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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 Jersey

Published simultaneously in Canada

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ISBN: 978-0-470-25958-0

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, Oral

Extended - Release Formulations

James Agalloco, Agalloco & Associates, Belle Mead, New Jersey, Sterile Product

Manufacturing

Fakhrul Ahsan, Texas Tech University, Amarillo, Texas, Nasal Delivery of Peptide and Nonpeptide Drugs James Akers, Akers Kennedy & Associates, Kansas City, Missouri, Sterile Product

Manufacturing

Raid G. Alany, The University of Auckland, Auckland, New Zealand, Ocular Drug

Delivery; 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 Drug

Delivery

Anil Kumar Anal, Living Cell Technologies (Global) Limited, Auckland, New

Zealand, Controlled - Release Dosage Forms

Gavin Andrews, Queen " s University Belfast, Belfast, Northern Ireland, Effects of

Grinding 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 Drug

Delivery

Maria Fernanda Bahia, University of Porto, Porto, Portugal, Vaginal Drug

Delivery

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 - On

Protein 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 Field

St é phanie Blanquet, Universit é d " Auvergne, Clermont - Ferrand, France, Recombi-

nant Saccharomyces Cerevisiae as New Drug Delivery System to Gut: In Vitro

Validation and Oral Formulation

Gary W. Bumgarner, Samford University, Birmingham, Alabama, Transdermal

Drug Delivery

Isidoro Caraballo, University of Sevilla, Seville, Spain, Tablet Design Stephen M. Carl, Purdue University, West Lafayette, Indiana, Biotechnology - Derived Drug Product Development; Regulatory Considerations in Approval of

Follow - On Protein Drug Products

Sudhir S. Chakravarthi, University of Nebraska Medical Center, College of Phar- macy, Omaha, Nebraska, Biodegradable Nanoparticles D.F. Chowdhury, University of Oxford, Oxford, United Kingdom, Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety Barbara R. Conway, Aston University, Birmingham, United Kingdom, Solid Dosage Forms Jos é das Neves, University of Porto, Porto, Portugal, Vaginal Drug Delivery Osama Abu Diak, Queen " s University Belfast, Belfast, Northern Ireland, Effects of Grinding in Pharmaceutical Tablet Production Brit S. Farstad, Instititue for Energy Technology, Isotope Laboratories, Kjeller,

Norway, Radiopharmaceutical Manufacturing

Dimitrios G. Fatouros, School of Pharmacy and Biomedical Sciences, Portsmouth,

England, Liposomes and Drug Delivery

Jelena Filipovi ç - Gr i , Faculty of Pharmacy and Biochemistry, University of Zagreb, Zagreb, Croatia, Nasal Powder Drug Delivery

CONTRIBUTORS vii

Eddy Castellanos Gil, Center of Pharmaceutical Chemistry and University of Havana, Havana, Cuba; University of Sevilla, Seville, Spain; University of Mont- pelier 1, Montpellier, France, Tablet Design Anita Hafner, Faculty of Pharmacy and Biochemistry, University of Zagreb,

Zagreb, Croatia, Nasal Powder Drug Delivery

A. Atilla Hincal, Hacettepe University Faculty of Pharmacy, Ankara, Turkey, Cyclodextrin - Based Nanomaterials in Pharmaceutical Field Michael Hindle, Virginia Commonwealth University, Richmond, Virginia, Aerosol

Drug Delviery

Bhaskara R. Jasti, University of the Pacifi c, Stockton, California, Semisolid Dosages:

Ointments, Creams, and Gels

Yiguang Jin, Beijing Institute of Radiation Medicine, Beijing, China, Nanotechnol- ogy in Pharmaceutical Manufacturing David Jones, Queen " s University Belfast, Belfast, Northern Ireland, Effects of

Grinding in Pharmaceutical Tablet Production

Anne Juppo, University of Helsinki, Helsinki, Finland, Oral Extended - Release

Formulations

Paraskevi Kallinteri, Medway School of Pharmacy, Universities of Greenwich and

Kent, England, Liposomes and Drug Delivery

Gregory T. Knipp, Purdue University, West Lafayette, Indiana, Biotechnology - Derived Drug Product Development; Regulatory Considerations in Approval of

Follow - On Protein Drug Products

Extended - Release Formulations

Beom - Jin Lee, Kangwon National University, Chuncheon, Korea, Pharmaceutical Preformulation: Physiochemical Properties of Excipients and Powders and Tablet

Characterization

Xiaoling Li, University of the Pacifi c, Stockton, California, Semisolid Dosages:

