Continuous pharmaceutical manufacturing is currently receiving much interest from industry and regulatory authorities, with the joint aim of allowing rapid access of novel therapeutics and existing medications to the public, without compromising high quality. Research groups from different academic institutions have significantly contributed to this field with an immense amount of published research addressing a variety of topics related to continuous processing. The book is structured to have individual chapters on the different continuous unit operations involved in drug substance and drug product manufacturing. A wide spectrum of topics are covered, including basic principles of continuous manufacturing, applications of continuous flow chemistry in drug synthesis, continuous crystallization, continuous drying, feeders and blenders, roll compaction and continuous wet granulation.The underlying theme for each of these chapters is to present to the reader the recent advances in modeling, experimental investigations and equipment design as they pertain to each individual unit operation. The book also includes chapters on quality by design (QbD) and process analytical technology (PAT) for continuous processing, process control strategies including new concepts of quality-by-control (QbC), real-time process management and plant optimization, business and supply chain considerations related to continuous manufacturing as well as safety guidelines related to continuous chemistry. A separate chapter is dedicated to discussing regulatory aspects of continuous manufacturing, with description of current regulatory environment quality/GMP aspects, as well as regulatory gaps and challenges. Our aim from publishing this book is to make it a valuable reference for readers interested in this topic, with a desire to gain a fundamental understanding of engineering principles and mechanistic studies utilized in understanding and developing continuous processes. In addition, our advanced readers and practitioners in this field will find that the technical content of Continuous Pharmaceutical Processing is at the forefront of recent technological advances, with coverage of future prospects and challenges for this technology.

The book presents a comprehensive and up-to-date overview of phytochemicals as efficient cancer therapeutics. Over the last few decades there has been a paradigm shift from conventional cancer therapeutic approaches to alternative and complementary medicinal approaches especially using phytoconstituents from natural products. As such, the book provides an in-depth understanding of phytochemicals targeting diverse signaling pathways involved in cancer along with the evaluation of the cancer modulatory effects of phytochemicals. It also highlights the potential modulatory effect of single nucleotide polymorphisms (SNPs) on the cancer-associated cellular pathways and their interactions with the phytochemicals. Further, it analyzes the drug delivery methods, bioavailability of active components of botanicals, and toxicity of phytochemicals. Lastly, the book elucidates the 3D cell culture and animal models systems to analyze the beneficial effects of phytochemicals in cancer.

Many newly proposed drugs suffer from poor water solubility, thus presenting major hurdles in the design of suitable formulations for administration to patients. Consequently, the development oftechniques and materials to overcome these hurdles is a major area of research in pharmaceutical companies.

Drug Delivery Strategies for Poorly Water-Soluble Drugs provides a comprehensive overview of currently used formulation strategies for hydrophobic drugs, including liposome formulation, cyclodextrin drug carriers, solid lipid nanoparticles, polymeric drug encapsulation delivery systems, self-microemulsifying drug delivery systems, nanocrystals, hydrosol colloidal dispersions, microemulsions, solid dispersions, cosolvent use, dendrimers, polymer- drug conjugates, polymeric micelles, and mesoporous silica nanoparticles. For each approach the book discusses the main instrumentation, operation principles and theoretical background, with a focus on criticalformulation features and clinical studies. Finally, the book includes some recent and novel applications, scale-up considerations and regulatory issues.

Drug Delivery Strategies for Poorly Water-Soluble Drugs is an essential multidisciplinary guide to this important area of drug formulation for researchers in industry and academia working in drugdelivery, polymers and biomaterials.

This edited book comprises of eight chapters dealing on various aspects of pharmaceutical technology for delivery of natural products. Book chapters deal with the solubility and bioavailability enhancement technologies for natural products. Emphasis has also been given on the significance of delivery strategies for improving the therapeutic efficacy of paclitaxel, galantamine and tea constituents.

