Factors to consider when selecting a nebulizer for a new inhaled drug product development program

Bibliography

• Newman SP. Inhaler treatment options in COPD. Eur Respir Rev 2005;14(96):102-8
   Google Scholar
• Ari A, Hess D, Myers TR, et al. A guide to aerosol delivery devices for respiratory therapists, 2nd edition. American Association for Respiratory Care. 2009. Available from: https://www.aarc.org/education/aerosol_devices/aerosol_delivery_guide2.pdf [Last accessed 15 July 2014]
   Google Scholar
• Tiddens HA, Bos AC, Mouton JW, et al. Inhaled antibiotics: dry or wet? Eur Respir J 2014;44(5):1308-18
   PubMed Web of Science ®Google Scholar
• 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(6):1308-31
   PubMed Web of Science ®Google Scholar
• Martin AR, Finlay WH. Nebulizers for drug delivery to the lungs. Expert Opin Drug Deliv 2014; [Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• Rau JL. Design principles of liquid nebulization devices currently in use. Respir Care 2002;47(11):1257-75
   PubMedGoogle Scholar
• O’Callaghan C, Barry PW. The science of nebulised drug delivery. Thorax 1997;52(Suppl 2):S31-44
   PubMedGoogle Scholar
• Nikander K, Denyer J. Breathing patterns. Eur Respir Rev 2000;10(76):576-9
   Google Scholar
• Nikander K, Denyer J. Adaptive Aerosol Delivery (AAD) technology. In: Rathbone MJ, Hadgraft J, Roberts MS, Lane ME, editors. Modified-release drug delivery technology. 2nd edition. Volume 2: Informa Healthcare; New York, NY: 2008. p. 603-12
   Google Scholar
• Welch MJ. Nebulization therapy for asthma: a practical guide for the busy pediatrician. Clin Pediatr 2008;47(8):744-56
   PubMed Web of Science ®Google Scholar
• Leung K, Louca E, Coates AL. Comparison of breath-enhanced to breath-actuated nebulizers for rate, consistency, and efficiency. Chest 2004;126(5):1619-27
   PubMed Web of Science ®Google Scholar
• Thomas SHL, O’Doherty MJ, Graham A, et al. Pulmonary deposition of nebulised amiloride in cystic fibrosis: comparison of two nebulisers. Thorax 1991;46(10):717-21
   PubMed Web of Science ®Google Scholar
• Goodman N, Morgan M, Nikander K, et al. Evaluation of patient-reported outcomes and quality of life with the I-neb AAD System in patients with chronic obstructive pulmonary disease. J Aerosol Med Pulm Drug Deliv 2010;23(Suppl 1):S61-70
   PubMedGoogle Scholar
• Dolovich MB, Dhand R. Aerosol drug delivery: developments in device design and clinical use. Lancet 2011;377:1032-45
   PubMed Web of Science ®Google Scholar
• Steckel H, Eskandar F. Factors affecting aerosol performance during nebulization with jet and ultrasonic nebulizers. Eur J Pharm Sci 2003;19:443-55
   PubMed Web of Science ®Google Scholar
• Berlinski A, Waldrep JC. Effect of aerosol delivery system and formulation on nebulized budesonide output. J Aerosol Med Pulm Drug Deliv 1997;10(4):307-18
   Google Scholar
• Nikander K, Turpeinen M, Wollmer P. The conventional ultrasonic nebulizer proved inefficient in nebulizing a suspension. J Aerosol Med Pulm Drug Deliv 1999;12(2):47-53
   Google Scholar
• Dahlbäck M. Behavior of nebulizing solutions and suspensions. J Aerosol Med Pulm Drug Deliv 1994;7(Suppl 1):S13-18
   Google Scholar
• Dhand R. Nebulizers that use a vibrating mesh or plate with multiple apertures to generate aerosol. Respir Care 2002;47(12):1406-16
   PubMedGoogle Scholar
• Ghazanfari T, Elhissi AM, Ding Z, et al. The influence of fluid physicochemical properties on vibrating-mesh nebulization. Int J Pharmacol 2007;339:103-11
   Google Scholar
• Denyer J, Dyche T. The Adaptive Aerosol Delivery (AAD) technology: past, present, and future. J Aerosol Med Pulm Drug Deliv 2010;23(Suppl 1):S1-10
