Models of deposition, pharmacokinetics, and intersubject variability in respiratory drug delivery

References

• Gross NJ, Barnes PJ. New therapies for asthma and chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2017;195:159–166.
   PubMed Web of Science ®Google Scholar
• Quon BS, Goss CH, Ramsey BW. Inhaled antibiotics for lower airway infections. Ann Am Thorac Soc. 2014;11:425–434.
   PubMedGoogle Scholar
• Cosa N, Costa JE. Inhaled pulmonary vasodilators for persistent pulmonary hypertension of the newborn: safety issues relating to drug administration and delivery devices. Medical Devices (Auckl). 2016;9:45–51.
   PubMedGoogle Scholar
• Pappert D, Busch T, Gerlach H, et al. Aerosolized prostacylcin versus inhaled nitric oxide in children with seere acute respiratory distress syndrome. Anesthesiology: J Am Soc Anesthesiologists. 1995;82:1507–1511.
   PubMed Web of Science ®Google Scholar
• Zwissler B, Kemming G, Habler O, et al. Inhaled prostacylcin (PGI2) versus inhaled nitric oxide in adult respiratory distress syndrome. Am J Respir Crit Care Med. 1996;154:1671–1677.
   PubMedGoogle Scholar
• Patton JS, Byron PR. Inhaling medicines: delivering drugs to the body through the lungs. Nat Rev Drug Discov. 2007;6:67–74.
   PubMed Web of Science ®Google Scholar
• Zarogoulidis P, Papanas N, Kouliatsis G, et al. Inhaled insulin: too soon to be forgotten? J Aerosol Med Pulm Drug Deliv. 2011;24:213–223.
   PubMed Web of Science ®Google Scholar
• San L, Estrada G, Oudovenko N, et al. PLACID study: A randomized trial comparing the efficacy and safety of inhaled loxapine versus intramuscular aripiprazole in acutely agitated patients with schizophrenia or bipolar disorder. European Neuropsychopharmacology. 2018;28:710–718.
   Google Scholar
• Tepper SJ. Orally inhaled dihydroergotamine: a review. Headache: Journal Head Face Pain. 2013;53:43–53.
   PubMed Web of Science ®Google Scholar
• Olanow CW, Stocchi F. Levodopa: A new look at an old friend. Movement disorders. 2018;33:859–866.
   Google Scholar
• Cipolla D, Gonda I. Inhaled nicotine replacement therapy. Asian Journal of Pharmaceutical Sciences. 2015;10:472–480.
   Web of Science ®Google Scholar
• Bakker E, Volpi S, Salonini E, et al. Improved treatment response to dornase alfa in cystic fibrosis patients using controlled inhalation. Eur Respir J. 2011;38:1328–1335.
   PubMed Web of Science ®Google Scholar
• Usmani OS, Barnes PJ. Assessing and treating small airways disease in asthma and chronic obstructive pulmonary disease. Ann Med. 2012;44:146–156.
   PubMed Web of Science ®Google Scholar
• Usmani OS, Biddiscombe MF, Barnes PJ. Regional lung deposition and bronchodilator response as a function of beta(2)-agonist particle size. Am J Respir Crit Care Med. 2005;172:1497–1504.
   PubMed Web of Science ®Google Scholar
• Finlay WH, Martin AR. Recent advances in predictive understanding of respiratory tract deposition. J Aerosol Med Pulm Drug Deliv. 2008;21:189–206.
   PubMed Web of Science ®Google Scholar
• Darquenne C. Aerosol deposition in health and disease. J Aerosol Med Pulm Drug Deliv. 2012;25:140–147.
   PubMed Web of Science ®Google Scholar
• Darquenne C, Hoover MD, Phalen RF. Inhaled aerosol dosimetry: some current research needs. J Aerosol Sci. 2016;99:1–5.
   PubMed Web of Science ®Google Scholar
• Hofmann W. Modelling inhaled particle deposition in the human lung - a review. J Aerosol Sci. 2011;42:693–724.
   Web of Science ®Google Scholar
• Rostami AA. Computational modeling of aerosol deposition in respiratory tract: a review. Inhal Toxicol. 2009;24:262–290.
