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What are lipid nanoparticles? How are they structured? How are they formed? What techniques are best to characterize them? How great is their potential as drug delivery systems? These questions and more are answered in this comprehensive and highly readable work on lipid nanoparticles. This work sets out to provide the reader with a clear and understandable understanding of the current practices in formulation, characterization and drug delivery of lipid nanoparticles. A comprehensive description of the current understanding of synthesis, characterization, stability optimization and drug incorporation of solid lipid nanoparticles is provided. Nanoparticles have attracted great interest over the past few decades with almost exponential growth in their research and application. Their small particle size and subsequent high surface area make them ideal in many uses, but particularly as drug carrier systems. Nanoparticles made from lipids are especially attractive because of their enhanced biocompatibility imparted by the lipid. The work provides a detailed description of the types of lipid nanoparticles available (e.g. SLN, NLC, LDC, PLN) and how they range from imperfect crystalline to amorphous in structure. Current thoughts on where drugs are situated (e.g. in the core, or at the interface) and how this can be manipulated are discussed. The many techniques for production, including the author's own variant of microwave heating, are fully discussed. Techniques for measuring arguably the most important characteristics of particle size and polydispersity are discussed, along with techniques to measure crystallinity, shape and drug capacity. Finally, a full chapter on techniques for measuring stability, both in the absence and presence of drugs, is discussed, along with suggestions on how to optimize that stability. This work appeals to students of colloid science, practitioners of research into drug delivery and academics alike.
This book is a structured approach to designing a product and its associated manufacturing process. It shows pharmaceutical engineers and scientists involved in product and process development how to utilize QbD practices and applications effectively while complying with government regulations. Material includes discussion of how to utilize design space, models, process control methodology, and cumulative process knowledge to seek improvements in manufacturing, while maintaining and enhancing product performance. Edited by three renowned researchers in the field, this invaluable resource is an essential tool for all pharmaceutical professionals.
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.
In this practice-oriented two volume handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and drug developers of all trades. Following an introduction tracing the rapid development of the protein therapeutics market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then goes on to review other key aspects such as pharmacokinetics, safety and immunogenicity, manufacture, formulation and delivery. The handbook then takes a look at current key clinical applications for protein therapeutics, from respiratory and inflammation to oncology and immune-oncology, infectious diseases and rescue therapy. Finally, several exciting prospects for the future of protein therapeutics are highlighted and discussed.
In his thesis, Kiyoun Lee describes his studies into tandem and organocatalytic oxa-conjugate addition reactions for the synthesis of complex tetrahydropyrans (THP). Readers gain insight into the new methods Lee employs for the synthesis of biologically interesting natural products including (+)-leucascandrolide A, (+)-dactylolide, and (+/-)diospongin A. The reactions Lee investigates are applicable to a broad range of substrates and proceed with excellent stereoselectivity. Moreover, the methodologies allow the synthesis of a wide range of THP-containing compounds. The development of reactions, such as those discussed by Lee, has the potential to impact natural product synthesis, pharmaceutical development and chemical biology.
What are the physical and chemical properties that determine how a drug interacts with the body? What determines which dosage form is best, if it will reach its intended target, and how it will be metabolised once it has entered the body? The Physicochemical Basis of Pharmaceuticals explores the phenomena which affect the formulation and bio-availability of drug substances to give a straightforward, accessible treatment of the essential concepts affecting the absorption and distribution of drugs. It provides the reader with the conceptual 'tool-kit' necessary to understand the physicochemical aspects of drug design and action, and shows how these concepts apply in practice. The book introduces key underlying physical chemistry principles before exploring pharmaceutical solutions, the pharmaceutical solid phase, solid - liquid dispersal systems, biological interfaces, absorption, distribution, metabolism and excretion, to give a complete view of the field. Focusing at all times on the essential principles and concepts, The Physicochemical Basis of Pharmaceuticals avoids excessive detail, presenting the key facts, backed up with pertinent examples and easy-to-digest illustrations, making it the ideal primer for those who need to understand physicochemical issues in the context of their broader field of study. Online Resource Centre For registered adopters of the text: * Figures from the book in electronic format, ready to download For students: * A hyperlinked bibliography of references given in the text.
