January 26, 2021

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Dosage Form Design Parameters

Dosage Form Design Parameters
Author : Anonim
Publisher : Academic Press
Release Date : 2018-07-25
Category : Medical
Total pages :810
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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
Author : Anonim
Publisher : Academic Press
Release Date : 2018-07-28
Category : Medical
Total pages :820
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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

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
Publisher : Academic Press
Release Date : 2009-03-10
Category : Medical
Total pages :978
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Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

Innovative Dosage Forms

Innovative Dosage Forms
Author : Yogeshwar Bachhav
Publisher : John Wiley & Sons
Release Date : 2019-10-28
Category : Science
Total pages :472
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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.

Pharmaceutical Dosage Forms and Drug Delivery

Pharmaceutical Dosage Forms and Drug Delivery
Author : Ram I. Mahato,Ajit S. Narang
Publisher : CRC Press
Release Date : 2007-06-07
Category : Medical
Total pages :336
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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.

How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms
Author : Bhavishya Mittal
Publisher : Academic Press
Release Date : 2016-10-05
Category : Medical
Total pages :190
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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 Drug Product Development and Process Optimization

Pharmaceutical Drug Product Development and Process Optimization
Author : Sarwar Beg,Majed Al Robaian,Mahfoozur Rahman,Syed Sarim Imam,Nabil Alruwaili,Sunil Kumar Panda
Publisher : CRC Press
Release Date : 2020-05-01
Category : Business & Economics
Total pages :354
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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.

Pharmaceutical Preformulation and Formulation

Pharmaceutical Preformulation and Formulation
Author : Mark Gibson
Publisher : CRC Press
Release Date : 2016-04-19
Category : Medical
Total pages :560
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Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the need for advanced information for drug preformulation and formulation and addresses the current trends in the continually evolving pharmaceutical industry. Topics include: Candidate drug selection Drug discovery and development Preformulation predictions and drug selections Product design to commercial dosage form Biopharmaceutical support in formulation Development The book is ideal for practitioners working in the pharmaceutical arena—including R&D scientists, technicians, and managers—as well as for undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology.

Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms

Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms
Author : Linda A. Felton
Publisher : CRC Press
Release Date : 2016-09-19
Category : Medical
Total pages :400
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Aqueous-based film coating has become routine in the pharmaceutical industry. This process eliminates the use of organic solvents and thus avoids economic, environmental, and toxicological issues related to residual solvents and solvent recovery. Aqueous-based coating, however, is complex and many variables may impact the final product and its performance. This fourth edition of Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms aims to provide insight into the factors and parameters that should be considered and controlled for the successful development and commercialization of a coated product. The fourth edition has been revised and expanded to reflect the most recent scientific advancements from the literature. The contributing authors explain in detail, using illustrated examples, appropriate steps to solve and ideally avoid formulation, processing, and stability problems and to achieve an optimized dosage form. Trade names and chemical names of commercially marketed coatings are used throughout the text to help familiarize the reader with the various materials available for pharmaceutical applications. This book will be a valuable resource for anyone in the pharmaceutical industry working in the area of aqueous-based film coating.

Pharmaceutical Dosage Forms and Drug Delivery, Second Edition

Pharmaceutical Dosage Forms and Drug Delivery, Second Edition
Author : Ram I. Mahato,Ajit S. Narang
Publisher : CRC Press
Release Date : 2011-10-25
Category : Medical
Total pages :512
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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.

Sample Preparation of Pharmaceutical Dosage Forms

Sample Preparation of Pharmaceutical Dosage Forms
Author : Beverly Nickerson
Publisher : Springer Science & Business Media
Release Date : 2011-08-05
Category : Medical
Total pages :397
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This book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods. These are critical activities in providing accurate and reliable data throughout the lifecycle of a drug product. This book is divided into four parts: • Part One covers dosage form and diluent properties that impact sample preparation of pharmaceutical dosage forms and the importance of sampling considerations in generating data representative of the drug product batch. • Part Two reviews specific sample preparation techniques typically used with pharmaceutical dosage forms. • Part Three discusses sample preparation method development for different types of dosage forms including addressing drug excipient interactions and post extraction considerations, as well as method validation and applying Quality by Design (QbD) principles to sample preparation methods. • Part Four examines additional topics in sample preparation including automation, investigating aberrant potency results, green chemistry considerations for sample preparation and the ideal case where no sample preparation is required for sample analysis.

