Download or read book Particles and Nanoparticles in Pharmaceutical Products written by Henk G. Merkus and published by Springer. This book was released on 2018-09-06 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: This edited volume brings together the expertise of numerous specialists on the topic of particles – their physical, chemical, pharmacological and toxicological characteristics – when they are a component of pharmaceutical products and formulations. The book discusses in detail properties such as the composition, size, shape, surface properties and porosity of particles with respect to how they impact the formulations and products in which they are used and the effective delivery of pharmaceutical active ingredients. It considers all dosage forms of pharmaceuticals involving particles, from powders to tablets, creams to ointments, and solutions to dry-powder inhalers, also including the latest nanomedicine products. Further, it discusses examples of particle toxicity, as well as the important subject of pharmaceutical industry regulations, guidelines and legislation. The book is of interest to researchers and practitioners who work on testing and developing pharmaceutical dosage and delivery systems.

Download or read book Pharmaceutical Powder and Particles written by Anthony J. Hickey and published by Springer. This book was released on 2019-09-06 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: This first monograph in the new AAPS book series concisely reviews important aspects of powder and particle systems and the critical quality attributes that should be used as a guide to future developments intended to maximize the control of product quality and performance. Drs. Hickey and Giovagnoli have written an essential primer for any scientists involved in powder or particle research and manufacturing. It is appropriate for those just entering the field or as a rapid reference for the experienced pharmaceutical scientist. The authors have both academic and industrial experience and the coverage includes solid state chemistry; crystallization; physical processes; particle size and distribution;particle interaction;manufacturing processes;quality by design;and a general discussion of the industry. Pharmaceutical Powder and Particles is intended to concisely review important aspects of powder and particle systems and the critical quality attributes that should be used as a guide to future developments intended to maximize the control of product quality and performance.

Download or read book Control of Particulate Matter Contamination in Healthcare Manufacturing written by Thomas A. Barber and published by CRC Press. This book was released on 1999-10-31 with total page 620 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers practical applications addressing the specifics of contamination, including particle origination, characterization, identification, and elimination, with a special focus on quality considerations. Written by an industry expert, this material offers a clear and concise understanding of particle populations and their control in stability, efficacy, and predictability in the manufacture of healthcare products. Complete with a full-color insert of micrographs illustrating commonly encountered particulate matter and over eighty figures, tables, and charts. Features

Download or read book Particulate Matter written by Felicia Luna Lemus and published by Akashic Books. This book was released on 2020-11-03 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: In concise and distilled prose, Lemus presents a collection of still lifes, landscapes, and portraits of a challenging year that threatened all she loved most. “A love story that’s profoundly rooted in the emotional, geographical, and sociopolitical terrain of today . . . Like song lyrics or snapshots, her wisps and fragments of language take on a coded and otherworldly atmosphere, one that conveys wonder and dread almost subliminally . . . Particulate Matter is a moving example of how to write about climate change, not didactically, but with the deep impact of both personal loss and literary elegance.” —NPR Books “A tiny, powerful flame of a book. Lemus’ writing lands like sparks and ash, fragmented and tinged with grief . . . Particulate Matter is . . . an exploration of the simultaneity of delight, yearning, grief and confusion of being in love with a person and a place. Of being alive at all.” —San Francisco Chronicle Particulate Matter is the story of a year in Felicia Luna Lemus’s marriage when the world turned upside down. It’s set in Los Angeles, and it’s about love and crisis, loss and grief, the city and the ocean, ancestral ghosts and history haunting. Nature herself seemed to howl. Fires raged and covered the house Lemus and her spouse shared in ash. Everything crystallized. It was the most challenging and terrifying time she had ever experienced, and yet it was also a time when the sublime beauty of the everyday shone through with particular power and presence.

