Inhalation Aerosols Physical and Biological Basis for Therapy, Third Edition

Inhalation aerosols continue to be the basis for successful lung therapy for several diseases, with therapeutic strategies and the range of technology significantly evolving in recent years. In response, this third edition takes a new approach to reflect the close integration of technology with its application. After briefly presenting the general considerations that apply to aerosol inhalation, the central section of the book uses the focus on disease and therapeutic agents to illustrate the application of specific technologies. The final integrated strategies section draws the major points from the applications for disease targets and drug products.

0. Introduction Anthony J. Hickey and Heidi M. Mansour Section 1 Fundamentals Physicochemical Properties of Respiratory Particles and Formulations B. Shekunov Particle Deposition in the Respiratory Tract and the Effect of Respiratory Disease Dr. William Bennett Mathematical Modeling of Inhaled Therapeutic Aerosol Deposition in the Respiratory Tract Jeffry Schroeter, Bahman Asgharian, and Julia Kimbell Lung transporters & absorption mechanisms in the lungs. Mohammed Ali Selo,, Hassan H. A. Al-Alak, Carsten Ehrhardt Bioavailability of inhaled compounds. L. Garcia-Contreras 3D models as tools for inhaled drug development. Sally-Ann Cryan, Jennifer Lorigan, Cian O’Leary Overview of the delivery technologies for inhalation aerosols Daniel F. Moraga-Espinoza, Ashlee D. Brunaugh, Silvia Ferrati, Lara A. Heersema, Matthew J. Herpin, Patricia P. Martins, Hairui Zhang, Hugh D. C. Smyth Section 2 Applications, Influence of Lung Disease Pathophysiology on Aerosol Deposition, Inhaler Device Technique in Respiratory Disease, & Clinical Outcomes in Drug Performance Assessment Neonatal & Pediatric Inhalation Drug Delivery Ariel Berlinski Asthma Omar Usmani Drug Delivery in Pulmonary Aspergillosis Sawittree Sahakijpijarn, Jay I. Peters, Robert O. Williams III Lung Cancer Inhalation Therapeutics Rajiv Dhand Inhaled Therapeutics in Chronic Obstructive Pulmonary Disease Tejas Sinha, Paul DeJulio and Philip Diaz Cystic fibrosis infection & Biofilm Busters Jennifer Fiegel and Sachin Gharse CURRENT AND FUTURE CFTR Therapeutics- Marne C. Hagemeijer, Gimano D. Amatngalim and Jeffrey M. Beekman Innate and Adaptive Barrier Properties of Airway Mucus Alison Schaefer, Samuel K. Lai Non-tuberculous mycobacteria (NTM) M. Ghadiri, P. M. Young, and D. Traini Inhalational Therapies for Non-CF Bronchiectasis Ashvini Damodaran, Dustin R. Fraidenburg, and Israel Rubinstein Pulmonary Fibrosis, Priya Muralidharan, Dr. Don Hayes, Jr, and Dr. Heidi M. Mansour Therapeutics in Pulmonary Hypertension Maria F. Acosta, Don Hayes, Jr., Jeffrey R. Fineman, Jason X.-J. Yuan, Stephen M. Black, and Heidi M. Mansour Respiratory distress syndrome, Heidi M. Mansour, Debra Droopad, and Julie G. Ledford Surfactant Aerosol Therapy for nRDS and ARDS Donovan B. Yeates Fundamentals in Nasal Drug Delivery Zachary Warnken, Yu jin Kim, Heidi M. Mansour, Robert O. Williams III, Hugh D.C. Smyth Inhaled therapeutics against TB: the promise of pulmonary treatment and prevention strategies in the clinic Dominique N; Kunda, Nitesh K. Miller, Elliott K.; Muttil, Pavan Section 3 Integrated strategies (reflecting combined elements from chapters 8-23): Inhaled medication: factors that affect lung deposition Joy Conway A Critical Perspective on Future developments based on the knowledge we have now Tania F. Bahamondez-Canas, Jasmim Leal, Hugh D.C. Smyth 26. Ensuring Effectiveness and Reproducibility of Inhaled Drug Treatment Anthony J Hickey 27. Conclusion A.J. Hickey, and H.M. Mansour

