Sample Preparation of Pharmaceutical Dosage Forms

Sample Preparation of Pharmaceutical Dosage Forms

Author: Beverly Nickerson

Publisher: Springer Science & Business Media

Published: 2011-08-05

Total Pages: 400

ISBN-13: 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.


Sample Preparation of Pharmaceutical Dosage Forms

Sample Preparation of Pharmaceutical Dosage Forms

Author: Beverly Nickerson

Publisher: Springer

Published: 2014-11-27

Total Pages: 0

ISBN-13: 9781489995827

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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.


Dosage Form Design Parameters

Dosage Form Design Parameters

Author:

Publisher: Academic Press

Published: 2018-07-25

Total Pages: 816

ISBN-13: 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


Dosage Form Design Considerations

Dosage Form Design Considerations

Author:

Publisher: Academic Press

Published: 2018-07-28

Total Pages: 881

ISBN-13: 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


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 Dosage Forms and Drug Delivery Systems

Pharmaceutical Dosage Forms and Drug Delivery Systems

Author: Howard C. Ansel

Publisher: Lippincott Williams & Wilkins

Published: 1999

Total Pages: 0

ISBN-13: 9780683305722

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This work covers the entire scope of pharmaceutics, from the basics of drug dosage and routes of administration to the finer points of drug discovery, drug product development, legislation and regulations governing quality standards and product approval for marketing.


FASTtrack Pharmaceutics Dosage Form and Design, 2nd edition

FASTtrack Pharmaceutics Dosage Form and Design, 2nd edition

Author: David S. Jones

Publisher: Pharmaceutical Press

Published: 2016-06-13

Total Pages: 433

ISBN-13: 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.


Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations

Author: Sarfaraz K. Niazi

Publisher: CRC Press

Published: 2004-04-27

Total Pages: 258

ISBN-13: 1420048457

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The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emul