Pharmaceutical Inhalation Aerosol Technology Third Edition

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

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.

This thoroughly revised and expanded reference provides authoritative discussions on the physiologic, pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosol. It analyzes the latest science and developments in the generation, administration and characterization of these compounds, showcasing current clinical applications, the efficiency and limitations of major aerosol products and emerging aerosol therapies impacting the field.

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.

The over-riding premise for biotechnology in this book is bringing novel products to market to substantially advance patient care and disease mitigation. Biotechnology, over its relatively brief existence of 40 years, has experienced a mercurial growth. The vast educational need for biotechnology information in this rapidly burgeoning field is a basic rationale here. However a more prominent underpinning is that, bringing biotech products to market for patient care involves success in the following four areas of engagement simultaneously - scientific advances for healthcare technologies, novel and varied products for untreated diseases, regulatory authorities, and biotech companies. Features Comprehensive coverage of biotechnology science topics used in development and manufacturing Addresses all the scientific technologies within biotechnology responsible for products on the market and the pipeline Presents business issues such as marketing and sales of the products, as well as companies engaged, and how biotech business has evolved

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.

The Mechanics of Inhaled Pharmaceutical Aerosols, An Introduction provides a unique and comprehensive treatment of the mechanics of inhaled pharmaceutical aerosols. The book covers a wide range of topics and many new perspectives are given by drawing on research from a variety of fields. Novel, in-depth expositions of the most common delivery devices are given, including nebulizers, dry powder inhalers and propellant metered dose inhalers. The behaviour of aerosols in the respiratory tract is explained in detail, with complete coverage of the fundamentals of current deposition models. The book begins by providing a comprehensive introduction to aspects of aerosol mechanics that are relevant to inhaled pharmaceutical aerosols. It then gives an exhaustive pedagogical description of the behaviour of evaporating and condensing droplets (both aqueous and propellant-based), an introductory chapter on lung geometry and inhalation patterns, and coverage of relevant aspects of fluid mechanics in the lung. Finally, the book provides invaluable, detailed coverage on the mechanics of common pharmaceutical aerosol delivery systems and deposition in the respiratory tract. Throughout the book are many detailed numerical examples that apply the salient concepts to typical inhaled pharmaceutical aerosols. This book will be of interest to scientists and engineers involved in the research and development of inhaled pharmaceutical aerosol products. Experienced practitioners will find many new perspectives that will greatly enhance their understanding of this complex and rapidly growing field. For those delivering therapeutic agents to the lung, this book is a must-have. Students and academics will find this book an invaluable tool and for newcomers it is a worthy guide to the diverse fields that must be understood to work in the area of inhaled pharmaceutical aerosols.

Drug delivery technologies represent a vast, vital area of research and development in pharmaceuticals. The demand for innovative drug delivery systems continues to grow, driving a variety of new developments. Drug Delivery Systems, Third Edition provides a comprehensive review of the latest research and development on drug delivery systems. Coverage includes liposomal, transmucosal, transdermal, oral, polymeric, and monoclonal antibody directed delivery. Each chapter provides a table of marketed and investigational products with numerous practical examples. The book also provides readers with a multitude of possible drug delivery systems that can be used to improve therapeutics, along with global and regulatory perspectives. This third edition contains a chapter on nanoscience and technology for drug delivery along with cutting-edge business intelligence and strategies. Written in a straightforward manner, the authors provide a global perspective on current and future advances and market opportunities. Supplying a cogent overview of the field and extensive guidance on where to get more information, it is an essential resource for anyone venturing into this area of drug development.

This edition offers new and expanded information on recent developments in stability data analysis, concepts of statistical outliners, bioequivalence studies, problems in sampling and devising limits for product release, covariance analysis and tolerance intervals, multiple endpoints and clinical data analysis, and more. student price which is available upon request from Marcel Dekker.

The source Dermal Absorption and Toxicity Assessment supplies a state-of-the-art overview of the dermal absorption process, and is divided into six well organized sections. Written by internationally recognized experts in the field, this Second Edition is a complete revised and updated text, covering the wide range of methods used to assess skin absorption and the various governmental and industrial programs concerned with skin permeation and toxicity. These include alternative in silico, in vitro, and in vivo strategies to conduct studies for regulatory requirements. To make room for this new expanded content, the editors are publishing a concurrent text entitled: Dermatological and Cosmetic Development with a concentration on subjects concerned with dermatological and cosmetic therapies

This reference provides a concise overview of the key principles in dose selection and optimization and demonstrates applicability to recent successful new drug applications. Compiling key issues and current research of safety, efficacy, and clinical pharmacology, and PK-PD, this volume critically highlights the multidisciplinary nature of drug development and spans the fields of pharmacokinetics, clinical pharmacology, biostatistics, and experimental medicine.

Modern Pharmaceutics examines the impact of pharmaceutical biotechnology, cell therapy, pharmacogenomics (biotherapeutics), and nanotechnology on current practice, and the potential for personalized medicines and implications for pediatric and geriatric formulations. Reflecting the shift away from physical pharmacy, Modern Pharmaceutics is the must-have current reference text for pharmaceutics and drug delivery.

The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.

This source expertly examines the discovery, biological structure, control, and continued clarification of endotoxin from a parenteral manufacturing perspective, with in-depth discussion of state-of-the-art technologies involving Limulus amebocyte lysate (LAL) such as assay development, automation, depyrogenation. Completely revised and expanded, this Third Edition contains the knowledge necessary to apply endotoxin testing in the increasingly complex pharmaceutical environment, featuring sections detailing the latest information regarding clinical advances, regulation standards, and validation procedures for computerized kinetic tests.

Highlights the application of freeze-drying to pharmaceuticals-illustrating practical & industry-tested methods of preserving & reactivating delicate biologicals & biochemicals. Discusses the basic principles & engineering aspects of lyophilization, & also the role of bulking agents, additives, cryoprotectants, antioxidants, free radicals, & other products that protect the biological integrity of active substances during freezing, drying, & storage.

Combining basic theory, current industrial practice, and useful regulatory aspects in an original overview of pharmaceutical stability, this thoroughly rewritten and enlarged reference/text examines data analysis of the packaged drug's stability, experimental methods for achieving stable marketed products, and the stability principles of drugs in dissolved, dispersed, and solid states.

An up-to-date, sequenced approach to drug dosage formulation, design and evaluation. This edition offers new chapters on regulatory aspects of the pharmaceutical industry in the European Union, the pharmaceutical needs of special populations, target-oriented drug delivery systems and more.

Updated to reflect current good manufacturing practice (CGMP) regulations, this text discusses current concepts in validation. New topics covered include: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation.

This work covers all aspects of the Food and Drug Administration's Good Laboratory Practice relgulations and techniques for implementation. This edition includes general knowledge on computer system validation, details on implementing GIPs in an automated laboratory, a forecast of the flexibility and effectiveness of GLPs in the changing laboratory environment, and a contemporary bibliography with new references.

Revised to ensure GMP compliance, this text examines US laws affecting domestic and multinational pharmaceutical manufacturing. It recommends practical ways to interpret and comply with FDA CGMP regulations while meeting the goals of a comprehensive controls system to preserve product integrity.