Interactions between drug particulates are crucial in determining drug dispersion and deaggregation, and ultimately delivery efficiency. This book combines principles and factors in pharmaceutical powder technology, critically reviews some of the studies carried out in dry powder formulation development, and proposes possible strategies for improving their efficiency. The majority of these principles are applicable to other pharmaceutical solid dosage forms (e.g. tablets and capsules.).

eBook available with sample pages: 0203209591

This set of six volumes provides a systematic and standardized description of 23,033 chemical components isolated from 6,734 medicinal plants, collected from 5,507 books/articles published in Chinese and international journals. A chemical structure with stereo-chemistry bonds is provided for each chemical component, in addition to conventional information, such as Chinese and English names, physical and chemical properties. It includes a name list of medicinal plants from which the chemical component was isolated. Furthermore, abundant pharmacological data for nearly 8,000 chemical components are presented, including experimental method, experimental animal, cell type, quantitative data, as well as control compound data. The seven indexes allow for complete cross-indexing. Regardless whether one searches for the molecular formula of a compound, the pharmacological activity of a compound, or the English name of a plant, the information in the book can be retrieved in multiple ways.

This Book explains and investigates how medicines are controlled in Europe, especially the EU. Based on penetrating documentary and interview research with the pharmaceutical industry, regulators and consumer organisations,it provides the first major critical examination of the new Europeanised systems of medicine regulation. The authors argue that the drive to produce and approve more drugs more quickly for a single European market dominates other considerations, such as improvements in democratic accountability, the independence of regulators and scientific expertise from commercial interests, and drug safety testing and surveillance.

Delivering an encompassing overview of the factors, varieties, and applications determining product containment, this concise reference provides authoritative information on containment processes. It reviews the historical context, definition, evolution, and application of containment technology, analyzes a variety of containment techniques in new and retrofitted construction, and examines "people protection" vs. "product protection" and the role of source-contamination in each. It also suggests conceptualizing containment options from the inception of a project for economical, at-the-source containment, identifies containment requirements and monitoring methods, as well as the current state of emission controls, and discusses the "dustiness" of powders and how this research is being defined, quantified, and used in containment design.

Given novel infectious diseases such as COVID-19 and antibiotic resistance new antimicrobial discovery is an important research area. Considering that nature is a vast source of bioactive molecules with antimicrobial activity, the main aim of this book is to present a comprehensive outlook of current research in the field of natural antimicrobials. It discusses the antimicrobial activity of medicinal plants, beehives, and mushrooms with a global coverage of antimicrobial agents from rich forests of Brazil (Amazon), North-Eastern forests of Peru, Argentina, Colombia, India, Bangladesh, Nepal, Middle East, Turkey, Croatia, Greece, Germany and Russia. The book covers the results of the in vitro screening of antimicrobial activities of extracts and isolated compounds from natural origins. It is divided into three sections: i) Section I, includes natural antimicrobials from plants; ii) Section II incorporates antimicrobial agents/secondary metabolites from plants, and (iii) Section III focuses on antimicrobials from mushrooms, beehive and delivery systems for different types of antimicrobials. Promising Antimicrobials From Natural Products is immensely useful for post graduate students, researchers in plant science, microbiology, biotechnology, pharmacology, pharma companies and those who are interested in herbal, eco-friendly, cost-effective and sustainable antimicrobials

Interactions Between Chinese Herbal Medicinal Products and Orthodox Drugs provides basic biomedical principles on adverse and beneficial interactions between Chinese herbal medicine (CHM) products (herbs and ready-made medications) and orthodox drugs. The book includes concise accounts of the trends of development and progress in Chinese medicine, pharmacological principles of CHM materials and mechanisms of interactions. Clinically relevant interactions are summarized in tables for easy reference with a catalogue of commonly used CHM products.
A unique chapter with an action plan is assigned to promote research and documentation of herb-drug interactions. This textbook is desperately needed by undergraduates, postgraduates, medical practitioners, health professionals, medications regulatory bodies, and R&D professionals in pharmaceutical industries who are involved in CHM products.

Natural products play an integral and ongoing role in promoting numerous aspects of scientific advancement, and many aspects of basic research programs are intimately related to natural products. The significance, therefore, of the Studies in Natural Product Chemistry series, edited by Professor Atta-ur-Rahman, cannot be overestimated. This volume, in accordance with previous volumes, presents us with cutting-edge contributions of great importance.

