Inhaled Pharmaceutical Product Development Perspectives

Book Description :

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

Book Description :

Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.

Book Description :

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.

Book Description :

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 Description :

Handbook of Lung Targeted Drug Delivery Systems: Recent Trends and Clinical Evidences covers every aspect of the drug delivery to lungs, the physiology and pharmacology of the lung, modelling for lung delivery, drug devices focused on lung treatment, regulatory requirements, and recent trends in clinical applications. With the advent of nano sciences and significant development in the nano particulate drug delivery systems there has been a renewed interest in the lung as an absorption surface for various drugs. The emergence of the COVID-19 virus has brought lung and lung delivery systems into focus, this book covers new developments and research used to address the prevention and treatment of respiratory diseases. Written by well-known scientists with years of experience in the field this timely handbook is an excellent reference book for the scientists and industry professionals. Key Features: Focuses particularly on the chemistry, clinical pharmacology, and biological developments in this field of research. Presents comprehensive information on emerging nanotechnology applications in diagnosing and treating pulmonary diseases Explores drug devices focused on lung treatment, regulatory requirements, and recent trends in clinical applications Examines specific formulations targeted to pulmonary systems

Book Description :

Inhaled medicines are widely used to treat pulmonary and systemic diseases. The efficacy and safety of these medicines can be influenced by the deposited fraction, the regional deposition pattern within the lungs and by post-depositional events such as drug dissolution, absorption and clearance from the lungs. Optimizing performance of treatments thus requires that we understand and are able to quantify these product and drug attributes. Inhaled Medicines: Optimizing Development through Integration of In Silico, In Vitro and In Vivo Approaches explores the current state of the art with respect to inhalation drug delivery, technologies available to assess product performance, and novel in silico methods now available to link in vitro product performance to clinical performance. Recent developments in the latter field, especially the prospect of integration of three-dimensional Computational Fluid Particle Methods (3D-CFPD) with physiologically based pharmacokinetic (PBPK models), unlocks the potential for in silico population studies that can help inform and optimize treatment and product development strategies. In this highly multidisciplinary field, where progress occurs at the intersection of several disciplines of engineering and science, this work aims to integrate current knowledge and understanding and to articulate a clear vision for future developments. ? Considers the healthcare needs driving the field, and where inhaled drugs could have the maximum impact ? Gives a concise account of the state of the art in key areas and technologies such as device and formulation technologies, clinically relevant in vitro performance assessment, medical imaging, as well as in silico modelling and simulation ? Articulates how the combination of in vitro product performance data, medical imaging and simulations technologies in the framework of large scale in silico pre-clinical trials could revolutionize the field ? Provides systematic and thorough referencing to sources offering a more-in-depth analysis of technical issues

Book Description :

Smokeless Tobacco Products: Characteristics, Usage, Health Effects, and Regulatory Implications, a title in the Emerging Issues in Analytical Chemistry series, presents an overview of research on the second most dangerous tobacco product. This book presents findings on public health risks emanating from the complex interaction between smokeless tobacco products and their users. It covers the key components of assessment and provides insight into scientific and public health considerations. The book does not take a simplistic condemnatory position, but rather conceptualizes tobacco use in terms of graduated public health danger and harm reduction. The book begins by introducing smokeless tobacco, its history of use, marketing, and implications for public health. It then continues with coverage of epidemiology, pathology and clinical implications, addiction, and treatment, and includes laboratory studies of human use. The following section explains the chemistry, biochemical mechanisms of carcinogenesis, and role of plant cultivation and manufacturing in toxicity. Finally, the book concludes by addressing regulatory considerations, the scientific basis of regulations, and the role of these products in harm reduction for smokers. This is the first resource of its kind to cover these topics together and in language appropriate to both specialists in the research community and informed persons responsible for legislative, funding, and public health matters in the community at large. Brings attention to smokeless tobacco product use and its association with addiction and disease Considers smokeless tobacco use historically and currently, as well as its place in a future harm-reduction conceptualization of tobacco Written by a distinguished, internationally recognized group of tobacco researchers from academia, independent research organizations, and the federal government with expertise in the many and various disciplines covered

Book Description :

Herbicides: Chemistry, Efficacy, Toxicology, and Environmental Impacts addresses contemporary debates on herbicide toxicology. The reader is offered a comprehensive overview of this complex topic, presented by internationally recognized experts. Information presented will inform discussions on the use of herbicides in modern agricultural and other systems, and their potential non-target effects on human populations and various ecosystems. The book covers these matters in concise language appropriate to engage both specialists in the research community and informed persons responsible for legislative, funding, and public health matters in the community at large. The use of herbicides is an essential pillar of modern agricultural production systems. Weeds, if uncontrolled, would reduce crop yield and result in massive economic damage. Recently, the heavy reliance on single herbicides has been linked to the development of weed resistance. To combat resistant weeds, farmers are advised to use a mix of several herbicides and to increase herbicide application rates. As a result, the toxicity of herbicides on human health and the environment has become a controversial topic. Offers a comprehensive overview of herbicide science in modern agricultural systems Addresses the complex problems that can arise from herbicide use and misuse, including weed resistance, pollution, and human health issues Uses recent examples to demonstrate the topical nature of this issue

