4,040
Views
8
CrossRef citations to date
0
Altmetric
Research Article

Lung Deposition Using the Respimat® Soft Mist™ Inhaler Mono and Fixed-Dose Combination Therapies: An In Vitro/In Silico Analysis

, , , &
Pages 91-100 | Received 21 Aug 2020, Accepted 12 Nov 2020, Published online: 11 Dec 2020

References

  • World Health Organization. Burden of COPD [Internet]. 2019. [cited 2019 Dec 12]. Available from: http://www.who.int/respiratory/copd/burden/en/.
  • World Health Organization. Chronic obstructive pulmonary disease (COPD) [Internet]. 2017. [cited 2019 Dec 20]. Available from: http://www.who.int/mediacentre/factsheets/fs315/en/.
  • McNulty W, Usmani OS. Techniques of assessing small airways dysfunction. Eur Clin Respir J. 2014;1:1. DOI:10.3402/ecrj.v1.25898
  • Singh D. Small airway disease in patients with chronic obstructive pulmonary disease. Tuberc Respir Dis (Seoul). 2017;80(4):317–324. DOI:10.4046/trd.2017.0080
  • Pisi R, Aiello M, Zanini A, et al. Small airway dysfunction and flow and volume bronchodilator responsiveness in patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2015;10:1191–1197. DOI:10.2147/COPD.S82509
  • Crisafulli E, Pisi R, Aiello M, et al. Prevalence of small-airway dysfunction among COPD patients with different GOLD stages and its role in the impact of disease. Respiration. 2017;93(1):32–41. DOI:10.1159/000452479
  • Lavorini F, Pedersen S, Usmani OS, et al. Dilemmas, confusion, and misconceptions related to small airways directed therapy. Chest. 2017;151(6):1345–1355. DOI:10.1016/j.chest.2016.07.035
  • Buhl R, Maltais F, Abrahams R, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4). Eur Respir J. 2015;45(4):969–979. DOI:10.1183/09031936.00136014
  • Singh D, Ferguson GT, Bolitschek J, et al. Tiotropium + olodaterol shows clinically meaningful improvements in quality of life. Respir Med. 2015;109(10):1312–1319. DOI:10.1016/j.rmed.2015.08.002
  • O'Donnell DE, Casaburi R, Frith P, et al. Effects of combined tiotropium/olodaterol on inspiratory capacity and exercise endurance in COPD. Eur Respir J. 2017;49(4):1601348. DOI:10.1183/13993003.01348-2016
  • Troosters T, Bourbeau J, Maltais F, et al. Enhancing exercise tolerance and physical activity in COPD with combined pharmacological and non-pharmacological interventions: PHYSACTO randomised, placebo-controlled study design. BMJ Open. 2016;6(4):e010106 DOI:10.1136/bmjopen-2015-010106
  • Anderson P. Use of Respimat Soft Mist inhaler in COPD patients. Int J Chron Obstruct Pulmon Dis. 2006;1(3):251–259. DOI:10.2147/copd.2006.1.3.251
  • Laube BL, Janssens HM, de Jongh FH, International Society for Aerosols in Medicine, et al. What the pulmonary specialist should know about the new inhalation therapies. Eur Respir J. 2011;37(6):1308–1331. DOI:10.1183/09031936.00166410
  • Johnstone A, Uddin M, Pollard A, et al. The flow inside an idealised form of the human extra-thoracic airway. Exp Fluids. 2004;37(5):673–689. DOI:10.1007/s00348-004-0857-4
  • Longest PW, Tian G, Walenga RL, et al. Comparing MDI and DPI aerosol deposition using in vitro experiments and a new stochastic individual path (SIP) model of the conducting airways. Pharm Res. 2012;29(6):1670–1688. DOI:10.1007/s11095-012-0691-y
  • Kolanjiyil AV, Kleinstreuer C. Computational analysis of aerosol-dynamics in a human whole-lung airway model. J Aerosol Sci. 2017;114:301–316. DOI:10.1016/j.jaerosci.2017.10.001
  • Kolanjiyil AV, Kleinstreuer C, Sadikot RT. Computationally efficient analysis of particle transport and deposition in a human whole-lung-airway model. Part II: dry powder inhaler application. Comput Biol Med. 2017;84:247–253. DOI:10.1016/j.compbiomed.2016.10.025
  • Hajian B, De Backer J, Vos W, et al. Functional respiratory imaging (FRI) for optimizing therapy development and patient care. Expert Rev Respir Med. 2016;10(2):193–206. DOI:10.1586/17476348.2016.1136216
  • COST: European Cooperation in Science & Technology. MP1404 - Simulation and pharmaceutical technologies for advanced patient-tailored inhaled medicines (SimInhale): Final Assessment Review [Internet]. [cited 2020 Jun 4]. Available from: https://e-services.cost.eu/files/domain_files/MPNS/Action_MP1404/final_achievement_report/final_achievement_report-MP1404.pdf.
