Pharmaceutical Suspensions From Formulation Development to Manufactu
Suspension dosage form is a preferred and widely accepted dosage forms for insoluble or poorly soluble drugs for various therapeutic applications. The suspension dosage form has long been used for insoluble and poorly soluble drugs for making oral, topica
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Alok K. Kulshreshtha Onkar N. Singh G. Michael Wall ●
Editors
Pharmaceutical Suspensions From Formulation Development to Manufacturing
ditors E Alok K. Kulshreshtha Alcon Research Ltd Forth Worth, TX USA [email protected]
Onkar N. Singh Alcon Research Ltd, Forth Worth, TX USA [email protected]
G. Michael Wall Alcon Research Ltd Forth Worth, TX USA [email protected]
ISBN 978-1-4419-1086-8 e-ISBN 978-1-4419-1087-5 DOI 10.1007/978-1-4419-1087-5 Springer New York Dordrecht Heidelberg London Library of Congress Control Number: 2009937643 © AAPS 2010 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)
Preface
The suspension dosage form has long been used for poorly soluble active ingredients for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts. A good understanding of the fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of a suspension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, viscometers, particle size analyzers, etc.) must be utilized to properly characterize the suspension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require clinical trials to establish the safety and efficacy of the drug product. All of this development work should culminate into a regulatory filing in accordance with the regulatory guidelines. Pharmaceutical Suspensions, From Formulation Development to Manufacturing, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system – poorly soluble active pharmaceutical ingredients suspended in a suitable vehicle. After discussing various disperse systems, the theory of disperse system
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