Controlled Drug Release Of Oral Dosage Forms

Controlled Drug Release Of Oral Dosage Forms
Author : Jean-Maurice Vergnaud
Publisher : CRC Press
Release Date : 1993-07-31
Category : Medical
Total pages :410
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Numerical analysis of matter transfer is an area that pharmacists find difficult, but which is a technique frequently used in preparing controlled drug release and oral dosage forms. This book provides clear and straightforward information enabling the reader to carry out numerical analysis of matter transfer - a vital processs when looking at the formulation of oral dosage forms with controlled drug release. The drug is dispersed in a polymeric matrix either biodegradable or not, the basis of which is the transfer of the liquid and the drug through dosage form. Information on this diffusion is found either through mathematical treatment when the problem is simple, or through numerical analysis for more complex problems. Professor Vergnaud demonstrates and clarifies these, modelling the process of drug delivery by using numerical analysis and computerization. A simulation of the process is provided, together with a determination of the effects of all parameters, and the author uses both mathematical and numerical models to predict the preparation of new dosage forms able to fulfil specific conditions.

Pharmaceutical Dosage Forms - Tablets

Pharmaceutical Dosage Forms - Tablets
Author : Larry L. Augsburger,Stephen W. Hoag
Publisher : CRC Press
Release Date : 2016-04-19
Category : Medical
Total pages :1552
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The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients. Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive resource of the design, formulation, manufacture, and evaluation of the tablet dosage form, an

ADME Processes in Pharmaceutical Sciences

ADME Processes in Pharmaceutical Sciences
Author : Alan Talevi,Pablo A. M. Quiroga
Publisher : Springer
Release Date : 2018-11-30
Category : Medical
Total pages :362
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Absorption, Distribution, Metabolism and Excretion (ADME) processes and their relationship with the design of dosage forms and the success of pharmacotherapy form the basis of this upper level undergraduate/graduate textbook. As an introduction oriented to pharmacy students, it is also written for scientist from different fields outside of pharmaceutics. (e.g. material scientist, material engineers, medicinal chemists) who might be working in a positions in pharmaceutical companies or whose work might benefit from basic training in the ADME concepts and some biological background. Pedagogical features such as objectives, keywords, discussion questions, summaries and case studies add valuable teaching tools. This book will provide not only general knowledge on ADME processes but also an updated insight on some hot topics such as drug transporters, multi-drug resistance related to pharmacokinetic phenomena, last generation pharmaceutical carriers (nanopharmaceuticals), in vitro and in vivo bioequivalence studies, biopharmaceuticals, pharmacogenomics, drug-drug and food-drug interactions, and in silico and in vitro prediction of ADME properties. In comparison with other similar textbooks, around half of the volume would be focused on the relationship between expanding scientific fields and ADME processes. Each of these burgeoning fields has a separate chapter in the second part of the volume, and was written with leading experts on the correspondent topic, including scientists and academics from USA and UK (Duquesne University School of Pharmacy, Indiana University School of Medicine, University of Utah College of Pharmacy, University of Maryland, University of Bath). Additionally, each of the initial chapters dealing with the generalities of drug absorption, distribution, metabolism and excretion would include relevant, classic examples related to each topic with appropriate illustrations (e.g. importance of active absorption of levodopa, implications in levodopa administration, drug drug interactions and food drug interactions emerging from the active uptake; intoxication with paracetamol as a result of glutathione depletion, CYP induction and its relationship with acute liver failure caused by paracetamol, etc). ADME Processes and Pharmaceutical Sciences is written as a core textbook for ADME processes, pharmacy, pharmacokinetics, drug delivery, biopharmaceutics, drug disposition, drug design and medicinal chemistry courses.

Current Concepts in the Pharmaceutical Sciences: Dosage Form Design and Bioavailability

Current Concepts in the Pharmaceutical Sciences: Dosage Form Design and Bioavailability
Author : James Swarbrick
Publisher : Unknown
Release Date : 1973
Category : Biopharmaceutics
Total pages :230
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