Download or read book Parenteral Products written by M. J. Groves and published by Elsevier. This book was released on 2014-05-20 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: Parenteral Products: The Preparation and Quality Control of Products for Injection deals with modern pharmaceutical practice in the preparation, quality control, and storage of injectable drug solutions. The book gives a basic background of parenteral solutions, the routes of administration, the effects of the different administrations of injection solutions, and the formulation of these products. The text discusses the theories of filtration, the different methods used, such as screen filters, depth filters, and the possible choices of filtration to capture any preselected unwanted particle size. Developments on sterilization of the product are given attention, citing techniques and equipment. The working and preparation conditions are discussed, since the sterile intravenous solutions, whether in large or small quantities, are done in quite the same procedures, with the similar equipment, and same organization. Equally important in the discussion are the monitoring and control of contamination by particulates through the application of standards known as the Coulter principle and the light-blockage method. The pharmaceutical problems encountered during the administration of large volume drip solutions are analyzed. This book is helpful for pharmacists, pharmaceutical students and professors, and those working in the pharmaceutical industry and hospital/health sector.

Download or read book Parenteral Quality Control written by Michael K. Akers and published by CRC Press. This book was released on 2002-11-20 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the book is a guide to test

Download or read book Design and Processing of Particulate Products written by Jim Litster and published by Cambridge University Press. This book was released on 2016-10-20 with total page 343 pages. Available in PDF, EPUB and Kindle. Book excerpt: A unique text providing comprehensive coverage of fundamental particle science, processing and technology. Including quantitative tools, real-world case studies and end-of-chapter problems, it is ideal for students in engineering and applied sciences, as well as for practitioners in a range of industries manufacturing particulate products.

Download or read book Waste Incineration and Public Health written by National Research Council and published by National Academies Press. This book was released on 2000-10-21 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Incineration has been used widely for waste disposal, including household, hazardous, and medical wasteâ€"but there is increasing public concern over the benefits of combusting the waste versus the health risk from pollutants emitted during combustion. Waste Incineration and Public Health informs the emerging debate with the most up-to-date information available on incineration, pollution, and human healthâ€"along with expert conclusions and recommendations for further research and improvement of such areas as risk communication. The committee provides details on: Processes involved in incineration and how contaminants are released. Environmental dynamics of contaminants and routes of human exposure. Tools and approaches for assessing possible human health effects. Scientific concerns pertinent to future regulatory actions. The book also examines some of the social, psychological, and economic factors that affect the communities where incineration takes place and addresses the problem of uncertainty and variation in predicting the health effects of incineration processes.

Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2005-09-05 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Sterile Drug Products written by Michael J. Akers and published by CRC Press. This book was released on 2016-04-19 with total page 517 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This

Download or read book Solid State Characterization of Pharmaceuticals written by Richard A. Storey and published by John Wiley & Sons. This book was released on 2011-03-31 with total page 557 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of solid state characterization is central to the pharmaceutical industry, as drug products are, in an overwhelming number of cases, produced as solid materials. Selection of the optimum solid form is a critical aspect of the development of pharmaceutical compounds, due to their ability to exist in more than one form or crystal structure (polymorphism). These polymorphs exhibit different physical properties which can affect their biopharmaceutical properties. This book provides an up-to-date review of the current techniques used to characterize pharmaceutical solids. Ensuring balanced, practical coverage with industrial relevance, it covers a range of key applications in the field. The following topics are included: Physical properties and processes Thermodynamics Intellectual guidance X-ray diffraction Spectroscopy Microscopy Particle sizing Mechanical properties Vapour sorption Thermal analysis & Calorimetry Polymorph prediction Form selection

Download or read book WHO Guidelines for Indoor Air Quality written by and published by World Health Organization. This book was released on 2010 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents WHO guidelines for the protection of public health from risks due to a number of chemicals commonly present in indoor air. The substances considered in this review, i.e. benzene, carbon monoxide, formaldehyde, naphthalene, nitrogen dioxide, polycyclic aromatic hydrocarbons (especially benzo[a]pyrene), radon, trichloroethylene and tetrachloroethylene, have indoor sources, are known in respect of their hazardousness to health and are often found indoors in concentrations of health concern. The guidelines are targeted at public health professionals involved in preventing health risks of environmental exposures, as well as specialists and authorities involved in the design and use of buildings, indoor materials and products. They provide a scientific basis for legally enforceable standards.

Download or read book Sterile Product Development written by Parag Kolhe and published by Springer Science & Business Media. This book was released on 2013-10-12 with total page 590 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.

