Download or read book Inhaled Pharmaceutical Product Development Perspectives written by Anthony J. Hickey and published by Elsevier. This book was released on 2017-11-23 with total page 110 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Pulmonary Drug Delivery written by Ali Nokhodchi and published by John Wiley & Sons. This book was released on 2015-08-03 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug therapy via inhalation route is at the cutting edge of modern drug delivery research. There has been significant progress on the understanding of drug therapy via inhalation products. However, there are still problems associated with their formulation design, including the interaction between the active pharmaceutical ingredient(s) (APIs), excipients and devices. This book seeks to cover some of the most pertinent issues and challenges of such formulation design associated with industrial production and desirable clinical outcome. The chapter topics have been selected with a view to integrating the factors that require consideration in the selection and design of device and formulation components which impact upon patient usability and clinical effectiveness. The challenges involved with the delivery of macromolecules by inhalation to both adult and pediatric patients are also covered. Written by leading international experts from both academia and industry, the book will help readers (formulation design scientists, researchers and post-graduate and specialized undergraduate students) develop a deep understanding of key aspects of inhalation formulations as well as detail ongoing challenges and advances associated with their development.

Download or read book Inhalation Drug Delivery written by Paolo Colombo and published by John Wiley & Sons. This book was released on 2013-02-11 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Inhaled Medicines written by Stavros Kassinos and published by Academic Press. This book was released on 2021-02-05 with total page 438 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book The Mechanics of Inhaled Pharmaceutical Aerosols written by Warren H. Finlay and published by Elsevier. This book was released on 2001-06-19 with total page 323 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Controlled Pulmonary Drug Delivery written by Hugh D.C. Smyth and published by Springer Science & Business Media. This book was released on 2011-06-24 with total page 560 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Leachables and Extractables Handbook written by Douglas J. Ball and published by John Wiley & Sons. This book was released on 2012-02-08 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Drug Delivery Approaches written by Bret Berner and published by John Wiley & Sons. This book was released on 2021-08-31 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explore this comprehensive discussion of the application of physiologically- and physicochemical-based models to guide drug delivery edited by leading experts in the field Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics delivers a thorough discussion of drug delivery options to achieve target profiles and approaches as defined by physical and pharmacokinetic models. The book offers an overview of drug absorption and physiological models, chapters on oral delivery routes with a focus on both PBPK and multiple dosage form options. It also provides an explanation of the pharmacokinetics of the formulation of drugs delivered by systemic transdermal routes. The distinguished editors have included practical and accessible resources that address the biological and delivery approaches to pulmonary and mucosal delivery of drugs. Emergency care settings are also described, with explorations of the relationship between parenteral infusion profiles and PK/PD. The future of drug delivery is addressed via discussions of virtual experiments to elucidate mechanisms and approaches to drug delivery and personalized medicine. Readers will also benefit from the inclusion of: A thorough introduction to the utility of mathematical models in drug development and delivery An exploration of the techniques and applications of physiologically based models to drug delivery Discussions of oral delivery and pharmacokinetic models and oral site-directed delivery A review of integrated transdermal delivery and pharmacokinetics in development An examination of virtual experiment methods for integrating pharmacokinetic, pharmacodynamic, and drug delivery mechanisms Alternative endpoints to pharmacokinetics for topical delivery Perfect for researchers, industrial scientists, graduate students, and postdoctoral students in the area of pharmaceutical science and engineering, Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics will also earn a place in the libraries of formulators, pharmacokineticists, and clinical pharmacologists.

Download or read book Metered Dose Inhaler Technology written by Tol S. Purewal and published by CRC Press. This book was released on 1997-12-31 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: Metered Dose Inhaler Technology explores the technologies of pressurized metered dose inhalation (MDI) delivery systems and provides practical, easy-to-use guidance to effective product formulation. With contributions from an international panel of authors, the book addresses the global phase-out of chloroflurocarbon chemicals (CFCs), the generation of propellant systems to replace them, and their associated new medications and therapies. Topics include the manufacture of metered dose inhalers, particle size analysis in inhalation therapy, development and testing, pharmcokinetics and metabolism of propellants, toxicology, and more.

Download or read book Pharmaceutical Drug Product Development and Process Optimization written by Sarwar Beg and published by CRC Press. This book was released on 2020-05-01 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Respiratory Drug Delivery 1989 written by Peter R. Byron and published by CRC Press. This book was released on 2018-04-20 with total page 574 pages. Available in PDF, EPUB and Kindle. Book excerpt: The focus of this book is on subjects related to drug delivery to the lung. The text spans topics from aerosol deposition through pharmaceutical chemistry and formulation to the final clinical evaluation of pharmaceutical products. Utilizing a multi-disciplinary approach, the chapters consider toxicology from the point of view of drugs and pharmaceutical excipients used in aerosols.

