Anthony J. Hickey - Böcker

Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities describes methods and procedures for consideration when developing inhaled pharmaceuticals, while commenting on product development strategies and their suitability to support regulatory submission. It bridges the gap between the aspirations of scientists invested in new technology development and the requirements that must be met for any new product.

The book brings together emerging analytical and inhalation technologies, providing perspectives that illuminate formulation and device design, development, regulatory compliance, and practice. Focusing on underlying scientific and technical principles known to be acceptable from the current regulatory perspective, this monograph will remain useful as a high-level guide to inhaled product development for the foreseeable future.

Discusses development strategies and best practices in the context of regulatory requirements Written by a broadly qualified expert drawing on the knowledge and critical opinions of key individuals in the field Includes a foreword by Charles G. Thiel

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.

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 aerosolsEmphasizes the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug deliveryAddresses the physics, chemistry and engineering principles while establishing disease relevanceExpands the ‘technology’ focus of the original volumes to address the title more directlyOffers an impressive breadth of coverage as well as an international flavour from outstanding editors and contributors

With step-by-step methods of drug production and knowledge of major unit operations and key concepts of pharmaceutical engineering, this guide will help to improve communication among the varied professionals working in the pharmaceutical industry. The updated volume reflects the acceleration occurring in processes to support new product development as the revolution initiated by characterization of the human genome at the turn of the millennium has an impact in transforming the treatment of disease.Key FeaturesThoroughly revised and expanded professional text illustrates how materials that are being processed have evolved as the understanding of the cell biology and biochemistry of disease has improved and new treatments have emerged based on the products of biotechnology.Emphasizes the importance of pharmaceutical engineering and addresses the advances in disease therapy including their implications for pharmaceutical process engineering.Each topic has been updated to reflect new developments occurring in the last decade.Describes biosynthesis, of particular relevance to proteins and nucleic acids as well as gene transfer by transfection and editing used currently in cell therapies for a variety of rare diseases.Exciting new chapter on artificial intelligence and machine learning as tools for process optimization.

The pharmaceutical applications of powder technology have long been recognized. Yet while many books focus on aspects of powder formation and behavior, there are few texts that explore the power of particulate science in the design, manufacture, and control of quality medicines. This revision discusses key principles and practical applications. The authors cover particulate material, its form and production, sampling from bodies of powder, particle size descriptors and statistics, behavior of particles and powder, instrumental analysis, particle size measurement and synergy of adopted techniques, and in vitro and in vivo performance criteria. Case studies are included in this new edition.This fully revised edition:Provides an essential account of particulate science including several new chapters on multicomponent particles, regulatory considerations and product developmentPresents a variety of topics ranging from the quality of published data on particle size in pharmaceuticals to the future of crystal engineeringReviews methods of particle measurement and their importance for specific applicationsDiscusses misconceptions and misunderstandings of particulate science together with lessons from other industries

Provides a review of novel pharmaceutical approaches for Tuberculosis drugs Presents a novel perspective on tuberculosis prevention and treatmentConsiders the nature of disease, immunological responses, vaccine and drug delivery, disposition and responseMultidisciplinary appeal, with contributions from microbiology, immunology, molecular biology, pharmaceutics, pharmacokinetics, chemical and mechanical engineering

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 aerosolsEmphasizes the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug deliveryAddresses the physics, chemistry and engineering principles while establishing disease relevanceExpands the ‘technology’ focus of the original volumes to address the title more directlyOffers an impressive breadth of coverage as well as an international flavour from outstanding editors and contributors

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.

With step-by-step methods of drug production and knowledge of major unit operations and key concepts of pharmaceutical engineering, this guide will help to improve communication among the varied professionals working in the pharmaceutical industry. Key features: REVISION OF A BESTSELLER - Updates include recent advances in the field to keep pharmaceutical scientists and technologists up-to-dateIDEAL INTRODUCTORY TEXT - Covers basic engineering principles, drug production, and development processes, so scientists can easily convert bulk pharmaceutical products into patient-ready dosage formsNEW INFORMATION - on quality principles that include quality by design; mathematical and statistical approaches to experimental design; computer aided design; and PAT (process analytical technology) keeps professionals at the forefront of their fieldCOMPREHENSIVE COVERAGE - Step-by-step methods of drug production, knowledge of major unit operations, and key concepts of pharmaceutical engineering will help to improve communication among the varied professionals working in the pharmaceutical industry

