How To Develop Robust Solid Oral Dosage Forms
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How To Develop Robust Solid Oral Dosage Forms
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Author : Bhavishya Mittal
language : en
Publisher: Academic Press
Release Date : 2016-10-05
How To Develop Robust Solid Oral Dosage Forms written by Bhavishya Mittal and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-10-05 with Medical categories.
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
Developing Solid Oral Dosage Forms
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Author : Yihong Qiu
language : en
Publisher: Academic Press
Release Date : 2009-03-10
Developing Solid Oral Dosage Forms written by Yihong Qiu and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-03-10 with Medical categories.
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
Generic Drug Product Development
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Author : Leon Shargel
language : en
Publisher: CRC Press
Release Date : 2013-10-24
Generic Drug Product Development written by Leon Shargel and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10-24 with Medical categories.
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 Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. Major topics discussed include: Active pharmaceutical ingredients Experimental formulation development, including a new section on Quality by Design (QbD) Scale-up Commercial product formulation Quality control and bioequivalence Drug product performance ANDA regulatory process Post-approval changes Post-marketing surveillance Legislative and patent challenges This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.
Generic Drug Product Development
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Author : Leon Shargel
language : en
Publisher: CRC Press
Release Date : 2004-12-28
Generic Drug Product Development written by Leon Shargel and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-12-28 with Medical categories.
Keeping pace with the latest technologies in the field, this guide describes the development of solid oral generic drug products from project initiation to market approval. Focusing on immediate-release and modified-release dosage forms, the book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulation, pharmaceutical ingredients, and bioequivalence, and considers key elements in the formulation of generic drug products including the availability of raw materials, chemical purity. It also highlights constraints in generic drug development that differ from the formulation design of a brand name pharmaceutical product.
Sample Preparation Of Pharmaceutical Dosage Forms
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Author : Beverly Nickerson
language : en
Publisher: Springer Science & Business Media
Release Date : 2011-08-05
Sample Preparation Of Pharmaceutical Dosage Forms written by Beverly Nickerson and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-08-05 with Medical categories.
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.
Design Of Experiments For Pharmaceutical Product Development
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Author : Sarwar Beg
language : en
Publisher: Springer Nature
Release Date : 2021-01-22
Design Of Experiments For Pharmaceutical Product Development written by Sarwar Beg and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-22 with Medical categories.
This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development. It discusses the applications of experimental designs that shall include oral, topical, transdermal, injectables preparations, and beyond for nanopharmaceutical product development, leading to dedicated case studies on various pharmaceutical experiments through illustrations, art-works, tables and figures. This book is a valuable guide for all academic and industrial researchers, pharmaceutical and biomedical scientists, undergraduate and postgraduate research scholars, pharmacists, biostatisticians, biotechnologists, formulations and process engineers, regulatory affairs and quality assurance personnel.
Solid Oral Dose Process Validation
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Author : Ajay Babu Pazhayattil
language : en
Publisher: Springer
Release Date : 2018-11-16
Solid Oral Dose Process Validation written by Ajay Babu Pazhayattil and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-11-16 with Medical categories.
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.
Innovative Dosage Forms
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Author : Yogeshwar Bachhav
language : en
Publisher: John Wiley & Sons
Release Date : 2019-12-04
Innovative Dosage Forms written by Yogeshwar Bachhav and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-12-04 with Science categories.
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.
Long Acting Animal Health Drug Products
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Author : Michael J. Rathbone
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-10-11
Long Acting Animal Health Drug Products written by Michael J. Rathbone and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-10-11 with Medical categories.
Long acting veterinary formulations play a significant role in animal health, production and reproduction within the animal health industry. Such technologies offer beneficial advantages to the veterinarian, farmer and pet owner. These advantages have resulted in them growing in popularity in recent years. The pharmaceutical scientist is faced with many challenges when innovating new products in this demanding field of controlled release. This book provides the reader with a comprehensive guide on the theories, applications, and challenges associated with the design and development of long acting veterinary formulations. The authoritative chapters of the book are written by some of the leading experts in the field. The book covers a wide scope of areas including the market influences, preformulation, biopharmaceutics, in vitro drug release testing and specification setting to name but a few. It also provides a detailed overview of the major technological advances made in this area. As a result this book covers everything a formulation scientist in industry or academia, or a student needs to know about this unique drug delivery field to advance health, production and reproduction treatment options and benefits for animals worldwide.
Process Systems Engineering For Pharmaceutical Manufacturing
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Author : Ravendra Singh
language : en
Publisher: Elsevier
Release Date : 2018-03-16
Process Systems Engineering For Pharmaceutical Manufacturing written by Ravendra Singh and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-16 with Technology & Engineering categories.
Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes. Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering. Introduces Process System Engineering (PSE) methods and tools for discovering, developing and deploying greener, safer, cost-effective and efficient pharmaceutical production processes Includes a wide spectrum of case studies where different PSE tools and methods are used to improve various pharmaceutical production processes with distinct final products Examines the future benefits and challenges for applying PSE methods and tools to pharmaceutical manufacturing