Nanotechnology has revolutionized the approach to designing and developing novel drug delivery systems. The last two decades have seen a great interest in the use of nanotechnology to offer efficient ways of delivering new and existing drugs and macromolecules. The focus of this book is the application of nanotechnology to deliver drugs and biological agents by the mucosal routes of administration i.e. nasal, pulmonary, buccal, and oral routes. It provides an overview of nanotechnology in drug delivery with a description of different types of nanoparticles, methods of preparation and characterization, and functionalization for site-specific drug delivery. The emphasis is on the use of nanoparticles in treating various cancers and infectious diseases. It broadens the use of nanoparticles by including biologics, including vaccines and immunotherapies, apart from drugs and acknowledges the concerns around the potential toxicity of nanoparticles to the host; several chapters will discuss the biodistribution of these nanoparticles when mucosal routes of administration are employed. Further, the interaction of nanoparticles with the host's immune cells is discussed. Moreover, it reviews the regulatory aspects of nanotechnology in product development, especially when delivered by the mucosal route of administration. Lastly, discusses the challenges and opportunities to manufacture nanoparticles on an industrial scale. This book is the first of its kind to focus on the design, development and delivery of nanoparticles when administered by different mucosal routes.

This book offers an authoritative review of biopharmaceuticals and their clinical relevance. Biopharmaceuticals have been showing high therapeutic potential by means of biological and biosimilar medicines, particularly for the treatment of cancer, chronic diseases (e.g. diabetes, Crohn's disease, psoriasis and rheumatoid arthritis), neurodegenerative disorders (e.g. multiple sclerosis), and they have also been contributing to the progress of innovative therapies such as assisted reproductive medicine. Since the eighties, several biopharmaceuticals have been approved and, due to patents expiration, many biosimilars are also marketed. In this book, readers will find the most relevant updated information about the main clinical applications of pharmaceutical biotechnology. The authors provide expert analysis about the industrial challenges of recombinant proteins and the different classes of biopharmaceuticals, including monoclonal antibodies, vaccines, growth factors and stem cells. Topics such as bioprinting technologies in tissue engineering, gene therapy and personalized medicine are also covered in this book. Professionals, students and researchers interested in this field will find this work an important account.

This book explores the possible development of neurokinin-3 receptor (NK3R) antagonists with reduced environmental impact. Pharmaceuticals are used to cure diseases and to alleviate symptoms in humans and animals. However, the stable, bioactive substances excreted by patients have unfavorable effects on non-target species. To overcome these disadvantages of these highly stable, potent substances, drug design to turn off bioactivity after release into the environment is needed. The book describes the development of eco-friendly NK3R antagonists by introducing a labile functional moiety and substituting a scaffold. This resulted in a novel NK3R antagonist that oxidized into its inactive form when exposed to air. Further, the book presents an efficient and easily achievable synthetic method of creating triazolopiperazine scaffolds, as well as a structure-activity relationship study involving scaffold hopping for decomposable motifs, which led to a novel photodegradable NK3R antagonist. Demonstrating that it is possible to develop compounds that convert into their inactive forms under environmental conditions, this book is useful for anyone interested in therapeutic agents with reduced environmental impact.

Membrane processes are increasingly used in pharmaceutical and biochemical engineering and biotechnology for concentration and purification, synthesis of molecules and drug delivery systems, and support for biochemical reactions. This book provides a state-of-the art overview of the classical membrane processes used in pharmaceutical and biochemical engineering and biotechnology, such as ultrafiltration, microfiltration, virus filtration, membrane chromatography, membrane emulsification, liquid membranes and membrane bioreactors. It describes the general rules (principles, choice of configurations, membranes, parameters, etc.), recent developments (fouling control, increase permeate flux and selectivity, etc.), applications, and theoretical descriptions. Further, it presents emerging processes such as solvent resistant nanofiltration and membrane crystallization.
Presents classical membrane processes such as ultrafiltration, microfiltration, virus filtration, membrane chromatography, membrane emulsification, liquid membranes and membrane bioreactorsPresents emerging processes such as solvent resistant nanofiltration and membrane crystallizationGives a complete description of each technique (principles, membrane materials and devices, fouling control, and theoretical description)Contains numerous examples of applicationsIncludes a uniformnotation throughout the book enhancing the presentation and understanding of the contentIncludes extensive list of references"

