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Dosage Form Design Parameters

Dosage Form Design Parameters Book
Author : Anonim
Publisher : Academic Press
Release : 2018-07-25
ISBN : 012814422X
Language : En, Es, Fr & De

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Book Description :

Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Dosage Form Design Considerations

Dosage Form Design Considerations Book
Author : Anonim
Publisher : Academic Press
Release : 2018-07-28
ISBN : 0128144246
Language : En, Es, Fr & De

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Book Description :

Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Innovative Dosage Forms

Innovative Dosage Forms Book
Author : Yogeshwar Bachhav
Publisher : John Wiley & Sons
Release : 2019-08-09
ISBN : 3527812202
Language : En, Es, Fr & De

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Book Description :

Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms Book
Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
Publisher : Academic Press
Release : 2016-11-08
ISBN : 0128026375
Language : En, Es, Fr & De

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Book Description :

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms Book
Author : Bhavishya Mittal
Publisher : Academic Press
Release : 2016-10-05
ISBN : 0128047321
Language : En, Es, Fr & De

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Book Description :

How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues

Pharmaceutical Dosage Forms and Drug Delivery

Pharmaceutical Dosage Forms and Drug Delivery Book
Author : Ram I. Mahato,Ajit S. Narang
Publisher : CRC Press
Release : 2007-06-07
ISBN : 1420009206
Language : En, Es, Fr & De

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Book Description :

Integrating aspects of physical pharmacy, biopharmaceuticals, drug delivery, and biotechnology, Pharmaceutical Dosage Forms and Drug Delivery elucidates basic physicochemical principles and their application in the design of dosage forms. The author addresses the relevance of these principles to the biopharmaceutical aspects of drugs. He explores the latest developments in the application of biomaterials, including polymers and biotechnology-based agents, to the development of novel dosage forms. The book covers physicochemical principles of dosage design, biopharmaceutical and physiological considerations, types of commonly used pharmaceutical dosage forms, introduction to polymeric biomaterials, protein and nucleic acid-based dosage forms, and novel and targeted drug delivery systems. It highlights the physicochemical parameters used for the design, development, and evaluation of biotechnological dosage forms and describes the biological barriers to drug absorption. Containing the right blend of mathematics, equations, diagrams, pictorials, and other pertinent information, this book provides a unified perspective that creates a greater overall understanding of basic science and cutting-edge technology.

Mucoadhesion of Chitosan and Derivatives

Mucoadhesion of Chitosan and Derivatives Book
Author : Ioannis Andrea Sogias
Publisher : Unknown
Release : 2009
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Understanding of chitosan solubility parameters, interactions with mucosal membranes and BCS class II drugs in formulations, targeting enhanced permeation and increased biovailability of poorly absorbable drugs.

Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms Book
Author : Larry L. Augsburger,Stephen W. Hoag
Publisher : CRC Press
Release : 2017-10-30
ISBN : 1351620398
Language : En, Es, Fr & De

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Book Description :

Pharmaceutical Dosage Forms: Capsules covers the development, composition, and manufacture of capsules. Despite the important role that capsules play in drug delivery and product development, few comprehensive texts on the science and technology of capsules have been available for the research and academic environments. This text addresses this gap, discussing how capsules provide unique capabilities and options for dosage form design and formulation.

Pharmaceutical Dosage Forms Parenteral Medications

Pharmaceutical Dosage Forms   Parenteral Medications Book
Author : Sandeep Nema,John D. Ludwig
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1420086464
Language : En, Es, Fr & De

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Book Description :

This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations. Volume two presents: • Chapters on aseptic facility design, environmental monitoring, and cleanroom operations. • A comprehensive chapter on pharmaceutical water systems. • A discussion of quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing. • A detailed chapter on processing of parenteral drug products (SVPs and LVPs). • Presentations on widely used sterilization technologies – steam, gas / chemical, radiation, filtration and dry heat. • An in-depth chapter on lyophilization.

Biomaterials and Bionanotechnology

Biomaterials and Bionanotechnology Book
Author : Anonim
Publisher : Academic Press
Release : 2019-05-29
ISBN : 0128144289
Language : En, Es, Fr & De

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Book Description :

Biomaterials and Bionanotechnology examines the current state of the field within pharmaceutical sciences and concisely explains the history of biomaterials including key developments. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biomaterials and bionanotechnology within drug discovery and drug development. Each chapter delves into a particular aspect of this fast-moving field to cover the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable dosage form, with particular focus on biomaterials and bionanomaterials. This book provides a comprehensive examination suitable for researchers working in the pharmaceutical, cosmetics, biotechnology, food and related industries as well as advanced students in these fields. Examines the most recent developments in biomaterials and nanomaterials for pharmaceutical sciences Covers important topics, such as the fundamentals of polymers science, transportation and bio interaction of properties in nanomaterials across biological systems, and nanotechnology in tissue engineering as they pertain specifically to pharmaceutical sciences Contains extensive references for further discovery on the role of biomaterials and nanomaterials in the drug discovery process