Download or read book U S Health in International Perspective written by National Research Council and published by National Academies Press. This book was released on 2013-04-12 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: The United States is among the wealthiest nations in the world, but it is far from the healthiest. Although life expectancy and survival rates in the United States have improved dramatically over the past century, Americans live shorter lives and experience more injuries and illnesses than people in other high-income countries. The U.S. health disadvantage cannot be attributed solely to the adverse health status of racial or ethnic minorities or poor people: even highly advantaged Americans are in worse health than their counterparts in other, "peer" countries. In light of the new and growing evidence about the U.S. health disadvantage, the National Institutes of Health asked the National Research Council (NRC) and the Institute of Medicine (IOM) to convene a panel of experts to study the issue. The Panel on Understanding Cross-National Health Differences Among High-Income Countries examined whether the U.S. health disadvantage exists across the life span, considered potential explanations, and assessed the larger implications of the findings. U.S. Health in International Perspective presents detailed evidence on the issue, explores the possible explanations for the shorter and less healthy lives of Americans than those of people in comparable countries, and recommends actions by both government and nongovernment agencies and organizations to address the U.S. health disadvantage.

Download or read book Sources of Contamination in Medicinal Products and Medical Devices written by Denise Bohrer and published by John Wiley & Sons. This book was released on 2012-09-25 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first one-volume guide to sources of contamination in pharmaceuticals and medical devices Most books dealing with contaminants in medicinal products often focus on analytical methods for detecting nonspecific impurities. Key to the work of the pharmaceutical chemist, this unique reference helps identify the sources of contamination in medicinal and pharmaceutical products and medical devices. Divided into three parts, Sources of Contamination in Medicinal Products and Medical Devices covers chemical, microbiological, and physical (particulate matter) contamination, including those originating from sterilization procedures. As compelling as a medical documentary, the book sheds light on how impurities and contaminants can enter the human body transported via a specific product or treatment. Focusing on only those medicinal products and medical devices that may lead to exposure to contaminants harmful to human health, the book offers a comprehensive, systematic look at the entire universe of medical contamination: Chemical contaminants including residual solvents, catalyst residuals, and genotoxic impurities in active pharmaceutical ingredients (APIs) Diagnostic imaging agents (i.e., radiopharmaceuticals and contrast agents) Microbiological and endotoxin contamination involving single and multiple dose products, medical devices, and biofilms Contamination from sterilization procedures, residuals from radiation sterilization, ionizing radiation on packaging materials and medical devices Medicinal gases and volatile anesthetics Biopharmaceuticals including recombinant DNA technology products Extractables and leachables from containers made of glass, plastics, and metal Each section of the book contains information on what contaminants could be expected in a particular product, and how they were generated and reached that product. With up-to-date regulatory guidelines for determining contamination, as well as methods for assessing, quantifying, avoiding and removing contaminants, Sources of Contamination in Medicinal Products and Medical Devices is essential to fully understanding the specific threats that undermine the safety of medicines and medical devices.

Download or read book FDA Approved Animal Drug Products written by and published by . This book was released on 1998 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Receptor Modeling for Air Quality Management written by P.K. Hopke and published by Elsevier. This book was released on 1991-06-03 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents the background and application of receptor models for the source identification and quantitative mass apportionment of airborne pollutants. Over the past decade, receptor models have become an accepted part of the process for developing effective and efficient air quality management plans. Information is provided on the ambient and source sampling and chemical analysis needed to provide the input data for receptor models. Commonly used models are described with examples so that the air quality specialist can see how these models are applied. Recent advances in several areas of the field are presented as well as the perspective of both U.S. Federal and State level air quality managers on how these models fit into the development of a management plan.The aim of the book is to provide a practical guide to persons who may be given the task of implementing receptor modeling as a part of some air quality management problem. The intention of all the chapter authors is to furnish both the basic information needed to begin doing receptor modeling as well as some insight into some of the problems related to the use of these models. These tools like any others used in solving complex technological problems are not a panacea, but do represent powerful aids in data analysis that can lead to insights as to how an airshed functions and thus, to effective and efficient air quality management strategies.