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PHARMACEUTICAL MANUFACTURING HANDBOOK
Production and
Processes
SHAYNE COX GAD, PH.D., D.A.B.T.
Gad Consulting Services
Cary, North Carolina
A JOHN WILEY & SONS, INC., PUBLICATION
PHARMACEUTICAL MANUFACTURING HANDBOOK
Production and
Processes
PHARMACEUTICAL MANUFACTURING HANDBOOK
Production and
Processes
SHAYNE COX GAD, PH.D., D.A.B.T.
Gad Consulting Services
Cary, North Carolina
A JOHN WILEY & SONS, INC., PUBLICATION
Copyright © 2008 by John Wiley & Sons, Inc. All rights reserved Published by John Wiley & Sons, Inc., Hoboken, New JerseyPublished simultaneously in Canada
No part of this publication may be reproduced, stored in a retrieval system, or transmitted in anyform or by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, except
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NJ 07030, (201) 748-6011, fax (201) 748-6008, or online at http://www.wiley.com/go/permission.Limit of Liability/Disclaimer of Warranty: While the publisher and author have used their best efforts
in preparing this book, they make no representations or warranties with respect to the accuracy or completeness of contents of this book and specifi cally disclaim any implied warranties ofmerchantability or fi tness for a particular purpose. No warranty may be created or extended by sales
representatives or written sales materials. The advice and strategies contained herein may not be suitable for your situation. You should consult with a professional where appropriate. Neither thepublisher nor author shall be liable for any loss of profi t or any other commercial damages, including
but not limited to special, incidental, consequential, or other damages. For general information on our other products and services or for technic al support, please contact our Customer Care Department within the United States at (800) 762-2974, outside the United States
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Printed in the United States of America
10 9 8 7 6 5 4 3 2 1
CONTRIBUTORS
Susanna Abrahms é n - Alami, AstraZeneca R & D Lund, Lund, Sweden, OralExtended - Release Formulations
James Agalloco, Agalloco & Associates, Belle Mead, New Jersey, Sterile ProductManufacturing
Fakhrul Ahsan, Texas Tech University, Amarillo, Texas, Nasal Delivery of Peptide and Nonpeptide Drugs James Akers, Akers Kennedy & Associates, Kansas City, Missouri, Sterile ProductManufacturing
Raid G. Alany, The University of Auckland, Auckland, New Zealand, Ocular DrugDelivery; Microemulsions as Drug Delivery Systems
Monique Alric, Universit é d " Auvergne, Clermont - Ferrand, France, Recombinant Saccharomyces Cerevisiae as New Drug Delivery System to Gut: In Vitro Valida- tion and Oral Formulation Sacide Alsoy Altinkaya, Izmir Institute of Technology, Urla - Izmir, Turkey, Con- trolled Release of Drugs from Tablet Coatings Maria Helena Amaral, University of Porto, Porto, Portugal, Vaginal DrugDelivery
Anil Kumar Anal, Living Cell Technologies (Global) Limited, Auckland, NewZealand, Controlled - Release Dosage Forms
Gavin Andrews, Queen " s University Belfast, Belfast, Northern Ireland, Effects ofGrinding in Pharmaceutical Tablet Production
Sophia G. Antimisiaris, School of Pharmacy, University of Patras, Rio, Greece,Liposomes and Drug Delivery
vi CONTRIBUTORS Robert D. Arnold, The University of Georgia, Athens, Georgia, Biotechnology -Derived Drug Product Development
C. Scott Asbill, Samford University, Birmingham, Alabama, Transdermal DrugDelivery
Maria Fernanda Bahia, University of Porto, Porto, Portugal, Vaginal DrugDelivery
Bernard Bataille, University of Montpelier 1, Montpellier, France, Tablet Design Gerald W. Becker, SSCI, West Lafayette, Indiana, Biotechnology - Derived Drug Product Development; Regulatory Considerations in Approval of Follow - OnProtein Drug Products
B. Wayne Bequette, Rensselaer Polytechnic Institute, Troy, New York, From Pilot Plant to Manufacturing: Effect of Scale - Up on Operation of Jacketed Reactors Erem Bilensoy, Hacettepe University Faculty of Pharmacy, Ankara, Turkey, Cyclo- dextrin - Based Nanomaterials in Pharmaceutical FieldSt é phanie Blanquet, Universit é d " Auvergne, Clermont - Ferrand, France, Recombi-
nant Saccharomyces Cerevisiae as New Drug Delivery System to Gut: In Vitro