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

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.

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.

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

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.

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.

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.