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Review

Inhalation devices: from basic science to practical use, innovative vs generic products

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Pages 1559-1571 | Received 16 Apr 2016, Accepted 27 May 2016, Published online: 20 Jun 2016

References

  • Agu RU, Ugwoke MI, Armand M, et al. The lung as a route for systemic delivery of therapeutic proteins and peptides. Respir Res. 2001;2:198–209.
  • Farr SJ, Otulana BA. Pulmonary delivery of opioids as pain therapeutics. Adv Drug Deliv Rev. 2006;58:1076–1088.
  • Martonen TB, Zhang Z, Yue G, et al. Fine particle deposition within human nasal airways. Inhal Toxicol. 2003;15:283–303.
  • Marijnissen J, Gradon L. Nanoparticles in medicine and environment. Inhalation and health effects. Dordrecht: Springer; 2010.
  • USP. Aerosols, nasal sprays, metered dose inhalers and dry powder inhalers. Rockville: US Pharmacopeial Convention; 2008.
  • European pharmacopeia. 8th ed. Strasburg: European Directorate for the Quality of Medicines and Healthcare; 2013.
  • Borgstrom L, Olsson B, Thorsson L. Degree of throat deposition can explain the variability in lung deposition of inhaled drugs. J Aerosol Med. 2006;19:473–483.
  • Hussain M, Renate W-H, Werner H. Effect of intersubject variability of extrathoracic morphometry, lung airways dimensions and respiratory parameters on particle deposition. J Thorac Dis. 2011;3:156–170.
  • Adi H, Young PM, Traini D. Co-deposition of a triple therapy drug formulation for the treatment of chronic obstructive pulmonary disease using solution-based pressurised metered dose inhalers. J Pharm Pharmacol. 2012;64:1245–1253.
  • Newman SP, Busse WW. Evolution of dry powder inhaler design, formulation, and performance. Respir Med. 2002;96:293–304.
  • Moskal A, Gradon L. Temporary and spatial deposition of aerosol particles in the upper human airways during breathing cycle. J Aerosol Sci. 2002;33:1525–1539.
  • Sosnowski TR, Moskal A, Gradon L. Dynamics of oropharyngeal aerosol transport and deposition with the realistic flow pattern. Inhal Toxicol. 2006;18:773–780.
  • Fresconi FE, Prasad AK. Secondary velocity fields in the conducting airways of the human lung. J Biomech Eng. 2007;129:722–732.
  • Moskal A, Sosnowski TR. Dynamics of aerosol pulse in a simplified mouth. Throat geometry and its significance for inhalation drug delivery. Chem Proc Eng. 2009;30:545–558.
  • Zhang Z, Kleinstreuer C. Transient airflow structures and particle transport in a sequentially branching lung airway model. Phys Fluids. 2002;14:862–880.
  • DiBlasi RM. Clinical controversies in aerosol therapy for infants and children. Respir Care. 2015;60:894-914; discussion 14-16.
  • Howarth PH. Why particle size should affect clinical response to inhaled therapy. J Aerosol Med. 2001;14(Suppl 1):S27-S34.
  • Van Den Berge M, Ten Hacken NH, Van Der Wiel E, et al. Treatment of the bronchial tree from beginning to end: targeting small airway inflammation in asthma. Allergy. 2013;68:16–26.
  • Bennett WD, Brown JS, Zeman KL, et al. Targeting delivery of aerosols to different lung regions. J Aerosol Med. 2002;15:179–188.
  • Zeman KL, Wu J, Bennett WD. Targeting aerosolized drugs to the conducting airways using very large particles and extremely slow inhalations. J Aerosol Med Pulm Drug Deliv. 2010;23:363–369.
  • Weibel ER. Morphometry of the human lung. Berlin: Springer; 1963.
  • van Aalderen WM, Garcia-Marcos L, Gappa M, et al. How to match the optimal currently available inhaler device to an individual child with asthma or recurrent wheeze. NPJ Prim Care Respir Med. 2015;25:14088.
  • Svartengren K, Lindestad P, Svartengren M, et al. Added external resistance reduces oropharyngeal deposition and increases lung deposition of aerosol particles in asthmatics. Am J Respir Crit Care Med. 1995;152:32–37.
  • Montgomery AB. Status of aerosolized pentamidine for treatment and of Pneumocystis carinii pneumonia. J Aerosol Med. 1989;2:233–238.
