Pharmaceutical Dosage Forms: Capsules

436 Pages·2018·74.676 MB·English

by  Larry L. Augsburger, Stephen W. Hoag

Pharmaceutical Dosage Forms
Capsules
http://taylorandfrancis.com
Pharmaceutical Dosage Forms
Capsules
Edited by
Larry L. Augsburger
Stephen W. Hoag
CRC Press
Taylor & Francis Group
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Library of Congress Cataloging‑in‑Publication Data
Names: Augsburger, Larry L., editor. | Hoag, Stephen W., editor.
Title: Pharmaceutical dosage forms. Capsules / [edited by] Larry L. Augsburger and Stephen W. Hoag.
Other titles: Capsules
Description: Boca Raton : CRC Press, [2017] | Includes bibliographical references and index.
Identifiers: LCCN 2017014862| ISBN 9781841849768 (hardback : alk. paper) | ISBN 9781315111896 (ebook)
Subjects: | MESH: Capsules--pharmacology | Drug Compounding
Classification: LCC RS200 | NLM QV 786.5.C3 | DDC 615.1/9--dc23
LC record available at https://lccn.loc.gov/2017014862
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We dedicate this book to Dr. Fridrun Podczeck whose untimely death
prevented her from seeing its publication after having worked so hard on her
chapters. Fridrun’s long and valiant battle with her illness, as well as her
strength of character as she dealt with its challenges, was simply amazing.
An internationally recognized researcher in pharmaceutics and process
engineering, Dr. Podczeck was one of the most productive pharmaceutical
scientists of our time who made outstanding contributions to the underlying
material and physicochemical science of solids and solid dosage forms,
especially capsules. Her research significantly promoted systematic formulation
development, rather than old-school pharmaceutical art and empiricism.
We also dedicate this book to our wives, Jeanette and Cathy, and our
families whose loving forbearance makes all things we do possible, including
editing and writing books. Thank you for all your love and support.
http://taylorandfrancis.com
Contents
Preface...............................................................................................................................................ix
Editors ...............................................................................................................................................xi
Contributors ...................................................................................................................................xiii
Chapter 1 Advances in Capsule Formulation Development and Technology ...............................1
Larry L. Augsburger and Stephen W. Hoag
Chapter 2 An Introduction to Two-Piece Hard Capsules and Their Marketing Benefits ...........15
Dennis Murachanian
Chapter 3 Hard Shell Capsules in Clinical Trials .......................................................................31
Moji Christianah Adeyeye and Amusa Adebayo
Chapter 4 Capsule Shell Manufacture ........................................................................................75
Brian E. Jones, Fridrun Podczeck, and Paul Lukas
Chapter 5 Non-Gelatin-Based Capsules ...................................................................................111
Sven Stegemann
Chapter 6 Hard Shell Capsule Filling Machines ......................................................................131
Donald K. Lightfoot
Chapter 7 Instrumented Automatic Capsule Filling Machines and Filling Machine
Simulation ................................................................................................................191
Larry L. Augsburger and Vikas Moolchandani
Chapter 8 Dry-Fill Formulation and Filling Technology .........................................................211
Pavan Heda, Vikas Agarwal, and Shailesh K. Singh
Chapter 9 Plug Formation .........................................................................................................237
Fridrun Podczeck
Chapter 10 Modeling Powder Filling during Encapsulation ......................................................283
Ammar Khawam
Chapter 11 Scale-Up and Transfer of Hard Shell Formulations across Machine Types ............307
Larry L. Augsburger and Michael Levin
vii
viii Contents
Chapter 12 Modified-Release Delivery Systems: Extended-Release Capsule Platform.............317
Reza Fassihi
Chapter 13 Analytical Testing and Evaluation of Capsules ........................................................345
Stuart L. Cantor and Asish K. Dutta
Chapter 14 Rheological Aspects of Capsule Shell Excipients and the Manufacture
of Encapsulated Formulations ..................................................................................373
Lawrence H. Block
Chapter 15 Quality-by-Design (QbD) for Capsule Formulation and Process Development:
Regulatory Science Relevance, Scientific Case Studies, and Future Challenges ......393
Huiquan Wu, Lin Xie, Stephen W. Hoag, Larry L. Augsburger,
and Mansoor Khan
Index ..............................................................................................................................................415
Preface
Invented more than 160 years ago, the capsule today is second only to the compressed tablet among
solid dosage in frequency of utilization for drug delivery, and its utilization is growing. According to
one estimate,* approximately 10–15% of FDA-approved drugs in 2014 were capsule formulations,
about double that in 2007. Originally intended to mask the unpleasant taste of certain medications,
today there are many other advantageous reasons and drivers for selecting the capsule for drug
delivery, as discussed in the various chapters of this book. Despite the growing utilization of the
capsule and the important roles it plays as a dosage form, the capsule has been relatively under-
served in the literature. To our knowledge, there have been only two prior published edited texts†,‡
devoted entirely to capsules, the most recent of which was published about 12 years ago. These
books were intended to fulfill the need to provide in one place a concise summary of the making
and filling of capsules, and of developing formulations for capsules. We are honored to have the
opportunity to join the efforts of these prior editors in providing an updated discussion and descrip-
tion of capsule formulation and filling technology and the role of capsules in drug delivery. We are
especially honored that Fridrun Podczeck, Brian E. Jones, and J. Michael Newton, editors and/or
authors of chapters of those earlier books, have also contributed to this book.
* Seuffert K. HPMC capsules gain credibility as alternative to gelatin. Tablets & Capsules 2016; 14: 41–45.
† Ridgway K, ed., Hard Capsules, Development & Technology, London, The Pharmaceutical Press 1987.
‡ Podczeck F, Jones BE, eds., Pharmaceutical Capsules, 2nd edition, London, The Pharmaceutical Press 2004.
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