Industry guidance for the selection of a delivery system for the development of novel respiratory products

Bibliography

• Asthma. World Health Organization fact sheet no 307. 2008. Available from: http://www.who.int/mediacentre/factsheets/fs307/en/ [Last accessed on 6 March 2015]
   Google Scholar
• Chronic obstructive pulmonary disease (COPD). World Health Organization fact sheet no 315. 2009. Available from: http://www.who.int/mediacentre/factsheets/fs315/en/ [Last accessed on 6 March 2015]
   Google Scholar
• Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med 2006;3(11):e442
   PubMed Web of Science ®Google Scholar
• Mathers C, Fat DM, Boerma JT. The global burden of disease: 2004 update. World Health Organization; Geneva: 2008
   Google Scholar
• Teva R&D in focus – Respiratory. Teva. 2013. Available from: http://www.ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-EventDetails&EventId=5033231 [Last accessed on 6 March 2015]
   Google Scholar
• Global pulmonary drug delivery systems market 2012-2016. TechNavio. 2013. Available from: http://www.researchandmarkets.com/research/h2ltl8/global_pulmonary [Last accessed on 6 March 2015]
   Google Scholar
• Ehrick JD, Wylie J, Goodey AP, et al. Orally inhaled fixed dose combination products for the treatment of asthma and chronic obstructive pulmonary disease: not simple math. Ther Deliv 2014;5:297-317
   PubMedGoogle Scholar
• Pritchard JN, Giles R. Opportunities in respiratory drug delivery. Ther Deliv 2014;5:1261-73
   PubMedGoogle Scholar
• Pritchard JN. What are meaningful device improvements for patients, providers and payers? In: Dalby RN, Byron PR, Peart JD, et al. editors. Respiratory Drug Delivery 2014. vol. 1. Davis Healthcare International; River Grove, IL: 2014. p. 217-28
   Google Scholar
• Inhalatorium. Available from: http://www.inhalatorium.com/ [Last accessed on 6 March 2015]
   Google Scholar
• Dinh K, Myers DJ, Glazer M, et al. In vitro aerosol characterization of Staccato® Loxapine. Int J Pharm 2011;403:101-8
   PubMed Web of Science ®Google Scholar
• Grana R, Benowitz N, Glantz SA. E-cigarettes: a scientific review. Circulation 2014;129:1972-86
   PubMed Web of Science ®Google Scholar
• Bleyer JM. A new method of laryngeal and bronchial medication by means of a spray and tube during the act of deep inspiration. J Am Med Assoc 1890;15:634-6
   Google Scholar
• Martin AR, Finlay WH. Nebulizers for drug delivery to the lungs. Expert Opin Drug Deliv 2015;12(6):889-900
   PubMed Web of Science ®Google Scholar
• Pritchard JN, von Hollen D, Hatley RHM. The utility of monitoring inhaled drug adherence and technique in clinical trials. In: Dalby RN, Byron PR, Peart JD, et al. editors. Respiratory Drug Delivery Europe 2015. vol. 1. Davis Healthcare International; River Grove, IL: 2015. p. 413-17
   Google Scholar
• Degtyareva Y, Metcalf A, Hardaker LEA, et al. Efficiency of the Micro mesh nebulizer tested with three different fill volumes. In: Dalby RN, Byron PR, Peart JD, et al. editors. Respiratory Drug Delivery Europe 2015. vol. 1. Davis Healthcare International; River Grove, IL: 2015. p. 401-4
   Google Scholar
• Boe J, Dennis JH, O’Driscoll BR, et al. European Respiratory Society Guidelines on the use of nebulizers. Guidelines prepared by a European Respiratory Society Task Force on the use of nebulizers. Eur Respir J 2001;18:228-42
   PubMed Web of Science ®Google Scholar
• Garcia-Aymerich J, Lange P, Benet M, et al. Regular physical activity reduces hospital admission and mortality in chronic obstructive pulmonary disease: a population based cohort study. Thorax 2006;61:772-8
   PubMed Web of Science ®Google Scholar
• Seemungal TAR, Hurst JR, Wedzicha JA, et al. Exacerbation rate, health status and mortality in COPD – a review of potential interventions. Int J COPD 2009;4:203-23
   Google Scholar
• Denyer J, Dyche T. The Adaptive Aerosol Delivery (AAD) technology: past, present and future. J Aerosol Med Pulm Drug Deliv 2010;23:S1-10
   PubMed Web of Science ®Google Scholar
• Elphick M, von Hollen D, Pritchard JN, et al. Factors to consider when selecting a nebulizer for a new inhaled drug product development program. Expert Opin Drug Deliv 2015;1-13
   Web of Science ®Google Scholar
• Hochrainer D, Hölz 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;18:273-82
   PubMedGoogle Scholar
• De Boer AH, Wissink J, Hagedoorn P, et al. In vitro performance testing of the novel Medspray® wet aerosol inhaler based on the principle of rayleigh break-up. Pharm Res 2008;25:1186-92
   PubMed Web of Science ®Google Scholar
• Young PM, Price R, Tobyn MJ, et al. Effect of humidity on aerosolization of micronized drugs. Drug Dev Ind Pharm 2003;29:959-66
   PubMed Web of Science ®Google Scholar