Book Description :

A title in the Emerging Issues in Analytical Chemistry series, Particulates Matter: Impact, Measurement, and Remediation of Airborne Pollutants provides the latest technical findings in the study of particulate matter (PM). It links these findings to awareness-raising and actionable schemes for legislated remediation and engineered solutions. Written in an engaging and informative manner, the book begins with a multi-disciplinary overview of the major sources and unique classes of PM, detection techniques, and their impact, including molecular changes resulting in health effects. It then goes one step further by proposing and examining the means to curtail and contain PM generation and ameliorate their impacts. Particulates Matter: Impact, Measurement, and Remediation of Airborne Pollutants offers a high-quality reference guide to PM that will greatly benefit technology leaders in environmental compliance groups, epidemiologists and other public health professionals focused on pollution and health, and researchers and scholars working in pollution, climate change, and urbanization. It may also be useful to advanced undergraduate and early graduate students in environmental sciences. Includes a summary of the current knowledge on nanoparticles as pollutants and their negative health effects Provides a framework for the evolution and maturation of air pollution characterization and mitigation Describes an integrated set of engineered solutions that account for the concatenated relationships between technology, policy, and society necessary for long-term success

Book Description :

Analytical Methods for Biomass Characterization and Conversion is a thorough resource for researchers, students and professors who investigate the use of biomass for fuels, chemicals and products. Advanced analytical chemistry methods and techniques can now provide detailed compositional and chemical measurements of biomass, biomass conversion process streams, intermediates and products. This volume from the Emerging Issues in Analytical Chemistry series brings together the current knowledge on each of these methods, including spectroscopic methods (Fourier Transform Infrared Spectroscopy, Near-infrared Spectroscopy, Solid State Nuclear Magnetic Resonance), pyrolysis (Gas Chromatography/Mass Spectrometry), Liquid Chromatography/High Performance Liquid Chromatography, Liquid Chromatography/Mass Spectrometry, and so on. Authors David C. Dayton and Thomas D. Foust show how these can be used for measuring biomass composition and for determining the composition of intermediates with regard to subsequent processing for biofuels, bio-chemicals and bio-based products. Covers the broad range of techniques and applications that have been developed and perfected in the last decade Highlights specific analyses required for understanding biomass conversion to select intermediates Provides references to seminal books, review articles and technical articles that go into greater depth, serving as a basis for further study

Book Description :

Detection of Drugs and Their Metabolites in Oral Fluid presents the analytical chemistry methods used for the detection and quantification of drugs and their metabolites in human oral fluid. The authors summarize the state of the science, including its strengths, weaknesses, unmet methodological needs, and cutting-edge trends. This volume covers the salient aspects of oral fluid drug testing, including specimen collection and handling, initial testing, point of collection testing (POCT), specimen validity testing (SVT), and confirmatory and proficiency testing. Analytes discussed include amphetamines, cannabinoids, cocaine, opiates, phencyclidine, cannabimimetics, and miscellaneous drugs. This practical guide helps users turn knowledge into practice, moving logically from an outline of the problem, to the evaluation of the appropriateness of oral fluid as a test medium, and finally to a consideration of detection methods and their validation and employment. Compares different collection and testing systems to assist readers involved in clinical or forensic practice in selecting oral fluid as the matrix of choice Provides a sound basis for the detection of drugs and their metabolites in oral fluid and the interpretation of both positive and negative Places the need, or lack thereof, for specimen validity testing and confirmation testing in context with the purposes of oral fluid testing Describes drugs and drug classes that can be tested, along with useful information on a patient/donor’s drug status

Book Description :

Doping, Performance-Enhancing Drugs, and Hormones in Sport: Mechanisms of Action and Methods of Detection examines the biochemistry and bioanalytical aspects of performance-enhancing drugs (PEDs) and other questionable procedures used by athletes to enhance performance. The book informs the specialist of emerging knowledge and techniques and allows the non-specialist to grasp the underlying science and current practice of the discipline. With clear and compelling language appropriate for a broad spectrum of readers, this book provides background on prevalence, types of agents, their actual or supposed benefits, and their negative effects on health. The technical aspects of detection are discussed, followed by a discussion of why detection is a problematic and still-evolving science. To facilitate comprehension, each chapter is organized in a uniform way with six sections: (1) standard medical uses, (2) why the drugs are used by athletes, (3) biological mechanism of action, (4) what research says about efficacy in improving performance, (5) major health side effects from use and abuse in sport, and 6) concluding key points. Presents the scientific concepts of how performance enhancers work, how they are used, and how they are detected and masked from detection Features language that is neither simplistic to scientists nor too sophisticated for a large, diverse global audience Provides a short “close-up” in each chapter to illustrate key topics that engage, entertain, and create a novel synthesis of thought

Book Description :

A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP)—such as metered dose inhalers, dry powder inhalers, and nasal sprays—pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.

