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Handbook of

Pharmaceutical
Controlled Release
Technology
executive editor
Donald L. Wise
Cambridge Scientific, Inc.
Cambridge, Massachusetts

associate editors
Lisa Brannon-Peppas DebraJ. Trantolo
Biogel Technology, Inc. Cambridge Scientific, Inc.
Indianapolis, Indiana Cambridge, Massachusetts
Alexander M. Klibanov Gary E. Wnek
Robert S. Langer Virginia Commonwealth University
Massachusetts Institute of Technology Richmond, Virginia
Cambridge, Massachusetts Michael J. Yaszemski
Antonios G. Mikos Mayo Clinic
Rice University Rochester, Minnesota
Houston, Texas
Nicholas A. Peppas
Purdue University
West Lafayette, Indiana

m
M A R C E L

D E K K E R
MARCEL DEKKER, INC. NEW YORK BASEL
Contents
Preface m

Part I: Polymers as Drug Delivery Carriers

1. Hydrophilic Cellulose Derivatives as Drug Delivery Carriers: 1


Influence of Substitution Type on the Properties of Compressed Matrix Tablets
Carmen Ferrero Rodriguez, Nathalie Bruneau, Jerome Barra, Dowthee Alfonso,
and Eric Doelker

2. Poly(Vinyl Alcohol) as a Drug Delivery Carrier 31


Surya K. Mallapragada and Shannon McCarthy-Schroeder

3. Development of Aery late and Methacrylate Polymer Networks for 47


Controlled Release by Photopolymerization Technology
Robert Scott, Jennifer H. Ward, and Nicholas A. Peppas

4. Smart Polymers for Controlled Drug Delivery 65


Joseph Kost and SmadarA. Lapidot

5. Complexing Polymers in Drug Delivery 89


Anthony M. Lowman

6. Polylactic and Polyglycolic Acids as Drug Delivery Carriers 99


Lisa Brannon-Peppas and Michel Vert

1 Use of Infrared and Raman Spectroscopy for Characterization of 131


Controlled Release Systems
A. B. Scranton, B. Drescher, E. W. Nelson, and J. L. Jacobs

8. Accurate Models in Controlled Drug Delivery Systems 155


Balaji Narasimhan

Part II: Mechanism-Based Classification of Controlled Release Devices

9. Drug Release from Swelling-Controlled Systems 183


Paolo Colombo, Patrizia Sand, Ruggero Bettini, Christopher S. Brazel,
and Nicholas A. Peppas

vii
viii Contents

10. Superporous Hydrogels as a Platform for Oral Controlled Drug Delivery 211
Jun Chen, Haesun Park, and Kinam Park

11. Osmotic Implantable Delivery Systems 225


Cynthia L. Stevenson, Felix Theeuwes, and Jeremy C. Wright

12. Bioadhesive Controlled Release Systems 255


Nicholas A. Peppas, Monica D. Little, and Yanbin Huang

Part III: Micro- and Nanoparticulate Release Systems

13. Microencapsulation Technology: Interfacial Polymerization Method 271


A. Atilla Hincal and H. Siiheyla Kas

14. Nanoparticulate Controlled Release Systems for Cancer Therapy 287


C. Dubernet, E. Fattal, and P. Couvreur

15. Microencapsulation Using Coacervation/Phase Separation: An Overview 301


of the Technique and Applications
H. Siiheyla Kas, and Levent Oner

16. Microsphere Preparation by Solvent Evaporation Method 329


A. Atilla Hincal and Sema

17. Nanosuspensions: A Formulation Approach for Poorly Soluble 345


and Poorly Bioavailable Drugs
R. H. Mullen B. H. L. Bohm, and M. J. Grau

18. Large-Scale Production of Solid Lipid Nanoparticles (SLN) 359


and Nanosuspensions (DissoCubes)
R. H. Miiller, A. Dingier, T. Schneppe, and S. Gohla

19. Solid Lipid Nanoparticles (SLN) as a Carrier System for the Controlled 377
Release of Drugs
R. H. Miiller, A. Lippacher, and S. Gohla

20. Stability of Encapsulated Substances in Poly(Lactide-co-Glycolide) 393


Delivery Systems
Steven P. Schwendeman, Anna Shenderova, Gaozhong Zhu, and Wenlei Jiang

