Inhaled Medicines

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

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.

Inhaled therapies form the cornerstone for treatment of patients with asthma and COPD. Evolving technology has resulted in availability of a wide range of devices for delivery of inhaled drugs. The four different delivery systems -- pressurized metered-dose inhalers, slow mist inhalers, dry powder inhalers, and nebulizers -- are unique in design and require distinct inhalational instructions for correct use. This book provides current information about inhalation devices, including their advantages and disadvantages, with guidance for optimal techniques of use. The book emphasizes appropriate selection of inhalation devices based on patient and health care professional factors as well as device attributes that allow selection of the right medication in the right inhalation device at the right time for the right patient. Key Features: • Addresses the objective of precision medicine – the right medication in the right inhaler device at the right time. • Inputs by international thought leaders who have published widely on inhaled medications and/or inhaled delivery systems for clinicians, trainees and respiratory therapists. • Discusses the development of audio-based systems and smart inhalers for patient monitoring.

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 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.

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.

The Mechanics of Inhaled Pharmaceutical Aerosols: An Introduction, Second Edition provides a concise, but thorough exposition of fundamental concepts in the field of pharmaceutical aerosols. This revised edition will allow researchers in the field to gain a thorough understanding of the field from first principles, allowing them to understand, design, develop and improve inhaled pharmaceutical aerosol devices and therapies. Chapters consider mechanics and deposition, specifically in the respiratory tract, while others discuss the mechanics associated with the three existing types of pharmaceutical inhalation devices. This text will be very useful for academics and for courses taught at both undergraduate and graduate levels. Because of the interdisciplinary nature of this book, it will also serve a wide audience that includes engineers and scientists involved with inhaled aerosol therapies. Provides a concise, but thorough exposition of fundamental concepts in the field of pharmaceutical aerosols Allows researchers in the field to gain an up-to-date, thorough understanding of the field from first principles Introduces the pharmaceutical aerosols field to the many engineers and scientists entering the area

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