• Feddah MR, Brown KF, Gipps EM, Davies NM. In-vitro characterisation of metered dose inhaler versus dry powder inhaler glucocorticoid products: influence of inspiratory flow rates. J Pharm Pharm Sci 2000;3:318-24
   PubMed Web of Science ®Google Scholar
• Janssens W, VandenBrande P, Hardeman E, et al. Inspiratory flow rates at different levels of resistance in elderly COPD patients. Eur Respir J 2008;31:78-83
   PubMed Web of Science ®Google Scholar
• Burnham T. Inhaler use technique and related interventions, an annotated bibliography. National Electronic Library for Medicines, Medicines Management Overview. August 2012. Available from: https://use-inhalers.com/sites/default/files/publicationpdf/Reference_Studies_Tom_Burnham.pdf [Last accessed on 9 March 2015]
   Google Scholar
• Stevenson CL, Bennett DB. Development of the Exubera® Insulin Pulmonary Delivery System. Mucosal Delivery of Biopharmaceuticals. Springer; US: 2014. 461-81
   Google Scholar
• Aydin M, Watts A, Becker D, et al. A flow rate dependence comparison of the active MicroDose inhaler and a passive DPI for delivery of conventional and engineered formulations. In: Dalby RN, Byron PR, Peart JD, et al. editors. Respiratory Drug Delivery 2010. vol. 3. Virginia Commonwealth University; Richmond, VA: 2010. p. 675-80
   Google Scholar
• Gradon L, Sosnowski TR. Formation of particles for dry powder inhalers. Adv Powder Technol 2014;25:43-55
   Web of Science ®Google Scholar
• Geller DE, Weers J, Heuerding S. Development of an inhaled dry-powder formulation of tobramycin using PulmoSphere™ technology. J Aerosol Med Pulm Drug Deliv 2011;24:175-82
   PubMed Web of Science ®Google Scholar
• Johnston B. Efficacy of inhaled Technosphere® insulin: a comparative review to injectable insulin. Pacific University Oregon: School of Physician Assistant Studies, 2014
   Google Scholar
• Pritchard JN. Recent advances in drug delivery via pressured metered-dose inhalers. In: Gradon EL, Marijnissen J, editors. Optimisation of aerosol drug delivery. Kluwer Academic; Dordrecht, NL: 2003. p. 105-22
   Google Scholar
• 2014 Assessment Report of the Medical Technical Options Committee. UNEP. 2015. Available from: http://ozone.unep.org/Assessment_Panels/TEAP/Reports/MTOC/MTOC-Assessment-Report-2014.pdf [Last accessed on 9 March 2015]
   Google Scholar
• Metz B, Kuijpers L, Solomon S, et al. editors. IPCC/TEAP special report: safeguarding the ozone layer and the global climate system: issues related to hydrofluorocarbons and perfluorocarbons. Cambridge University Press; UK: 2005. pp 478
   Google Scholar
• Parikh D, Karki S, Hipkiss D. Engineered combination respiratory medicines for localised lung delivery. In: Dalby RN, Byron PR, Peart JD, et al. editors. Respiratory Drug Delivery 2012. vol. 3. DHI Publishing; River Grove, IL: 2012. p. 699-704
   Google Scholar
• Compositions, Methods & Systems for Respiratory Delivery of Two or More Active Agents. US8324266
   Google Scholar
• Nikander K, Nicholls C, Denyer J, Pritchard JN. The evolution of spacers and valved holding chambers. J Aerosol Med Pulm Drug Deliv 2014;27:S4-23
   PubMed Web of Science ®Google Scholar
• Slator L, von Hollen D, Sandell D, Hatley RHM. In vitro comparison of the effect of inhalation delay and flow rate on the emitted dose from three valved holding chambers. J Aerosol Med Pulm Drug Deliv 2014;27:S37-43
   PubMed Web of Science ®Google Scholar
• Janssens HM, Heijnen EMEW, de Jong VM, et al. Aerosol delivery from spacers in wheezy infants: a daily life study. Eur Respir J 2000;16:850-6
   PubMed Web of Science ®Google Scholar
• Tong Minh K, von Hollen D, von Königslöw AJ, et al. An instrumented valved holding chamber with facemask to measure application forces and flow in young asthmatic children. J Aerosol Med Pulm Drug Deliv 2014;27:S55-62
   PubMed Web of Science ®Google Scholar
• Van den Berge M, ten Hacken NHT, van der Wiel E, Postma DS. Treatment of the bronchial tree from beginning to end: targeting small airway inflammation in asthma. Allergy 2013;68:16-26
   PubMed Web of Science ®Google Scholar
• Pritchard JN, Nikander K. Impact of intervention and feedback on adherence to treatment. In: Dalby RN, Byron PR, Peart JD, et al. editors. Respiratory Drug Delivery 2012. vol. 1. DHI Publishing; River Grove, IL: 2012. p. 271-82
   Google Scholar
• Melani AS, Bonavia M, Cilenti V, et al. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med 2011;105:930-8
   PubMed Web of Science ®Google Scholar
• Hay M, Thomas DW, Craighead JL, et al. Clinical development success rates for investigational drugs. Nat Biotechnol 2014;32:40-51
   PubMed Web of Science ®Google Scholar
• Waite D; Comparison of OIP Experiences in Different Markets. IPAC-RS Respiratory Conference. March 18-20. 2014. Available from: http://ipacrs.org/assets/uploads/outputs/12-Day_1_OIC_2014_Waite.pdf
   Google Scholar