21. Development of Polysaccharide Nanoparticles as Novel Drug Carrier Systems 413


C. Vauthier and P. Couvreur

Part IV: Classification of Controlled Release Devices According to


Administration Site

22. An Overview of Controlled Release Systems 431


S. Venkatraman, N. Davar, A. Chester, and L. Kleiner
Contents ix

23. Research and Development Aspects of Oral Controlled-Release Dosage Forms 465
Yihong Qiu and Guohua Zhang

24. A Gastrointestinal Retentive Microparticulate System to Improve Oral 505


Drug Delivery
Y. Kawashima, H. Takeuchi, and H. Yamamoto

25. In Vitro-In Vivo Correlations in the Development of Solid Oral Controlled 527
Release Dosage Forms
Yihong Qiu, Emil E. Samara, and Guoliang Cao

26. Gamma Scintigraphy in the Analysis of the Behavior of Controlled 551


Release Systems
C. G. Wilson and N. Washington

27. Electrically Assisted Transdermal Delivery of Drugs 567


Ajay K. Banga

28. A Novel Method Based on Artificial Neural Networks for Optimizing 583
Transdermal Drug Delivery Systems
Kozo Takayama and Tsuneji Nagai

29. Transdermal Drug Delivery by Skin Electroporation 597


Tani Chen, Robert Longer, and James C. Weaver

30. Enhancement of Transdermal Transport Using Ultrasound in Combination 607


with Other Enhancers
Samir Mitragotri, Robert Langer, and Joseph Kost

31. Electrotransport Systems for Transdermal Delivery: 617


A Practical Implementation of Iontophoresis
Erik R. Scott, J. Bradley Phipps, J. Richard Gyory, and Rama V. Padmanabhan

Part V: Peptide and Protein Release Systems

32. Controlled Release Protein Therapeutics: Effects of Process 661


and Formulation on Stability
Paul A. Burke

33. Solid-State Chemical Stability of Peptides and Proteins: Application 693


to Controlled Release Formulations
Elizabeth M. Topp, Yuan Song, Ashley Wilson, Rong Li, Michael J. Hageman,
and Richard L. Schowen

34. Growth Factor Release from Biodegradable Hydrogels 725


to Induce Neovascularization
Yoshito Ikada and Yasuhiko Tabata
x Contents

35. Biopolymers for Release of Interleukin-2 for Treatment of Cancer 743


Debra J. Trantolo, Joseph D. Gresser, A. Ganiyu Jimoh, Donald L. Wise,
and James C. Yang

Part VI: Medical Applications of Drug Delivery

36. Osmotic Drug Delivery from Asymmetric Membrane Film-Coated 751


Dosage Forms
Mary Tanya am Ende, Scott M. Herbig, Richard W. Korsmeyer,
and Mark B. Chidlaw

37. Controlled Release Pain Management Systems 787


Vasif Hasirci, Dilek Sendil, Leonidas C. Goudas, Daniel B. Carr,
and Donald L. Wise

38. Biodegradable Systems for Long-Acting Nestorone 807


Debra J. Trantolo, Donald L. Wise, A. J. Moo-Young, Yung-Yueh Hsu,
and Joseph D. Gresser

39. Preparation and Evaluation of Buprenorphine Microspheres 821


for Parenteral Administration
William R. Ravis, Yuh-Jing Lin, and Ram Murty

40. Prolonged Release of Hydromorphone from a Novel Poly(Lactic-co-Glycolic) 837


Acid Depot System: Initial In Vitro and In Vivo Observations
Leonidas C. Goudas, Daniel B. Carr, Richard M. Kream, Louis Shuster,
William M. Vaughan, Joseph D. Gresser, Donald L. Wise,
and Debra J. Trantolo

41. Incorporation of an Active Agent into a Biodegradable Cement: 849


Encapsulation of the Agent as Protection from Chemical Degradation
During Cure and Effect on Release Profile
Joseph D. Gresser, Debra J. Trantolo, Pattisapu R. J. Gangadharam,
Hisanori X. Nagaoka, Yung-Yueh Hsu, and Donald L. Wise

42. The Pharmacoeconomic Value of Controlled Release Dosage Forms 865


Laura B. Gardner

Index 873