This book presents the state of the art in glycoscience and proposes a road map for the coming decade, focusing on the potential of glycoscience research to shed light on important basic science issues and give rise to exciting new applications, especially in the field of diagnosis and therapeutics. Individual sections offer in-depth coverage of various topics relating to glycans and biopharmaceuticals, glycans in medical science and medicine, glycan technologies, glycans in food and nutrients, and glycan-related materials and their uses. In addition, the book presents an exemplary training course on glycomics and highlights educational and analytical web resources, and also includes glossaries and boxes summarizing key facts to ensure ease of understanding for non-expert readers and students. Written by more than 150 active participants in the Japan Consortium for Glycobiology and Glycotechnology (JCGG), whose goal is to promote the development of interdisciplinary glycoscience and establish a global network in the field, it is a valuable resource for students, postdocs, and researchers in the life sciences as well as for stakeholders and professionals in government, funding agencies and industry.

"Pharmacology for Chemists, Second Edition" is aimed at industrial and academic organic chemists holding advanced degrees who are entering the field of medicinal chemistry, and who have had little or no education in or exposure to the biological sciences, especially physiology and pharmacology. The first portion of this book concentrates on biological/pharmacological principles and concepts, and the second portion demonstrates how these concepts and principles are applicable to the medicinal chemists efforts, by describing some selected categories of drugs as examples. The book is not intended to be a textbook of pharmacology, but rather is intended to serve as a tool to prepare the reader for further study and more in depth reading.

The second edition defines the tools used in QA/QC, especially the application of statistical tools during analytical data treatment. Clearly written and logically organized, it takes a generic approach applicable to any field of analysis. The authors begin with the theory behind quality control systems, then detail validation parameter measurements, the use of statistical tests, counting the margin of error, uncertainty estimation, traceability, reference materials, proficiency tests, and method validation. New chapters cover internal quality control and equivalence method, changes in the regulatory environment are reflected throughout, and many new examples have been added to the second edition.

Describing recent developments in the engineering and generation of plants as production platforms for biopharmaceuticals, this book includes both vaccines and monoclonal antibodies. It has a particular emphasis on targeting diseases which predominate in less developed countries, encompassing the current state of technologies and describing expression systems and applications. This book also includes a variety of vaccine case studies, protecting against pervasive infectious diseases such as rabies, influenza and HIV.

The book provides a reference for years to come, written by world-renowned expert investigators studying sex differences, the role of sex hormones, the systems biology of sex, and the genetic contribution of sex chromosomes to metabolic homeostasis and diseases. In this volume, leaders of the pharmaceutical industry present their views on sex-specific drug discovery. Many of the authors presented at the Keystone Symposium on "Sex and gender factors affecting metabolic homeostasis, diabetes and obesity" to be held in March 2017 in Lake Tahoe, CA. This book will generate new knowledge and ideas on the importance of gender biology and medicine from a molecular standpoint to the population level and to provide the methods to study them. It is intended to be a catalyst leading to gender-specific treatments of metabolic diseases. There are fundamental aspects of metabolic homeostasis that are regulated differently in males and females, and influence both the development of diabetes and obesity and the response to pharmacological intervention. Still, most preclinical researchers avoid studying female rodents due to the added complexity of research plans. The consequence is a generation of data that risks being relevant to only half of the population. This is a timely moment to publish a book on sex differences in diseases as NIH leadership has asked scientists to consider sex as a biological variable in preclinical research, to ensure that women get the same benefit of medical research as men.

This book examines stealth liposomes from a multidisciplinary approach, which includes theoretical polymer physics, organic synthesis, colloid science, and biology. Discussions include theory, chemistry, biochemistry, pharmacology, preclinical studies in model systems, and medical applications in humans.