This timely and compact monograph addresses how to determine drug permeability across the blood-brain barrier more effectively. Focusing on the physiological mechanisms that influence the passage of agents into the brain, the book covers the latest research on the blood-brain barrier, the current problems of and solutions to drug delivery to the central nervous system (CNS), existing strategies, and prospects for future research. Avoid excessive in vivo experimentation and utilize timesaving in vitro techniques. A concise reference with reviews from nearly 40 international specialists in diverse fields, The Blood-Brain Barrier and Drug Delivery to the CNS -assesses the properties of the blood-brain barrier to determine and measure drug permeability in animals and humans -presents techniques to predict successful drug uptake through in vitro systems or by computation of physicochemical parameters -examines the multidrug resistance protein P-glycoprotein as a natural transporter -analyzes current drug designs to known requirements for transport -looks at drug delivery systems for the brain -and much more! Densely packed with over 800 literature references, drawings, photographs, x-rays, tables, and equations, The Blood-Brain Barrier and Drug Delivery to the CNS is a vital addition to the bookshelves of biochemists, pharmacists, clinical and research pharmacologists, neuroscientists and neurologists, and graduate and medical school students in these disciplines.

Sustained-Release Injectable Products focuses on the development process for sustained-release versions of drugs and delivery systems and administration routes. From the rationale and basic product development principles to regulatory issues and the approval process, expert contributions address virtually every aspect. They bring together common threads that apply to any sustained-release formulation, such as scale-up, safety, biocompatibility, analytical challenges, and quality assurance.

Key features: The most comprehensive resource available on the biodiversity of algal species, their industrial production processes and their use for human consumption in food, health and varied applications. Emphasis on basic and applied research, addressing aspects of scale-up for commercial exploitation for the development of novel phytochemicals (phytochemicals from algae). Addresses the underexplored and underutilized potential of chemicals from marine sources for health benefits. Each chapter, written by expert contributors from around the world, includes Summary Points, Figures and Tables, as well as up-to-date references. The first book in this two-volume set explores the diversity of algal constituents for health and disease applications. The commercial value of chemicals of value to food and health is about $6 billion annually, of which 30 percent relates to micro and macro algal metabolites and products for health food applications. This comprenhensive volume looks in detail at algal genomics and metabolomics as well as mass production of microalgae. As a whole, the two-volume set covers all micro and macro algal forms and their traditional uses; their constituents which are of value for food, feed, specialty chemicals, bioactive compounds for novel applications, and bioenergy molecules. Bio-business and the market share of algae-based products are also dealt with, providing global perspectives.

Completely revised, this second edition provides the practical, hands-on labeling information needed to secure rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, it explains the relevant laws, regulations, and requirements in major markets worldwide and provides examples of compliance and noncompliance. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, over the counter products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more.

Offering a detailed, step-by-step guide to building a compliant cleaning validation program, Cleaning Validation: A Practical Approach covers trends in control, procedures, cleaning agents and tools, sampling techniques, analytical methods, and regulatory issues. The author provides practical examples, database formats, standard operating procedures, work instructions, protocols, and reports. He gives readers the tools they need to develop an effective and manageable program that will not only be acceptable to both US and non-US regulatory authorities but will conserve an organization's time, money, and people resources.

A vast number of diagnostic and therapeutic decisions are based on measuring blood concentrations of molecules, yet most biochemical and pharmacological events actually take place in the tissues. Microdialysis is a key semi-invasive sampling technique to measure in vivo drug penetration to the target site in humans, the method being feasible in virtually every organ. Authored by international experts in this cutting edge field, this book will provide a comprehensive overview of microdialysis and its application for measuring drug distribution in drug development.

Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors' experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development. Discusses differences in the work of a biostatistician in small pharma and big pharma. Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels. Describes some useful statistical background that can be capitalized upon in the drug development enterprise. Explains some hot topics and current trends in biostatistics in simple, non-technical terms. Discusses incompleteness of any system of standard operating procedures, rules and regulations. Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial. Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed. Discusses realistic planning of open-ended projects.