   Google Scholar
• ICRP. Human respiratory tract model for radiological protection. ICRP Publication 66. Ann ICRP 24(1–3). Elsevier Science: Tarrytown, NY, 1994.
   Google Scholar
• Martin AR, Finlay WH. A general, algebraic equation for predicting total respiratory tract deposition of micrometer-sized aerosol particles in humans. J Aerosol Sci. 2007;38:246–253.
   Web of Science ®Google Scholar
• Rudolf G, Kobrich R, Modeling SW. Algebraic formulation of regional aerosol deposition in man. J Aerosol Sci. 1990;21:S403–S406.
   Web of Science ®Google Scholar
• Stahlhofen W, Rudolf G, James AC. Intercomparison of experimental regional aerosol deposition data. Journal Aerosol Medicine-Deposition Clearance Effects Lung. 1989;2:285–308.
   Google Scholar
• Finlay WH. The mechanics of inhaled pharmaceutical aerosols: an introduction. London: Academic Press; 2001.
   Google Scholar
• Darquenne C, Fleming JS, Katz I, et al. Bridging the gap between science and clinical efficacy: physiology, imaging, and modeling of aerosols in the lung. J Aerosol Med Pulm Drug Deliv. 2016;29:107–126.
   PubMed Web of Science ®Google Scholar
• Findeisen W. Uber das Absetzen kleiner in der Luft suspendierter Teilchen in der menschilchen Lunge bei der Atmung Pfleuger Arch. Ges Physiol. 1935;236:367–379.
   Google Scholar
• Finlay WH, Stapleton KW, Chan HK, et al. Regional deposition of inhaled hygroscopic aerosols: in vivo SPECT compared with mathematical modeling. J Appl Physiol. 1996;81:374–383.
   PubMed Web of Science ®Google Scholar
• Katz I, Pichelin M, Caillibotte G, et al. Controlled, parametric, individualized, 2D, and 3D imaging measurements of aerosol deposition in the respiratory tract of healthy human subjects: preliminary comparisons with simulations. Aerosol Sci Technol. 2013;47:714–723.
   Web of Science ®Google Scholar
• Finlay WH. Estimating the type of hygroscopic behavior exhibited by aqueous droplets. Journal Aerosol Medicine-Deposition Clearance Effects Lung. 1998;11:221–229.
   PubMedGoogle Scholar
• Javaheri E, Shemirani FM, Pichelin M, et al. Deposition modeling of hygroscopic saline aerosols in the human respiratory tract: comparison between air and helium-oxygen carrier gases. J Aerosol Sci. 2013;64:81–93.
   Web of Science ®Google Scholar
• Asgharian B, Hofmann W, Bergmann R. Particle deposition in a multiple-path model of the human lung. Aerosol Sci Technol. 2001;34:332–339.
   Web of Science ®Google Scholar
• Carrigy NB, Ruzycki CA, Golshahi L, et al. Pediatric in vitro and in silico models of deposition via oral and nasal inhalation. J Aerosol Med Pulm Drug Deliv. 2014;27:149–169.
   PubMed Web of Science ®Google Scholar
• Yang MY, Ruzycki C, Verschuer J, et al. Examining the ability of empirical correlations to predict subject specific in vivo extrathoracic aerosol deposition during tidal breathing. Aerosol Sci Technol. 2017;51:363–376.
   Web of Science ®Google Scholar
• Carrigy NB, Martin AR, Finlay WH. Use of extrathoracic deposition models for patient-specific dose estimation during inhaler design. Curr Pharm Des. 2015;21:3984–3992.
   PubMed Web of Science ®Google Scholar
• Borgstrom L, Olsson B, Thorsson L. Degree of throat deposition can explain the variability in lung deposition of inhaled drugs. Journal Aerosol Medicine-Deposition Clearance Effects Lung. 2006;19:473–483.
   PubMedGoogle Scholar
• Grgic B, Finlay WH, Burnell PKP, et al. In vitro intersubject and intrasubject deposition measurements in realistic mouth-throat geometries. J Aerosol Sci. 2004;35:1025–1040.
