Spray Drying of Vaccines

Spray Drying of Vaccines

Author: Cordin Arpagaus

Publisher: Springer Nature

Published: 2023-04-03

Total Pages: 610

ISBN-13: 3031243234

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This book addresses the stabilization of vaccine powders by spray drying and provides an overview of the current state of the art on a laboratory and industrial scale. The book aims to familiarize readers with the advances in vaccine spray drying technology to understand its application potential better. In particular, the book addresses the design of aseptic spray dryers, parameters affecting the spray drying process, sterile powder processing, cleaning procedures, and powder filling. In addition, different drying technologies for the production of dry powder vaccines are compared to discuss the unique capabilities of spray drying as a particle technology for vaccines. Special attention is given to research studies on spray-dried vaccines published over the past 30 years, with key findings from laboratory research to clinical trials. Potential applications of spray-dried vaccines and routes of administration are presented in detail. Finally, an outlook is given on how close the aseptic spray-drying of vaccines is to the market and the challenges that need to be overcome to be commercially successful. The book's target audience is academics, researchers, vaccine developers, industry experts, students, and possibly funders, including government agencies, who are active in the field. In addition, the book is a reference source for those involved in the vaccine formulation and biopharmaceutical processing industry.


Book Synopsis Spray Drying of Vaccines by : Cordin Arpagaus

Download or read book Spray Drying of Vaccines written by Cordin Arpagaus and published by Springer Nature. This book was released on 2023-04-03 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book addresses the stabilization of vaccine powders by spray drying and provides an overview of the current state of the art on a laboratory and industrial scale. The book aims to familiarize readers with the advances in vaccine spray drying technology to understand its application potential better. In particular, the book addresses the design of aseptic spray dryers, parameters affecting the spray drying process, sterile powder processing, cleaning procedures, and powder filling. In addition, different drying technologies for the production of dry powder vaccines are compared to discuss the unique capabilities of spray drying as a particle technology for vaccines. Special attention is given to research studies on spray-dried vaccines published over the past 30 years, with key findings from laboratory research to clinical trials. Potential applications of spray-dried vaccines and routes of administration are presented in detail. Finally, an outlook is given on how close the aseptic spray-drying of vaccines is to the market and the challenges that need to be overcome to be commercially successful. The book's target audience is academics, researchers, vaccine developers, industry experts, students, and possibly funders, including government agencies, who are active in the field. In addition, the book is a reference source for those involved in the vaccine formulation and biopharmaceutical processing industry.

Drying Technologies for Biotechnology and Pharmaceutical Applications

Drying Technologies for Biotechnology and Pharmaceutical Applications

Author: Satoshi Ohtake

Publisher: John Wiley & Sons

Published: 2020-06-02

Total Pages: 394

ISBN-13: 3527341129

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A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.


Book Synopsis Drying Technologies for Biotechnology and Pharmaceutical Applications by : Satoshi Ohtake

Download or read book Drying Technologies for Biotechnology and Pharmaceutical Applications written by Satoshi Ohtake and published by John Wiley & Sons. This book was released on 2020-06-02 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.

Lyophilized Biologics and Vaccines

Lyophilized Biologics and Vaccines

Author: Dushyant Varshney

Publisher: Springer

Published: 2015-05-19

Total Pages: 399

ISBN-13: 1493923838

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This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.


Book Synopsis Lyophilized Biologics and Vaccines by : Dushyant Varshney

Download or read book Lyophilized Biologics and Vaccines written by Dushyant Varshney and published by Springer. This book was released on 2015-05-19 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.

