Supercritical Fluid Technology For Drug Product Development

Interconnecting the fundamentals of supercritical fluid (SCF) technologies, their current and anticipated utility in drug delivery, and process engineering advances from related methodological domains and pharmaceutical applications, this volume unlocks the potential of supercritical fluids to further the development of improved pharmaceutical products-from drug powders for respiratory delivery to drug delivery systems for controlled release.

Supercritical fluid technology can be seen as a green and environmentally friendly alternative to conventional. Current information on these topics is spread through different publications in different peer-reviewed journals. The editors were therefore of

Practical Application of Supercritical Fluid Chromatography for Pharmaceutical Research and Development provides a valuable “go-to reference for many difficult-to-solve challenges using pertinent chromatographic theory, first-hand case studies, and examples provided from academic and industry experts. This text also enables professors teaching an analytical instrumental course to introduce and instruct students about one of the most sustainable and powerful separation methods currently available. While the text has broad applicability across industrial sectors, it focuses primarily on application in the pharmaceutical industry. The book is designed to allow readers to align current HPLC/UHPLC capabilities with SFC as an orthogonal tool for project specific methods in the pharmaceutical industry. It highlights where SFC falls on the spectrum of useful chromatographic tools for routine and challenging separative methods. Experienced HPLC users who are interested in developing knowledge in orthogonal separation techniques, as well as newcomers to the field of separation science, will find this text particularly useful. Chapters address where SFC may fit the analytical needs of the pharmaceutical industry and alert the readers as to where the technique will not fit. Readers will gain an understanding of how and where SFC may be applied and adapted more routinely across the pharmaceutical industry as a ‘green’ way of undertaking separation opportunities and challenges. Areas within the pharmaceutical industry include early drug discovery, process chemistry, and late stage development and manufacturing. Describes approaches to SFC column and mobile phase selection for method development for both analytical and preparative tasks Gives practical examples of how analytical SFC enables the monitoring of synthetic reactions including unstable intermediates, chiral and achiral polar reactants and products across small and large modalities Provides need-focused case studies for pharmaceutical analysts, process chemists, and contract chemistry facilities that can benefit from monitoring or purifying polar intermediates, mutagenic impurities, nitrosamines and other reaction by-products including excipients and metabolites

Supercritical Fluid Technology for Energy and Environmental Applications covers the fundamental principles involved in the preparation and characterization of supercritical fluids (SCFs) used in the energy production and other environmental applications. Energy production from diversified resources — including renewable materials — using clean processes can be accomplished using technologies like SCFs. This book is focused on critical issues scientists and engineers face in applying SCFs to energy production and environmental protection, the innovative solutions they have found, and the challenges they need to overcome. The book also covers the basics of sub- and supercritical fluids, like the thermodynamics of phase and chemical equilibria, mathematical modeling, and process calculations. A supercritical fluid is any substance at a temperature and pressure above its critical point where distinct liquid and gas phases do not exist. At this state the compound demonstrates unique properties, which can be "fine-tuned," making them suitable as organic solvents in a range of industrial and laboratory processes. This volume enables readers to select the most appropriate medium for a specific situation. It helps instructors prepare course material for graduate and postgraduate courses in the area of chemistry, chemical engineering, and environmental engineering. And it helps professional engineers learn supercritical fluid-based technologies and use them in solving the increasingly challenging environmental issues. Relates theory, chemical characteristics, and properties of the particular supercritical fluid to its various applications Covers the fundamentals of supercritical fluids, like thermodynamics of phase and chemical equilibria, mathematical modeling, and process calculations Includes the most recent applications of supercritical fluids, including energy generation, materials synthesis, and environmental protection

Industrial Scale Application of Subcritical and Supercritical Fluids for Design of Products fills the gap between fundamentals and industrial implantation of various high-pressure process technologies. The book covers the design, start-up and maintenance of real industrial plants, also providing readers with insights on their construction and operational essentials. It is ideal for chemical engineers who operate high pressure units and different researchers who create supercritical fluid technology to solve problems surrounding product fractionation, product formulation, synthesis in SCF, and product development using supercritical fluids technologies. There are some books that describe high pressure technologies and research in the area of sub- and supercritical fluids, but this book presents fundamental data on thermodynamics and mass transfer, topics that are absolutely essential for the design of industrial plants. Includes thermodynamic and mass transfer data necessary for industrial plant design Explains the mechanisms of reactions in a supercritical fluid environment Lists numerous industrial processes for the production of many consumers products, like pharmaceuticals, food, etc.

Although supercritial fluid (SCF) technology is now widely used in extraction and purification processes (in the petrochemical, food and pharmaceuticals industries), this book is the first to address the new application of cleaning. The objective is to provide a roadmap for readers who want to know whether SCF technology can meet their own processing and cleaning needs. It is particularly helpful to those striving to balance the requirements for a clean product and a clean environment. The interdisciplinary subject matter will appeal to scientists and engineers in all specialties ranging from materials and polymer sciences to chemistry and physics. It is also useful to those developing new processes for other applications, and references given at the end of each chapter provide links to the wider body of SCF literature. The book is organized with topics progressing from the fundamental nature of the supercritical state, through process conditions and materials interactions, to economic considerations. Practical examples are included to show how the technology has been successfully applied. The first four chapters consider principles governing SCF processing, detailing issues such as solubility, design for cleanability, and the dynamics of particle removal. The next three chapters discuss surfactants and microemulsions, SCF interaction with polymers, and the use of supercritical carbon dioxide (CO2) as a cleaning solvent. The closing chapters focus on more practical considerations such as scaleup, equipment costs, and financial analysis.

Globalization and industrialization involve a number of reactions, products, extractions, and separations that require the use of organic solvents. These solvents are responsible for a number of ecological concerns, including atmospheric and land toxicity. Conventional organic solvents are regarded as volatile organic compounds; some are even limited due to their potential for ozone layer depletion. While supercritical liquids exhibit physical properties that could make them ideal substitutes for these volatile compounds, there is particular interest in the use of carbon dioxide as a solvent of crude material. In particular, carbon dioxide has apparent ‘green’ properties, like its noncombustible nature, the fact that it is generally nonpoisonous, and its relative inertness. Thus, the use of supercritical carbon dioxide can provide practical improvements to the sustainability of industrial products and processes. This book provides in-depth literature in the area of industrial green processes, focusing on the separation, purification, and extraction of compounds utilizing supercritical carbon dioxide as a green solvent.

The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.