   Web of Science ®Google Scholar
• Golshahi L, Vehring R, Noga M, et al. In vitro deposition of micrometer-sized particles in the extrathoracic airways of children during tidal oral breathing. J Aerosol Sci. 2013;57:14–21.
   Web of Science ®Google Scholar
• Golshahi L, Noga M, Finlay W. Deposition of inhaled micrometer-sized particles in oropharyngeal airway replicas of children at constant flow rates. J Aerosol Sci. 2012;49:21–31.
   Web of Science ®Google Scholar
• Garcia GJ, Tewksbury EW, Wong BA, et al. Interindividual variability in nasal filtration as a function of nasal cavity geometry. J Aerosol Med Pulm Drug Deliv. 2009;22:139–155.
   PubMed Web of Science ®Google Scholar
• Golshahi L, Noga M, Thompson R, et al. In vitro deposition measurement of inhaled micrometer-sized particles in extrathoracic airways of children and adolescents during nose breathing. J Aerosol Sci. 2011;42:474–488.
   Web of Science ®Google Scholar
• Storey-Bishoff J, Noga M, Finlay W. Deposition of micrometer-sized aerosol particles in infant nasal airway replicas. J Aerosol Sci. 2008;39:1055–1065.
   Web of Science ®Google Scholar
• Martin AR, Finlay WH. In vitro testing of pharmaceutical aerosols and in vitro/in vivo correlations: empirical deposition correlations. Dhand R. editor. ISAM. Textbook of aerosol medicine. International Society for Aerosols in Medicine. 253–282.2012.
   Google Scholar
• Wong J, Chan H-K, Kwok PCL. Electrostatics in pharmaceutical aerosols for inhalation. Ther Deliv. 2013;4:981–1002.
   PubMedGoogle Scholar
• Azhdarzadeh M, Olfert JS, Vehring R, et al. Effect of electrostatic charge on oral-extrathoracic deposition for uniformly charged monodisperse aerosols. J Aerosol Sci. 2014;68:38–45.
   Web of Science ®Google Scholar
• Azhdarzadeh M, Olfert JS, Vehring R, et al. Effect of Induced Charge on Deposition of Uniformly Charged Particles in a Pediatric Oral-Extrathoracic Airway. Aerosol Sci Technol. 2014;48:508–514.
   Web of Science ®Google Scholar
• Azhdarzadeh M, Olfert JS, Vehring R, et al. Effect of electrostatic charge on deposition of uniformly charged monodisperse particles in the nasal extrathoracic airways of an infant. J Aerosol Med Pulm Drug Deliv. 2015;28:30–34.
   PubMed Web of Science ®Google Scholar
• Kwok PCL, Trietsch SJ, Kumon M, et al. Electrostatic charge characteristics of jet nebulized aerosols. J Aerosol Med Pulm Drug Deliv. 2010;23:149–159.
   PubMed Web of Science ®Google Scholar
• Kwok PCL, Glover W, Chan HK. Electrostatic charge characteristics of aerosols produced from metered dose inhalers. J Pharm Sci. 2005;94:2789–2799.
   PubMed Web of Science ®Google Scholar
• Dehaan WH, Finlay WH. Predicting extrathoracic deposition from dry powder inhalers. J Aerosol Sci. 2004;35:309–331.
   Web of Science ®Google Scholar
• Finlay W, Martin A. Modeling of aerosol deposition with interface devices. Journal of Aerosol Medicine. 2007;20:S19–S28.
   PubMedGoogle Scholar
• Grgic B, Martin AR, Finlay WH. The effect of unsteady flow rate increase on in vitro mouth-throat deposition of inhaled boluses. J Aerosol Sci. 2006;37:1222–1233.
   Web of Science ®Google Scholar
• Golshahi L, Noga M, Vehring R, et al. An in vitro study on the deposition of micrometer-sized particles in the extrathoracic airways of adults during tidal oral breathing. Ann Biomed Eng. 2013;41:979–989.
   PubMed Web of Science ®Google Scholar
• Shemirani FM, Hoe S, Lewis D, et al. In vitro investigation of the effect of ambient humidity on regional delivered dose with solution and suspension MDIs. J Aerosol Med Pulm Drug Deliv. 2013;26:215–222.
