Supercritical Fluid Technology For Drug Product Development
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Supercritical Fluid Technology for Drug Product Development by Peter York,Uday B. Kompella,Boris Y. Shekunov Pdf
Interconnecting the fundamentals of supercritical fluid (SCF) technologies, their current and anticipated utility in drug delivery, and process engineering advances from related methodological domains and pharmaceutical applications, this volume unlocks the potential of supercritical fluids to further the development of improved pharmaceutical products-from drug powders for respiratory delivery to drug delivery systems for controlled release.
Current Trends of Supercritical Fluid Technology in Pharmaceutical, Nutraceutical and Food Processing Industries by Ana Rita C. Duarte,Catarina Maria Martins Duarte Pdf
Supercritical fluid technology can be seen as a green and environmentally friendly alternative to conventional. Current information on these topics is spread through different publications in different peer-reviewed journals. The editors were therefore of
Practical Application of Supercritical Fluid Chromatography for Pharmaceutical Research and Development by Anonim Pdf
Practical Application of Supercritical Fluid Chromatography for Pharmaceutical Research and Development provides a valuable “go-to reference for many difficult-to-solve challenges using pertinent chromatographic theory, first-hand case studies, and examples provided from academic and industry experts. This text also enables professors teaching an analytical instrumental course to introduce and instruct students about one of the most sustainable and powerful separation methods currently available. While the text has broad applicability across industrial sectors, it focuses primarily on application in the pharmaceutical industry. The book is designed to allow readers to align current HPLC/UHPLC capabilities with SFC as an orthogonal tool for project specific methods in the pharmaceutical industry. It highlights where SFC falls on the spectrum of useful chromatographic tools for routine and challenging separative methods. Experienced HPLC users who are interested in developing knowledge in orthogonal separation techniques, as well as newcomers to the field of separation science, will find this text particularly useful. Chapters address where SFC may fit the analytical needs of the pharmaceutical industry and alert the readers as to where the technique will not fit. Readers will gain an understanding of how and where SFC may be applied and adapted more routinely across the pharmaceutical industry as a ‘green’ way of undertaking separation opportunities and challenges. Areas within the pharmaceutical industry include early drug discovery, process chemistry, and late stage development and manufacturing. Describes approaches to SFC column and mobile phase selection for method development for both analytical and preparative tasks Gives practical examples of how analytical SFC enables the monitoring of synthetic reactions including unstable intermediates, chiral and achiral polar reactants and products across small and large modalities Provides need-focused case studies for pharmaceutical analysts, process chemists, and contract chemistry facilities that can benefit from monitoring or purifying polar intermediates, mutagenic impurities, nitrosamines and other reaction by-products including excipients and metabolites
Industrial Scale Application of Subcritical and Supercritical Fluids for Design of Products by Zeljko Knez,Christoph Luetge Pdf
Industrial Scale Application of Subcritical and Supercritical Fluids for Design of Products fills the gap between fundamentals and industrial implantation of various high-pressure process technologies. The book covers the design, start-up and maintenance of real industrial plants, also providing readers with insights on their construction and operational essentials. It is ideal for chemical engineers who operate high pressure units and different researchers who create supercritical fluid technology to solve problems surrounding product fractionation, product formulation, synthesis in SCF, and product development using supercritical fluids technologies. There are some books that describe high pressure technologies and research in the area of sub- and supercritical fluids, but this book presents fundamental data on thermodynamics and mass transfer, topics that are absolutely essential for the design of industrial plants. Includes thermodynamic and mass transfer data necessary for industrial plant design Explains the mechanisms of reactions in a supercritical fluid environment Lists numerous industrial processes for the production of many consumers products, like pharmaceuticals, food, etc.
Advanced Nanotechnology and Application of Supercritical Fluids by Inamuddin,Abdullah M. Asiri Pdf
Globalization and industrialization involve a number of reactions, products, extractions, and separations that require the use of organic solvents. These solvents are responsible for a number of ecological concerns, including atmospheric and land toxicity. Conventional organic solvents are regarded as volatile organic compounds; some are even limited due to their potential for ozone layer depletion. While supercritical liquids exhibit physical properties that could make them ideal substitutes for these volatile compounds, there is particular interest in the use of carbon dioxide as a solvent of crude material. In particular, carbon dioxide has apparent ‘green’ properties, like its noncombustible nature, the fact that it is generally nonpoisonous, and its relative inertness. Thus, the use of supercritical carbon dioxide can provide practical improvements to the sustainability of industrial products and processes. This book provides in-depth literature in the area of industrial green processes, focusing on the separation, purification, and extraction of compounds utilizing supercritical carbon dioxide as a green solvent.
Generic Drug Product Development by Isadore Kanfer,Leon Shargel Pdf
The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.
