Long Acting Injections and Implants

Long acting injections and implants improve therapy, enhance patient compliance, improve dosing convenience, and are the most appropriate formulation choice for drugs that undergo extensive first pass metabolism or that exhibit poor oral bioavailability.

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

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Jeremy C. Wright



Diane J. Burgess

Editors

Long Acting Injections and Implants

Editors Jeremy C. Wright DURECT Corporation Cupertino, CA, USA [email protected]

Diane J. Burgess Department of Pharmaceutical Sciences School of Pharmacy University of Connecticut Storrs, CT, USA [email protected]

ISSN 2192-6204 ISBN 978-1-4614-0553-5 e-ISBN 978-1-4614-0554-2 DOI 10.1007/978-1-4614-0554-2 Springer New York Dordrecht Heidelberg London Library of Congress Control Number: 2011937763 © Controlled Release Society, 2012 All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Springer Science+Business Media, LLC, 233 Spring Street, New York, NY 10013, USA), except for brief excerpts in connection with reviews or scholarly analysis. Use in connection with any form of information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed is forbidden. The use in this publication of trade names, trademarks, service marks, and similar terms, even if they are not identified as such, is not to be taken as an expression of opinion as to whether or not they are subject to proprietary rights. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)

This book is dedicated to friends and family. Especially both editors dedicate the book to their respective parents (George Gartly Burgess and Violet Isobel Burgess; William C. Wright and Jenny J. Wright).

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Preface

The evolving complexity of human therapeutics requires the development of novel drug delivery systems. This book encapsulates in a single volume the concepts essential for understanding the science and technology associated with the research and development of long acting injections and implants. It provides a comprehensive overview of the scientific and regulatory challenges associated with these delivery systems. Critical contributions to this area are the array of formulations that make up the spectrum of long acting injections and implant dosage forms. These include microspheres, liposomes, in situ forming depots, suspensions, implants, lipophilic solutions, and osmotic implants. Such formulations have the potential to maintain therapeutic drug concentrations for durations from days to months, can be engineered to maintain characteristics such as zero-order or pulsatile drug release, and, in some cases (e.g., liposomes) can provide targeted drug delivery to the site of action. These attributes lead to increased patient compliance and convenience, reduced fluctuations in plasma profiles, and reduced plasma concentrations making it possible to administer higher drug concentrations to the site of action while reducing the overall dose. Thus, unwanted side effects can be minimized or reduced. In addition, long acting injections and implants can provide a means for the delivery