   PubMed Web of Science ®Google Scholar
• Burnell PK, Asking L, Borgström L, et al. Studies of the human oropharyngeal airspaces using magnetic resonance imaging IV—the oropharyngeal retention effect for four inhalation delivery systems. J Aerosol Med. 2007;20:269–281.
   PubMedGoogle Scholar
• Delvadia R, Hindle M, Longest PW, et al. In vitro tests for aerosol deposition II: iVIVCs for different dry powder inhalers in normal adults. J Aerosol Med Pulm Drug Deliv. 2013;26:138–144.
   PubMed Web of Science ®Google Scholar
• Delvadia RR, Longest PW, Byron PR. In vitro tests for aerosol deposition. I: scaling a physical model of the upper airways to predict drug deposition variation in normal humans. J Aerosol Med Pulm Drug Deliv. 2012;25:32–40.
   PubMed Web of Science ®Google Scholar
• Verbanck S, Ghorbaniasl G, Biddiscombe MF, et al. Inhaled Aerosol Distribution in Human Airways: A Scintigraphy-Guided Study in a 3D Printed Model. J Aerosol Med Pulm Drug Deliv. 2016;29:525–533.
   PubMed Web of Science ®Google Scholar
• Verbanck S, Kalsi HS, Biddiscombe MF, et al. Inspiratory and expiratory aerosol deposition in the upper airway. Inhal Toxicol. 2011;23:104–111.
   PubMed Web of Science ®Google Scholar
• Weers JG, Clark AR, Rao N, et al. In vitro-in vivo correlations observed with indacaterol-based formulations delivered with the breezhaler. J Aerosol Med Pulm Drug Deliv. 2015;28:268–280.
   PubMed Web of Science ®Google Scholar
• Zhang Y, Gilbertson K, Finlay WH. In vivo-in vitro comparison of deposition in three mouth-throat models with Qvar and Turbuhaler inhalers. J Aerosol Med. 2007;20:227–235.
   PubMedGoogle Scholar
• Zhou Y, Sun J, Cheng Y-S. Comparison of deposition in the USP and physical mouth–throat models with solid and liquid particles. J Aerosol Med Pulm Drug Deliv. 2011;24:277–284.
   PubMed Web of Science ®Google Scholar
• Haynes A, Mundry T, Durbha P, et al. Design of ciprofloxacin dry powder for inhalation. In: Dalby RN, Bryron PR, Peart J, et al., editors. Respiratory Drug Delivery 2016. LLC: Scottsdale, Arizona: Davis Healthcare International Publishing; 2016. p. 455–458.
   Google Scholar
• Weers J, Clark A. The impact of inspiratory flow rate on drug delivery to the lungs with dry powder inhalers. Pharm Res. 2017;34:507–528.
   PubMed Web of Science ®Google Scholar
• Europe C. European Pharmacopoeia 5.1. 2.9.18 preparations for inhalation. Strasbourg: Council of Europe; 2005.
   Google Scholar
• Wei X, Hindle M, Delvadia RR, et al. In vitro tests for aerosol deposition. v: using realistic testing to estimate variations in aerosol properties at the trachea. J Aerosol Med Pulm Drug Deliv. 2017;30:339–348.
   PubMed Web of Science ®Google Scholar
• Ruzycki CA, Martin AR, Vehring R, et al. An in vitro examination of the effects of altitude on dry powder inhaler performance. J Aerosol Med Pulm Drug Deliv. 2018;31:221–236.
   Web of Science ®Google Scholar
• Golshahi L, Finlay WH. An idealized child throat that mimics average pediatric oropharyngeal deposition. Aerosol Sci Technol. 2012;46:1–4.
   Web of Science ®Google Scholar
• Ruzycki CA, Golshahi L, Vehring R, et al. Comparison of in vitro deposition of pharmaceutical aerosols in an idealized child throat with in vivo deposition in the upper respiratory tract of children. Pharm Res. 2014;31:1525–1535.
   PubMed Web of Science ®Google Scholar
• Agency EM. Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for the treatment of asthma in children and adolescents, 2009.
   Google Scholar
• Javaheri E, Golshahi L, Finlay W. An idealized geometry that mimics average infant nasal airway deposition. J Aerosol Sci. 2013;55:137–148.