Reveals important new results from clinical trials conducted in Scandinavia, Scotland, Australia, Canada, and the United States. This timely reference reviews the vast body of clinical trial evidence supporting the once controversial view that high levels of serum cholesterol are a major risk factor in coronary heart disease (CHD). The studies presented in Cholesterol-Lowering Therapy: Evaluation of Clinical Trial Evidence promote cholesterol reduction as a highly successful means of preventing heart disease in various populations. Investigates past, current, and upcoming controlled clinical trials of cholesterol-reduction therapies, comparing effects of statins and bile acid sequestrants to triglyceride-lowering drugs and antioxidants. Written by more than 25 distinguished international researchers, Cholesterol-Lowering Therapy: Evaluation of Clinical Trial Evidence -highlights historical studies of dietary trials designed to reduce CHD -covers tests of HMG CoA reductase inhibitors for patients with and without CHD -illuminates CHD risk factors such as diabetes, hypertension, obesity, and smoking -explores blood levels of homocysteine and lipoprotein(a) and other recently identified CHD risk factors -reviews metabolism of lipoproteins expressed in high (HDL) and low (LDL) density lipoprotein cholesterol -and more! Containing over 700 instructive tables, drawings, photographs, and bibliographic citations, Cholesterol-Lowering Therapy: Evaluation of Clinical Trial Evidence is a must-read resource for cardiologists, pharmacologists, and upper-level undergraduate, graduate, and medical school students in these disciplines.

Finding consistent, analytical discussions of processes and principles of lyophilization can be challenging and often frustrating. The first resource to gather information about the field, Lyophilization: Introduction and Basic Principles is still the book to have on lyophilization. Presenting information in an easy-to-read style, the book comprehensively and authoritatively covers the field. Using plain, unpretentious language, author Thomas A. Jennings pulls together information from diverse sources to provide an authoritative compendium of the lyophilization process and its basic principles. He provides important discussions about the nature of the container-closure system and the equipment, tools, and environments required. Case studies and examples of solutions illustrate the many ways problems can be addressed in the lyophilization process. The book covers: -Properties of lyophilized materials -Product formulation requirements and the thermal properties of formulations -Importance of process water -Phase changes -Thermal analytical methods -Freezing, primary, and secondary drying processes -Effect of vacuum freeze-dryers, both now and in the future Including over 150 illustrations, global symbols, and more than 350 references, this book is the complete guide to lyophilization, its analytical methods, measurement of process parameters, and equipment.

This book addresses the use of food hydrocolloids as agents for encapsulating biological active ingredients. It details the challenges of poorly-controlled rate of hydration, thickness, decrease in viscosity upon storage, and susceptibility to microbial contamination. Food Hydrocolloids as Encapsulating Agents in Delivery Systems briefly describes various emerging biomaterials including food gums, starches, beta glucans, and proteins for their potential role as wall material in the development of nutraceutical delivery systems. Further, it describes different techniques of fabrication of nanodelivery systems. Features: Provides an introduction to food hydrocolloids as encapsulating agents Covers starches and their derivatives as delivery systems Includes gum-based delivery systems Discusses the classification, isolation, and purification of protein delivery systems This book would be helpful to food scientists and pharmaceutical scientists working in areas including nanotechnology, polymer chemistry, and nutraceutical delivery, as well as regulators and government researchers in US FDA, USDA, and UK FSA regulatory agencies.

"The most significant changes in isolation technology during the past five years have not been in the technology itself but in its increased acceptance. This acceptance is clearly demonstrated by the series of monographs, guidelines, and standards produced by regulatory bodies to describe best practice in the design and operation of isolators. Thoroughly revised and updated, Isolation Technology: A Practical Guide, Second Edition provides an in-depth overview of new standards and new technology. Here's what's new in the Second Edition: ""

This invaluable reference presents a comprehensive review of the basic methods for characterizing bioadhesive materials and improving vehicle targeting and uptake-offering possibilities for reformulating existing compounds to create new pharmaceuticals at lower development costs.
Evaluates the unique carrier characteristics of bioadhesive polymers and their power to enhance localization of delivered agents, local bioavailability, and drug absorption and transport
Written by over 50 international experts and reflecting broad knowledge of both traditional bioadhesive strategies and novel clinical applications, Bioadhesive Drug Delivery Systems
discusses mechanical and chemical bonding, polymer-mucus interactions, the effect of surface energy in bioadhesion, polymer hydration, and mucus rheology
analyzes biochemical properties of mucus and glycoproteins, cell adhesion molecules, and cellular interaction with two- and three-dimensional surfaces
covers microbalances and magnetic force transducers, atomic force microscopy, direct measurements of molecular level adhesions, and methods to measure cell-cell interactions
examines bioadhesive carriers, diffusion or penetration enhancers, and lectin-targeted vehicles
describes vaginal, nasal, buccal, ocular, and transdermal drug delivery
reviews bioadhesive interactions with the mucosal tissues of the eye and mouth, and those in the respiratory, urinary, and gastrointestinal tracts
explores issues of product development, clinical testing, and production
and more
Amply referenced with over 1400 bibliographic citations, and illustrated with more than 300 drawings, photographs, tables, and display equations, Bioadhesive Drug Delivery Systems serves as a sound basis for innovation in bioadhesive systems and an excellent introduction to the subject. This unique reference is ideal for pharmaceutical scientists and technologists; chemical, polymer, and plastics engineers; biochemists; physical, surface, and colloid chemists; biologists; and upper-level undergraduate and graduate students in these disciplines.

