Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
Author: Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
Publsiher: Academic Press
Total Pages: 978
Release: 2009-03-10
ISBN 10: 9780080932729
ISBN 13: 008093272X
Language: EN, FR, DE, ES & NL

Developing Solid Oral Dosage Forms Book Review:

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

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
Author: Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
Publsiher: Academic Press
Total Pages: 1176
Release: 2016-11-08
ISBN 10: 0128026375
ISBN 13: 9780128026373
Language: EN, FR, DE, ES & NL

Developing Solid Oral Dosage Forms Book Review:

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

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
Author: Yihong Qiu,Geoff G. Z. Zhang
Publsiher: Academic Press
Total Pages: 943
Release: 2009
ISBN 10: 9780444532428
ISBN 13: 0444532420
Language: EN, FR, DE, ES & NL

Developing Solid Oral Dosage Forms Book Review:

This book 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

How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms
Author: Bhavishya Mittal
Publsiher: Academic Press
Total Pages: 190
Release: 2016-10-05
ISBN 10: 0128047321
ISBN 13: 9780128047323
Language: EN, FR, DE, ES & NL

How to Develop Robust Solid Oral Dosage Forms Book Review:

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

Generic Drug Product Development

Generic Drug Product Development
Author: Leon Shargel,Isadore Kanfer
Publsiher: CRC Press
Total Pages: 397
Release: 2013-10-24
ISBN 10: 1420086367
ISBN 13: 9781420086362
Language: EN, FR, DE, ES & NL

Generic Drug Product Development Book Review:

In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral

Sample Preparation of Pharmaceutical Dosage Forms

Sample Preparation of Pharmaceutical Dosage Forms
Author: Beverly Nickerson
Publsiher: Springer Science & Business Media
Total Pages: 397
Release: 2011-08-05
ISBN 10: 9781441996312
ISBN 13: 1441996311
Language: EN, FR, DE, ES & NL

Sample Preparation of Pharmaceutical Dosage Forms Book Review:

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.

Pharmaceutical Preformulation and Formulation

Pharmaceutical Preformulation and Formulation
Author: Mark Gibson
Publsiher: CRC Press
Total Pages: 560
Release: 2016-04-19
ISBN 10: 1420073184
ISBN 13: 9781420073188
Language: EN, FR, DE, ES & NL

Pharmaceutical Preformulation and Formulation Book Review:

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.

Formulation and Analytical Development for Low Dose Oral Drug Products

Formulation and Analytical Development for Low Dose Oral Drug Products
Author: Jack Zheng
Publsiher: John Wiley & Sons
Total Pages: 432
Release: 2009-03-04
ISBN 10: 9780470386354
ISBN 13: 0470386355
Language: EN, FR, DE, ES & NL

Formulation and Analytical Development for Low Dose Oral Drug Products Book Review:

There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

Solid state Chemistry of Drugs

Solid state Chemistry of Drugs
Author: Stephen R. Byrn
Publsiher: Ssci Incorporated
Total Pages: 574
Release: 1999
ISBN 10:
ISBN 13: UOM:39015050244899
Language: EN, FR, DE, ES & NL

Solid state Chemistry of Drugs Book Review:

Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms

Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms
Author: Linda A. Felton
Publsiher: CRC Press
Total Pages: 400
Release: 2016-09-19
ISBN 10: 1315352923
ISBN 13: 9781315352923
Language: EN, FR, DE, ES & NL

Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms Book Review:

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.

In Vitro In Vivo Correlations

In Vitro In Vivo Correlations
Author: David B. Young,John G. Devane,Jackie Butler
Publsiher: Springer Science & Business Media
Total Pages: 300
Release: 2013-03-08
ISBN 10: 1468460366
ISBN 13: 9781468460360
Language: EN, FR, DE, ES & NL

In Vitro In Vivo Correlations Book Review:

This book represents the invited presentations and some of the posters presented at the conference entitled "In Vitro-In Vivo Relationship (IVIVR) Workshop" held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development.

Innovative Dosage Forms

Innovative Dosage Forms
Author: Yogeshwar Bachhav
Publsiher: John Wiley & Sons
Total Pages: 472
Release: 2019-10-28
ISBN 10: 3527343962
ISBN 13: 9783527343966
Language: EN, FR, DE, ES & NL

Innovative Dosage Forms Book Review:

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.

Solid Oral Dose Process Validation

Solid Oral Dose Process Validation
Author: Ajay Babu Pazhayattil,Naheed Sayeed-Desta,Emilija Fredro-Kumbaradzi,Jordan Collins
Publsiher: Springer
Total Pages: 92
Release: 2018-11-16
ISBN 10: 3030024725
ISBN 13: 9783030024727
Language: EN, FR, DE, ES & NL

Solid Oral Dose Process Validation Book Review:

Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance’s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.

Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations
Author: Safaraz K. Niazi
Publsiher: CRC Press
Total Pages: 464
Release: 2016-04-19
ISBN 10: 1420081314
ISBN 13: 9781420081312
Language: EN, FR, DE, ES & NL

Handbook of Pharmaceutical Manufacturing Formulations Book Review:

No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster

Essential Pharmaceutics

Essential Pharmaceutics
Author: Ashlee D. Brunaugh,Hugh D. C. Smyth,Robert O. Williams III
Publsiher: Springer Nature
Total Pages: 193
Release: 2019-11-05
ISBN 10: 3030317455
ISBN 13: 9783030317454
Language: EN, FR, DE, ES & NL

Essential Pharmaceutics Book Review:

Particularly in healthcare fields, there is growing movement away from traditional lecture style course towards active learning and team-based activities to improve learning and build higher level thinking through application of complex problems with a strong foundation of facts and data. Essential Pharmaceutics is suited to this modern teaching style, and is the first book of its kind to provide the resources and skills needed for successful implementation of an active learning pharmaceutics course.This text offers a format that is specifically suited for integration in an active learning, team-based classroom setting. It is ideal for self-learning for the beginning pharmaceutics student, based upon the extensive utilization of figures, tables, and its overview of essential topics in pharmaceutics. Also unique to this text is the integration of case studies based upon modern pharmaceutical products which are designed to reinforce importance pharmaceutical concepts and teach essential skills in literature review and patent searching. Case studies covering all topics covered in the text have been developed by the authors that allow application of the content in the flipped-classroom pharmaceutical course.

In Vitro Drug Release Testing of Special Dosage Forms

In Vitro Drug Release Testing of Special Dosage Forms
Author: Nikoletta Fotaki,Sandra Klein
Publsiher: John Wiley & Sons
Total Pages: 312
Release: 2019-10-11
ISBN 10: 1118675835
ISBN 13: 9781118675830
Language: EN, FR, DE, ES & NL

In Vitro Drug Release Testing of Special Dosage Forms Book Review:

Guides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at the site of application and the site of drug release. This unique book is the first to cover the field of in vitro release testing of special dosage forms in one volume. Featuring contributions from an international team of experts, it presents the state of the art of the use of in vitro drug release methodologies for assessing special dosage forms’ performances and describes the different techniques required for each one. In Vitro Drug Release Testing of Special Dosage Forms covers the in vitro release testing of: lipid based oral formulations; chewable oral drug products; injectables; drug eluting stents; inhalation products; transdermal formulations; topical formulations; vaginal and rectal delivery systems and ophthalmics. The book concludes with a look at regulatory aspects. Covers both oral and non-oral dosage forms Describes current regulatory conditions for in vitro drug release testing Features contributions from well respected global experts in dissolution testing In Vitro Drug Release Testing of Special Dosage Forms will find a place on the bookshelves of anyone working with special dosage forms, dissolution testing, drug formulation and delivery, pharmaceutics, and regulatory affairs.

Pharmaceutical Dosage Forms Tablets

Pharmaceutical Dosage Forms   Tablets
Author: Larry L. Augsburger,Stephen W. Hoag
Publsiher: CRC Press
Total Pages: 1552
Release: 2016-04-19
ISBN 10: 1420063863
ISBN 13: 9781420063868
Language: EN, FR, DE, ES & NL

Pharmaceutical Dosage Forms Tablets Book Review:

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

The Medicinal Plant Industry

The Medicinal Plant Industry
Author: R. O. B. Wijesekera
Publsiher: Routledge
Total Pages: 280
Release: 2017-07-12
ISBN 10: 1351409859
ISBN 13: 9781351409858
Language: EN, FR, DE, ES & NL

The Medicinal Plant Industry Book Review:

As the medicinal plant industry blooms into a billion dollar business, it reaches beyond collection, propagation, harvesting and sale of crude vegetal drugs into product formulation, packaging and dispensing of sophisticated phyto-pharmaceuticals and herbal preparations. The scientific study of these medicines and the systematic uplifting of the industry to preserve the ancient and serve the modern, is now a global challenge. The Medicinal Plant Industry puts together the various facets of this multi-disciplinary industry and its global interest. It discusses the dire need for developing countries to acquire technologies and techniques for programmed cultivation of medicinal plants. It addresses a wide variety of topics including the old philosophies, modern impact of traditional medicines, and methods of assessing the spontaneous flora for industrial utilization. It covers aspects of cultivation and climatic variations, biological assessment and formulation, process technologies, phytochemical research and information sources. The book reviews highly developed traditional medicine in China and India, and covers experiences in Africa and other continents.

FDA Bioequivalence Standards

FDA Bioequivalence Standards
Author: Lawrence X. Yu,Bing V. Li
Publsiher: Springer
Total Pages: 465
Release: 2014-09-05
ISBN 10: 1493912526
ISBN 13: 9781493912520
Language: EN, FR, DE, ES & NL

FDA Bioequivalence Standards Book Review:

This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.

Oral Controlled Release Formulation Design and Drug Delivery

Oral Controlled Release Formulation Design and Drug Delivery
Author: Hong Wen,Kinam Park
Publsiher: John Wiley & Sons
Total Pages: 376
Release: 2011-01-14
ISBN 10: 9781118060322
ISBN 13: 1118060326
Language: EN, FR, DE, ES & NL

Oral Controlled Release Formulation Design and Drug Delivery Book Review:

This book describes the theories, applications, and challenges for different oral controlled release formulations. This book differs from most in its focus on oral controlled release formulation design and process development. It also covers the related areas like preformulation, biopharmaceutics, in vitro-in vivo correlations (IVIVC), quality by design (QbD), and regulatory issues.