Micro- and Nanotechnology in Vaccine Development

Micro- and Nanotechnology in Vaccine Development

Author: Mariusz Skwarczynski

Publisher: William Andrew

Published: 2016-09-20

Total Pages: 460

ISBN-13: 0323400299

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This book provides a comprehensive overview of how use of micro- and nanotechnology (MNT) has allowed major new advance in vaccine development research, and the challenges that immunologists face in making further progress. MNT allows the creation of particles that exploit the inherent ability of the human immune system to recognize small particles such as viruses and toxins. In combination with minimal protective epitope design, this permits the creation of immunogenic particles that stimulate a response against the targeted pathogen. The finely tuned response of the human immune system to small particles makes it unsurprising that many of the lead adjuvants and vaccine delivery systems currently under investigation are based on nanoparticles. Provides a comprehensive and unparalleled overview of the role of micro- and nanotechnology in vaccine development Allows researchers to quickly familiarize themselves with the broad spectrum of vaccines and how micro- and nanotechnologies are applied to their development Includes a combination of overview chapters setting out general principles, and focused content dealing with specific vaccines, making it useful to readers from a variety of disciplines


Book Synopsis Micro- and Nanotechnology in Vaccine Development by : Mariusz Skwarczynski

Download or read book Micro- and Nanotechnology in Vaccine Development written by Mariusz Skwarczynski and published by William Andrew. This book was released on 2016-09-20 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive overview of how use of micro- and nanotechnology (MNT) has allowed major new advance in vaccine development research, and the challenges that immunologists face in making further progress. MNT allows the creation of particles that exploit the inherent ability of the human immune system to recognize small particles such as viruses and toxins. In combination with minimal protective epitope design, this permits the creation of immunogenic particles that stimulate a response against the targeted pathogen. The finely tuned response of the human immune system to small particles makes it unsurprising that many of the lead adjuvants and vaccine delivery systems currently under investigation are based on nanoparticles. Provides a comprehensive and unparalleled overview of the role of micro- and nanotechnology in vaccine development Allows researchers to quickly familiarize themselves with the broad spectrum of vaccines and how micro- and nanotechnologies are applied to their development Includes a combination of overview chapters setting out general principles, and focused content dealing with specific vaccines, making it useful to readers from a variety of disciplines

Spray-Freeze-Drying of Foods and Bioproducts

Spray-Freeze-Drying of Foods and Bioproducts

Author: S. Padma Ishwarya

Publisher: CRC Press

Published: 2022-04-08

Total Pages: 359

ISBN-13: 1000571459

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Spray-freeze-drying (SFD) is a synergistic drying technology that imbibes in it the merits of both spray drying and freeze-drying, whilst overcoming the limitations of these predecessor technologies. SFD produces uniquely powdered food and pharmaceutical products with porous microstructure and superior quality attributes. Owing to its atomization step and ultra-low-temperature operation, SFD is a competent drying technique for the production of valuable but sensitive bioactive components. Despite the costs and complexities involved, SFD has a competitive edge over the conventional drying techniques in providing distinctive product attributes. The applications of spray-freeze-drying in the area of food and bioproducts span across the product categories of instant food powders, dry flavors, active pharmaceutical ingredients, poorly water-soluble drugs, probiotics, proteins, enzymes and vaccines. Spray-Freeze-Drying of Foods and Bioproducts: Theory, Applications and Perspectives is the first exclusive title on this interesting drying technique. It provides a comprehensive understanding of the fundamentals of SFD and its food and pharmaceutical applications. The scope of this book, comprising 12 chapters, has been organizedunder four major headings: fundamentals of process-stages, applications with case-studies, recent advancements and the processing bottlenecks and solutions. Key Features Provides examples and case studies of nuances and intricacies associated with each stage of the spray-freeze-drying process Highlights the applications of spray-freeze-drying in the production of food products including soluble coffee, dairy powders, probiotics and flavors Serves as a ready-reckoner of characterization methods for spray-freeze-dried products Contains 200+ illustrations and tabulations The contents of this book are organized to cater to the knowledge needs of students, academicians, researchers and professionals in the food and pharmaceutical industry.