  • Newman SP, Steed KP, Reader SJ, et al. Efficient delivery to the lungs of flunisolide aerosol from a new portable hand-held multidose nebulizer. J Pharm Sci. 1996;85:960–964.
  • Hochrainer D, Holz H, Kreher C, et al. Comparison of the aerosol velocity and spray duration of Respimat Soft Mist inhaler and pressurized metered dose inhalers. J Aerosol Med. 2005;18:273–282.
  • Simis K, Lei M, Lu AT, et al. Nicotine aerosol generation from thermally reversible zinc halide complexes using the Staccato system. Drug Dev Ind Pharm. 2008;34:936–942.
  • Yeo LY, Friend JR, McIntosh MP, et al. Ultrasonic nebulization platforms for pulmonary drug delivery. Expert Opin Drug Deliv. 2010;7:663–679.
  • Martin AR, Finlay WH. Nebulizers for drug delivery to the lungs. Expert Opin Drug Deliv. 2015;12:889–900.
  • Van Dyke RE, Nikander K. Delivery of iloprost inhalation solution with the HaloLite, Prodose, and I-neb Adaptive Aerosol Delivery systems: an in vitro study. Respir Care. 2007;52:184–190.
  • Denyer J, Dyche T. The Adaptive Aerosol Delivery (AAD) technology: past, present, and future. J Aerosol Med Pulm Drug Deliv. 2010;23(Suppl 1):S1-S10.
  • Dhand R. Intelligent nebulizers in the age of the Internet: the I-neb Adaptive Aerosol Delivery (AAD) system. J Aerosol Med Pulm Drug Deliv. 2010;23(Suppl 1):iii–v.
  • Mazela J, Chmura K, Kulza M, et al. Aerosolized albuterol sulfate delivery under neonatal ventilatory conditions: in vitro evaluation of a novel ventilator circuit patient interface connector. J Aerosol Med Pulm Drug Deliv. 2014;27:58–65.
  • Cheng YS, Fu CS, Yazzie D, et al. Respiratory deposition patterns of salbutamol pMDI with CFC and HFA-134a formulations in a human airway replica. J Aerosol Med. 2001;14:255–266.
  • Wilkes W, Fink J, Dhand R. Selecting an accessory device with a metered-dose inhaler: variable influence of accessory devices on fine particle dose, throat deposition, and drug delivery with asynchronous actuation from a metered-dose inhaler. J Aerosol Med. 2001;14:351–360.
  • Erzinger S, Schueepp KG, Brooks-Wildhaber J, et al. Facemasks and aerosol delivery in vivo. J Aerosol Med. 2007;20(Suppl 1):S78-S83; discussion S83-S84.
  • Giraud V, Roche N. Misuse of corticosteroid metered-dose inhaler is associated with decreased asthma stability. Eur Respir J. 2002;19:246–251.
  • Newman SP. Principles of metered-dose inhaler design. Respir Care. 2005;50:1177–1190.
  • Stein SW, Sheth P, Hodson PD, et al. Advances in metered dose inhaler technology: hardware development. AAPS PharmSciTech. 2014;15:326–338.
  • Newman SP, Weisz AW, Talaee N, et al. Improvement of drug delivery with a breath actuated pressurised aerosol for patients with poor inhaler technique. Thorax. 1991;46:712–716.
  • Jones V, Fernandez C, Diggory P. A comparison of large volume spacer, breath-activated and dry powder inhalers in older people. Age Ageing. 1999;28:481–484.
  • Devadason SG, Huang T, Walker S, et al. Distribution of technetium-99m-labelled QVAR delivered using an Autohaler device in children. Eur Respir J. 2003;21:1007–1011.
  • Vehring R, Lechuga-Ballesteros D, Joshi V, et al. Cosuspensions of microcrystals and engineered microparticles for uniform and efficient delivery of respiratory therapeutics from pressurized metered dose inhalers. Langmuir. 2012;28:15015–15023.
  • Islam N, Gladki E. Dry powder inhalers (DPIs) – a review of device reliability and innovation. Int J Pharm. 2008;360:1–11.
  • Canonica GW, Arp J, Keegstra JR, et al. Spiromax, a new dry powder inhaler: dose consistency under simulated real-world conditions. J Aerosol Med Pulm Drug Deliv. 2015;28:309–319.
