Pharmaceutical Inhalation Aerosol Technology 

Pharmaceutical Inhalation Aerosol Technology

Two previous editions of the book Pharmaceutical Inhalation Aerosol Technology (PhIAT) were pub-lished in 1993 and 2004. The first edition appeared at a time when few books on aerosol technology were available, notably those of WC Hinds (Aerosol Technology, Wiley) and PC Reist (Introduction to Aerosol Science) that had only been available for a decade. There were few general texts on medical aerosols, and those were in specialized areas, notably several volumes by Stephen Newman. With this background, the original PhIAT book was intended to broadly cover all aspects of the field from lung biology (pharmacol-ogy, physiology, and anatomy) to drug product manufacturing, performance, and clinical applications. In the intervening decades many new volumes have appeared and much more has been published on aerosol physics, formulation and device development, and therapeutic strategies, supported by the commercial-ization of many new drug products.

This edition of PhIAT not only provides an update on many topics addressed in the 2nd edition, but also expands the “technology” focus of the original volumes to address the title more directly. Since the major purpose of any book should be its utility to the reader, it is logical to look at the topic from the perspective of clear unmet needs. The new text covers all aspects of product development and manu-facturing encompassing the important areas of preformulation, formulation, device selection, and drug product evaluation. In order to expand the scope to consider previously unaddressed aspects of phar-maceutical inhalation aerosol technology, considerations of the patient interface have been restricted to those aspects of aerosol delivery, lung deposition, and clearance that are used as measures of effective dose delivery.

The introduction of Dr. Sandro da Rocha as co-editor of the new edition reflects the intention to bring engineering principles to bear on this important topic and to stress the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery.

We are grateful to the publishing staff, in particular, Hilary LaFoe and Jessica Poile for their assis-tance in navigating the manuscript through the process.

This book is dedicated in memory of Professor Paul Myrdal, outstanding scientist, educator, family man, and friend. He is missed by all.

Anthony J. Hickey is Distinguished RTI Fellow at the Research Triangle Institute, Emeritus Professor of Molecular Pharmaceutics of the Eshelman School of Pharmacy (2010–present, Professor 1993–2010), and Adjunct Professor of 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 joined the faculty at the University of Illinois at Chicago (1988–1993). In 1990 he received the 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); 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 United States patents on a variety of inhaler device technologies, pulmonary, 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; founder and CEO of Astartein, Inc. (2013–present); member of the Pharmaceutical Dosage Forms Expert Committee of the United States Pharmacopeia (USP, 2010–2015, Chair of the Sub-committee on Aerosols); and formerly Chair of the Aerosols Expert Committee of the USP (2005–2010). Dr. Hickey conducts a multidisci-plinary research program in the field of pulmonary drug and vaccine delivery for treatment and prevention of a variety of diseases.

Sandro R.P. da Rocha is a full professor in the Department of Pharmaceutics in the School of Pharmacy and director for Pharmaceutical Engineering—School of Pharmacy at Virginia Commonwealth University (VCU). He also holds a joint appointment in Chemical and Life Science Engineering and is a full member of the Massey Cancer Center at VCU. He obtained his BSc and MSc in Chemical Engineering at USFM and UFSC, respectively, in Brazil, and a PhD in 2000 from the University of Texas at Austin in Chemical Engineering. After a postdoctoral position in Chemistry and Biochemistry also at the University of Texas at Austin, Dr. da Rocha joined the faculty at Wayne State University in Detroit, MI, where he worked until 2015. Professor da Rocha has contributed extensively to the area of  pulmonary drug delivery, particularly through the development of novel pressurized metered dose inhaler formula-tions and of nanotherapeutics for pulmonary drug delivery, both areas having  potential applications in the treatment of a variety of pulmonary disorders. Professor da Rocha has received numerous awards and recognition for his work, including visiting appointments at foreign institutions where he has developed collaborative efforts and taught in the area of nanomedicine and pulmonary drug delivery. Professor da Rocha has delivered a number of lectures nationally and internationally in the area of pulmonary nanotherapeutics and has written manuscripts and book chapters with his  collaborators that include visiting faculty, postdoctoral fellows, PhD, undergraduate, graduate, and high-school  students, who now hold key positions in the industry, academia, and government in various areas including pulmonary pharmaceutics.


Anthony J. Hickey and Sandro R.P. da Rocha

A number of outstanding texts on foundational elements of the topics discussed in this book exist, and the reader is encouraged to familiarize themselves with these materials, as they describe basic principles (Finlay, 2001), specific (Purewal and Grant, 1997, Srichana, 2016 and Zeng et al, 2000) and general dos-age forms (Colombo et al., 2013, Hickey, 2007, Newman, 2009, Smyth and Hickey, 2011), and analytical methods (Tougas et al., 2013).

The advances in pharmaceutical inhalation aerosol technology occurring since the turn of the mil-lennium have increased the potential of pulmonary drug delivery substantially. While some of the new developments had their origins in earlier work, we have seen the appearance of new propellants and new regulations considering the phase out of what we still consider new propellants, new dry powder inhalers, nebulizers, and a new category of product, soft mist inhalers.

In parallel with these new products, the breadth of application has increased to include the treatment of chronic obstructive pulmonary disease, a range of infectious diseases, diabetes, idiopathic pulmonary fibrosis, and pulmonary arterial hypertension. Pre-clinical studies and clinical trials covering yet a range of other potential applications of orally inhaled products include the use of a broader range of biologics and also nanomaterials that may help further advance the pulmonary drug delivery market.

Successful aerosol therapy has given research and development a boost, and the prospects of even greater opportunities for disease management is emerging from patient compliance, adherence tools, and new classes of drugs for local and systemic delivery through the lungs.

This text is focused on the active pharmaceutical ingredient, formulation development, device design, process and product engineering, and analytical methods to assess critical quality attributes underpin-ning safe and efficacious dosage forms.

Figure 1.1 depicts the sequence in which these topics will be presented, which follows the product development pathway. The conclusion of the volume is a discussion of bioequivalence testing and the interface between the dosage form and the patient. This reflects the point at which design and engineering controls, which are embedded in a regulated environment of quality by design, give way to biological factors.

It is intended that the materials covered in subsequent sections familiarize the reader with the underly-ing science and engineering associated with the design and characterization of complex dosage forms required to deliver orally inhaled aerosols. The platform of knowledge will be useful in considering options for specific applications and is a point from which to launch new technologies that will frame  future developments in the field as described in a companion text (Hickey and Mansour, in press).


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