This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)
Written as an introductory pharmacology text, Basic Pharmacology: Understanding Drug Actions and Reactions provides the in-depth discussion of the chemical and molecular pharmacology fundamentals that pharmacy students require to move on to more advanced study. The book covers the principles of chemistry and biology necessary to understand drug action at the cellular level. It emphasizes the chemical and physical properties of drugs, drug absorption and distribution, drug interactions with cellular receptors, and drug metabolism and interactions. The book effectively explains chemical and molecular pharmacology principles with extensive use of model drug molecules.
This book provides professionals in the pharmaceutical industries a basic understanding of the key elements of pharmaceutical and biotech manufacturing and design. The emphasis is to prepare or reinforce skills required for personnel to knowledgeably deal with projects and programs often performed by consulting firms, engineering firms, and/or consultants. It provides important information on pharmaceutical operation issues required for meeting regulatory guidelines, plant support design, and project engineering specifics, as well as HVAC systems, water systems, electric systems, and quality assurance. Individuals employed by pharmaceutical, bio-tech, engineering firms, and consulting firms will need this resource.
With the prospect of revolutionizing specific technologies, this book highlights the most exciting and impactful current research in the fields of cellulose-based superabsorbent hydrogels with their smart applications. The book assembles the newest synthetic routes, characterization methods, and applications in the emergent area. Leading experts in the field have contributed chapters representative of their most recent research results, shedding light on the enormous potential of this field and thoroughly presenting cellulose-based hydrogel functioning materials. The book is intended for the polymer chemists, academic and industrial scientists and engineers, pharmaceutical and biomedical scientists and agricultural engineers engaged in research and development on absorbency, absorbent products and superabsorbent hydrogels. It can also be supportive for undergraduate and graduate students.
The first review describes examples of very promising compounds discovered from plants acquired from Africa, Southeast Asia, the Americas, and the Caribbean region with potential anticancer activity. These include plant secondary metabolites of the diphyllin lignan, penta[b]benzofuran, triterpenoid, and tropane alkaloid types. The second review presents 40 more erythrinan alkaloids, which were either new or were missed out in the last major reviews, bringing to a total of 154 known erythrinan alkaloids known to date. The reported pharmacological activities of the new and known alkaloids showed a greater bias towards central nervous system and related activities. Other prominent activities reported were antifeedant or insecticidal, cytotoxicity/anti-tumor/anti-cancer/estrogenic, antiprotozoal, antiinflammatory, antioxidant, antifungal and antiviral activities.
This edited volume presents current research in biostatistics with emphasis on biopharmaceutical applications. Featuring contributions presented at the 2017 ICSA Applied Statistics Symposium held in Chicago, IL on June 25 to 28, 2017, this book explores timely topics that have a high potential impact on statistical methodology and future research in biostatistics and biopharmaceuticals. The theme of this conference was Statistics for a New Generation: Challenges and Opportunities, in recognition of the advent of a new generation of statisticians. The conference attracted statisticians working in academia, government, and industry; domestic and international statisticians. From the conference, the editors selected 28 high-quality presentations and invited the speakers to prepare full chapters for this book. These contributions are divided into four parts: Part I Biostatistical Methodology, Part II Statistical Genetics and Bioinformatics, Part III Regulatory Statistics, and Part IV Biopharmaceutical Research and Applications.Featuring contributions on topics such as statistics in genetics, bioinformatics, biostatistical methodology, and statistical computing, this book is beneficial to researchers, academics, practitioners and policy makers in biostatistics and biopharmaceuticals.
Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Vaccine Manufacturing and Production will serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in facility designs and supply issues. This book will provide insight to the issues scientists face when producing a vaccine, the steps that are involved, and will serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facility set-up. Highlights include: * Comprehensive coverage of vaccine production : from a process point of view- fermentation to purification to formulation developments; from a production point of view - from facility design to manufacturing; and from a regulatory point of view - requirements from government agencies * Authors from different major pharmaceutical and biotechnology companies * Describes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market
Drug resistance is a fundamental factor in treatment failure in diseases like leishmaniasis, although additional factors also play a role in this phenomenon. This volume is the second edition of a well-received book that provides a comprehensive update on the pathology of the disease, as well as on the concept of parasitic drug resistance, its molecular basis, consequences and possible treatments. A valuable resource for scientists both from academia and industry involved in biomedical research and drug design, the book provides the knowledge needed to understand leishmaniasis and to contibute to combatting this disease worldwide.