   PubMed Web of Science ®Google Scholar
• McCallion ON, Taylor KM, Thomas M, et al. Nebulization of fluids of different physiochemical properties with air-jet and ultrasonic nebulizers. Pharmaceut Res 1995;12(11):1682-8
   PubMed Web of Science ®Google Scholar
• Finlay WH, Lange CF, King M, et al. Lung delivery of aerosolized dextran. Am J Respir Crit Care Med 2000;161:91-7
   PubMed Web of Science ®Google Scholar
• Beck-Broichsitter M, Knuedeler MC, Seeger W, et al. Controlling the droplet size of formulations nebulized by vibrating-membrane technology. Eur J Pharm Biopharm 2014;87:524-9
   PubMed Web of Science ®Google Scholar
• Beck-Broichsitter M, Oesterheld N, Knuedeler MC, et al. On the correlation of output rate and aerodynamic characteristics in vibrating-mesh-based aqueous aerosol delivery. Int J Pharm 2014;461:34-7
   PubMed Web of Science ®Google Scholar
• Beck-Broichsitter M, Knuedeler MC, Oesterheld N, et al. Boosting the aerodynamic properties of vibrating-mesh nebulized polymeric nanosuspensions. Int J Pharm 2014;459:23-9
   PubMed Web of Science ®Google Scholar
• Hardaker LE, Hatley RH. In vitro characterization of the I-neb Adaptive Aerosol Delivery (AAD) System. J Aerosol Med Pulm Drug Deliv 2010;23(Suppl 1):S11-20
   PubMedGoogle Scholar
• Chrystyn H, Abdelmobody M, Eagland D, et al. Improved pulmonary delivery and retention of a budesonide Nanagel clear solution. In: Dalby RN, Byron PR, Peart J, et al. editors. Respiratory Drug Delivery 2009. Volume 2: DHI Publishing; River Grove, IL: 2009. p. 405-8
   Google Scholar
• Ali HS, York P, Amani A, et al. Evaluation of a nanodispersion formulation prepared through microfluidic reactors for pulmonary delivery of budesonide using nebulizers. Iran J Pharm Res 2014;13(3):785-95
   PubMed Web of Science ®Google Scholar
• Britland S, Finter W, Chrystyn H, et al. Droplet aerodynamics, cellular uptake, and efficacy of a nebulizable corticosteroid nanosuspension are superior to a micronized dosage form. Biotechnol Prog 2012;28(5):1152-9
   PubMed Web of Science ®Google Scholar
• Niven RW, Ip AY, Mittelman SD, et al. Protein nebulization: I. Stability of lactate dehydrogenase and recombinant granulocyte-colony stimulating factor to air-jet nebulization. Int J Pharm 1994;109:17-26
   Web of Science ®Google Scholar
• Dhand R. Aerosol delivery during mechanical ventilation: from basic techniques to new devices. J Aerosol Med Pulm Drug Deliv 2008;21(1):45-60
   PubMed Web of Science ®Google Scholar
• Tservistas M, Lintz FC, Keller M. Impact of the nebulization principle on the biological activity of labile formulations containing liposomes, peptides, and proteins. In: Dalby RN, Byron PR, Peart J, et al. editors: Respiratory Drug Delivery IX. Volume 3: DHI Publishing; River Grove, IL: 2004. p. 613-16
   Google Scholar
• Elhissi AM, Faizi M, Naji WF, et al. Physical stability and aerosol properties of liposomes delivered using an air-jet nebulizer and novel micropump device with large mesh apertures. Int J Pharm 2007;334:62-70
   PubMed Web of Science ®Google Scholar
• Kleemann E, Schmehl T, Gessler T, et al. Iloprost-containing liposomes for aerosol application in pulmonary arterial hypertension: formulation aspects and stability. Pharm Res 2007;24(2):277-87
   PubMed Web of Science ®Google Scholar
• Gaspar MM, Gobbo O, Ehrhardt C. Generation of liposome aerosols with the Aeroneb Pro and the AeroProbe nebulizers. J Liposome Res 2010;20(1):55-61
   PubMed Web of Science ®Google Scholar
• Olschewski H, Walmrath D, Schermuly R, et al. Aerosolized prostacyclin and iloprost in severe pulmonary hypertension. Ann Intern Med 1996;124:820-4
