle size characterization, in Hickey AJ (ed): Pharmaceutical Inhalation Aerosol Technology, ed 2.New York, Dekker, 2004, pp 345-384.
54. Sayes CM, Staats H, Hickey AJ: Scale of health: Indices of safety and efficacy in the evolving environment of large biological datasets.Pharm Res 2014, Epub ahead of print.
55. Crowder TM, et al: Fundamental effects of particle morphology on lung delivery: Predictions of Stokes' law and the particular relevance to dry powder inhaler formulation and development.Pharm Res 2002; 19: 239-245.
56. Lai SK, Wang YY, Hanes J: Mucus-penetrating nanoparticles for drug and gene delivery to mucosal tissues.Adv Drug Deliv Rev 2009; 61: 158-171.
57. Walter E, et al: Hydrophilic poly(DL-lactideco-glycolide) microspheres for the delivery of DNA to human-derived macrophages and dendritic cells.J Control Release 2001; 76: 149-168.
58. Geiser M, et al: Ultrafine particles cross cellular membranes by nonphagocytic mechanisms in lungs and in cultured cells.Environ Health Perspect 2005; 113: 1555-1560.
59. Bharatwaj B, et al: Polymeric nanocarriers for transport modulation across the pulmonary epithelium: dendrimers, polymeric nanoparticles, and their nanoblends.AAPS J 2014; 16: 522-538.
60. Effros RM: Solute transport following aerosol deposition in the lungs; in Hickey AJ (ed): Inhalation Aerosols: Physical and Biological Basis for Therapy.New York, Informa Healthcare, 2007, pp 127-145.
61. Effros RM, et al: Resistance of the pulmonary epithelium to movement of buffer ions.Am J Physiol Lung Cell Mol Physiol 2003; 285: L476-L483.
62. Bryan R, et al: The effects of aerosolized dextran in a mouse model of Pseudomonas aeruginosa pulmonary infection.J Infect Dis 1999; 179: 1449-1458.
63. Niven RW, Rypacek F, Byron PR: Solute absorption from the airways of the isolated rat lung.III.Absorption of several peptidaseresistant, synthetic polypeptides: Poly-(2-hydroxyethyl)-aspartamides.Pharm Res 1990; 7: 990-994.
64. Matsukawa Y, et al: Size-dependent dextran transport across rat alveolar epithelial cell monolayers.J Pharm Sci 1997; 86: 305-309.
65. Schanker LS, Mitchell EW, Brown RA Jr: Species comparison of drug absorption from the lung after aerosol inhalation or intratracheal injection.Drug Metab Dispos 1986; 14: 79-88.
66. Cooney D, Kazantseva M, Hickey AJ: Development of a size-dependent aerosol deposition model utilising human airway epithelial cells for evaluating aerosol drug delivery.Altern Lab Anim 2004; 32: 9.
67. Adjei AL, Gupta PK: Inhalation Delivery of Therapeutic Peptides and Proteins.New York, Dekker, 1997.
68. Patton JS, Platz RM: Routes of delivery: case studies: (2) pulmonary delivery of peptides and proteins for systemic action.Adv Drug Deliv Rev 1992; 8: 17.
69. Adjei A, Garren J: Pulmonary delivery of peptide drugs: effect of particle size on bioavailability of leuprolide acetate in healthy male volunteers.Pharm Res 1990; 7: 565-569.
70. Patton JS, Trinchero P, Platz RM: Bioavailability of pulmonary delivered peptides and proteins: Interferon alpha, calcitonins and parathyroid hormones.J Control Release 1990; 28: 6.
71. Tepper SJ: Orally inhaled dihydroergotamine: A review.Headache 2013; 53(suppl 2):43-53.
72. Currier G, Walsh P: Safety and efficacy review of inhaled loxapine for treatment of agitation.Clin Schizophr Relat Psychoses 2013; 7: 25-32.
73. Alexander-Williams JM, Rowbotham DJ: Novel routes of opioid administration.Br J Anaesth 1998; 81: 3-7.
74. Gessler T, Seeger W, Schmehl T: Inhaled prostanoids in the therapy of pulmonary hypertension.J Aerosol Med Pulm Drug Deliv 2008; 21: 1-12.
75. Matsui H, Grubb BR, Tarran R, Randall SH, Gatzby JT, Davis CW, Boucher R: Evidence for periciliary aqueous layer depletion, not abnormal ion composition, in the pathogenesis of cystic fibrosis airways disease.Cell 1998; 95: 1005-1015.
76. Zhang JY, Wang YF, Prakash C: Xenobioticmetabolizing enzymes in human lung.Current Drug Metabolism 2006; 7: 939-948.
77. Brown RP, et al: Physiological parameter values for physiologically based pharmacokinetic models.Toxicol Ind Health 1997; 13: 407-484.
78. Klaassen CD: Casarett & Doull's Toxicology: The Basic Science of Poisons, ed 6.New York, McGraw Hill, 2001.