  • Harper NJ, Gray S, De Groot J, et al. The design and performance of the exubera pulmonary insulin delivery system. Diabetes Technol Ther. 2007;9(Suppl 1):S16-S27.
  • Nelson H, Kemp JP, Bieler S, et al. Comparative efficacy and safety of albuterol sulfate Spiros inhaler and albuterol metered-dose inhaler in asthma. Chest. 1999;115:329–335.
  • Hoppentocht M, Hagedoorn P, Frijlink HW, et al. Technological and practical challenges of dry powder inhalers and formulations. Adv Drug Deliv Rev. 2014;75:18–31.
  • Olsson B, Asking L. Critical aspects of the function of inspiratory flow driven inhalers. J Aerosol Med. 1994;7(Suppl 1):S43-S47.
  • Kruger P, Ehrlein B, Zier M, et al. Inspiratory flow resistance of marketed dry powder inhalers (DPI). Eur Respir J. 2014;44(Suppl 58):4635.
  • Olsson B. Aerosol particle generation from dry powder inhalers: can they equal pressurized metered dose inhalers? J Aerosol Med. 1995;8(Suppl 3):S13-S18; discussion S19.
  • Gac J, Sosnowski TR, Gradon L. Turbulent flow energy for aerosolization of powder particles. J Aerosol Sci. 2008;3:113–126.
  • Chrystyn H, Price D. Not all asthma inhalers are the same: factors to consider when prescribing an inhaler. Prim Care Respir J. 2009;18:243–249.
  • Demoly P, Hagedoorn P, de Boer AH, et al. The clinical relevance of dry powder inhaler performance for drug delivery. Respir Med. 2014;108:1195–1203.
  • Zeng XM, Martin GP, Marriott C, et al. Lactose as a carrier in dry powder formulations: the influence of surface characteristics on drug delivery. J Pharm Sci. 2001;90:1424–1434.
  • Pilcer G, Amighi K. Formulation strategy and use of excipients in pulmonary drug delivery. Int J Pharm. 2010;392:1–19.
  • Rahimpour Y, Hamishehkar H. Lactose engineering for better performance in dry powder inhalers. Adv Pharm Bull. 2012;2:183–187.
  • Gradon L, Sosnowski TR. Formation of particles for dry powder inhalers. Adv Powder Technol. 2014;25:43–55.
  • Chow AH, Tong HH, Chattopadhyay P, et al. Particle engineering for pulmonary drug delivery. Pharm Res. 2007;24:411–437.
  • Nielsen KG, Skov M, Klug B, et al. Flow-dependent effect of formoterol dry-powder inhaled from the Aerolizer. Eur Respir J. 1997;10:2105–2109.
  • Weuthen T, Roeder S, Brand P, et al. In vitro testing of two formoterol dry powder inhalers at different flow rates. J Aerosol Med. 2002;15:297–303.
  • Chrystyn H. The Diskus: a review of its position among dry powder inhaler devices. Int J Clin Pract. 2007;61:1022–1036.
  • Wetterlin K. Turbuhaler: a new powder inhaler for administration of drugs to the airways. Pharm Res. 1988;5:506–508.
  • Borgstrom L, Asking L, Thorsson L. Idealhalers or realhalers? A comparison of Diskus and Turbuhaler. Int J Clin Pract. 2005;59:1488–1495.
  • Chodosh S, Flanders JS, Kesten S, et al. Effective delivery of particles with the HandiHaler dry powder inhalation system over a range of chronic obstructive pulmonary disease severity. J Aerosol Med. 2001;14:309–315.
  • Siddiqui MA, Plosker GL. The Novolizer: a multidose dry powder inhaler. Treat Respir Med. 2005;4:63–69.
  • Corradi M, Chrystyn H, Cosio BG, et al. NEXThaler, an innovative dry powder inhaler delivering an extrafine fixed combination of beclometasone and formoterol to treat large and small airways in asthma. Expert Opin Drug Deliv. 2014;11:1497–1506.
  • Svedsater H, Dale P, Garrill K, et al. Qualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013;13:72.
  • Azouz W, Chetcuti P, Hosker HS, et al. The inhalation characteristics of patients when they use different dry powder inhalers. J Aerosol Med Pulm Drug Deliv. 2015;28:35–42.