   PubMed Web of Science ®Google Scholar
• Olschewski H, Ghofrani HA, Walmrath D, et al. Inhaled prostacyclin and iloprost in severe pulmonary hypertension secondary to lung fibrosis. Am J Respir Crit Care Med 1999;160(2):600-7
   PubMed Web of Science ®Google Scholar
• Gessler T, Schmehl T, Hoeper MM, et al. Ultrasonic versus jet nebulization of iloprost in severe pulmonary hypertension. Eur Respir J 2001;17(1):14-19
   PubMed Web of Science ®Google Scholar
• Ghofrani HA, Friese G, Discher T, et al. Inhaled iloprost is a potent acute pulmonary vasodilator in HIV-related severe pulmonary hypertension. Eur Respir J 2004;23:321-6
   PubMed Web of Science ®Google Scholar
• Hsu HH, Rubin LJ. Iloprost inhalation solution for the treatment of pulmonary arterial hypertension. Expert Opin Pharmacother 2005;6(11):1921-30
   PubMed Web of Science ®Google Scholar
• Weber A, Morlin G, Cohen M, et al. Effect of nebulizer type and antibiotic concentration on device performance. Pediatr Pulmonol 1997;23:249-60
   PubMed Web of Science ®Google Scholar
• Hagerman JE, Hancock KE, Klepser ME. Aerosolised antibiotics: a critical appraisal of their use. Expert Opin Drug Deliv 2006;3(1):71-86
   PubMedGoogle Scholar
• Beasley R, Rafferty P, Holgate ST. Adverse reactions to the non-drug constituents of nebuliser solutions. Br J Clin Pharmac 1988;25:283-7
   PubMed Web of Science ®Google Scholar
• 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(2):184-90
   PubMed Web of Science ®Google Scholar
• Highlights of Prescribing Information. Cayston (Aztreonam for inhalation solution). Gilead Sciences, Inc., Foster City, CA, 2012. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050814s007lbl.pdf [Last accessed 10 November 2014]
   Google Scholar
• Summary of Product Characteristics. Ventavis 10 microgram/ml nebuliser solution. Bayer Pharma, Berlin, Germany. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000474/WC500048691.pdf [Last accessed 10 November 2014]
   Google Scholar
• Usmani OS, Biddiscombe MF, Barnes PJ. Regional lung deposition and bronchodilator response as a function of β2-agonist particle size. Am J Respir Crit Care Med 2005;172:1497-504
   PubMed Web of Science ®Google Scholar
• Boe J, Dennis JH, O’Driscoll BR, et al. European respiratory society guidelines on the use of nebulizers. Eur Respir J 2001;18:228-42
   PubMed Web of Science ®Google Scholar
• Brand P, Schulte M, Wencker M, et al. Lung deposition of inhaled α1-proteinase inhibitor in cystic fibrosis and α1-antitrypsin deficiency. Eur Respir J 2009;34(2):354-60
   PubMed Web of Science ®Google Scholar
• Nikander K, Prince I, Coughlin S, et al. Mode of breathing - tidal or slow and deep - through the I-neb Adaptive Aerosol Delivery (AAD) system affects lung deposition of 99mTc-DTPA. J Aerosol Med Pulm Drug Deliv 2010;23(Suppl 1):S37-43
   PubMed Web of Science ®Google Scholar
• Laube BL, Jashnani R, Dalby RN, et al. Targeting aerosol deposition in patients with cystic fibrosis: effects of alterations in particle size and inspiratory flow rate. Chest 2000;118(4):1069-76
   PubMed Web of Science ®Google Scholar
• Bennett WD. Controlled inhalation of aerosolised therapeutics. Expert Opin Drug Deliv 2005;2(4):763-7
   PubMedGoogle Scholar
• Denyer J, Black A, Nikander K, et al. Domiciliary experience of the target inhalation mode (TIM) breathing maneuver in patients with cystic fibrosis. J Aerosol Med Pulm Drug Deliv 2010;23(Suppl 1):S45-54
   PubMed Web of Science ®Google Scholar
• Brand P, Beckmann H, Enriquez MM, et al. Peripheral deposition of α1-protease inhibitor using commercial inhalation devices. Eur Respir J 2003;22:263-7
   PubMed Web of Science ®Google Scholar
