Ciprofloxacin Dry Powder for Inhalation (ciprofloxacin DPI): Technical design and features of an efficient drug–device combination

Weycker, 2005, Prevalence and economic burden of bronchiectasis, Clin. Pulm. Med., 12, 205, 10.1097/01.cpm.0000171422.98696.ed

Chalmers, 2012, Short- and long-term antibiotic treatment reduces airway and systemic inflammation in non-cystic fibrosis bronchiectasis, Am. J. Respir. Crit. Care Med., 186, 657, 10.1164/rccm.201203-0487OC

Flume, 2015, Clinical applications of pulmonary delivery of antibiotics, Adv. Drug Deliv. Rev., 85, 1, 10.1016/j.addr.2014.10.009

Tunney, 2013, Lung microbiota and bacterial abundance in patients with bronchiectasis when clinically stable and during exacerbation, Am. J. Respir. Crit. Care Med., 187, 1118, 10.1164/rccm.201210-1937OC

Barker, 2000, Tobramycin solution for inhalation reduces sputum Pseudomonas aeruginosa density in bronchiectasis, Am. J. Respir. Crit. Care Med., 162, 481, 10.1164/ajrccm.162.2.9910086

Ciprofloxacin summary of product characteristics. https://www.medicines.org.uk/emc/medicine/20346/SPC/Ciproxin+Tablets+500mg/#PHARMACODYNAMIC_PROPS (Accessed 6 December 2017).

Wilson, 2013, Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study, Eur. Respir. J., 41, 1107, 10.1183/09031936.00071312

Maltz, 2011, Device engineering insights into TOBI Podhaler: a development case study of high efficiency powder delivery to cystic fibrosis patients, 55

R. Endermann, H. Labischinski, C. Ladel, U. Petersen, B. Newton, Treatment of bacterial diseases of the respiratory organs, Patent application US 2004/0254194 A1, 2004.

J.P. Wong, Liposome-encapsulated ciprofloxacin, Patent EP0652008 A1, https://register.epo.org/application?number=EP94305331 (Accessed 6 December 2017).

Cipolla, 2013, Liposomal formulations for inhalation, Ther. Deliv., 4, 1047, 10.4155/tde.13.71

Weers, 2014, The PulmoSphere™ platform for pulmonary drug delivery, Ther. Deliv., 5, 277, 10.4155/tde.14.3

Weers, 2006, Embedded crystals in low density particles: formulation, manufacture, and properties, 297

Rooney, 1992, Phospholipid composition, biosynthesis, and secretion, 511

Ikegami, 1993, Surfactant metabolism, Semin. Perinatol., 17, 233

Geller, 2011, Development of an inhaled dry-powder formulation of tobramycin using PulmoSphereTM technology, J. Aerosol Med. Pulm. Drug Deliv., 24, 175, 10.1089/jamp.2010.0855

Miller, 2015, Physical characterization of tobramycin inhalation powder I: rational design of a stable engineered-particle formulation for delivery to the lungs, Mol. Pharm., 12, 2582, 10.1021/acs.molpharmaceut.5b00147

Florence, 2011

Chew, 2001, Use of solid corrugated particles to enhance powder aerosol performance, Pharm. Res. (N. Y.), 18, 1570, 10.1023/A:1013082531394

Weers, 2015, Formulation of dry powders for inhalation, J. Pharmacol. Sci., 104, 3259, 10.1002/jps.24574

Labiris, 2003, Pulmonary drug delivery. Part I: physiological factors affecting therapeutic effectiveness of aerosolized medications, Br. J. Clin. Pharmacol., 56, 588, 10.1046/j.1365-2125.2003.01892.x

U.S. Pharmacopeia Monograph Ciprofloxacin. http://www.pharmacopeia.cn/v29240/usp29nf24s0_m17865.html (Accessed 6 December 2017).

European Pharmacopoeia Monograph Ciprofloxacin. http://online.edqm.eu/EN/entry.htm# (Accessed 6 December 2017).

Stass, 2017, Ciprofloxacin dry powder for inhalation in patients with non-cystic fibrosis bronchiectasis or chronic obstructive pulmonary disease and in healthy volunteers, J. Aerosol Med. Pulm. Drug Deliv., 30, 53, 10.1089/jamp.2015.1282

Clark, 2015, The role of inspiratory pressures in determining flow rates through dry powder inhalers: a review, Curr. Pharmaceut. Des., 21, 3974, 10.2174/1381612821666150820105800

Elkins, 2014, Inspiratory flows and volumes in subjects with non-CF bronchiectasis using a new dry powder inhaler device, Open Respir. Med. J., 8, 8, 10.2174/1874306401408010008

Haynes, 2016, Design of ciprofloxacin dry powder for inhalation, Reg. Dev. Dialog., 3, 455

DeHaan, 2004, Predicting extrathoracic deposition from dry powder inhalers, J. Aerosol Sci., 35, 309, 10.1016/j.jaerosci.2003.09.002

Finlay, 2010, Choosing 3-D mouth-throat dimensions: a rational merging of medical imaging and aerodynamics, Respir. Drug Deliv., 1, 185

