Prof. of Drug Substances, Excipients and Related Methodology
Prof. of Drug Substances, Excipients and Related Methodology

Author: Abdulrahman Al-Majed

Publisher: Academic Press

Published: 2021-01-16

Total Pages: 328

ISBN-13: 0128241284

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Profiles of Drug Substances, Excipients, and Related Methodology, Volume 46 contains comprehensive profiles of five drug compounds: Darunavir, Bisoprolol, Betaxolol, Rabeprazole and Irbesartan. In addition, the work contains a chapter reviewing Bioassay Methods and Their Applications in Herbal Drug Research. The comprehensive reviews in the book cover all aspects of drug development and the formulation of drugs, helping readers understand how the drug development community remains essential to all phases of pharmaceutical development. In addition, this work answers why such profiles are of immeasurable importance to workers in the field. The scope of the Profiles series encompasses review articles and database compilations that fall within one or more of the following five broad categories: Physical Profiles of Drug Substances and Excipients, Analytical Profiles of Drug Substances and Excipients, ADME Profiles of Drug Substances and Excipients, Methodology Related to the Characterization of Drug Substances and Excipients, and Methods of Chemical Synthesis. - Contains contributions from leading authorities - Presents an excellent overview on the physical, chemical and biomedical properties of some regularly prescribed drugs - Includes a cumulative index in each volume

Profiles of Drug Substances, Excipients and Related Methodology
Profiles of Drug Substances, Excipients and Related Methodology

Author: Harry G. Brittain

Publisher: Academic Press

Published: 2011-07-15

Total Pages: 399

ISBN-13: 0123877024

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Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients. - Presents comprehensive reviews covering all aspects of drug development and formulation of drugs - Profiles creatine monohydrate and fexofenadine hydrochloride, as well as five others - Meets the information needs of the drug development community

Profiles of Drug Substances, Excipients, and Related Methodology
Profiles of Drug Substances, Excipients, and Related Methodology

Author: Abdulrahman Al-Majed

Publisher: Academic Press

Published: 2022-04-06

Total Pages: 400

ISBN-13: 0323854834

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Profiles of Drug Substances, Excipients, and Related Methodology, Volume 47 covers all aspects of drug development and formulation of drugs, meeting the information needs of the drug development community that are essential to all phases of pharmaceutical development. This updated release includes comprehensive profiles of five drug compounds: Vinpocetine; Loratadine; Ticagrelor; Lodenafil; Danazol. The volume also contains a chapter reviewing "Application of Chemometrics using direct Spectroscopic methods as a QC tool in Pharmaceutical Industry and their Validation. - Contains contributions from leading authorities - Presents an excellent overview of the physical, chemical and biomedical properties of regularly prescribed drugs - Contains a cumulative index for easy access to information

Profiles of Drug Substances, Excipients and Related Methodology
Profiles of Drug Substances, Excipients and Related Methodology

Author: Harry G. Brittain

Publisher: Academic Press

Published: 2010-02-27

Total Pages: 407

ISBN-13: 0123808855

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Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients. - Presents comprehensive reviews covering all aspects of drug development and formulation of drugs - Profiles creatine monohydrate and fexofenadine hydrochloride, as well as five others - Meets the information needs of the drug development community

Pharmaceutical Excipients
Pharmaceutical Excipients

Author: Otilia M. Y. Koo

Publisher: John Wiley & Sons

Published: 2016-10-03

Total Pages: 369

ISBN-13: 1118992423

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This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients

Analytical Profiles of Drug Substances and Excipients
Analytical Profiles of Drug Substances and Excipients

Author:

Publisher: Academic Press

Published: 1994-09-05

Total Pages: 625

ISBN-13: 0080861180

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Although the official compendia define a drug substance as to identity, purity, strength, and quality, they normally do not provide other physical or chemical data, nor do they list methods of synthesis or pathways of physical or biological degradation and metabolism. Such information is scattered throughout the scientific literature and the files of pharmaceutical laboratories. Edited by the Associate Director of Analytical Research and Development for the AmericanAssociation of Pharmaceutical Scientists, Analytical Profiles of Drug Substances and Excipients brings this information together into one source. The scope of the series has recently been expanded to include profiles of excipient materials.

Excipient Applications in Formulation Design and Drug Delivery
Excipient Applications in Formulation Design and Drug Delivery

Author: Ajit S Narang

Publisher: Springer

Published: 2015-10-07

Total Pages: 700

ISBN-13: 3319202065

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In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.

Formulation and Analytical Development for Low-Dose Oral Drug Products
Formulation and Analytical Development for Low-Dose Oral Drug Products

Author: Jack Zheng

Publisher: John Wiley & Sons

Published: 2009-02-09

Total Pages: 506

ISBN-13: 0470056096

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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.

Pharmaceutical Quality by Design
Pharmaceutical Quality by Design

Author: Walkiria S. Schlindwein

Publisher: John Wiley & Sons

Published: 2018-01-05

Total Pages: 319

ISBN-13: 1118895215

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A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.