* An important reference which provides an overview of the current and recently introduced methodologies for testing the immunotoxic risks in drug candidates* Helps readers understand the significance of the methods and approaches to immunotoxicology testing* Aids drug scientists in industry and regulatory areas to consolidate approaches to immunotox testing* Offers a definitive assessment of nonclinical models to study the toxic impacts (bio)pharmaceuticals can have on the immune system* Includes chapter authors from across the pharma industry, bringing a real-world and applied perspective to immunotox testing
"Practical Utility of Biomarkers in Drug Discovery and Development" covers all aspects of biomarker research applied to drug discovery and development and contains state-of-the-art appraisals on the practical utility of genomic, biochemical, and protein biomarkers. Case histories and lessons from successful and unsuccessful applications of biomarkers are included along with key chapters on GLP validation, safety biomarkers and proteomics biomarkers. Regulatory agency perspectives and initiatives both in the US and internationally are also discussed.
Biopharmaceuticals, the term for genetically engineered therapeutic proteins, monoclonal antibodies, and nucleic acid-based products, have become an increasing part of the pharmaceutical armament. While this category of drugs accounts for approximately 25% of all new drugs coming to market, very few references exist that review these commercially available products. Until now, accessing data on the list of currently approved biopharmaceuticals has been laborious and patchy. Directory of Approved Biopharmaceutical Products brings together key information on various aspects of these compounds, presenting a brief summary of each biopharmaceutical currently approved for medical use. Each summary includes the scientific and trade name, year and regions approved, approved indications, manufacturer, marketing right, method of manufacture, scientific overview, and therapeutic properties. Based on information gathered from regulatory agencies and pharmaceutical manufacturers, the book presents the most comprehensive data currently available in a single, convenient volume. This comprehensive and consistent approach will save professionals in the pharmaceutical industry hours spent trawling the literature - and provides a singular resource for future reference.
Mass Spectrometry in Drug Discovery summarizes the theory, instrumentation, techniques, and application of mass spectrometry and atmospheric pressure ionization to screening, evaluating, and improving the performance and quality of drug candidates. It provides time- and cost-efficient approaches for the generation and analysis of effective pharmaceuticals, covers advances in combinatorial chemistry, molecular biology, bioanalysis automation, and computing, and demonstrates the use of mass spectrometry in the assessment of disease states, drug targets, and potential drug agents.
This book describes the principles and applications of the spherical crystallization technique, from the standpoint of its inventor. After an introduction on the history of particle design engineering and nanotechnology, the concept of spherical crystallization itself is clearly explained. Attention then turns to the application of spherical crystallization in pharmaceutical processes. It is explained how the technique can provide physicochemical properties suitable for direct tableting of active pharmaceutical ingredients and how it has enabled the development of a novel particulate design platform from single to complex system. Subsequent chapters describe the roles of polymeric spherical crystallization in the preparation of novel microspheres, microballoons for drug delivery systems (DDS) and the development of biocompatible and biodegradable poly(D,L-lactide-co-glycolide) (PLGA) nanospheres. The various applications of PLGA nanospheres composite within oral-, pulmonary-, transdermal DDS and cosmetics are fully discussed. Finally, future perspectives are presented on use of the technology in the design and industrial-scale manufacture of new drug delivery systems, highlighting how a continuous pharmaceutical process that meets US Food and Drug Administration quality requirements should soon be introduced.
Recent technological advances have led to a rapid acceleration in our ability to gather genetic data. The complete genetic sequences are now known to several organisms and accelerated programmes are in place for sequencing many other genomes, including human. The speed with which complete sequencing can be accomplished will continue to increase as new technologies come online. In principle, the scope for developing new diagnostic techniques and drugs is now greater than at any time in human history, but the pathway from genetic information to usable drug is a long and complex one.
This exciting book brings together a high-calibre group of experts to discuss the practical application of genomic information to the development of drugs. The subjects covered include the current state of the art in sequencing technology, the applications of these new technologies to sequencing the genomes of various organisms, and the challenge of proteomics. Additional contributions deal with legal and ethical implications of the new uses of genetic data, and functional genomes from the point of view of the pharmaceutical industry.