Book Description :

A practical and science-based approach for addressingtoxicological concerns related to leachables and extractablesassociated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal DrugProducts (OINDP)—such as metered dose inhalers, dry powderinhalers, and nasal sprays—pose potential safety risks fromleachables and extractables, chemicals that can be released ormigrate from these components into the drug product. Addressing theconcepts, background, historical use, and development of safetythresholds and their utility for qualifying leachables andextractables in OINDP, the Leachables and Extractables Handbooktakes a practical approach to familiarize readers with the recentrecommendations for safety and risk assessment established througha joint effort of scientists from the FDA, academia, and industry.Coverage includes best practices for the chemical evaluation andmanagement of leachables and extractables throughout thepharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify andrisk-assess container closure system leachables and extractables indrug products Principles for defining toxicological safety thresholds that areapplicable to OINDP and potentially applicable to other drugproducts Regulatory perspectives, along with an appendix of key terms anddefinitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulationdevelopment scientists, component suppliers, regulatory affairsspecialists, and toxicologists will all benefit from the wealth ofinformation offered in this important text.

Book Description :

Inhaled medicines are widely used to treat pulmonary and systemic diseases. The efficacy and safety of these medicines can be influenced by the deposited fraction, the regional deposition pattern within the lungs and by post-depositional events such as drug dissolution, absorption and clearance from the lungs. Optimizing performance of treatments thus requires that we understand and are able to quantify these product and drug attributes. Inhaled Medicines: Optimizing Development through Integration of In Silico, In Vitro and In Vivo Approaches explores the current state of the art with respect to inhalation drug delivery, technologies available to assess product performance, and novel in silico methods now available to link in vitro product performance to clinical performance. Recent developments in the latter field, especially the prospect of integration of three-dimensional Computational Fluid Particle Methods (3D-CFPD) with physiologically based pharmacokinetic (PBPK models), unlocks the potential for in silico population studies that can help inform and optimize treatment and product development strategies. In this highly multidisciplinary field, where progress occurs at the intersection of several disciplines of engineering and science, this work aims to integrate current knowledge and understanding and to articulate a clear vision for future developments. ● Considers the healthcare needs driving the field, and where inhaled drugs could have the maximum impact ● Gives a concise account of the state of the art in key areas and technologies such as device and formulation technologies, clinically relevant in vitro performance assessment, medical imaging, as well as in silico modelling and simulation ● Articulates how the combination of in vitro product performance data, medical imaging and simulations technologies in the framework of large scale in silico pre-clinical trials could revolutionize the field ● Provides systematic and thorough referencing to sources offering a more-in-depth analysis of technical issues

Book Description :

This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development. It discusses the applications of experimental designs that shall include oral, topical, transdermal, injectables preparations, and beyond for nanopharmaceutical product development, leading to dedicated case studies on various pharmaceutical experiments through illustrations, art-works, tables and figures. This book is a valuable guide for all academic and industrial researchers, pharmaceutical and biomedical scientists, undergraduate and postgraduate research scholars, pharmacists, biostatisticians, biotechnologists, formulations and process engineers, regulatory affairs and quality assurance personnel.

Book Description :

There has been a rapid evolution in the field of inhalation drug therapy, including new drugs, increased regulation and quality control, and strong pressure from generics. Inhalation Drug Therapy brings together the most current inhalation drug research, as well as practical developments and processes, into one essential guide. Focusing on inhalation products and specific equipment and techniques used in manufacturing and quality control, the book balances research with the industrial aspects of creating the drugs, and features a highly regarded author team with both academic and industry experience.

Book Description :

Perspectives on Bioequivalence Pathways for Drug Product Approval: Across Dosage Form, Route of Administration and Geographical Jurisdictions explains the role of alternative approaches to bioequivalence across various dosage forms, route of administration and regulatory bodies with an ultimate aim of reducing clinical trial and bioequivalence study burden encompassing human volunteers. There is a growing awareness on minimizing the role of human volunteers, especially healthy human volunteers, in drug testing for studying the sameness of a new product with that of existing approved product. This book covers several administration routes and deals with biowaivers for dosage form, routes of administration and geographical jurisdiction. Divided into five sections, including oral drug products, ophthalmic drug products, topical and transdermal drug products, orally inhaled and nasal drug products, and complex injectables, this book includes multiple real-world case studies alongside theory and protocols. Perspectives on Bioequivalence Pathways for Drug Product Approval: Across Dosage Form, Route of Administration and Geographical Jurisdictions focusses on alternative bioequivalence approaches that can be fostered to minimize human testing along with instigating new ideas and opening new avenues for the development of such approaches. It will be useful to pharmaceutical scientists working to produce affordable medicines to all as well as regulatory agencies, pharmaceutical companies, formulation scientists, clinical scientists would get benefited by the book, as it would help in designing the clinical strategy for the product in terms of highlighting the bioequivalence against available marketed product. Covers different administration routes and different jurisdictions in a single source Includes all relevant case studies and requirements/understandings of various global regulatory bodies Deals specifically with biowaivers for dosage form, routes of administration and geographical jurisdiction

Book Description :

This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key “aging” markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.

Book Description :

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.