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    Design and Manufacture of Pharmaceutical Tablets
    Design and Manufacture of Pharmaceutical Tablets
    Design and Manufacture of Pharmaceutical Tablets
    Ebook118 pages1 hour

    Design and Manufacture of Pharmaceutical Tablets

    By Reynir Eyjolfsson

    3.5/5

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    About this ebook

    Design and Manufacture of Pharmaceutical Tablets offers real world solutions and outcomes of formulation and processing challenges of pharmaceutical tablets.  This book includes numerous practical examples related to actual formulations that have been validated and marketed and covers important data in the areas of stability, dissolution, bioavailibity and processing.  It provides important background and theoretical information on design and manufacturing and includes a full section dedicated to design experimental methodology and statistics.  In addition, this book offers a a general discussion of excipients used in proper tablet design along with practical examples related to excipients.  Drug development scientists in industry and academia, as well as students in the pharmaceutical sciences will greatly benefit from the practical knowledge and case examples provided throughout this book.
    • Incorporates important mathematical models and computational applications
    • Includes unique content on central composite design and augmented simplex lattice
    • Provides background on important design principles with emphasis on quality-based design (QBD) of pharmaceutical dosage forms
    LanguageEnglish
    PublisherAcademic Press
    Release dateOct 9, 2014
    ISBN9780128021873
    Design and Manufacture of Pharmaceutical Tablets
    Author

    Reynir Eyjolfsson

    Dr. Eyjolfsson entered pharmacy in 1959, having studied at the University of Iceland and then at the Pharmaceutical University of Denmark, Copenhagen 1961-1964 (MsPharm 1964). Dr. Eyjolfsson earned a Ph.D. in the chemistry of natural product from same university in 1968. He moved to Iceland in 1971 and has worked with drug formulation science at Pharmaco, Delta, Actavis until 2010. Dr. Eyjolfsson is an author of approximately 30 scientific papers in peer reviewed journals mainly on phytochemistry and pharmaceutics. He has designed many different dosage forms but mostly conventional tablets and slow release tablets.

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    3.5/5

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    • 1/5
      Best book ever about tablet production I have ever read

    Book preview

    Design and Manufacture of Pharmaceutical Tablets - Reynir Eyjolfsson

    Design and Manufacture of Pharmaceutical Tablets

    Reynir Eyjolfsson

    Table of Contents

    Cover

    Title page

    Copyright Page

    Dedication

    Preface

    Abbreviations

    Chapter One: Introduction

    Abstract

    1.1. General considerations [1, 2]

    1.2. Particle sizes [3]

    1.3. Excipients [4]

    1.4. Equipment

    1.5. Mixing of pharmaceutical powders [5]

    1.6. Design of experiments [6–9]

    Chapter Two: Conventional-Release (CR) Tablets

    Abstract

    2.1. Low-dose tablet by direct compression (DC)

    2.2. High-dose tablet by direct compression

    2.3. Low-solubility API, low-dose tablet by wet granulation (WG) [1]

    2.4. Soluble API, low-dose tablet by wet granulation

    2.5. Low-solubility API, high-dose tablet by wet granulation

    2.6. Soluble API, high-dose tablet by wet granulation [2]

    Chapter Three: Slow-Release (SR) Tablets

    Abstract

    3.1. Slow-release tablet using a lipophilic release control agent

    3.2. Slow-release tablet using Eudragit and Methocel as release control agents

    3.3. Slow-release tablet using a mixture of Methocels as release control agent [1]

    Index

    Copyright Page

    Academic Press is an imprint of Elsevier

    32 Jamestown Road, London NW1 7BY, UK

    525 B Street, Suite 1800, San Diego, CA 92101-4495, USA

    225 Wyman Street, Waltham, MA 02451, USA

    The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, UK

    Copyright © 2015 Elsevier Inc. All rights reserved.

    No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publisher’s permissions policies and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions.

    This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein).

    Notices

    Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary.

    Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility.

    To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein.

    British Library Cataloguing-in-Publication Data

    A catalogue record for this book is available from the British Library.

    Library of Congress Cataloging-in-Publication Data

    A catalog record for this book is available from the Library of Congress.

    ISBN: 978-0-12-802182-8

    For information on all Academic Press publicationsvisit our website at http://store.elsevier.com/

    Dedication

    This book is dedicated to my fellow pioneers at Pharmaco, Delta, and later Actavis, who laid the foundations to what Actavis is today: the third largest pharmaceutical generics company in the world.

    Preface

    Many excellent books have been written about the design and manufacture of pharmaceutical tablets, but they are all more or less theoretical, offering few and limited examples of real-life formulations. Almost invariably, these examples lack information on processing details, stability (shelf life), dissolution, and bioavailability. In view of this, there is really a need for a book describing real-life practical examples that have been validated and researched as to bioavailability. These aspects frequently appear daunting to newcomers to tablet formulation science and even to experienced professionals. From this author’s experience the conclusion is: If only I had had a book on the practical aspects of these matters when I started my career in this field things would have been much easier and more satisfying.

    This book is an attempt to improve on this situation by offering nine real-life tablet formulations and processing examples. In order to avoid conceivable commercial conflicts the identities of the active pharmaceutical ingredients (APIs) are not revealed but some of their physicochemical properties are disclosed.

    Primarily, theoretical aspects are not dealt with in this book as they are readily available elsewhere. There is emphasis on design of experiments (DOE) but this is mostly restricted to practical examples. Also, mixing of pharmaceutical powders is given special attention. This author admits that his views may be in conflict with the practices generally employed in the pharmaceutical industry but he is of the opinion that if his approach to powder mixing were followed, problems with tablet content uniformity would be virtually nonexistent!

    Best thanks to the wonderful staff at Elsevier Inc., particularly my editors, Ms. Kristine Jones and Ms. Molly McLaughlin, for their patience and never-failing help.

    Hafnarfjordur, Iceland, July 2014

    Reynir Eyjolfsson, reynirey@mmedia.is

    Abbreviations

    Al/Al     aluminum/aluminum

    Al/PVC     aluminum/polyvinyl chloride

    ANOVA     analysis of variance

    API     active pharmaceutical ingredient

    ASL     augmented simplex

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