There have been major advancements in the pharmacologic treatment of eye diseases over the past decade. With newly discovered disease targets and novel approaches to deliver therapeutic compounds to the eye, patients are seeing improved outcomes. Not only are there better treatments for diseases where treatments existed, we now have effective therapy for previously untreatable and blinding eye disorders. This volume will cover the pharmacologic treatment of eye diseases from the front of the eye including eyelids, conjunctiva and cornea all the way back to the retina and optic nerve. The first section of the volume reviews general principles of ocular pharmacology, pharmacokinetics, pharmaceutical sciences, and drug delivery. In addition, the volume provides an up to date guide to the pharmacologic approach to the key eye diseases that threaten sight or ocular function.
Edited by the most prominent person in the field and top researchers at US pharmaceutical companies, this is a unique resource for drug developers and physiologists seeking a molecular-level understanding of ion channel pharmacology.
After an introduction to the topic, the authors evaluate the structure and function of ion channels, as well as related drug interaction. A section on assay technologies is followed by a section each on calcium, sodium and potassium channels. Further chapters cover genetic and acquired channelopathies, before the book closes with a look at safety issues in ion channel drug development.
For medicinal and pharmaceutical chemists, biochemists, molecular biologists and those working in the pharmaceutical industry.
Drug discovery is a constantly developing and expanding area of research. Developed to provide a comprehensive guide, the Handbook of Medicinal Chemistry covers the past, present and future of the entire drug development process. Highlighting the recent successes and failures in drug discovery, the book helps readers to understand the factors governing modern drug discovery from the initial concept through to a marketed medicine. With chapters covering a wide range of topics from drug discovery processes and optimization, development of synthetic routes, pharmaceutical properties and computational biology, the handbook aims to enable medicinal chemists to apply their academic understanding to every aspect of drug discovery. Each chapter includes expert advice to not only provide a rigorous understanding of the principles being discussed, but to provide useful hints and tips gained from within the pharmaceutical industry. This expertise, combined with project case studies, highlighting and discussing all areas of successful projects, make this an essential handbook for all those involved in pharmaceutical development.
Pediatric Drug Development, Second Edition, encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of pediatric drug development.
Organic and medicinal chemistry are definitely the principal branches of chemistry as they are more widely studied than any other subjects in chemistry. Very often, organic and medicinal chemistry have been defined as a hybrid discipline of many other subjects that include biology, chemistry, medicine and pharmacy. The synthesis of molecules, mechanism of a process, studies of new reagents, natural products, biological and pharmacological evaluation of molecules against different components of cells are the key subjects in these two areas. On the basis of unlimited possibilities, one can imagine several scopes exist for students, researchers and industrialists to study and explore organic and medicinal chemistry. In this book, an attempt has been made to include diverse research topics to benefit the readers from different standpoints. This book has nine chapters (Volume 2) from active authors. Bhalla and his group have written two chapters in this volume. In the first chapter, Berry and Bhalla have demonstrated recent progress on the pharmacological profile of pyrazole and imidazole conjugates. In the second chapter, Kumari and Bhalla have explored the synthesis of optically active beta lactams. Sahoo and Banik have explored new quinazolines synthesis and their medicinal and pharmacological properties in Chapter Three. Perchyonok has described natural biomaterials for veterinary therapy through an in vitro approach in the fourth chapter. In the fifth chapter, Perchyonok et al. have also reported studies on cytotoxicity biomaterials containing chitosan hydrogels. Philips has demonstrated the synthesis and applications of pharmacologically relevant phosphonates and phosphinites in Chapter Six. Basu and Banik have explored apoptosis in the inhibition of cancer in Chapter Seven. Maji and Ganguly have demonstrated the use of mushrooms as a food in Chapter Eight. Bandyopadhyay et al. have studied key enzymes that are responsible in cancer and their mechanism of action in the ninth chapter. Scientists are convinced that organic and medicinal chemistry have no boundaries in science. The application of these chemical and medicinal sciences is huge and they are related to many significant discoveries. On this basis, the book will be useful for chemists, biologists, clinicians, pharmacists, biotechnologists, industrialists and engineers who are working in the field of interdisciplinary science as well as specific chemical and medicinal science.
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