This book explores the use of various plant polysaccharides for pharmaceutical purposes, including drug delivery. It examines the exploitation of plant polysaccharides' auxiliary functions to enhance drug release, stability, bioavailability and target specificity. Plant-derived materials are at the center of drug-delivery research thanks to their non-toxicity, biodegradability, ready availability, eco-friendliness and low extraction costs. These materials include polysaccharides, a class of naturally occurring polymers consisting of glucose monomers, which serve as storage carbohydrates in cereals, root vegetables, rhizomes, seeds, fruits, etc.

A comprehensive overview of the current research on inflammation and immunopharmacology, with particular attention to the use of anti-inflammatory drugs, this book discusses future trends in this area of pharmacological research. It addresses an audience with basic knowledge in the inflammatory process, immune system and pharmacology. The book meets the needs of graduate students, junior and senior researchers and is useful as a source of the most current information for those already working in these fields.

This brief explores recent progress in the area of polysaccharides and their composites and nanocomposites. It is a complete resource for the evolving field of polysaccharide based biomaterials and their applications in different fields. The volume focuses on their composition, properties, characterization, chemistry and applications and also highlights recent developments in polysaccharide based composites and nanocomposites spurred by advances in polymer technology and biotechnology. Divided into different sections featuring alginates, carrageenans, cellulose, starch, chitin, chitosan, gums, etc, each chapter presents chemical, physical, and biological attributes, and reviews the recent research performed such as drug carriers, selective water absorption materials from oil-water emulsions, purification of water, biomedical applications, etc. The authors hope that this brief will help to inspire scientists towards novel sources for chemicals, materials, and energy in the years to come.

Written in four parts, this book provides a dedicated and in-depth reference for blending within the pharmaceutical manufacturing industry. It links the science of blending with regulatory requirements associated with pharmaceutical manufacture. The contributors are a combination of leading academic and industrial experts, who provide an informed and industrially relevant perspective of the topic. This is an essential book for the pharmaceutical manufacturing industry, and related academic researchers in pharmaceutical science and chemical and mechanical engineering.

This book addresses a range of synthesis and characterization techniques that are critical for tailoring and broadening the various aspects of polymer gels, as well as the numerous advantages that polymer gel-based materials offer. It presents a comprehensive collection of chapters on the recent advances and developments in the science and fundamentals of both synthetic and natural polymer-based gels. Topics covered include: synthesis and structure of physically/chemically cross-linked polymer-gels/polymeric nanogels; gel formation through non-covalent cross-linking; molecular design and characterization; polysaccharide-based polymer gels: synthesis, characterization, and properties; modified polysaccharide gels: silica-based polymeric gels as platforms for the delivery of pharmaceuticals; gel-based approaches in genomic and proteomic sciences; emulgels in drug delivery; and organogels. The book provides a cutting-edge resource for researchers and scientists working in various fields involving polymers, biomaterials, bio-nanotechnology and functional materials.

Early anthropological evidence for plant use as medicine is 60,000 years old as reported from the Neanderthal grave in Iraq. The importance of plants as medicine is further supported by archeological evidence from Asia and the Middle East. Today, around 1.4 billion people in South Asia alone have no access to modern health care, and rely instead on traditional medicine to alleviate various symptoms. On a global basis, approximately 50 to 80 thousand plant species are used either natively or as pharmaceutical derivatives for life-threatening conditions that include diabetes, hypertension and cancers. As the demand for plant-based medicine rises, there is an unmet need to investigate the quality, safety and efficacy of these herbals by the "scientific methods". Current research on drug discovery from medicinal plants involves a multifaceted approach combining botanical, phytochemical, analytical, and molecular techniques. For instance, high throughput robotic screens have been developed by industry; it is now possible to carry out 50,000 tests per day in the search for compounds, which act on a key enzyme or a subset of receptors. This and other bioassays thus offer hope that one may eventually identify compounds for treating a variety of diseases or conditions. However, drug development from natural products is not without its problems. Frequent challenges encountered include the procurement of raw materials, the selection and implementation of appropriate high-throughput bioassays, and the scaling-up of preparative procedures. Research scientists should therefore arm themselves with the right tools and knowledge in order to harness the vast potentials of plant-based therapeutics. The main objective of Plant and Human Health is to serve as a comprehensive guide for this endeavor. Volume 1 highlights how humans from specific areas or cultures use indigenous plants. Despite technological developments, herbal drugs still occupy a preferential place in a majority of the population in the third world and have slowly taken roots as alternative medicine in the West. The integration of modern science with traditional uses of herbal drugs is important for our understanding of this ethnobotanical relationship. Volume 2 deals with the phytochemical and molecular characterization of herbal medicine. Specifically, it focuess on the secondary metabolic compounds, which afford protection against diseases. Lastly, Volume 3 discusses the physiological mechanisms by which the active ingredients of medicinal plants serve to improve human health. Together this three-volume collection intends to bridge the gap for herbalists, traditional and modern medical practitioners, and students and researchers in botany and horticulture.

