Amorphous Solid Dispersions Theory and Practice

This volume offers a comprehensive guide on the theory and practice of amorphous solid dispersions (ASD) for handling challenges associated with poorly soluble drugs. In twenty-three inclusive chapters, the book examines thermodynamics and kinetics of the

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Series Editor Michael J. Rathbone

For further volumes: http://www.springer.com/series/8875

Navnit Shah • Harpreet Sandhu • Duk Soon Choi Hitesh Chokshi • A. Waseem Malick Editors

Amorphous Solid Dispersions Theory and Practice

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Editors Navnit Shah Kashiv Pharma LLC Bridgewater New Jersey USA Harpreet Sandhu Merck & Co., Inc. Summit New Jersey USA Duk Soon Choi Kashiv Pharma LLC Bridgewater New Jersey USA

Hitesh Chokshi Roche Pharma Research & Early Development Roche Innovation Center New York New York USA A. Waseem Malick Pharmaceutical and Analytical R&D Hoffmann-La Roche Ltd. Nutley New Jersey USA

ISSN 2192-6204 ISSN 2192-6212 (electronic) ISBN 978-1-4939-1597-2 ISBN 978-1-4939-1598-9 (eBook) DOI 10.1007/978-1-4939-1598-9 Springer New York Heidelberg Dordrecht London Library of Congress Control Number: 2014947686 © Controlled Release Society 2014 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. Exempted from this legal reservation are brief excerpts in connection with reviews or scholarly analysis or material supplied specifically for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Duplication of this publication or parts thereof is permitted only under the provisions of the Copyright Law of the Publisher’s location, in its current version, and permission for use must always be obtained from Springer. Permissions for use may be obtained through RightsLink at the Copyright Clearance Center. Violations are liable to prosecution under the respective Copyright Law. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. While the advice and information in this book are believed to be true and accurate at the date of publication, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)

To extraordinary scientists at Hoffmann-La Roche who advanced the field of amorphous science to transform poorly soluble “sand-like” compounds into important medicines

Preface

The idea of writing this book was triggered by the development of ASD utilizing microprecipitated bulk powder (MBP) technology at Hoffmann-La Roche and the successful application of t