• Saiman L, Siegel J. Cystic Fibrosis Foundation. Infection control recommendations for patients with cyctic fibrosis: microbiology, important pathogens, and infection control practices to prevent patient-to-patient transmission. Infect Control Hosp Epidemiol 2003;24(5 Suppl):S6-52
   PubMed Web of Science ®Google Scholar
• Jentzsch NS, Camargos PA, Colosimo EA, et al. Monitoring adherence to beclomethasone in asthmatic children and adolescents through four different methods. Allergy 2009;64(10):1458-62
   PubMed Web of Science ®Google Scholar
• Riekert K. Promoting adherence and increasing life span. Adv Stud Med 2009;9(1):14-19
   Google Scholar
• Nikander K, Pearce LJ, Smith NJ, et al. The impact of electronic monitors on patients’ adherence to inhaled medications. In: Dalby RN, Byron PR, Peart J, et al. editors: Respiratory Drug Delivery. Volume 3: DHI Publishing; River Grove, IL: 2012. p. 673-8
   Google Scholar
• Bender B, Wamboldt FS, O’Connor SL, et al. Measurement of children’s asthma medication adherence by self report, mother report, canister weight, and Doser CT. Ann Allergy Asthma Immunol 2000;85:416-21
   PubMed Web of Science ®Google Scholar
• Arias Llorente RP, Bousoño García C, Díaz Martín JJ. Treatment compliance in children and adults with cystic fibrosis. J Cyst Fibros 2008;7(5):359-67
   PubMed Web of Science ®Google Scholar
• Masterson TL, Wildman BG, Newberry BH, et al. Impact of age and gender on adherence to infection control guidelines and medical regimens in cystic fibrosis. Pediatr Pulmonol 2011;46(3):295-301
   PubMed Web of Science ®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(6):930-8
   PubMed Web of Science ®Google Scholar
• Turner J, Wright E, Mendella L, et al. Predictors of patient adherence to long-term home nebulizer therapy for COPD. Chest 1995;108(2):394-400
   PubMed Web of Science ®Google Scholar
• Apter AJ, Reisine ST, Affleck G, et al. Adherence with twice-daily dosing of inhaled steroids: socioeconomic and health-belief differences. Am J Respir Crit Care Med 1998;157:1810-17
   PubMed Web of Science ®Google Scholar
• Coutts JA, Gibson NA, Paton JY. Measuring compliance with inhaled medication in asthma. Arch Dis Child 1992;67(3):332-3
   PubMed Web of Science ®Google Scholar
• Mann M, Eliasson O, Patel K, et al. A comparison of the effects of bid and qid dosing on compliance with inhaled flunisolide. Chest 1992;101:496-9
   PubMed Web of Science ®Google Scholar
• Tashkin DP. Multiple dose regimens: impact on compliance. Chest 1995;107:176S-82S
   PubMed Web of Science ®Google Scholar
• Balzano G, Battiloro R, Biraghi M, et al. Effectiveness and acceptability of a domiciliary multidrug inhalation treatment in elderly patients with chronic airflow obstruction: metered dose inhaler versus jet nebulizer. J Aerosol Med 2000;13(1):25-33
   PubMedGoogle Scholar
• Newman S. Improving inhaler technique, adherence to therapy and the precision of dosing: major challenges for pulmonary drug delivery. Expert Opin Drug Deliv 2014;11(3):365-78
   PubMed Web of Science ®Google Scholar
• Price D, Bosnic-Anticevich S, Briggs A, et al. Inhaler competence in asthma: common errors, barriers to use and recommended solutions. Respir Med 2013;107(1):37-46
   PubMed Web of Science ®Google Scholar
• Denyer J. Adherence monitoring in drug delivery. Expert Opin Drug Deliv 2010;7(10):1127-31
   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 J, et al. editors: Respiratory Drug Delivery. Volume 1: DHI Publishing; River Grove, IL: 2012. p. 271-82
   Google Scholar
• Burgess SW, Sly PD, Devadason SG. Providing feedback on adherence increases use of preventive medication by asthmatic children. J Asthma 2010;47(2):198-201