Book Synopsis Spray-Freeze-Drying of Foods and Bioproducts by : S. Padma Ishwarya

Download or read book Spray-Freeze-Drying of Foods and Bioproducts written by S. Padma Ishwarya and published by CRC Press. This book was released on 2022-04-08 with total page 359 pages. Available in PDF, EPUB and Kindle. Book excerpt: Spray-freeze-drying (SFD) is a synergistic drying technology that imbibes in it the merits of both spray drying and freeze-drying, whilst overcoming the limitations of these predecessor technologies. SFD produces uniquely powdered food and pharmaceutical products with porous microstructure and superior quality attributes. Owing to its atomization step and ultra-low-temperature operation, SFD is a competent drying technique for the production of valuable but sensitive bioactive components. Despite the costs and complexities involved, SFD has a competitive edge over the conventional drying techniques in providing distinctive product attributes. The applications of spray-freeze-drying in the area of food and bioproducts span across the product categories of instant food powders, dry flavors, active pharmaceutical ingredients, poorly water-soluble drugs, probiotics, proteins, enzymes and vaccines. Spray-Freeze-Drying of Foods and Bioproducts: Theory, Applications and Perspectives is the first exclusive title on this interesting drying technique. It provides a comprehensive understanding of the fundamentals of SFD and its food and pharmaceutical applications. The scope of this book, comprising 12 chapters, has been organizedunder four major headings: fundamentals of process-stages, applications with case-studies, recent advancements and the processing bottlenecks and solutions. Key Features Provides examples and case studies of nuances and intricacies associated with each stage of the spray-freeze-drying process Highlights the applications of spray-freeze-drying in the production of food products including soluble coffee, dairy powders, probiotics and flavors Serves as a ready-reckoner of characterization methods for spray-freeze-dried products Contains 200+ illustrations and tabulations The contents of this book are organized to cater to the knowledge needs of students, academicians, researchers and professionals in the food and pharmaceutical industry.

Comprehensive Biotechnology

Comprehensive Biotechnology

Author:

Publisher: Elsevier

Published: 2019-07-17

Total Pages: 4876

ISBN-13: 0444640479

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Comprehensive Biotechnology, Third Edition, Six Volume Set unifies, in a single source, a huge amount of information in this growing field. The book covers scientific fundamentals, along with engineering considerations and applications in industry, agriculture, medicine, the environment and socio-economics, including the related government regulatory overviews. This new edition builds on the solid basis provided by previous editions, incorporating all recent advances in the field since the second edition was published in 2011. Offers researchers a one-stop shop for information on the subject of biotechnology Provides in-depth treatment of relevant topics from recognized authorities, including the contributions of a Nobel laureate Presents the perspective of researchers in different fields, such as biochemistry, agriculture, engineering, biomedicine and environmental science


Book Synopsis Comprehensive Biotechnology by :

Download or read book Comprehensive Biotechnology written by and published by Elsevier. This book was released on 2019-07-17 with total page 4876 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comprehensive Biotechnology, Third Edition, Six Volume Set unifies, in a single source, a huge amount of information in this growing field. The book covers scientific fundamentals, along with engineering considerations and applications in industry, agriculture, medicine, the environment and socio-economics, including the related government regulatory overviews. This new edition builds on the solid basis provided by previous editions, incorporating all recent advances in the field since the second edition was published in 2011. Offers researchers a one-stop shop for information on the subject of biotechnology Provides in-depth treatment of relevant topics from recognized authorities, including the contributions of a Nobel laureate Presents the perspective of researchers in different fields, such as biochemistry, agriculture, engineering, biomedicine and environmental science

Handbook of Pharmaceutical Granulation Technology

Handbook of Pharmaceutical Granulation Technology

Author: Dilip M. Parikh

Publisher: CRC Press

Published: 2021-05-11

Total Pages: 905

ISBN-13: 1000366383

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Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies


Book Synopsis Handbook of Pharmaceutical Granulation Technology by : Dilip M. Parikh

Download or read book Handbook of Pharmaceutical Granulation Technology written by Dilip M. Parikh and published by CRC Press. This book was released on 2021-05-11 with total page 905 pages. Available in PDF, EPUB and Kindle. Book excerpt: Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies

Handbook of Nanoparticles

Handbook of Nanoparticles

Author: Mahmood Aliofkhazraei

Publisher: Springer

Published: 2015-08-07

Total Pages: 2000

ISBN-13: 9783319131887

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This Handbook covers all aspects of Nanoparticles, from their preparation to their practical application. The chapters present different ways to synthesize nanometer particles, as well as their functionalization and other surface treatments to allow them to a practical use. Several industrial applications of such nanometer particles are also covered in this Handbook. It is a complete reference for those working with Nanotechnology at the lab level, from students to professionals.


