Table Of ContentAqueous Polymeric
Coatings for
Pharmaceutical
Dosage Forms
Fourth Edition
DRUGS AND THE PHARMACEUTICAL SCIENCES
A Series of Textbooks and Monographs
Series Executive Editor
James Swarbrick
PharmaceuTech, Inc.
Pinehurst, North Carolina
Recent Titles in Series
Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Fourth Edition,
Linda A. Felton
Good Design Practices for GMP Pharmaceutical Facilities, Second Edition,
Terry Jacobs and Andrew A. Signore
Handbook of Bioequivalence Testing, Second Edition, Sarfaraz K. Niazi
Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition,
edited by Leon Shargel and Isadore Kanfer
Drug Stereochemistry: Analytical Methods and Pharmacology, Third Edition,
edited by Krzysztof Jozwiak, W. J. Lough, and Irving W. Wainer
Pharmaceutical Powder Compaction Technology, Second Edition,
edited by Metin Çelik
Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition,
edited by Steven W. Baertschi, Karen M. Alsante, and Robert A. Reed
Pharmaceutical Process Scale-Up, Third Edition, edited by Michael Levin
Sterile Drug Products: Formulation, Packaging, Manufacturing and Quality,
Michael J. Akers
Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products,
Third Edition, edited by Louis Rey and Joan C. May
Oral Drug Absorption: Prediction and Assessment, edited by Jennifer B. Dressman
and Christos Reppas
Generic Drug Product Development: Specialty Dosage Forms, edited by
Leon Shargel and Isadore Kanfer
Generic Drug Product Development: International Regulatory Requirements
for Bioequivalence, edited by Isadore Kanfer and Leon Shargel
Active Pharmaceutical Ingredients: Development, Manufacturing, and
Regulation, Second Edition, edited by Stanley Nusim
Pharmaceutical Statistics: Practical and Clinical Applications, Fifth Edition,
edited by Sanford Bolton and Charles Bon
Biodrug Delivery Systems: Fundamentals, Applications and Clinical
Development, edited by Mariko Morishita and Kinam Park
Biodrug Delivery Systems: Fundamentals, Applications and Clinical
Development, edited by Mariko Morishita and Kinam Park
A complete listing of all volumes in this series
can be found at www.crcpress.com
Aqueous Polymeric
Coatings for
Pharmaceutical
Dosage Forms
Fourth Edition
Edited by
Linda A. Felton
University of New Mexico
Albuquerque, NM, USA
CRC Press
Taylor & Francis Group
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To James W. McGinity, who got me interested in film-coating
technology and has been a great mentor throughout my career.
Contents
Preface...............................................................................................................................................ix
Editor ................................................................................................................................................xi
Contributors ...................................................................................................................................xiii
Chapter 1 Introduction to Aqueous-Based Polymeric Coating .....................................................1
Klaus Knop
Chapter 2 Pseudolatex Dispersions for Controlled Drug Delivery .............................................11
Brian Carlin, Shirley Yang, Jian-Xin Li, and Linda A. Felton
Chapter 3 Processing and Equipment Considerations for Aqueous Coatings ............................49
Philip J. Hadfield
Chapter 4 Mechanical Properties of Polymeric Films Prepared from Aqueous Dispersions ....83
Linda A. Felton, Patrick B. O’Donnell, and James W. McGinity
Chapter 5 A Proactive Approach to Troubleshooting the Application of Film Coatings
to Oral Solid Dosage Forms .....................................................................................101
Stuart C. Porter
Chapter 6 Adhesion of Polymeric Films ...................................................................................135
Linda A. Felton and James W. McGinity
Chapter 7 Influence of Coloring Agents on the Properties of Polymeric Coating Systems .....151
Nasser N. Nyamweya, Stephen W. Hoag, Tanvi M. Deshpande,
and Linda A. Felton
Chapter 8 Process and Formulation Factors Affecting Drug Release from Pellets Coated
with the Ethylcellulose-Pseudolatex Aquacoat® ......................................................177
Juergen Siepmann, Florence Siepmann, Ornlaksana Paeratakul,
and Roland Bodmeier
Chapter 9 Chemistry and Application Properties of Poly(meth)acrylate Systems ...................207
Brigitte Skalsky and Hans-Ulrich Petereit
Chapter 10 Application of HPMC and HPMCAS to Aqueous Film Coating
of Pharmaceutical Dosage Forms ............................................................................247
Sakae Obara, Anisul Quadir, and Hiroyasu Kokubo
vii
viii Contents
Chapter 11 Applications of Formulated Systems for the Aqueous Film Coating
of Pharmaceutical Oral Solid Dosage Forms ...........................................................285
Ali R. Rajabi-Siahboomi and Thomas P. Farrell
Chapter 12 Substrate Considerations when Coating Solid Dosage Forms .................................307
Elena Macchi and Linda A. Felton
Chapter 13 Polymer Interactions with Drugs and Excipients .....................................................319
L. Diane Bruce and James W. McGinity
Chapter 14 Physical Aging of Polymers and Its Effect on the Stability of Solid Oral
Dosage Forms ...........................................................................................................351
Linda A. Felton, Shawn A. Kucera, and James W. McGinity
Index ..............................................................................................................................................375
Preface
While the elimination of organic solvents from film-coating systems circumvents problems associ-
ated with residual solvents and solvent recovery, the use of aqueous-based coatings presents its own
challenges to the pharmaceutical scientist. Aqueous film-coating technology has become a routine
process in the pharmaceutical industry, yet its intrinsic complexity has limited our full understand-
ing of all the variables that impact product performance. This fourth edition of Aqueous Polymeric
Coatings for Pharmaceutical Dosage Forms aims to provide more insight into the factors and
parameters that should be considered and controlled for the successful development and subsequent
commercialization of an optimized coated product.
Since the third edition of this text was published, considerable advances in aqueous-based film-
coating technologies have been made. Publications in the scientific literature have focused on many
issues, including the interaction of drugs with functional polymers, the influence of processing
parameters on coating quality, and the introduction of new polymeric coating materials. The fourth
edition has been revised and expanded to reflect the most recent scientific advancements from the
literature. Some of the world’s leading experts in aqueous film-coating technology have contributed
to this edition. Chapters from the third edition have been updated, and new chapters address sub-
jects such as substrate considerations and proactive troubleshooting. A new introductory chapter
provides a broad overview of film coating and is designed to orient the novice to the subject. The
contributing authors have attempted to explain in detail, using illustrated examples, appropriate
steps to solve and ideally avoid formulation, processing, and stability problems and to achieve an
optimized dosage form.
As with the prior editions, the prime objective of this fourth edition is to further expand the
number of new researchers to this field of pharmaceutical technology and to stimulate new ideas,
concepts, and product opportunities. Trade names and chemical names of commercially marketed
coatings are used throughout the text to help familiarize the reader with the various polymers avail-
able for pharmaceutical applications. This book will be a valuable resource for anyone in the phar-
maceutical industry working in the area of aqueous-based film coating.
I would like to thank the chapter authors for their contributions and our readers who over the past
several years have provided many useful comments and suggestions. As usual, your comments and
constructive criticism on this edition will continue to be appreciated.
Linda A. Felton
ix
