This new two-volume set, Drug Delivery Approaches and Nanosystems, Volume 1: Novel Drug Carriers and Volume 2: Drug Targeting Aspects of Nanotechnology presents a comprehensive look at the state-of-the-art research and developments in drug delivery systems using nanotechnology and its applications. Many methods of drug delivery systems have been used, but very few of them have been validated for medical use. A major reason for the above situation, the editors believe, is due to the gap between academia and research, and the gap between academic research and real-time clinical applications and needs. These volumes address that gap. Volume 1 addresses the ubiquitous applications of nanotechnology or nano-sized materials in the medical field and the real-world challenges and complexities of current drug delivery methodologies and techniques, while Volume 2 focuses on drug targeting aspects of nanotechnology. Together they provide a thorough review of the applications of nanotechnology or nano-sized materials in the medical field and the real-world challenges and complexities of current drug delivery methodologies and techniques. These two volumes will provide a plethora of real-world information for the application of drug delivery approaches via nanotechnology that will be valuable to scientists and researchers as well as faculty and students. The volumes are available separately or together as a set.

The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms. Key Features: Reviews how extrusion has become an accepted technology to continuously mix active pharmaceutical ingredients with excipients Focuses on equipment and process technology Explains various extrusion system configurations as a manufacturing methodology for a variety of dosage forms Presents new opportunities available only via extrusion and future trends Includes contributions of experts from the process and equipment fields

This book addresses the issues relating to a wide variety of ocular diseases from which millions of people suffer. Long-term challenges include visual impairment and ocular blindness. Certain ocular diseases are quite rare, whereas others, such as cataracts, age-related macular degeneration (AMD), and glaucoma, are very common, especially in the aging population. A rapid expansion of new technologies in ocular drug delivery and new drug candidates, including biologics, to treat these challenging diseases in the retina and posterior segments of the eye have recently emerged. These approaches are necessary because the eye has many unique barriers to drug delivery. Thus, this timely reference Drug Delivery for the Retina and Posterior Segment Disease compiles and analyzes recent advances in the research and development of drug delivery systems for retina and posterior segment diseases of the eye, with an emphasis on the use of implantable devices, iontophoresis as well as micro- and nanoparticles.

This volume, the first of the two-volume Drug Delivery Approaches and Nanosystems series, presents a full picture of the state-of-the-art research and development in drug delivery systems using nanotechnology and its applications. It addresses the ever-expanding application of nanotechnology or nano-sized materials in the medical field and the real-world challenges and complexities of current drug delivery methodologies and techniques. Many methods of drug delivery systems have been used, but very few of them have been validated for medical use. A major reason for the above situation, the editors believe, is the gap between academia and research, and the gap between academic research and real-time clinical applications and needs. This volume addresses that gap. This volume presents 12 chapters that provide information about the preparation and characterization of nanocomposite materials used in drug delivery systems; advanced research of carbon nanotubes, nanocomposite materials, and polymer-clay, ceramics, and silicate glass-based nanocomposites; and the functionality of graphene nanocomposites. The book also provides detailed information on the application of nanotechnology in drug delivery systems in health care systems and medicine. The book describes how nanostructures are synthesized and draws attention to wide variety of nanostructures available for biological research and treatment applications. This valuable volume provides a wealth of information that will be valuable to scientists and researchers, faculty, and students. Volume 2 of the two-volume series is subtitled Drug Targeting Aspects of Nanotechnology. The volumes are available separately or as a set.

The title of this proceedings comes from the book The Antibiotic Paradox by Stuart B. Levy (Plenum Publishing Corporation, 1992), referring to the paradox that the more antibiotics are used to treat infectious diseases, the less effective they become. When antibiotics were first introduced, they were considered wonder drugs because they were so effective. But with time bacteria have become resistant to nearly all antibiotics, and resistance is spreading faster than new antibiotics are being developed. This book will identify the issues concerning resistance, as well as describe efforts to develop new drugs that overcome the problem of resistance.

Although the role of liposomes in drug targeting has been discussed extensively in several reviews and books, there has been no comprehensive coverage of related methodology. This book constitutes the first attempt to put together all aspects of lipsome technology as applied to medical sciences. Volume I deals directly with methods for the preparation of liposomes and auxiliary techniques.

Phage Display in Biotechnology and Drug Discovery, Second Edition provides a comprehensive view of the impact and promise of phage display in drug discovery and biotechnology. Building on the success of its previous edition, the book discusses current theories, principles, and methods in the field and demonstrates applications for peptide phage display, protein phage display, and the development of novel antibodies. The book provides readers with an overview of the amazing breadth of the impact that phage display technology has had on the study of proteins in general as well as the development of proteins. It will be a valuable resource for those interested in using phage display and recombinant antibodies in basic research and drug discovery. Key Features: Describes the basic principles of phage display and the methods and systems that have been developed for key applications Outlines applications for peptide phage display in the development of vaccines and high- throughput screens as well as the exploration of protein-protein interactions and enzyme substrate characteristics Details the use of phage display in the engineering of protein stability, the identification and mapping of protein-protein interactions, and the development of catalysts Provides broad coverage of the impact of phage display technology on the development of protein therapeutics Presents expert opinions on future challenges in the field