  • Lu D, Lee SL, Lionberger RA, et al. International guidelines for bioequivalence of locally acting orally inhaled drug products: similarities and differences. AAPS J. 2015;17:546–557.
  • CHMP. Guideline on the pharmaceutical quality of inhalation and nasal products. London: EMA; 2005.
  • Lee SL, Saluja B, Garcia-Arieta A, et al. Regulatory considerations for approval of generic inhalation drug products in the US, EU, Brazil, China, and India. AAPS J. 2015;17:1285–1304.
  • Borg JJ, Tanti A, Kouvelas D, et al. European Union pharmacovigilance capabilities: potential for the new legislation. Ther Adv Drug Saf. 2015;6:120–140.
  • Moskal A, Sosnowski TR. Computational fluid dynamics (CFD) and direct visualization studies of aerosol release from two cyclohaler-type dry powder inhalers. J Drug Deliv Sci Technol. 2012;22:161–165.
  • CHMP. 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 use in the treatment of asthma in children and adolescents. London: EMA; 2009.
  • Apiou-Sbirlea G, Newman S, Fleming J, et al. Bioequivalence of inhaled drugs: fundamentals, challenges and perspectives. Ther Deliv. 2013;4:343–367.
  • Laube BL, Janssens HM, De Jongh FH, et al. What the pulmonary specialist should know about the new inhalation therapies. Eur Respir J. 2011;37:1308–1331.
  • Ari A, Restrepo RD. American association for respiratory care. Aerosol delivery device selection for spontaneously breathing patients: 2012. Respir Care. 2012;57:613–626.
  • Everard ML. Inhalation therapy for infants. Adv Drug Deliv Rev. 2003;55:869–878.
  • Everard ML. Inhaler devices in infants and children: challenges and solutions. J Aerosol Med. 2004;17:186–195.
  • Taffet GE, Donohue JF, Altman PR. Considerations for managing chronic obstructive pulmonary disease in the elderly. Clin Interv Aging. 2014;9:23–30.
  • Ari A, de Andrade AD, Sheard M, et al. Performance comparisons of jet and mesh nebulizers using different interfaces in simulated spontaneously breathing adults and children. J Aerosol Med Pulm Drug Deliv. 2015;28:281–289.
  • 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.
  • Mahler DA, Waterman LA, Ward J, et al. Comparison of dry powder versus nebulized beta-agonist in patients with COPD who have suboptimal peak inspiratory flow rate. J Aerosol Med Pulm Drug Deliv. 2014;27:103–109.
  • GOLD Global Strategy for the diagnosis, management and prevention of COPD. 2016. [cited 2016 Apr 12]. Available from: www.goldcopd.org
  • Atkins PJ. Dry powder inhalers: an overview. Respir Care. 2005;50:1304-1312; discussion 12.
  • Al-Showair RA, Tarsin WY, Assi KH, et al. Can all patients with COPD use the correct inhalation flow with all inhalers and does training help? Respir Med. 2007;101:2395–2401.
  • Jarvis S, Ind PW, Shiner RJ. Inhaled therapy in elderly COPD patients; time for re-evaluation? Age Ageing. 2007;36:213–218.
  • Mahler DA, Waterman LA, Gifford AH. Prevalence and COPD phenotype for a suboptimal peak inspiratory flow rate against the simulated resistance of the Diskus® dry powder inhaler. J Aerosol Med Pulm Drug Deliv. 2013;26:174–179.
  • Gradon L, Sosnowski T, Ruminski W, et al. Inhaler for powder drug administration. EP2157990B1. Munich: European Patent Bulletin 2014/31; 2014.
  • Lavorini F, Braido F, Baiardini I, et al. Asthma and COPD: interchangeable use of inhalers. A document of Italian Society of Allergy, Asthma and Clinical Immmunology (SIAAIC) & Italian Society of Respiratory Medicine (SIMeR). Pulm Pharmacol Ther. 2015;34:25–30.
  • Williams AE, Chrystyn H. Survey of pharmacists’ attitudes towards interchangeable use of dry powder inhalers. Pharm World Sci. 2007;29:221–227.
  • Borg JJ, Aislaitner G, Pirozynski M, et al. Strengthening and rationalising pharmacovigilance in the European Union. Where is Europe heading to? A review of the new EU legislation on pharmacovigilance. Drug Saf. 2011;34:187–197.

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