Novel Drug Delivery Systems

806 Pages·1991·28.12 MB·English

by  Yie W. Chien

Novel Drug
Delivery Systems
DRUGS AND THE PHARMACEUTICAL SCIENCES
A Series of Textbooks and Monographs
edited by
James Swarbrick
School of Pharmacy
University of North Carolina
Chapel Hill, North Carolina
Volume 1. PHARMACOKINETICS, Milo Gibaldi and Donald Perrier
Volume 2. GOOD MANUFACTURING PRACTICES FOR PHARMA
CEUTICALS: A PLAN FOR TOTAL QUALITY CONTROL, Sidney
H. Willig, Murray M. Tuckerman, and William S. Hitchings IV
Volume 3. MICROENCAPSULATION, edited by J. R. Nixon
Volume 4. DRUG METABOLISM: CHEMICAL AND BIOCHEMICAL AS
PECTS, Bernard Testa and Peter Jenner
Volume 5. NEW DRUGS: DISCOVERY AND DEVELOPMENT, edited by
Alan A. Rubin
Volume 6. SUSTAINED AND CONTROLLED RELEASE DRUG DELIVERY
SYSTEMS, edited by Joseph R. Robinson
Volume 7. MODERN PHARMACEUTICS, edited by Gilbert S. Banker and
Christopher T. Rhodes
Volume 8. PRESCRIPTION DRUGS IN SHORT SUPPLY: CASE HISTORIES,
Michael A. Schwartz
Volume 9. ACTIVATED CHARCOAL: ANTIDOTAL AND OTHER MEDICAL
USES, David 0. Cooney
Volume 10. CONCEPTS IN DRUG METABOLISM (in two parts), edited by
Peter Jenner and Bernard Testa
Volume 11. PHARMACEUTICAL ANALYSIS: MODERN METHODS (in two
parts), edited by James W. Munson
Volume 12. TECHNIQUES OF SOLUBILIZATION OF DRUGS, edited by
Samuel H. Yalkowsky
Volume 13. ORPHAN DRUGS, edited by Fred E. Kerch
Volume 14. NOVEL DRUG DELIVERY SYSTEMS: FUNDAMENTALS, DE
VELOPMENTAL CONCEPTS, BIOMEDICAL ASSESSMENTS, Vie
W. Chien
Volume 15. PHARMACOKINETICS, SECOND EDITION, REVISED AND EX
PANDED, Milo Gibaldi and Donald Perrier
Volume16. GOOD MANUFACTURING PRACTICES FOR
PHARMACEUTICALS: A PLAN FOR TOTAL QUALITY CON
TROL, SECOND EDITION, REVISED AND EXPANDED, Sidney
H. Willig, Murray M. Tuckerman, and William S. Hitchings IV
Volume 17. FORMULATION OF VETERINARY DOSAGE FORMS, edited by
Jack Blodinger
Volume 18. DERMATOLOGICAL FORMULATIONS: PERCUTANEOUS AB
SORPTION, Brian W. Barry
Volume 19. THE CLINICAL RESEARCH PROCESS IN THE PHAR
MACEUTICAL INDUSTRY, edited by Gary M. Matoren
Volume 20. MICROENCAPSULATION AND RELATED DRUG PROCESSES,
Patrick B. Deasy
Volume 21. DRUGS AND NUTRIENTS: THE INTERACTIVE EFFECTS, edited
by Daphne A. Roe and T. Colin Campbell
Volume 22. BIOTECHNOLOGY OF INDUSTRIAL ANTIBIOTICS, Erick J.
Vandamme
Volume 23. PHARMACEUTICAL PROCESS VALIDATION, edited by Bernard
T. Loftus and Robert A. Nash
Volume 24. ANTICANCER AND INTERFERON AGENTS: SYNTHESIS AND
PROPERTIES, edited by Raphael M. Ottenbrite and George B.
Butler
Volume 25. PHARMACEUTICAL STATISTICS: PRACTICAL AND CLINICAL
APPLICATIONS, Sanford Bolton
Volume 26. DRUG DYNAMICS FOR ANALYTICAL, CLINICAL, AND BIO
LOGICAL CHEMISTS, Benjamin J. Gudzinowicz, Burrows T.
Younkin, Jr., and Michael J. Gudzinowicz
Volume 27. MODERN ANALYSIS OF ANTIBIOTICS, edited by Adjoran
Aszalos
Volume 28. SOLUBILITY AND RELATED PROPERTIES, Kenneth C. James
Volume 29. CONTROLLED DRUG DELIVERY: FUNDAMENTALS AND AP
PLICATIONS, SECOND EDITION, REVISED AND EXPANDED,
edited by Joseph R. Robinson and Vincent H. Lee
Volume 30. NEW DRUG APPROVAL PROCESS: CLINICAL AND REGULA
TORY MANAGEMENT, edited by Richard A. Guarino
Volume 31. TRANSDERMAL CONTROLLED SYSTEMIC MEDICATIONS,
edited by Yie W. Chien
Volume 32. DRUG DELIVERY DEVICES: FUNDAMENTALS AND APPLI
CATIONS, edited by Praveen Tyle
Volume 33. PHARMACOKINETICS: REGULATORY - INDUSTRIAL - ACA
DEMIC PERSPECTIVES, edited by Peter G. Welling and Francis
L S. Tse
Volume 34. CLINICAL DRUG TRIALS AND TRIBULATIONS, edited by Allen
E. Cato
Volume 35. TRANSDERMAL DRUG DELIVERY: DEVELOPMENTAL ISSUES
AND RESEARCH INITIATIVES, edited by Jonathan Hadgraftand
Richard H. Guy
Volume 36. AQUEOUS POLYMERIC COATINGS FOR PHARMACEUTICAL
DOSAGE FORMS, edited by James W. McGinity
Volume 37. PHARMACEUTICAL PELLETIZATION TECHNOLOGY, edited by
Isaac Ghebre-Sellassie
Volume 38. GOOD LABORATORY PRACTICE REGULATIONS, edited by
Allen F. Hirsch
Volume 39. NASAL SYSTEMIC DRUG DELIVERY, Yie W. Chien, Kenneth S.
E. Su, and Shyi-Feu Chang
Volume 40. MODERN PHARMACEUTICS, SECOND EDITION, REVISED AND
EXPANDED, edited by Gilbert S. Banker and Christopher T.
Rhodes
Volume 41. SPECIALIZED DRUG DELIVERY SYSTEMS: MANUFACTURING
AND PRODUCTION TECHNOLOGY, edited by Praveen Tyle
Volume 42. TOPICAL DRUG DELIVERY FORMULATIONS, edited by David
W. Osborne and Anton H. Amann
Volume 43. DRUG STABILITY: PRINCIPLES AND PRACTICES, Jens T.
Carstensen
Volume 44. PHARMACEUTICAL STATISTICS: PRACTICAL AND CLINICAL