Bioreactors: Animal Cell Culture Control for Bioprocess Engineering presents the design, fabrication, and control of a new type of bioreactor meant especially for animal cell line culture. The new bioreactor, called the "see-saw bioreactor," is ideal for the growth of cells with a sensitive membrane. The see-saw bioreactor derives its name from its principle of operation in which liquid columns in either limb of the reactor alternately go up and down. The working volume of the reactor is small, to within 15 L. However, it can easily be scaled up for large production in volume of cell mass in the drug and pharmaceutical industries. The authors describe the principle of operation of the see-saw bioreactor and how to automatically control the bioprocess. They discuss different control strategies as well as the thorough experimental research they conducted on this prototype bioreactor in which they applied a time delay control for yield maximization. To give you a complete understanding of the design and development of the see-saw bioreactor, the authors cover the mathematical model they use to describe the kinetics of fermentation, the genetic algorithms used for deriving the optimal time trajectories of the bioprocess variables, and the corresponding control inputs for maximizing the product yield. One chapter is devoted to the application of time delay control. Following a description of the bioreactor's working setup in the laboratory, the authors sum up their investigation and define the future scope of work in terms of design, control, and software sensors.

This book is devoted to a broader understanding of liposomes as a versatile tool used in many domains, including basic research and applied technology, focusing on less common applications and recent developments. Over the past few years, new types of liposomes made of nonphospholipid molecules have opened new perspectives in applications. These lipid vesicles, already used in cosmetology, are being manufactured for industrial and agricultural uses. However, "Stealth" liposomes, pH-sensitive liposomes, and cationic liposomes have enlarged and improved the application field of liposomes in clinical research. The book covers these different uses of liposomes with particular attention to new formulations and new applications.

Providing guidance for chemists and other scientists entering pharmaceutical discovery and development, this up-to-the-minute reference presents contributions from an international group of nearly 50 renowned researchersa "offering a solid grounding in synthetic "and" physical organic chemistry, and clarifying the roles of various specialties in the development of new drugs.

Featuring over 1000 references, tables, and illustrations, "Process Chemistry in the Pharmaceutical Industry" is sure to find its way to the bookshelves of organic, physical, analytical, process, and medicinal chemists and biochemists; pharmacists; and upper-level undergraduate and graduate students in these disciplines.

Bringing together nearly forty collaborators from academic and industrial laboratories, this reference furnishes an overview of the subject from a historical, kinetic, and chemical context. A source of expertise for a rapidly changing and expanding field, the book provides a framework for drug metabolism in drug discovery and development. Containing tables, drawings, photographs, and equations, it highlights the importance of pharmacokinetics and cytochrome P450, explains clearance, volume of distribution, sequential metabolism, and nonlinear kinetics, summarizes concepts of Phase 1 and 2 metabolites, evaluates tertiary amine metabolism and reactive metabolite chemistry, and more.

"Provides a wide range of information on the composition, utilization, and evaluation of colorants and pigments in food, pharmaceuticals, and cosmetic products. Tabulates key data for food, drug, and cosmetic colorants by Color Index Numbers. Thoroughly describes the relationships between coloring reactions."

"Cannabis sativa" has been a source of man-mad products for over 5000 years. This book contains a series of dissertations, supported by over 700 references, on the history, ethnobotany, chemistry and analysis, and cultivation and processing of cannabis. The medicinal and non-medicinal uses of the plant and its derivates are viewed in the context of national and international legislation to define and control its use. Developments in cannabinoid pharmacology research and receptor theory are also discussed.