   PubMed Web of Science ®Google Scholar
• Spencer T, Dyche T, Nikander K, et al. The association of true adherence, inhalation time and treatment time for patients using the I-neb AAD System. In: Dalby RN, Byron PR, Peart J, et al. editors: Respiratory Drug Delivery. Volume 3: DHI Publishing; River Grove, IL: 2012. p. 679-84
   Google Scholar
• McCormack P, McNamara PS, Southern KW. A randomised controlled trial of breathing modes for adaptive aerosol delivery in children with cystic fibrosis. J Cyst Fibros 2011;10(5):343-9
   PubMed Web of Science ®Google Scholar
• Tashkin DP, Rand C, Nides M, et al. A nebulizer chronolog to monitor compliance with inhaler use. Am J Med 1991;91(Suppl 4A):33S-6S
   PubMed Web of Science ®Google Scholar
• Nides MA, Tashkin DP, Simmons MS, et al. Improving inhaler adherence in a clinical trial through the use of the nebulizer chronolog. Chest 1993;104:501-7
   PubMed Web of Science ®Google Scholar
• Simmons MS, Nides MA, Rand CS, et al. Trends in compliance with bronchodilator inhaler use between follow-up visits in a clinical trial. Chest 1996;109:963-8
   PubMed Web of Science ®Google Scholar
• Simmons MS, Nides MA, Rand CS, et al. Unpredictability of deception in compliance with physician-prescribed bronchodilator inhaler use in a clinical trial. Chest 2000;118:290-5
   PubMed Web of Science ®Google Scholar
• Nikander K, Denyer J, Dodd M, et al. The adaptive aerosol delivery system in a telehealth setting: patient acceptance, performance and feasibility. J Aerosol Med Pulm Drug Deliv 2010;23(Suppl 1):S21-7
   PubMedGoogle Scholar
• Implementing adaptive trial design: operational considerations and the role of the CRO. Pharmaceutical Product Development. 2012. Available from: http://www.ppdi.com/∼/media/Files/PPDI%20Files/Expert%20Community/Whitepapers/ImplementingAdaptiveTrialDesign.ashx [Last accessed 17 June 2014]
   Google Scholar
• Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design. EMEA. European Medicines Agency, London, UK; 2007. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003616.pdf [Last accessed 17 June 2014]
   Google Scholar
• Myshko D. Adapting to adaptive drug development. Pharma Voice; 2013. p. 28-30
   Google Scholar
• Smith DL. Patient nonadherence in clinical trials: could there be a link to postmarketing patient safety? Drug Inf J 2012;46(1):27-34
   Web of Science ®Google Scholar
• Gaydos B, Anderson KM, Berry D, et al. Good practices for adaptive clinical trials in pharmaceutical product development. Biostatistics 2009;43:539-56
   Google Scholar
• Salama RO, Young PM, Rogueda P, et al. Advances in drug delivery: is triple therapy the future for the treatment of chronic obstructive pulmonary disease? Expert Opin Pharmacother 2011;12(12):1913-32
   PubMed Web of Science ®Google Scholar
• Hanrahan JP, Hanania NA, Calhoun WJ, et al. Effect of nebulized arformoterol on airway function in COPD: results from two randomized trials. J Chron Obstruct Pulmon Dis 2008;5:25-34
   Web of Science ®Google Scholar
• Guidance for industry: adaptive design clinical trials for drugs and biologics. US Food and Drug Administration. FDA Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. 2010. Available from: http://www.fda.gov/downloads/Drugs/.../Guidances/ucm201790.pdf [Last accessed 17 June 2014]
   Google Scholar
• Von Hollen D, Hatley RH, Pritchard JN, et al. Factors to consider when selecting a nebulizer in drug development. In: Dalby RN, Byron PR, Peart J, et al. editors. Respiratory Drug Delivery 2014. Volume 2: Virginia Commonwealth University; Richmond, VA: 2014. p. 539-44
   Google Scholar