APPLICATIONS, SECOND EDITION, REVISED AND EXPANDED,
Sanford Bolton
Volume 45. BIODEGRADABLE POLYMERS AS DRUG DELIVERY SYSTEMS,
edited by Mark Chasin and Robert Langer
Volume 46. PRECLINICAL DRUG DISPOSITION: A LABORATORY HAND
BOOK, Francis L. S. Tse and James J. Jaffe
Volume 47. HPLC IN THE PHARMACEUTICAL INDUSTRY, edited by God
win W. Fong and Stanley K. Lam
Volume 48. PHARMACEUTICAL BIOEQUIVALENCE, edited by Peter G.
Welling, Francis L. S. Tse, and Shrikant V. Dighe
Volume 49. PHARMACEUTICAL DISSOLUTION TESTING, Umesh V.
Banakar
Volume 50. NOVEL DRUG DELIVERY SYSTEMS, SECOND EDITION,
REVISED AND EXPANDED, Vie W. Chien
Volume 51. MANAGING THE CLINICAL DRUG DEVELOPMENT PROCESS,
David M. Cocchetto and Ronald V. Nardi
Volume 52. GOOD MANUFACTURING PRACTICES FOR PHARMACEU
TICALS: A PLAN FOR TOTAL QUALITY CONTROL, THIRD
EDITION, edited by Sidney H. Willig and James Stoker
Additional Volumes in Preparation
PRODRUGS: TOPICAL AND OCULAR DRUG DELIVERY, edited
by Kenneth B. Sloan
Second Edition, mused aid Expanded
Yie W. Chien
Controlled Drug-Delivery Research Center
College of Pharmacy
Rutgers University
Piscataway, New Jersey
informa
healthcare
New York London
CRC Press
Taylor & Francis Group
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© 1991 by Taylor & Francis Group, LLC
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Version Date: 20130322
International Standard Book Number-13: 978-1-84184-967-6 (eBook - PDF)
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the appropriate best practice guidelines. Because of the rapid advances in medical science, any information or advice
on dosages, procedures or diagnoses should be independently verified. The reader is strongly urged to consult the drug
companies’ printed instructions, and their websites, before administering any of the drugs recommended in this book.
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To Margaret, my wife, for
her understanding and encouragement
To Linda, my daughter, for
her efforts and support
Preface
This second edition of Novel Drug Delivery Systems has maintained the same ob
jective as that of the first edition: to present a comprehensive, coherent treatment of
the science, technology, and regulation of rate-controlled administration of thera
peutic agents, with comprehensive coverage of the basic concepts, fundamental prin
ciples, biomedical rationales, and potential applications.
Since the successful introduction of the first edition in 1982, much progress has
been made in the science and technology of rate-controlled drug administration. It
was my intention to rewrite this well-received book with incorporation of all the
important scientific discoveries in recent years into the second edition. All the chap
ters have been extensively rewritten and updated, and new chapters have been added
on the rate-controlled delivery of drugs across various mucosae and digestive tract
membranes. A special chapter has been added on the issues associated with the sys
temic delivery of peptide/protein drugs, a new generation of therapeutic agents, via
parenteral and nonparenteral routes of administration.
Over the years, the responses we have received from the readers have been very
encouraging and have demonstrated to us that the book has been successful in pro
viding a useful source of scientific information for biomedical researchers and phar
maceutical R&D scientists/managers with diverse backgrounds who need to acquire
the core knowledge critical to the conceptualization, development, and optimization
of rate-controlled drug delivery. In addition, I also received several constructive
comments and suggestions that I have implemented in writing this new edition to
further enhance the quality of the book. One example of such changes is that the
chapter on the fundamental aspects of rate-controlled drug delivery has been moved
to the beginning of the book, preceding the chapters on rate-controlled drug delivery
through various routes of administration. Also, the chapter on regulatory consider
ations in controlled drug delivery has been expanded to incorporate new guidelines
used in the regulatory approval process.
Overall, the objective set for writing this new edition has been the same as for
the first edition, that is, to provide the readers with a broad spectrum of scientific
information in a concise, systematic manner, but with new vision and wider scope.
Yie W. Chien
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