Download or read book Advances in Pulmonary Drug Delivery written by Philip Chi Lip Kwok and published by CRC Press. This book was released on 2016-12-19 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: The respiratory tract has been used to deliver biologically active chemicals into the human body for centuries. However, the lungs are complex in their anatomy and physiology, which poses challenges to drug delivery. Inhaled formulations are generally more sophisticated than those for oral and parenteral administration. Pulmonary drug development is therefore a highly specialized area because of its many unique issues and challenges. Rapid progress is being made and offers novel solutions to existing treatment problems. Advances in Pulmonary Drug Delivery highlights the latest developments in this field.

Download or read book Handbook of Lung Targeted Drug Delivery Systems written by Yashwant Pathak and published by CRC Press. This book was released on 2021-10-18 with total page 1065 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

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

Download or read book Case Studies in Modern Drug Discovery and Development written by Xianhai Huang and published by John Wiley & Sons. This book was released on 2012-04-19 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn why some drug discovery and development efforts succeed . . . and others fail Written by international experts in drug discovery and development, this book sets forth carefully researched and analyzed case studies of both successful and failed drug discovery and development efforts, enabling medicinal chemists and pharmaceutical scientists to learn from actual examples. Each case study focuses on a particular drug and therapeutic target, guiding readers through the drug discovery and development process, including drug design rationale, structure-activity relationships, pharmacology, drug metabolism, biology, and clinical studies. Case Studies in Modern Drug Discovery and Development begins with an introductory chapter that puts into perspective the underlying issues facing the pharmaceutical industry and provides insight into future research opportunities. Next, there are fourteen detailed case studies, examining: All phases of drug discovery and development from initial idea to commercialization Some of today's most important and life-saving medications Drugs designed for different therapeutic areas such as cardiovascular disease, infection, inflammation, cancer, metabolic syndrome, and allergies Examples of prodrugs and inhaled drugs Reasons why certain drugs failed to advance to market despite major research investments Each chapter ends with a list of references leading to the primary literature. There are also plenty of tables and illustrations to help readers fully understand key concepts, processes, and technologies. Improving the success rate of the drug discovery and development process is paramount to the pharmaceutical industry. With this book as their guide, readers can learn from both successful and unsuccessful efforts in order to apply tested and proven science and technologies that increase the probability of success for new drug discovery and development projects.

Download or read book Fundamentals of Drug Delivery written by Heather A. E. Benson and published by John Wiley & Sons. This book was released on 2021-10-12 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive guide to the current research, major challenges, and future prospects of controlled drug delivery systems Controlled drug delivery has the potential to significantly improve therapeutic outcomes, increase clinical benefits, and enhance the safety of drugs in a wide range of diseases and health conditions. Fundamentals of Drug Delivery provides comprehensive and up-to-date coverage of the essential principles and processes of modern controlled drug delivery systems. Featuring contributions by respected researchers, clinicians, and pharmaceutical industry professionals, this edited volume reviews the latest research in the field and addresses the many issues central to the development of effective, controlled drug delivery. Divided in three parts, the book begins by introducing the concept of drug delivery and discussing both challenges and opportunities within the rapidly evolving field. The second section presents an in-depth critique of the common administration routes for controlled drug delivery, including delivery through skin, the lungs, and via ocular, nasal, and otic routes. The concluding section summarizes the current state of the field and examines specific issues in drug delivery and advanced delivery technologies, such as the use of nanotechnology in dermal drug delivery and advanced drug delivery systems for biologics. This authoritative resource: Covers each main stage of the drug development process, including selecting pharmaceutical candidates and evaluating their physicochemical characteristics Describes the role and application of mathematical modelling and the influence of drug transporters in pharmacokinetics and drug disposition Details the physiology and barriers to drug delivery for each administration route Presents a historical perspective and a look into the possible future of advanced drug delivery systems Explores nanotechnology and cell-mediated drug delivery, including applications for targeted delivery and toxicological and safety issues Includes comprehensive references and links to the primary literature Edited by a team of of internationally-recognized experts, Fundamentals of Drug Delivery is essential reading for researchers, industrial scientists, and advanced students in all areas of drug delivery including pharmaceutics, pharmaceutical sciences, biomedical engineering, polymer and materials science, and chemical and biochemical engineering.

Download or read book Excipient Development for Pharmaceutical Biotechnology and Drug Delivery Systems written by Ashok Katdare and published by CRC Press. This book was released on 2006-07-28 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.