Olsson, 2013, Validation of a general in vitro approach for prediction of total lung deposition in healthy adults for pharmaceutical inhalation products, J. Aerosol Med. Pulm. Drug Deliv., 26, 355, 10.1089/jamp.2012.0986

Delvadia, 2013, In vitro tests for aerosol deposition II: IVIVCs for different dry powder inhalers in normal adults, J. Aerosol Med. Pulm. Drug Deliv., 26, 138, 10.1089/jamp.2012.0975

Weers, 2015, In vitro–in vivo correlations observed with indacaterol-based formulations delivered with the Breezhaler, J. Aerosol Med. Pulm. Drug Deliv., 28, 268, 10.1089/jamp.2014.1178

Pavkov, 2013, Dynamic inspiratory flow characteristics through the T-326 dry powder inhaler in cystic fibrosis, RDD Eur., 2, 325

Stass, 2013, Tolerability and pharmacokinetic properties of ciprofloxacin dry powder for inhalation in patients with cystic fibrosis: a phase I, randomized, dose-escalation study, Clin. Therapeut., 35, 1571, 10.1016/j.clinthera.2013.08.003

Smith, 1986, Pharmacokinetics and sputum penetration of ciprofloxacin in patients with cystic fibrosis, Antimicrob. Agents Chemother., 30, 614, 10.1128/AAC.30.4.614

Cipro (ciprofloxacin hydrochloride) Tablets US Label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s073,020780s030lbl.pdf (Accessed 6 December 2017).

Stass, 2013, Inhalation of a dry powder ciprofloxacin formulation in healthy subjects: a phase I study, Clin. Drug Invest., 33, 419, 10.1007/s40261-013-0082-0

Goldfarb, 1986, Single-dose pharmacokinetics of oral ciprofloxacin in patients with cystic fibrosis, J. Clin. Pharmacol., 26, 222, 10.1002/j.1552-4604.1986.tb02938.x

Stass, 2015, Safety and pharmacokinetics of ciprofloxacin dry powder for inhalation in cystic fibrosis: a phase I, randomized, single-dose, dose-escalation study, J. Aerosol Med. Pulm. Drug Deliv., 28, 106, 10.1089/jamp.2013.1056

Dorkin, 2015, Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis, BMJ Open Respir. Res., 2, e000100, 10.1136/bmjresp-2015-000100

Brodt, 2014, Inhaled antibiotics for stable non-cystic fibrosis bronchiectasis: a systematic review, Eur. Respir. J., 44, 382, 10.1183/09031936.00018414

Parkins, 2011, Tobramycin Inhalation Powder™: a novel drug delivery system for treating chronic Pseudomonas aeruginosa infection in cystic fibrosis, Expet Rev. Respir. Med., 5, 609, 10.1586/ers.11.56

Konstan, 2011, Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: the EAGER trial, J. Cyst. Fibros., 10, 54, 10.1016/j.jcf.2010.10.003

McCullough, 2014, Treatment adherence and health outcomes in patients with bronchiectasis, BMC Pulm. Med., 14, 107, 10.1186/1471-2466-14-107

Weers, 2015, Antimicrobial therapy – barriers to effective treatment, Adv. Drug Deliv. Rev., 85, 24, 10.1016/j.addr.2014.08.013

McCullough, 2015, Defining the content and delivery of an intervention to Change AdhereNce to treatment in BonchiEctasis (CAN-BE): a qualitative approach incorporating the Theoretical Domains Framework, behavioral change techniques and stakeholder expert panels, BMC Health Serv. Res., 15, 342, 10.1186/s12913-015-1004-z

Quint, 2016, Changes in the incidence, prevalence and mortality of bronchiectasis in the UK from 2004 to 2013: a population-based cohort study, Eur. Respir. J., 47, 186, 10.1183/13993003.01033-2015

Chalmers, 2014, The Bronchiectasis Severity Index: an international derivation and validation study, Am. J. Respir. Crit. Care Med., 189, 576, 10.1164/rccm.201309-1575OC

Goeminne, 2014, Mortality in non-cystic fibrosis bronchiectasis: a prospective cohort analysis, Respir. Med., 108, 287, 10.1016/j.rmed.2013.12.015

McDonnell, 2014, Non cystic fibrosis bronchiectasis: a longitudinal retrospective observational cohort study of Pseudomonas persistence and resistance, Respir. Med.

TOBI Podhaler Package Insert 2015. https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/tobipodhaler.pdf (Accessed 6 December 2017).

Schwarz, 2015, Colobreathe for the treatment of cystic fibrosis-associated pulmonary infections, Pulm. Therapeut., 1, 19, 10.1007/s41030-015-0007-6

Harrison, 2014, Inhaled versus nebulised tobramycin: a real world comparison in adult cystic fibrosis (CF), J. Cyst. Fibros., 13, 692, 10.1016/j.jcf.2014.04.004

De Soyza, 2018, RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis, Eur. Respir. J., 51, 10.1183/13993003.02052-2017

Aksamit, 2018, RESPIRE 2: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis, Eur. Respir. J., 51, 10.1183/13993003.02053-2017