   Web of Science ®Google Scholar
• Tavernini S, Church T, Lewis D, et al. Deposition of micrometer-sized aerosol particles in neonatal nasal airway replicas. Aerosol Sci Technol. 2018;52:407–419.
   Web of Science ®Google Scholar
• Tavernini S, Church TK, Lewis DA, et al. Scaling an idealized infant Nasal airway geometry to mimic inertial filtration of neonatal Nasal airways. J Aerosol Sci. 2018;118:14–21.
   Web of Science ®Google Scholar
• Burrowes KS, De Backer J, Kumar H. Image-based computational fluid dynamics in the lung: virtual reality or new clinical practice? Wiley Interdiscip Rev Syst Biol Med. 2017;9:e1392.
   PubMed Web of Science ®Google Scholar
• Kleinstreuer C, Zhang Z. Airflow and particle transport in the human respiratory system. Annu Rev Fluid Mech. 2010;42:301–334.
   Web of Science ®Google Scholar
• Longest PW, Holbrook LT. In silico models of aerosol delivery to the respiratory tract - development and applications. Adv Drug Deliv Rev. 2012;64:296–311.
   PubMed Web of Science ®Google Scholar
• Ruzycki CA, Javaheri E, Finlay WH. The use of computational fluid dynamics in inhaler design. Expert Opin Drug Deliv. 2013;10:307–323.
   PubMed Web of Science ®Google Scholar
• Longest PW, Hindle M. Small airway absorption and microdosimetry of inhaled corticosteroid particles after deposition. Pharm Res. 2017;34:2049–2065.
   PubMed Web of Science ®Google Scholar
• Walenga RL, Longest PW. Current inhalers deliver very small doses to the lower tracheobronchial airways: assessment of healthy and constricted lungs. J Pharm Sci. 2016;105:147–159.
   PubMed Web of Science ®Google Scholar
• Bos AC, van Holsbeke C, de Backer JW, et al. Patient-specific modeling of regional antibiotic concentration levels in airways of patients with cystic fibrosis: are we dosing high enough? PLoS One. 2015;10:e0118454.
   PubMed Web of Science ®Google Scholar
• Longest PW, Tian G, Khajeh-Hosseini-Dalasm N, et al. Validating whole-airway CFD predictions of DPI aerosol deposition at multiple flow rates. J Aerosol Med Pulm Drug Deliv. 2016;29:461–481.
   PubMed Web of Science ®Google Scholar
• Longest PW, Tian G, Delvadia R, et al. Development of a stochastic individual path (SIP) model for predicting the deposition of pharmaceutical aerosols: effects of turbulence, polydisperse aerosol size, and evaluation of multiple lung lobes. Aerosol Sci Technol. 2012;46:1271–1285.
   Web of Science ®Google Scholar
• Oakes JM, Shadden SC, Grandmont C, et al. Aerosol transport throughout inspiration and expiration in the pulmonary airways. Int J Numer Method Biomed Eng. 2017;33:e2847.
   Web of Science ®Google Scholar
• Poorbahrami K, Oakes JM. Regional flow and deposition variability in adult female lungs: a numerical simulation pilot study. Clinical Biomechanics. doi:10.1016/j.clinbiomech.2017.12.014. [Epub ahead of print].
   Google Scholar
• Hastedt J, Backman P, Clark AR, et al. Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP workshop march 16-17th, 2015 in Baltimore, MD. AAPS Open. 2016;2:1.
   Google Scholar
• Olsson B, Bondesson E, Borgstrom L, et al. Pulmonary drug metabolism, clearance, and absorption. In: Smith HDC, Hickey T, editors. Controlled pulmonary drug delivery. Springer Science & Business Media, 2011.
   Google Scholar
• Sakagami M. In vivo, in vitro and ex vivo models to assess pulmonary absporption and disposition of inhaled therapeutics for systemic delivery. Adv Drug Deliv Rev. 2006;58:1030–1060.
   PubMed Web of Science ®Google Scholar
• Hickey AJ. Controlled delivery of inhaled therapeutic agents. Journal of Controlled Release. 2014;190:182–188.