The historical approach to the interpretation of physical, chemical and biological phenomena has been to consider relationships with causative factors that can be reduced to linearity allowing simple and direct interpretation. However, it is increasingly evident that there is often more information in the data than linear interpretations allow. The current capacity for computers to assist in identifying non-linear relationships allows greater interpretation of data which illuminates the phenomena allowing the information to be translated into knowledge that can be used wisely to promote various desirable pharmaceutical outcomes. This short volume is intended to stimulate the reader to contemplate research and development areas in which the data might be more accurately interpreted to allow greater understanding and ultimately control of the pharmaceutically complex phenomena.

The pace of new research and level of innovation repeatedly introduced into the field of drug delivery to the lung is surprising given its state of maturity since the introduction of the pressurized metered dose inhaler over a half a century ago.

The pace of new research and level of innovation repeatedly introduced into the field of drug delivery to the lung is surprising given its state of maturity since the introduction of the pressurized metered dose inhaler over a half a century ago. It is clear that our understanding of pulmonary drug delivery has now evolved to the point that inhalation aerosols can be controlled both spatially and temporally to optimize their biological effects. These abilities include controlling lung deposition, by adopting formulation strategies or device technologies, and controlling drug uptake and release through sophisticated particle technologies. The large number of contributions to the scientific literature and variety of excellent texts published in recent years is evidence for the continued interest in pulmonary drug delivery research. This reference text endeavors to bring together the fundamental theory and practice of controlled drug delivery to the airways that is unavailable elsewhere. Collating and synthesizing the material in this rapidly evolving field presented a challenge and ultimately a sense of achievement that is hopefully reflected in the content of the volume.

The pharmaceutical applications of powder technology have long been recognized. Yet while many books focus on aspects of powder formation and behavior, there has been no text that explores the power of particulate science in the design, manufacture, and control of quality medicines. Until now. A Guide to Pharmaceutical Particulate Science discusses key principles of particulate science and their practical applications.The authors cover particulate material, its form and production, sampling from bodies of powder, particle size descriptors and statistics, behavior of particles, instrumental analysis, particle size measurement and synergy of adopted techniques, physical behavior of a powder, and in vitro and in vivo performance criteria. They draw the components of particulate science into a single concise description of their current and potential uses in product development. Exploring the growth in knowledge of particle properties and the variety of technological advances in particle manufacture, A Guide to Pharmaceutical Particulate Science gives readers the tools they need to grasp the science and its use in the industry.

Nanotechnology in Pharmaceutical Aerosol Science and Pulmonary Delivery presents a comprehensive reference dedicated to the intersection of nanotechnology and inhalation drug delivery. Edited by internationally recognized experts Professors Heidi M. Mansour and Anthony J. Hickey, this authoritative volume explores the design, development, and evaluation of inhaled nanomedicines for targeted pulmonary therapy.Bringing together contributions from leading researchers across academia, industry, and regulatory sectors, the book covers a wide spectrum of topics—from the physicochemical properties of nanomaterials and formulation strategies, to advanced in vitro and in vivo models, biopharmaceutical classification, and regulatory perspectives. Chapters delve into cutting-edge applications including nanoliposomes, nanocrystals, dendrimers, exosomes, and inhaled biologics, with a strong emphasis on translational science and therapeutic innovation.It serves as an essential resource for pharmaceutical scientists, nanotechnologists, biomedical scientists, clinicians, industrial scientists, and regulatory professionals. In addition, it serves as a valuable scientific resource for educators and students.

This first monograph in the new AAPS book series concisely reviews important aspects of powder and particle systems and the critical quality attributes that should be used as a guide to future developments intended to maximize the control of product quality and performance.

Non-linear phenomena pervade the pharmaceutical sciences. Understanding the interface between each of these phenomena and the way in which they contribute to overarching processes such as pharmaceutical product development may ultimately result in more efficient, less costly and rapid implementation.

Non-linear phenomena pervade the pharmaceutical sciences. Understanding the interface between each of these phenomena and the way in which they contribute to overarching processes such as pharmaceutical product development may ultimately result in more efficient, less costly and rapid implementation.