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

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

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, 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

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.

Given their direct impact on the health and quality of life for millions, inhalers represent a major turning point in the history of modern medicine. Inhaler devices: Fundamentals, design and drug delivery provides readers with an introduction to the fundamentals of inhaler technology, with a comprehensive discussion of the history of inhalers as well as a discussion on current research and development. Part one discusses the fundamentals and development of inhaler devices as well as drug formulations for inhalers. The treatment of asthma is also discussed. Part two reviews recent developments in drug formulation and nanotechnology for inhaler devices, emerging inhaler technology and possible future trends. Inhaler devices: Fundamentals, design and drug delivery is an essential design guide for good industrial practice, and will be an invaluable resource for those researching and treating conditions such as asthma; and those developing and manufacturing inhalation devices. Introduces the fundamentals of inhaler technology Discusses the history of inhalers as well as current research and development as well as possible future trends Considers the development of inhaler devices, drug formulations and discusses the treatment of asthma

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.

Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety, and stability of the final medicinal product. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field. Following on from Pharmaceutical Formulation, which covered traditional dosage forms such as tablets and capsules, this volume expands upon those formulations to cover a more diverse range of less common dosage forms. Novel routes of administration are covered from inhalational, dermal and transdermal formulations to ocular, oral suspensions, vaccines and nanoparticle drug delivery. The methods through which these formulations are processed and manufactured is also covered, providing essential knowledge to ensure quality, efficiency, and acceptable costing. Specialised Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry and will equip readers with the ability to effectively and reliably produce products which can be approved, manufactured and made available to administer to patients.

Millions of Americans use e-cigarettes. Despite their popularity, little is known about their health effects. Some suggest that e-cigarettes likely confer lower risk compared to combustible tobacco cigarettes, because they do not expose users to toxicants produced through combustion. Proponents of e-cigarette use also tout the potential benefits of e-cigarettes as devices that could help combustible tobacco cigarette smokers to quit and thereby reduce tobacco-related health risks. Others are concerned about the exposure to potentially toxic substances contained in e-cigarette emissions, especially in individuals who have never used tobacco products such as youth and young adults. Given their relatively recent introduction, there has been little time for a scientific body of evidence to develop on the health effects of e-cigarettes. Public Health Consequences of E-Cigarettes reviews and critically assesses the state of the emerging evidence about e-cigarettes and health. This report makes recommendations for the improvement of this research and highlights gaps that are a priority for future research.

Some people suffer from chronic, debilitating disorders for which no conventional treatment brings relief. Can marijuana ease their symptoms? Would it be breaking the law to turn to marijuana as a medication? There are few sources of objective, scientifically sound advice for people in this situation. Most books about marijuana and medicine attempt to promote the views of advocates or opponents. To fill the gap between these extremes, authors Alison Mack and Janet Joy have extracted critical findings from a recent Institute of Medicine study on this important issue, interpreting them for a general audience. Marijuana As Medicine? provides patients--as well as the people who care for them--with a foundation for making decisions about their own health care. This empowering volume examines several key points, including: Whether marijuana can relieve a variety of symptoms, including pain, muscle spasticity, nausea, and appetite loss. The dangers of smoking marijuana, as well as the effects of its active chemical components on the immune system and on psychological health. The potential use of marijuana-based medications on symptoms of AIDS, cancer, multiple sclerosis, and several other specific disorders, in comparison with existing treatments. Marijuana As Medicine? introduces readers to the active compounds in marijuana. These include the principal ingredient in Marinol, a legal medication. The authors also discuss the prospects for developing other drugs derived from marijuana's active ingredients. In addition to providing an up-to-date review of the science behind the medical marijuana debate, Mack and Joy also answer common questions about the legal status of marijuana, explaining the conflict between state and federal law regarding its medical use. Intended primarily as an aid to patients and caregivers, this book objectively presents critical information so that it can be used to make responsible health care decisions. Marijuana As Medicine? will also be a valuable resource for policymakers, health care providers, patient counselors, medical faculty and students--in short, anyone who wants to learn more about this important issue.

This guideline defines ventilation and then natural ventilation. It explores the design requirements for natural ventilation in the context of infection control, describing the basic principles of design, construction, operation and maintenance for an effective natural ventilation system to control infection in health-care settings.

Critical care medicine is an evolving speciality in which the amount of available information is growing daily and spread across a myriad of books, journals and websites. This essential guide brings together this information in an easy-to-use format. Up-to-date, relevant, and evidence-based information on the management of the critically ill is combined in one resource, ideal for the use of Intensive Care Units, High Dependency Units, acute medical or surgical wards, Accident and Emergency departments and operating theatres. The book is designed such that each subject will form a self-contained topic in its own right, laid out across two or four pages to facilitate the key aim of rapid and easy access to information. This makes the information included simple to find, read and absorb, so that the book can be consulted in the clinic or ward setting for information on the optimum management of a particular condition. With chapters written by internationally renowned critical care specialists and edited by the three of the leading figures in UK Critical Care, this book should be an essential resource for all critical care physicians.

This book provides a practical, stepwise, evidence-based approach to effective management of patients with difficult to treat asthma. The impact of asthma on morbidity and healthcare utilization increases exponentially with severity. Severe refractory asthma accounts for less than 5% of all asthma. Its prevalence, however, is often overestimated as there are several other confounding factors that make asthma ‘difficult to treat’. Many novel (albeit expensive) therapies are now available and providers caring for patients with severe asthma are charged with selecting the best evidence treatment. This calls for complex and nuanced decision-making. Whether people with asthma gain and maintain control over their condition depends not only on the availability of effective drugs, but also multiple patient and healthcare provider behaviors. Therefore, now more than ever, it has become increasingly important to differentiate “difficult” from “severe refractory” asthma to allow identification of patients most likely to benefit from these therapies. This volume delves into the current understanding of mechanisms and increasingly recognized heterogeneity of this complex disease. It discusses a structured approach to identification and optimization of factors contributing to poor asthma control, including nonadherence, comorbidities and occupational/environmental triggers. The book includes ‘state of the art’ reviews on recent advances in traditional and targeted asthma therapies, as well as a glimpse into what the future may hold. Highlights include a comprehensive guide to management of severe asthma in children and pregnancy, as well as practical considerations to management of asthma based on different clinical phenotypes. Each chapter is authored by leading experts in the field who share their own clinical approach. This is an ideal guide for clinical pulmonologists and allergist/immunologists, as well as primary care providers, physician extenders in specialty practice, physicians in pulmonary/allergy training, and even industry partners.

With the improvements in formulation science and certain transdermal delivery technologies, the non-invasive mode of drug delivery is now ready to compete with traditional methods of oral and injectible routes of drug delivery. The Handbook of Non-Invasive Drug Delivery Systems encompasses the broad field of non-invasive drug delivery systems that include drug delivery via topical, transdermal-passive, transdermal-active (device- aided enhanced penetration), trans-mucosal membrane, trans-ocular membrane as well as delivery via alveolar membrane from inhaled medication. Patient compliance has been found to be much higher when administrated by non-invasive routes and therefore they are considered to be a preferred mode of drug delivery. The book includes both science and technological aspects of new drug delivery systems. Its unique focus is that it is on new drug delivery systems that are considered to be "non-invasive". Other unique features include a chapter on Regulatory Aspects of non-invasive systems and one on FDA guidance for topical nano-drug delivery. Two chapters covering market trends and perspectives, as well as providing guidance to those marketing such systems are also included.