Book Synopsis Handbook of Nanoparticles by : Mahmood Aliofkhazraei

Download or read book Handbook of Nanoparticles written by Mahmood Aliofkhazraei and published by Springer. This book was released on 2015-08-07 with total page 2000 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Handbook covers all aspects of Nanoparticles, from their preparation to their practical application. The chapters present different ways to synthesize nanometer particles, as well as their functionalization and other surface treatments to allow them to a practical use. Several industrial applications of such nanometer particles are also covered in this Handbook. It is a complete reference for those working with Nanotechnology at the lab level, from students to professionals.

Immunomic Discovery of Adjuvants and Candidate Subunit Vaccines

Immunomic Discovery of Adjuvants and Candidate Subunit Vaccines

Author: Darren R. Flower

Publisher: Springer Science & Business Media

Published: 2012-12-09

Total Pages: 316

ISBN-13: 1461450705

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This volume will address an important emergent area within the field of immunomics: the discovery of antigens and adjuvants within the context of reverse vaccinology. Conventional approaches to vaccine design and development requires pathogens to be cultivated in the laboratory and the immunogenic molecules within them to be identifiable. Conventional vaccinology is no longer universally successful, particularly for recalcitrant pathogens. By using genomic information we can study vaccine development in silico: 'reverse vaccinology', can identify candidate subunits vaccines by identifying antigenic proteins and by using equally rational approaches to identify novel immune response-enhancing adjuvants.


Book Synopsis Immunomic Discovery of Adjuvants and Candidate Subunit Vaccines by : Darren R. Flower

Download or read book Immunomic Discovery of Adjuvants and Candidate Subunit Vaccines written by Darren R. Flower and published by Springer Science & Business Media. This book was released on 2012-12-09 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume will address an important emergent area within the field of immunomics: the discovery of antigens and adjuvants within the context of reverse vaccinology. Conventional approaches to vaccine design and development requires pathogens to be cultivated in the laboratory and the immunogenic molecules within them to be identifiable. Conventional vaccinology is no longer universally successful, particularly for recalcitrant pathogens. By using genomic information we can study vaccine development in silico: 'reverse vaccinology', can identify candidate subunits vaccines by identifying antigenic proteins and by using equally rational approaches to identify novel immune response-enhancing adjuvants.

Pharmaceutical Inhalation Aerosol Technology, Third Edition

Pharmaceutical Inhalation Aerosol Technology, Third Edition

Author: Anthony J. Hickey

Publisher: CRC Press

Published: 2019-03-26

Total Pages: 784

ISBN-13: 0429619561

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This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and clearance that are used as measures of effective dose delivery. Key Features: Provides a thoroughly revised and expanded reference with authoritative discussions on the physiologic,pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosols Emphasizes the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery Addresses the physics, chemistry and engineering principles while establishing disease relevance Expands the ‘technology’ focus of the original volumes to address the title more directly Offers an impressive breadth of coverage as well as an international flavour from outstanding editors and contributors


Book Synopsis Pharmaceutical Inhalation Aerosol Technology, Third Edition by : Anthony J. Hickey

Download or read book Pharmaceutical Inhalation Aerosol Technology, Third Edition written by Anthony J. Hickey and published by CRC Press. This book was released on 2019-03-26 with total page 784 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and clearance that are used as measures of effective dose delivery. Key Features: Provides a thoroughly revised and expanded reference with authoritative discussions on the physiologic,pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosols Emphasizes the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery Addresses the physics, chemistry and engineering principles while establishing disease relevance Expands the ‘technology’ focus of the original volumes to address the title more directly Offers an impressive breadth of coverage as well as an international flavour from outstanding editors and contributors