  • Pitcairn G, Reader S, Pavia D, et al. Deposition of corticosteroid aerosol in the humanlung by Respimat® Soft Mist™ inhaler compared to deposition by metered dose inhaler or by Turbuhaler® dry powder inhaler. J Aerosol Med. 2005;18(3):264–272. DOI:10.1089/jam.2005.18.264
  • Newman SP, Brown J, Steed KP, et al. Lung deposition of fenoterol and flunisolide delivered using a novel device for inhaled medicines: comparison of RESPIMAT with conventional metered-dose inhalers with and without spacer devices. Chest. 1998;113(4):957–963. DOI:10.1378/chest.113.4.957
  • Ciciliani AM, Langguth P, Wachtel H. In vitro dose comparison of Respimat® inhaler with dry powder inhalers for COPD maintenance therapy. Int J Chron Obstruct Pulmon Dis. 2017;12:1565–1577. DOI:10.2147/COPD.S115886
  • Koch A, Pizzichini E, Hamilton A, et al. Lung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat® versus placebo and formoterol twice daily in patients with GOLD 2–4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis. 2014;9:697–714. DOI:10.2147/COPD.S62502. eCollection 2014.
  • Brand P, Hederer B, Austen G, et al. Higher lung deposition with Respimat Soft Mist inhaler than HFA-MDI in COPD patients with poor technique. Int J Chron Obstruct Pulmon Dis. 2008;3(4):763–770.
  • Wachtel H, Flüge T, Gössl R. Flow-pressure-energy-power: which is the essential factor in breathing patterns of patients using inhalers? Respir Drug Deliv. 2006;2:511–514.
  • European Directorate for the Quality of Medicines Healthcare. European Pharmacopoeia (Ph. Eur.). 10th ed. Strasbourg, France: EDQM Council of Europe; 2020. (Council of Europe, editor.).
  • Finlay WH. The mechanics of inhaled pharmaceutical aerosols: an introduction. London: Academic Press; 2001.