Anthony J. Hickey, PhD, DSc, is Distinguished RTI Fellow, at the Research Triangle Institute (2010-present), Emeritus Professor of Molecular Pharmaceutics of the Eshelman School of Pharmacy (1993-2010), and Adjunct Professor Biomedical Engineering in the School of Medicine at the University of North Carolina at Chapel Hill. He obtained PhD (1984) and DSc (2003) degrees in pharmaceutical sciences from Aston University, Birmingham, United Kingdom, following postdoctoral positions at the University of Kentucky (1984-1988). Dr. Hickey thenjoined the faculty at the University of Illinois at Chicago (1988-1993). In 1990, he received the Association of Pharmaceutical Scientists (AAPS) Young Investigator Award in Pharmaceutics and Pharmaceutical Technology. He is a Fellow of the Royal Society of Biology (2000), the American Association of Pharmaceutical Scientists (2003), the American Association for the Advancement of Science (2005), and the Royal Society of Biology (2017). He received the Research Achievement Award of the Particulate Presentations and Design Division of the Powder Technology Society of Japan (2012), the Distinguished Scientist Award of the American Association of Indian Pharmaceutical Scientists (2013), the David W. Grant Award in Physical Pharmacy of the American Association of Pharmaceutical Scientists (2015), the Thomas T. Mercer Joint Prize for Excellence in Inhaled Medicines and Pharmaceutical Aerosols of the American Association for Aerosol Research and the International Society for Aerosols in Medicine (2017). He has published numerous papers and chapters (over 250) in the pharmaceutical and biomedical literature, one of which received the AAPS Meritorious Manuscript Award in 2001. He has edited five texts on pharmaceutical inhalation aerosols and co-authored three others on pharmaceutical process engineering, pharmaceutical particulate science, and pharmaco complexity. He holds 25 U.S. patents on a variety of inhaler device technologies, andpulmonary and oral drug delivery formulation technologies. He is founder (1997, and formerly president and CEO, 1997-2013) of Cirrus Pharmaceuticals, Inc., which was acquired by Kemwell Pharma in 2013; founder (2001, and formerly CSO, 2002-2007) of Oriel Therapeutics, Inc, which was acquired by Sandoz in 2010; and founder and CEO of Astartein, Inc. (2013-present). He is a member of the Pharmaceutical Dosage Forms Expert Committee of the United States Pharmacopeia (USP, 2010–2015, Chair of the Subcommittee on Aerosols), and formerly Chair of the Aerosols Expert Committee of the USP (2005-2010). Dr. Hickey conducts a multidisciplinary research program in the field of pulmonary drug and vaccine delivery for treatment and prevention of a variety of diseases. Heidi M. Mansour, PhD, RPh, is a tenured Associate Professor of Pharmaceutical Sciences in the College of Pharmacy with joint faculty appointments in the BIO5 Research Institute and the College of Medicine in the Division of Translational and Regenerative Medicine at The University of Arizona (UA) in Tucson, Arizona. Dr. Mansour has faculty member affiliations in the UA Institute of the Environment, and the UA NCI Comprehensive Cancer Center. She lectures in the BS Pharmaceutical Sciences undergraduate program, the Pharm.D. professional program and in the Pharmaceutics and Pharmacokinetics track of the graduate program at The University of Arizona. In addition to teaching, Dr. Mansour serves as Faculty Advisor in the Pharm.D./PhD Dual Degree Joint Program and Director of the Pharmaceutics and Pharmacokinetics track in the Pharmaceutical Sciences graduate program in The UA College of Pharmacy. Dr. Mansour has published over 80 peer-reviewed scientific journal papers, 9 book chapters, 2 edited books, and over 100 scientific conference abstracts. She serves on the editorial advisory boards of the the Royal Society of Chemistry Molecular Systems Design & Engineering, APhA/FIP Journal of Pharmaceutical Sciences, and Pharmaceutical Technology. Dr. Mansour is an annual Faculty Instructor at ISAM (International Society of Aerosols in Medicine) Aerosol School, instructor in two online webinars on inhalation aerosol drug delivery, and instructor in Buchi Advanced Spray Drying short courses. She was recently Co-Chair of the Drug Delivery: New Devices & Emerging Therapies Group in (ISAM, and has been an expert member of the National Institutes of Health (NIH) NICHD U.S. Pediatric Formulations Initiative New Drug Delivery Systems Aerosols Working Group for several years. Dr. Mansour currently serves on the Drug/Device Discovery and Development (DDDD) Committee of the American Thoracic Society (ATS). She regularly serves as an expert reviewer for scientific journals and grant funding agencies including NIH study sections; Department of Defense (DOD) study panels; National Science Foundation (NSF) study panels; the American Association for the Advancement of Science (AAAS); Catalent Drug Delivery Institute; a