All medicinal products have to be licensed before marketing in any of the EEC, Nordic and EFTA countries. This book provides a systematic account of the major technical, administrative and legal requirements for registering a product in any of the national markets within the EEC, using the existing procedures, with guidance as to how these procedures are likely to change with the creation of a single European market in pharmaceuticals after 1992. The book should be of value to the pharmaceutical industry and their suppliers (the bulk excipient and active substance manufacturers); to government regulatory agencies; and to members of many technical, professional, scientific, medical and regulatory societies and organizations concerned directly and indirectly with medicinal products - particularly to members of the pharmaceutical and medical professions. There is an enormous interest in this subject in the EEC, the USA and Japan due to the likelihood of the creation in 1992 of a single market with some 350,000 patients.

A practical guide for chemists in the pharmaceutical industry to making automated analyses of drugs that will meet the standards of regulatory agencies. Reviews the standard techniques of high-performance liquid chromatography, specialized detection methods, automation in pharmaceutical analysis, an

This book presents an overview of the diverse and complex influences that link the mechanisms of adverse drug interactions (ADIs) with their clinical effects. It provides information to busy prescribers in a user-friendly form to ensure that they minimize the risk of harm to patients by ADI.

Illustrates the use of systems such as in-process control, quality auditing, and specifications, stressing a troubleshooting, cost-effective approach to product packaging for maximized early lead time to the customer. Addressing the needs of the pharmaceutical industry, the approaches supplied are l

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes. Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.

This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.

Fills a gap between the existing studies of proteins, which tend to be highly technical and geared toward the practicing protein chemist, and biochemistry textbooks, which focus on general principles. Scientists cover a dozen topics by presenting fundamental principles, an overview, and the practica

Novel drug delivery technologies strive to bypass challenging biological layers to elicit desired pharmacological activity. The skin, one of our key defensive barriers, allows certain topically applied substances and toxins to pass. The dermatokinetics of a drug determines the efficacy of treatment of skin disorders. Presenting the first comprehensive reference on this important area of research, Dermatokinetics of Therapeutic Agents includes a general overview of the theoretical as well as practical aspects of dermatokinetics and addresses the impact of a drug delivery system on the dermatokinetics of drugs. Chapters and illustrations cover introductory aspects and the significance, methods, and models used in dermatokinetic studies of therapeutic agents. Topics include: Theoretical Models for Dermatokinetics of Therapeutic Agents Drug Delivery Approaches to Modulate Dermatokinetics of Drugs Conventional Methods of Cutaneous Drug Sampling Cutaneous Microdialysis Sampling Substrates by Skin Permeabilization Spectroscopic Techniques in Dermatokinetics Studies Regulatory Perspective of Dermatokinetic Studies

Biomedical Application of Nanoparticles explores nanoparticles, their chemical and physicals properties, and how they interact in biological systems with proteins, immune system and targeted cells. Risk assessment of nanoparticles for human is described, including: cellular paradigms, transcriptomics and toxicogenomics. Finally, the applications of nanoparticles in medicine and antioxidant regenerative therapeutics are presented in several chapters with emphasis on how nanoparticles enhance transport of drugs across biological membrane barriers and therefore may enhance drug bioavailability.

Recent advances in immunology and biology have opened new horizons in cancer therapy, included in the expanding array of cancer treatment options, which are immunotherapies, or cancer vaccines, for both solid and blood borne cancers. Cancer Vaccines: From Research to Clinical Practice is the first text in the field to bring immunotherapy treatments from the laboratory trial to the bedside for the practicing oncologist. Cancer Vaccines: From Research to Clinical Practice: Analyzes the most promising classes of investigational immunotherapies, integrating their scientific rationale and clinical potential Discusses "theranostics" as pertaining to immunotherapy, i.e., using molecular diagnostics to identify patients that would most likely benefit from a therapy Presents the new paradigm of biomarker guided R&D and clinical development in immunotherapy of cancer Reviews bottlenecks in translational process of immunotherapies and offers strategies to resolve them

This book is a compilation and commentary of selected laws and regulations pertaining to the general practice of pharmacy in the United States. It is designed to be of assistance to practicing pharmacists, those seeking licensure by reciprocity, and other interested healthcare professionals.

The first chapter in volume 111 summarizes research on the sesterterpenoids, which are known as a relatively small group of natural products. However, they express a variety of simple to complicated chemical structures. This chapter focuses on the chemical structures of sesterterpenoids and how their structures are synthesized in Nature. The second chapter is devoted to marine-derived fungi, which play an important role in the search for structurally unique secondary metabolites, some of which show promising pharmacological activities that make them useful leads for drug discovery. Marine natural product research in China in general has made enormous progress in the last two decades as described in this chapter on fungal metabolites. This contribution covers 613 new natural products reported from 2001 to 2017 from marine-derived fungi obtained from algae, sponges, corals, and other marine organisms from Chinese waters.

