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Ajit S. Narang • Sai HS. Boddu

Editors

Excipient Applications

in Formulation Design

and Drug Delivery

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ISBN 978-3-319-20205-1 ISBN 978-3-319-20206-8 (eBook) DOI 10.1007/978-3-319-20206-8

Library of Congress Control Number: 2015948174 Springer Cham Heidelberg New York Dordrecht London © Springer International Publishing Switzerland 2015

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.

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.

The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made.

Printed on acid-free paper

Springer International Publishing AG Switzerland is part of Springer Science+Business Media (www.springer.com)

Editors

Ajit S. Narang

Bristol-Myers Squibb, Co. New Brunswick

New Jersey USA

Sai HS. Boddu

Division of Industrial Pharmacy Department of Pharmacy Practice The University of Toledo Toledo

Ohio USA

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ix

Preface

In my role as an advanced drug delivery scientist and educator with keen interests in the fields of biopharmaceutics and drug targeting, I recognize the central role excipients play in all pharmaceutical drug applications. I am therefore happy to preface this book that addresses the fundamental science behind and the current understanding of excipient applications in such depth.

This book presents emerging research and perspectives on the use of excipients in pharmaceutical formulations. It also addresses some of the fundamental principles and key considerations related to the use of excipients such as compatibility studies, chemistry of drug-excipient interactions, and the mechanisms by which excipients may influence the biological response of drugs. The authors detail specialized applications such as the emerging field of characterizing the reactive impurities in excipients and harmonizing the composition profile of excipients from different sources and vendors. In the area of drug delivery, this book focuses on the role of excipients in modulating drug release, improving drug stability, and the development of bioequivalent and stable generic formulations.

Each chapter was contributed by chosen experts in their respective fields, and provides an in-depth perspective into a spectrum of excipient focused topics that are contemporary and highly relevant.

This book captures current topics of interest and the latest research updates in the field of pharmaceutical excipients; areas of interest to the biopharmaceutical industry users, excipient manufacturers, and regulatory bodies.

I give my best wishes to the reader and my hope that you get the best out of this book!

Gert Storm, Ph.D., Professor Biopharmaceutics/Targeted Nanomedicine

Department of Pharmaceutics Utrecht University, 3508 TB Utrecht The Netherlands

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