This timely volume explores the impact of autophagy in various human diseases, emphasizing the cell biological aspects and focusing on therapeutic approaches to these diseases. The chapters cover autophagy and its potential applications on diseases ranging from obesity, osteoarthritis, pulmonary fibrosis, and inflammation, through ALS, Parkinson's, retinal degeneration, breast cancer, alcoholic liver disease and more. The final chapters round out the book with a discussion of autophagy in drug discovery and 'bench to bedside'. Chapters are contributed by leading authorities and describe the general concepts of autophagy in health and disease, marrying cell biology and pharmacology and covering: studies derived from preclinical experiments, manufacturing considerations,and regulatory requirements pertaining to drug discovery and manufacturing and production. This volume will be useful for basic scientists as well as already practicing clinicians and advanced graduate students.

This book comprehensively reviews the state-of-the-art strategies developed for protein-protein interaction (PPI) inhibitors, and highlights the success stories in new drug discovery and development. Consisting of two parts with twelve chapters, it demonstrates the design strategies and case studies of small molecule PPI inhibitors. The first part discusses various discovery strategies for small molecule PPI inhibitors, such as high throughput screening, hot spot-based design, computational approaches, and fragment-based design. The second part presents recent advances in small molecule inhibitors, focusing on clinical candidates and new PPI targets. This book has broad appeal and is of significant interest to the pharmaceutical science and medicinal chemistry communities.

This book is the first to be entirely devoted to the challenging art of handling membrane proteins out of their natural environment, a key process in biological and pharmaceutical research, but one plagued with difficulties and pitfalls. Written by one of the foremost experts in the field, Membrane Proteins in Aqueous Solutions is accessible to any member of a membrane biology laboratory. After presenting the structure, functions, dynamics, synthesis, natural environment and lipid interactions of membrane proteins, the author discusses the principles of extracting them with detergents, the mechanisms of detergent-induced destabilization, countermeasures, and recent progress in developing detergents with weaker denaturing properties. Non-conventional alternatives to detergents, including bicelles, nanodiscs, amphipathic peptides, fluorinated surfactants and amphipols, are described, and their relative advantages and drawbacks are compared. The synthesis and solution properties of the various types of amphipols are presented, as well as the formation and properties of membrane protein/amphipol complexes and the transfer of amphipol-trapped proteins to detergents, nanodiscs, lipidic mesophases, or living cells. The final chapters of the book deal with applications: membrane protein in vitro folding and cell-free expression, solution studies, NMR, crystallography, electron microscopy, mass spectrometry, amphipol-mediated immobilization of membrane proteins, and biomedical applications. Important features of the book include introductory sections describing foundations as well as the state-of-the-art for each of the biophysical techniques discussed, and topical tables which organize a widely dispersed literature. Boxes and annexes throughout the book explain technical aspects, and twelve detailed experimental protocols, ranging from in vitro folding of membrane proteins to single-particle electron cryomicroscopy, have been contributed by and commented on by experienced users. Membrane Proteins in Aqueous Solutions offers a concise, accessible introduction to membrane protein biochemistry and biophysics, as well as comprehensive coverage of the properties and uses of conventional and non-conventional surfactants. It will be useful both in basic and applied research laboratories and as a teaching aid for students, instructors, researchers, and professionals within the field.