Pharmaceutical Dissolution Testing.pdf

Pharmaceutical

Dissolution Testing

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Pharmaceutical

Dissolution Testing

Edited by

Jennifer Dressman

Johann Wolfang Goethe University

Frankfurt, Germany

Johannes Krämer

Phast GmbH

Homburg/Saar, Germany

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Published in 2005 by

Taylor & Francis Group

6000 Broken Sound Parkway NW, Suite 300

Boca Raton, FL 33487-2742

No claim to original U.S. Government works

Printed in the United States of America on acid-free paper

10987654321

International Standard Book Number-10: 0-8247-5467-0 (Hardcover)

International Standard Book Number-13: 978-0-8247-5467-9 (Hardcover)

This book contains information obtained from authentic and highly regarded sources. Reprinted material is

quoted with permission, and sources are indicated. A wide variety of references are listed. Reasonable efforts

have been made to publish reliable data and information, but the author and the publisher cannot assume

responsibility for the validity of all materials or for the consequences of their use.

No part of this book may be reprinted, reproduced, transmitted, or utilized in any form by any electronic,

mechanical, or other means, now known or hereafter invented, including photocopying, microfilming, and

recording, or in any information storage or retrieval system, without written permission from the publishers.

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Catalog record is available from the Library of Congress

Visit the Taylor & Francis Web site at

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Taylor & Francis Group

is the Academic Division of T&F Informa plc.

This book is dedicated to dissolution scientists the world over, and to our

spouses, Torsten and Heike, without whose support this work would not

have been possible.

Preface

Over the last 20 years, the ﬁeld of dissolution testing has

expanded considerably to address not only questions of

quality control of dosage forms but additionally to play an

important role in screening formulations and in the evolving

bioequivalence paradigm. Through our participation in var-

ious workshops held by the FIP, AAPS, and APV, it became

clear to us that there is an international need for a book cover-

ing all aspects of dissolution testing, from the apparatus

through development of methodology to the analysis and

interpretation of results. Pharmaceutical Dissolution Testing

is our response to this perceived need: a book dedicated to

the equipment and methods used to test whether drugs are

released adequately from dosage forms when administered

orally. The focus on orally administered dosage forms results

from the dominance of the oral route of administration on the

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