   PubMed Web of Science ®Google Scholar
• Byron PR. Predictions of drug residence times in regions of the human respiratory tract following human inhalation. J Pharm Sci. 1986;75:433–438.
   PubMed Web of Science ®Google Scholar
• Gonda I. Drugs administered directly into the respiratory tract: modeling of the duration of effective drug levels. J Pharm Sci. 1988;77:340–346.
   PubMed Web of Science ®Google Scholar
• Backman P, Tehler U, Olsson B. Predicting exposure after oral inhalation of the selective glucocorticoid receptor modulator, AZD5423, based on dose, deposition pattern, and mechanistic modeling of pulmonary disposition. J Aerosol Med Pulm Drug Deliv. 2017;30:108–117.
   PubMed Web of Science ®Google Scholar
• Boger E, Friden M. Physiologically based pharmacokinetic/pharmacodynamic modeling accurately predicts the better bronchodilatory effect of inhaled versus oral salbutamol dosage forms. J Aerosol Med Pulm Drug Deliv. doi:10.1089/jamp.2017.1436. [Epub ahead of print].
   Google Scholar
• Caniga M, Cabal A, Mehta K, et al. Preclinical experimental and mathematical approaches for assessing effective doses of inhaled drugs, using mometasone to support human dose predictions. J Aerosol Med Pulm Drug Deliv. 2016;29:362–377.
   PubMed Web of Science ®Google Scholar
• Martin AR, Finlay WH. Model calculations of regional deposition and disposition for single doses of inhaled liposomal and dry powder ciprofloxacin. J Aerosol Med Pulm Drug Deliv. 2018;31:49–60.
   PubMed Web of Science ®Google Scholar
• Backman P, Arora S, Couet W, et al. Advances in experimental and mechanistic computational models to understand pulmonary exposure to inhaled drugs. Eur J Pharm Sci. 2018;113:41–52.
   PubMed Web of Science ®Google Scholar
• Finlay WH, Wong JP. Regional lung deposition of nebulized liposome-encapsulated ciprofloxacin. Int J Pharm. 1998;167:121–127.
   Web of Science ®Google Scholar
• Finlay WH, Lange CF, King M, and Speert DP. Lung delivery of aerosolized dextran. Am J Respir Crit Care Med. 2000;161:91–97.
   PubMed Web of Science ®Google Scholar
• Hoe S, Ivey JW, Boraey MA, et al. Use of a fundamental approach to spray-drying formulation design to facilitate the development of multi-component dry powder aerosols for respiratory drug delivery. Pharm Res. 2014;31:459–465.
   Web of Science ®Google Scholar
• Lange CF, Hancock REW, Samuel J, et al. In vitro aerosol delivery and regional airway surface liquid concentration of a liposomal cationic peptide. J Pharm Sci. 2001;90:1647–1657.
   Google Scholar
• Sweeney LG, Wang Z, Loebenberg R, et al. Spray-freeze-dried liposomal ciprofloxacin powder for inhaled aerosol drug delivery. Int J Pharm. 2005;305:180–185.
   PubMed Web of Science ®Google Scholar
• Wei X, Hindle M, Kaviratna A, et al. In vitro tests for aerosol deposition. vi: realistic testing with different mouth–throat models and in vitro—in vivo correlations for a dry powder inhaler, metered dose inhaler, and soft mist inhaler. J Aerosol Med Pulm Drug Deliv. doi:10.1089/jamp.2018.1454. [Epub ahead of print].
   Web of Science ®Google Scholar
• Ruzycki CA, Yang M, Chan H-K, et al. Improved prediction of intersubject variability in extrathoracic aerosol deposition using algebraic correlations. Aerosol Sci Technol. 2017;51:667–673.
   Web of Science ®Google Scholar
• Weber B, Hochhaus G. A pharmacokinetic simulation tool for inhaled corticosteroids. Aaps J. 2013;15:159–171.
   PubMed Web of Science ®Google Scholar
• Greenblatt EE, Winkler T, Harris RS, et al. What causes uneven aerosol deposition in the bronchoconstricted lung? A quantitative imaging study. J Aerosol Med Pulm Drug Deliv. 2016;29:57–75.
   PubMed Web of Science ®Google Scholar