This book provides a comprehensive introduction to advanced drug delivery and targeting, covering their principles, current applications, and potential future developments. This edition has been updated to reflect significant trends and cutting-edge advances that have occurred since the first edition was published. All the original chapters have been retained, but the material therein has been updated. Eight new chapters have been added that deal with entirely new technologies and approaches.

An estimated 1 in 20 patients are admitted to the hospital due to problems with their medication and 1 in 100 hospitalized patients are harmed due to medication errors during their stay. The prescribing of medications is the most common health care intervention and medication safety is relevant to all health care professionals and patients, in all health care settings. Safety in Medication Use provides an overview of the theory and practice of medication safety, summarizing the international literature and practical suggestions for local practice Each chapter is written by one or more authors from around the world who were chosen because of their standing in their field. The book covers three broad areas: problems in the medication use process, approaches to understanding and resolving them, and putting solutions into practice. Topics discussed include: Measuring medication errors Improvement science Safety culture Incident reporting and feedback approaches Educational interventions Communication between health care professionals Interventions for safer work systems Electronic prescribing and medication administration record systems Innovations in dispensing Patient involvement in medication safety Each chapter is a primer on the topic, drawing on the international literature, with the chapters on solutions followed by an "expert summary" of the implications for practice. This valuable resource describes an international body of work that shows not only how widespread medication errors are, but also discusses interventions that can reduce such errors to improve patient safety.

This book presents new approaches for skin aging and photocarcinogenesis and topical formulations based on nanocarrier systems for skin disorders. It discusses cosmeceuticals, laser, photodynamic therapy, and melatonin-based treatments as important strategies for photoaging management. Photodynamic therapy and melatonin can be used in the photocarcinogenesis context, too. Therefore, the inclusion of this strong antioxidant in sunscreen products could be a promising approach. The book discusses topical formulations, including emulsions (conventional formulations and emulsions stabilized by solid particles), nail films, and nanocarriers used for the delivery of actives in various skin and nail diseases such as acne, psoriasis, atopic dermatitis, fungal diseases, leishmaniasis, and skin cancer. Finally, several nanocarriers are introduced, such as lipid vesicles (ranging from the first-generation conventional liposomes to the more recent deformable vesicles), liquid crystalline nanodispersions, gelatin, and solid lipid nanoparticles. Their composition, formulation, characterization, and topical applications are also discussed. Although this is a broad topic, the most important (nano)pharmaceutical formulations are presented in the book.

Written by an author with more than 40 years of teaching experience in the field, Experiments in Pharmaceutical Chemistry, Second Edition responds to a critical classroom need for material on directed laboratory investigations in biological and pharmaceutical chemistry. This new edition supplies 75 experiments, expanding the range of topics to 22 major areas of pharmaceutical chemistry. These include biochemical groups, botanical classes important to pharmacy, and major drug classifications: Carbohydrates Lipids Proteins Enzymes Inorganics Vitamins Steroids Plant Acids Flavonoids Alkaloids Tannins Resins Glycosides Gums Balsams Volatile Oils Analgesics Anesthetics Sulfa Drugs (Sulfonamides) Psychotropic Drugs Antibiotics Nucleic Acids Sections contain introductions to basic concepts underlying the fields addressed and a specific bibliography relating to each field. Each experiment provides detailed instructions in a user-friendly format, and can be carried out, in most cases, without the need for expensive instrumentation. This comprehensive laboratory manual offers much-needed instructional material for teaching laboratory classes in pharmaceutical chemistry. The breadth of subject matter covered provides a variety of choices for structuring a laboratory course.

As the medicinal plant industry blooms into a billion dollar business, it reaches beyond collection, propagation, harvesting and sale of crude vegetal drugs into product formulation, packaging and dispensing of sophisticated phyto-pharmaceuticals and herbal preparations. The scientific study of these medicines and the systematic uplifting of the industry to preserve the ancient and serve the modern, is now a global challenge. The Medicinal Plant Industry puts together the various facets of this multi-disciplinary industry and its global interest. It discusses the dire need for developing countries to acquire technologies and techniques for programmed cultivation of medicinal plants. It addresses a wide variety of topics including the old philosophies, modern impact of traditional medicines, and methods of assessing the spontaneous flora for industrial utilization. It covers aspects of cultivation and climatic variations, biological assessment and formulation, process technologies, phytochemical research and information sources. The book reviews highly developed traditional medicine in China and India, and covers experiences in Africa and other continents.

This timely book provides a succinct summary of methods for the synthesis of bioactive heterocycles using a multicomponent reaction (MCR) approach. The majority of pharmaceuticals and biologically active agrochemicals are heterocycles while countless additives and modifiers used in industrial applications are heterocyclic in nature. With the recent introduction of high-throughput biological evaluation, the importance of MCRs for drug discovery has been recognized and considerable efforts have been focused especially on the design and development of multi-component procedures for the generation of various bioactive heterocycles due to their significant therapeutic potential.