The Role of Microstructure in Topical Drug Product Development

Following the Semi-solid Microstructure Workshop sponsored by BASF and hosted by the Rutgers Center for Dermal Research, a pharmaceutical product development working group was formed. The group, known as the Q3 Working Group, selected the following f

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Nigel Langley Bozena Michniak-Kohn David W. Osborne Editors

The Role of Microstructure in Topical Drug Product Development

AAPS Advances in the Pharmaceutical Sciences Series Volume 36

Series Editor Yvonne Perrie, Strathclyde Institute of Pharmacy, University of Strathclyde, Bearsden, Dunbartonshire, UK

The AAPS Advances in the Pharmaceutical Sciences Series, published in partnership with the American Association of Pharmaceutical Scientists, is designed to deliver volumes authored by opinion leaders and authorities from around the globe, addressing innovations in drug research and development, and best practice for scientists and industry professionals in the pharma and biotech industries. More information about this series at http://www.springer.com/series/8825

Nigel Langley  •  Bozena Michniak-Kohn David W. Osborne Editors

The Role of Microstructure in Topical Drug Product Development

Editors Nigel Langley Pharma Solutions BASF Corporations Tarrytown, NY, USA

Bozena Michniak-Kohn Rutgers The State University of New Jersey Piscataway, NJ, USA

David W. Osborne Product Development Arcutis Westlake Village, CA, USA

ISSN 2210-7371     ISSN 2210-738X (electronic) AAPS Advances in the Pharmaceutical Sciences Series ISBN 978-3-030-17354-8    ISBN 978-3-030-17355-5 (eBook) https://doi.org/10.1007/978-3-030-17355-5 © AAPS (American Association of Pharmaceutical Scientists) 2019 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. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland

Foreword

Today, we are at the beginning of a scientific renaissance that is demystifying the ancient art of developing topical formulations and opening a new dimension of scientific understanding. The enormous practical implications of this new knowledge to our e