Encyclopedia of Pharmaceutical Technology by James Swarbrick Pdf
Presenting authoritative and engaging articles on all aspects of drug development, dosage, manufacturing, and regulation, this Third Edition enables the pharmaceutical specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and constant companion for years to com
Advanced Supercritical Fluids Technologies by Igor Pioro Pdf
Using SuperCritical Fluids (SCFs) in various processes is not new, because Mother Nature has been processing minerals in aqueous solutions at critical and supercritical pressures for billions of years. Somewhere in the 20th century, SCFs started to be used in various industries as working fluids, coolants, chemical agents, etc. Written by an international team of experts and complete with the latest research, development, and design, Advanced Supercritical Fluids Technologies is a unique technical book, completely dedicated to modern and advanced applications of supercritical fluids in various industries.Advanced Supercritical Fluids Technologies provides engineers and specialists in various industries dealing with SCFs as well as researchers, scientists, and students of the corresponding departments with a comprehensive overview of the current status, latest trends and developments of these technologies.Dr Igor Pioro is a professor at the University of Ontario Institute of Technology, Canada, and the Founding Editor of the ASME Journal of Nuclear Engineering and Radiation Science.
Quality by Design for Biopharmaceutical Drug Product Development by Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe Pdf
This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.
Generic Drug Product Development by Leon Shargel,Isadore Kanfer Pdf
Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products. The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.
Pharmaceutical Drug Product Development and Process Optimization by Sarwar Beg,Majed Al Robaian,Mahfoozur Rahman,Syed Sarim Imam,Nabil Alruwaili,Sunil Kumar Panda Pdf
Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.
Inhalation Aerosols by Anthony J. Hickey,Heidi M. Mansour Pdf
Inhalation aerosols continue to be the basis for successful lung therapy for several diseases, with therapeutic strategies and the range of technology significantly evolving in recent years. In response, this third edition takes a new approach to reflect the close integration of technology with its application. After briefly presenting the general considerations that apply to aerosol inhalation, the central section of the book uses the focus on disease and therapeutic agents to illustrate the application of specific technologies. The final integrated strategies section draws the major points from the applications for disease targets and drug products.
High Pressure Fluid Technology for Green Food Processing by Tiziana Fornari,Roumiana P. Stateva Pdf
The aim of this book is to present the fundamentals of high pressure technologies from the perspective of mass transfer phenomena and thermodynamic considerations. Novel food applications are exposed and their relation to chemical analysis, extraction, reaction and particle formation processes are outlined. The chapters are written by a diverse group of scientists with expertise in chemistry, food processes, analytical chemistry, chemical engineering and chemical engineering thermodynamics, and biotechnology. The mission of green food engineering is to promote innovative technologies that reduce or eliminate the use or generation of hazardous materials (solvents, reagents) in the design and operation of food related processes, with the view to improve food safety and quality. Several efficient, environmentally friendly and benign technologies based on the use of high pressure and green solvents have demonstrated to be sustainable alternatives to traditional processes in the food industry. Although hundreds of new ideas are being published in the open literature, reliable engineering tools to simulate and design those processes are still under development. High Pressure Fluid Technology for Green Food Processing presents in-depth analyses and outlines the ways towards their maturity. Tiziana Fornari, Research Institute of Food Science (CIAL) Universidad Autonoma de Madrid, Madrid, Spain Roumiana P. Stateva, Institute of Chemical Engineering, Bulgarian Academy of Sciences, Sofia, Bulgaria
Handbook of Pharmaceutical Granulation Technology by Dilip M. Parikh Pdf
The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the re
Supercritical Fluid Cleaning by Samuel P. Sawan Pdf
Although supercritial fluid (SCF) technology is now widely used in extraction and purification processes (in the petrochemical, food and pharmaceuticals industries), this book is the first to address the new application of cleaning. The objective is to provide a roadmap for readers who want to know whether SCF technology can meet their own processing and cleaning needs. It is particularly helpful to those striving to balance the requirements for a clean product and a clean environment. The interdisciplinary subject matter will appeal to scientists and engineers in all specialties ranging from materials and polymer sciences to chemistry and physics. It is also useful to those developing new processes for other applications, and references given at the end of each chapter provide links to the wider body of SCF literature. The book is organized with topics progressing from the fundamental nature of the supercritical state, through process conditions and materials interactions, to economic considerations. Practical examples are included to show how the technology has been successfully applied. The first four chapters consider principles governing SCF processing, detailing issues such as solubility, design for cleanability, and the dynamics of particle removal. The next three chapters discuss surfactants and microemulsions, SCF interaction with polymers, and the use of supercritical carbon dioxide (CO2) as a cleaning solvent. The closing chapters focus on more practical considerations such as scaleup, equipment costs, and financial analysis.