  • Yeh HC, Schum GM. Models of human lung airways and their application to inhaled particle deposition. Bull Math Biol. 1980;42(3):461–480. DOI:10.1007/BF02460796
  • Nici L, Mammen MJ, Charbek E, et al. Pharmacologic management of COPD: an official American Thoracic Society clinical practice guideline. Am J Respir Crit Care Med. 2020;201(9):e56–e69. DOI:10.1164/rccm.202003-0625ST
  • Ikeda T, Anisuzzaman A, Yoshiki H, et al. Regional quantification of muscarinic acetylcholine receptors and β-adrenoceptors in human airways. Br J Pharmacol. 2012;166(6):1804–1814. DOI:10.1111/j.1476-5381.2012.01881.x
  • Alagha K, Palot A, Sofalvi T, et al. Long-acting muscarinic receptor antagonists for the treatment of chronic airway diseases. Ther Adv Chronic Dis. 2014;5(2):85–98. DOI:10.1177/2040622313518227
  • Kang K, Kim HH, Choi Y. Tiotropium is predicted to be a promising drug for COVID-19 through transcriptome-based comprehensive molecular pathway analysis. Viruses. 2020;12(7):776. DOI:10.3390/v12070776
  • Haruna A, Oga T, Muro S, et al. Relationship between peripheral airway function and patient-reported outcomes in COPD: a cross-sectional study. BMC Pulm Med. 2010;10:10 DOI:10.1186/1471-2466-10-10
  • Higham A, Quinn AM, Cancado JED, et al. The pathology of small airways disease in COPD: historical aspects and future directions. Respir Res. 2019;20(1):49 DOI:10.1186/s12931-019-1017-y
  • DeHaan WH, Finlay WH. In vitro monodisperse aerosol deposition in a mouth and throat with six different inhalation devices. J Aerosol Med. 2001;14(3):361–367. DOI:10.1089/089426801316970321
  • Stapleton K-W, Guentsch E, Hoskinson M, et al. On the suitability of k–ε turbulence modeling for aerosol deposition in the mouth and throat: a comparison with experiment. J Aerosol Sci. 2000;31(6):739–749. DOI:10.1016/S0021-8502(99)00547-9
  • Finlay WH, Martin AR. Recent advances in predictive understanding of respiratory tract deposition. J Aerosol Med Pulm Drug Deliv. 2008;21(2):189–206. DOI:10.1089/jamp.2007.0645
  • Wei X, Huynh BK, Kaviratna A, et al. Comparing aerosol doses and aerodynamic particle size distributions from a dry powder inhaler, pressurized metered dose inhaler, and soft mist inhaler using realistic and compendial in vitro testing. Respir Drug Deliv. 2018;2:675–680.
  • Marple VA, Olson BA, Santhanakrishnan K, et al. Next generation pharmaceutical impactor: a new impactor for pharmaceutical inhaler testing. Part III. Extension of archival calibration to 15 L/min. J Aerosol Med. 2004;17(4):335–343. DOI:10.1089/jam.2004.17.335
  • Darquenne C. Aerosol deposition in health and disease. J Aerosol Med Pulm Drug Deliv. 2012;25(3):140–147. DOI:10.1089/jamp.2011.0916
  • Jabbal S, Poli G, Lipworth B. Does size really matter?: Relationship of particle size to lung deposition and exhaled fraction. J Allergy Clin Immunol. 2017;139(6):2013–2014.e1. DOI:10.1016/j.jaci.2016.11.036
  • 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(3):227–235. DOI:10.1089/jam.2007.0584
  • The United States Pharmacopeial Convention. <601> Inhalation and nasal drug products—aerosols, sprays, and powders—performance quality tests [Internet]. 2015. [cited 2019 Dec 31]. Available from: https://www.uspnf.com/print/pdf/node/62616.
  • Cheng YS, Zhou Y, Su WC. Deposition of particles in human mouth–throat replicas and a USP induction port. J Aerosol Med Pulm Drug Deliv. 2015;28(3):147–155. DOI:10.1089/jamp.2013.1105
  • Mitchell J, Copley M, Sizer Y, et al. Adapting the Abbreviated Impactor Measurement (AIM) concept to make appropriate inhaler aerosol measurements to compare with clinical data: a scoping study with the “Alberta” Idealized Throat (AIT) inlet. J Aerosol Med Pulm Drug Deliv. 2012;25(4):188–197. DOI:10.1089/jamp.2011.0925
  • Dhand R, Eicher J, Hansel M, et al. Improving usability and maintaining performance: human-factor and aerosol-performance studies evaluating the new reusable Respimat inhaler. Int J Chron Obstruct Pulmon Dis. 2019;14:509–523. DOI:10.2147/COPD.S190639
  • Capstick TG, Clifton IJ. Inhaler technique and training in people with chronic obstructive pulmonary disease and asthma. Expert Rev Respir Med. 2012;6(1):91–101. DOI:10.1586/ers.11.89
  • Grgic B, Finlay WH, Heenan AF. Regional aerosol deposition and flow measurements in an idealized mouth and throat. J Aerosol Sci. 2004;35(1):21–32. DOI:10.1016/S0021-8502(03)00387-2
  • 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(6):461–481. DOI:10.1089/jamp.2015.1281