Integrated Pharmaceutics

Integrated Pharmaceutics Book
Author : Antoine Al-Achi,Mali Ram Gupta,William Craig Stagner
Publisher : John Wiley & Sons
Release : 2013-02-11
ISBN : 0470596929
Language : En, Es, Fr & De

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Book Description :

Focusing on the application of physical pharmacy, drug design, and drug regulations as they relate to produce effective dosage forms for drug delivery, Integrated Pharmaceutics provides a comprehensive picture of pharmaceutical product design, describing the science and art behind the concepts of dosage form development. Combining physical pharmacy, product design, and regulatory affairs issues in a single book, the authors address topics governing drug regulations of United States, European, and Japanese agencies and detail new regulatory guidelines, including quality by design, design space analysis, and blend sample uniformity.

Water Insoluble Drug Formulation

Water Insoluble Drug Formulation Book
Author : Ron Liu
Publisher : CRC Press
Release : 2008-01-18
ISBN : 9781420009552
Language : En, Es, Fr & De

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Book Description :

Scientists have attributed more than 40 percent of the failures in new drug development to poor biopharmaceutical properties, particularly water insolubility. Issues surrounding water insolubility can postpone, or completely derail, important new drug development. Even much-needed reformulation of currently marketed products can be significantly affected by these challenges. Water Insolubility is the Primary Culprit in over 40% of New Drug Development Failures The most comprehensive resource on the topic, this second edition of Water Insoluble Drug Formulation brings together a distinguished team of experts to provide the scientific background and step-by-step guidance needed to deal with solubility issues in drug development. Twenty-three chapters systematically describe solubility properties and their impact on formulation, from theory to industrial practice. With detailed discussion on how these properties contribute to solubilization and dissolution, the text also features six brand new chapters on water-insoluble drugs, exploring regulatory aspects, pharmacokinetic behavior, early phase formulation strategies, lipid based systems for oral delivery, modified release of insoluble drugs, and scalable manufacturing aspects. The book includes more than 15 water-insoluble drug delivery systems or technologies, illustrated with case studies featuring oral and parenteral applications. Highlighting the most current information and data available, this seminal volume reflects the significant progress that has been made in nearly all aspects of this field.

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry Book
Author : Mary T. am Ende,David J. am Ende
Publisher : John Wiley & Sons
Release : 2019-04-09
ISBN : 1119285496
Language : En, Es, Fr & De

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Book Description :

A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.

Pharmaceutical Dosage Forms and Drug Delivery Second Edition

Pharmaceutical Dosage Forms and Drug Delivery  Second Edition Book
Author : Ram I. Mahato,Ajit S. Narang
Publisher : CRC Press
Release : 2011-10-25
ISBN : 1439849196
Language : En, Es, Fr & De

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Book Description :

In the second edition of Pharmaceutical Dosage Forms and Drug Delivery the authors integrate aspects of physical pharmacy, biopharmaceuticals, drug delivery, and biotechnology, emphasizing the increased attention that the recent spectacular advances in dosage form design and drug delivery, gene therapy, and nanotechnology have brought to the field. Highlights of the Second Edition: Additional author Ajit S. Narang brings an industrial practitioner perspective with increased focus on pharmacy math and statistics, and powders and granules Reorganized into three parts: Introduction, Physicochemical Principles, and Dosage Forms Chapters on pharmaceutical calculations, compounding principles, and powders and granules provide a complete spectrum of application of pharmaceutical principles Expansion of review questions and answers clarifies concepts for students and adds to their grasp of key concepts covered in the chapter Coverage of complexation and protein binding aspects of physical pharmacy includes the basic concepts as well as recent progress in the field Although there are numerous books on the science of pharmaceutics and dosage form design, most cover different areas of the discipline and do not provide an integrated approach to the topics. This book not only provides a singular perspective of the overall field, but it supplies a unified source of information for students, instructors, and professionals.

Pharmaceutical Dosage Forms Parenteral Medications

Pharmaceutical Dosage Forms   Parenteral Medications Book
Author : Sandeep Nema,John D. Ludwig
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1420086480
Language : En, Es, Fr & De

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Book Description :

This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations. Volume three presents: • An in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables. • Specific chapters on parenteral administrations devices, injection site pain assessment, and parenteral product specifications and stability testing. • Forward-thinking discussions on the future of parenteral product manufacturing, and siRNA delivery systems. • New chapters covering recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), and validation of drug product manufacturing process.

