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Dosage Form Design Considerations

Dosage Form Design Considerations
Author:
Publisher: Academic Press
Total Pages: 820
Release: 2018-07-28
Genre: Medical
ISBN: 0128144246

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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


Dosage Form Design Parameters

Dosage Form Design Parameters
Author:
Publisher: Academic Press
Total Pages: 810
Release: 2018-07-25
Genre: Medical
ISBN: 012814422X

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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


How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms
Author: Bhavishya Mittal
Publisher: Academic Press
Total Pages: 192
Release: 2016-10-05
Genre: Medical
ISBN: 0128047321

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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 Quality by Design

Pharmaceutical Quality by Design
Author: Sarwar Beg
Publisher: Academic Press
Total Pages: 448
Release: 2019-03-27
Genre: Business & Economics
ISBN: 0128163720

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Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies


Innovative Dosage Forms

Innovative Dosage Forms
Author: Yogeshwar Bachhav
Publisher: John Wiley & Sons
Total Pages: 470
Release: 2019-12-04
Genre: Science
ISBN: 3527343962

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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.


FASTtrack Pharmaceutics Dosage Form and Design, 2nd edition

FASTtrack Pharmaceutics Dosage Form and Design, 2nd edition
Author: David S. Jones
Publisher: Pharmaceutical Press
Total Pages: 433
Release: 2016-06-13
Genre: Medical
ISBN: 0857110780

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FASTtrack Pharmaceutics – Dosage Form and Design focuses on what you really need to know in order to pass your pharmacy exams. It provides concise, bulleted information, key points, tips and an all-important self-assessment section, including MCQs.


Sample Preparation of Pharmaceutical Dosage Forms

Sample Preparation of Pharmaceutical Dosage Forms
Author: Beverly Nickerson
Publisher: Springer Science & Business Media
Total Pages: 400
Release: 2011-08-05
Genre: Medical
ISBN: 1441996311

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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.


Pharmaceutical Dosage Forms - Parenteral Medications

Pharmaceutical Dosage Forms - Parenteral Medications
Author: Sandeep Nema
Publisher: CRC Press
Total Pages: 328
Release: 2016-04-19
Genre: Medical
ISBN: 1420086480

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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 Dosage Forms and Drug Delivery

Pharmaceutical Dosage Forms and Drug Delivery
Author: Ram I. Mahato
Publisher: CRC Press
Total Pages: 334
Release: 2007-06-07
Genre: Medical
ISBN: 1420009206

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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.


Handbook of Pharmaceutical Salts Properties, Selection, and Use

Handbook of Pharmaceutical Salts Properties, Selection, and Use
Author: P. Heinrich Stahl
Publisher: John Wiley & Sons
Total Pages: 392
Release: 2008-08-04
Genre: Medical
ISBN: 9783906390581

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This comprehensive up-to-date guide and information source is an instructive companion for all scientists involved in research and development of drugs and, in particular, of pharmaceutical dosage forms. The editors have taken care to address every conceivable aspect of the preparation of pharmaceutical salts and present the necessary theoretical foundations as well as a wealth of detailed practical experience in the choice of pharmaceutically active salts. Altogether, the contributions reflect the multidisciplinary nature of the science involved in selection of suitable salt forms for new drug products.