Pharmaceutical Dosage Forms and Drug Delivery

Pharmaceutical Dosage Forms and Drug Delivery Book
Author : Ram I. Mahato,Ajit S. Narang
Publisher : CRC Press
Release : 2007-06-07
ISBN : 9780849392856
Language : En, Es, Fr & De

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Book Description :

Integrating aspects of physical pharmacy, biopharmaceuticals, drug delivery, and biotechnology, Pharmaceutical Dosage Forms and Drug Delivery elucidates basic physicochemical principles and their application in the design of dosage forms. The author addresses the relevance of these principles to the biopharmaceutical aspects of drugs. He explores the latest developments in the application of biomaterials, including polymers and biotechnology-based agents, to the development of novel dosage forms. The book covers physicochemical principles of dosage design, biopharmaceutical and physiological considerations, types of commonly used pharmaceutical dosage forms, introduction to polymeric biomaterials, protein and nucleic acid-based dosage forms, and novel and targeted drug delivery systems. It highlights the physicochemical parameters used for the design, development, and evaluation of biotechnological dosage forms and describes the biological barriers to drug absorption. Containing the right blend of mathematics, equations, diagrams, pictorials, and other pertinent information, this book provides a unified perspective that creates a greater overall understanding of basic science and cutting-edge technology.

Drug Delivery Systems

Drug Delivery Systems Book
Author : Anonim
Publisher : Academic Press
Release : 2019-10-23
ISBN : 0128145080
Language : En, Es, Fr & De

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Book Description :

Drug Delivery Systems examines the current state of the field within pharmaceutical science and concisely explains the history of drug delivery systems, including key developments. The book translates the physicochemical properties of drugs into drug delivery systems administered via various routes, such as oral, parenteral, transdermal and inhalational. Regulatory and product development topics are also explored. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of drug delivery systems within the pharmaceutical sciences industry and research, as well as in chemical engineering. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists. This book provides a comprehensive examination that is suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnologies, and related industries. Provides up-to-date information on how to translate the physicochemical properties of drugs into drug delivery systems Explores how drugs are administered via various routes, such as oral, parenteral, transdermal and inhalational Contains extensive references and further reading for course and self-study

Extended Release Dosage Forms

Extended Release Dosage Forms Book
Author : Laezek Krowczynski
Publisher : CRC Press
Release : 2020-03-25
ISBN : 1000083632
Language : En, Es, Fr & De

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Book Description :

First Published in 1987, this book offers a full, comprehensive guide to the process of administering the correct dosage in medicine. Carefully compiled and filled with a vast repertoire of notes, diagrams, and references this book serves as a useful reference for students of medicine, and other practitioners in their respective fields.

Theory and Practice of Contemporary Pharmaceutics

Theory and Practice of Contemporary Pharmaceutics Book
Author : Tapash K. Ghosh,Bhaskara R. Jasti
Publisher : CRC Press
Release : 2021-02-25
ISBN : 1134441959
Language : En, Es, Fr & De

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Book Description :

With a shift toward problem-based learning and critical thinking in many health science fields, professional pharmacy training faces a shift in focus as well. Although the Accreditation Council for Pharmacy Education (ACPE) has recently suggested guidelines for problem solving to be better integrated into pharmacy curriculum, pharmacy books currently available either address this material inadequately or lack it completely. Theory and Practice of Contemporary Pharmaceutics addresses this problem by challenging pharmacy students to think critically in preparation for situations that arise in clinical practice. This book offers a wealth of up-to-date information, organized in a logical sequence, corresponding to the art and science required for formulators in industry and dispensing pharmacists in the community. It breaks down the subject to its simplest form and includes numerous examples, case studies, and problems. In addition to presenting basic scientific principles, each chapter includes a self-evaluation tutorial designed to help you evaluate your understanding of the subject matter, numerical problems that provide practice in finding mathematical solutions, and case studies that measure your overall grasp of the subject matter by challenging you to craft a plausible solution to a real-life scenario using the concepts presented in that chapter. Written by authors selected from academia, industry, and regulatory agencies, the book presents an objective and balanced view of pharmaceutical science and its application. The authors' insights are extremely helpful to pharmacy students as well as practicing pharmacists involved in the development and/or dispensation of existing and new generation biotechnology-based drug products. This simplified and user-friendly book will present pharmaceutics in a way that it has never been presented before and will help prepare students and pharmacists for the competitive and challenging nature of the professional market.