Ointments, Creams, and Gels

David J. Lindley, Purdue University, West Lafayette, Indiana, Biotechnology -

Derived Drug Product Development

Roberto Londono, Washington State University, Pullman, Washington, Liquid

Dosage Forms

Ravichandran Mahalingam, University of the Pacifi c, Stockton, California, Semi- solid Dosages: Ointments, Creams, and Gels Kenneth R. Morris, Purdue University, West Lafayette, Indiana,

Biotechnology -

Derived Drug Product Development; Regulatory Considerations in Approval of

Follow - On Protein Drug Products

Erin Oliver, Rutgers, The State University of New Jersey, Piscataway, New Jersey, Biotechnology - Derived Drug Product Development; Regulatory Considerations in Approval of Follow - On Protein Drug Products viii CONTRIBUTORS Iv á n Pe ñ uelas, University of Navarra, Pamplona, Spain, Radiopharmaceutical

Manufacturing

Omanthanu P. Perumal, South Dakota State University, Brookings, South Dakota, Role of Preformulation in Development of Solid Dosage Forms Katharina M. Picker - Freyer, Martin - Luther - University Halle - Wittenberg, Institute of Pharmaceutics and Biopharmaceutics, Halle/Saale, Germany, Tablet Produc- tion Systems Satheesh K. Podaralla, South Dakota State University, Brookings, South Dakota, Role of Preformulation in Development of Solid Dosage Forms Dennis H. Robinson, University of Nebraska Medical Center, College of Phar- macy, Omaha, Nebraska, Biodegradable Nanoparticles Arcesio Rubio, Caracas, Venezuela, Liquid Dosage Forms Maria V. Rubio - Bonilla, Research Associate, College of Pharmacy, Washington State University, Pullman, Washington, Liquid Dosage Forms Ilva D. Rupenthal, The University of Auckland, Auckland, New Zealand, Ocular

Drug Delivery

Maria In ê s Rocha Miritello Santoro, Department of Pharmacy, Faculty of Pharma- ceutical Sciences, University of S ã o Paulo, S ã o Paulo, Brazil, Packaging and

Labeling

Helton M.M. Santos, University of Coimbra, Coimbra, Portugal, Tablet

Compression

Raymond K. Schneider, Clemson University, Clemson, South Carolina, Clean - Facility Design, Construction, and Maintenance Issues Anil Kumar Singh, Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of S ã o Paulo, S ã o Paulo, Brazil, Packaging and Labeling Jo ã o J.M.S. Sousa, University of Coimbra, Coimbra, Portugal, Tablet

Compression

Shunmugaperumal Tamilvanan, University of Antwerp, Antwerp, Belgium, Prog- ress in Design of Biodegradable Polymer - Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein; Oil - in - Water Nanosized

Emulsions: Medical Applications

Chandan Thomas, Texas Tech University, Amarillo, Texas, Nasal Delivery of

Peptide and Nonpeptide Drugs

Gavin Walker, Queen " s University Belfast, Belfast, Northern Ireland, Effects of

Grinding in Pharmaceutical Tablet Production

Jingyuan Wen, The University of Auckland, Auckland, New Zealand, Microemul- sions as Drug Delivery Systems Hui Zhai, Queen " s University Belfast, Belfast, Northern Ireland, Effects of Grind- ing in Pharmaceutical Tablet Production ix

CONTENTS

PREFACE xiii

SECTION 1 MANUFACTURING SPECIALTIES 1

1.1 Biotechnology-Derived Drug Product Development 3

Stephen M. Carl, David J. Lindley, Gregory T. Knipp, Kenneth R. Morris, Erin Oliver, Gerald W. Becker, and Robert D. Arnold

1.2 Regulatory Considerations in Approval on Follow-On Protein

Drug Products 33

Erin Oliver, Stephen M. Carl, Kenneth R. Morris, Gerald W. Becker, and

Gregory T. Knipp

1.3 Radiopharmaceutical Manufacturing 59

Brit S. Farstad and Iván Peñuelas

SECTION 2 ASEPTIC PROCESSING 97

2.1 Sterile Product Manufacturing 99

James Agalloco and James Akers

SECTION 3 FACILITY 137

3.1 From Pilot Plant to Manufacturing: Effect of Scale-Up on

Operation of Jacketed Reactors 139

B. Wayne Bequette

x CONTENTS

3.2 Packaging and Labeling 159

Maria Inês Rocha Miritello Santoro and Anil Kumar Singh

3.3 Clean-Facility Design, Construction, and Maintenance Issues 201

Raymond K. Schneider

SECTION 4 NORMAL DOSAGE FORMS 233

4.1 Solid Dosage Forms 235

Barbara R. Conway

4.2 Semisolid Dosages: Ointments, Creams, and Gels 267

Ravichandran Mahalingam, Xiaoling Li, and Bhaskara R. Jasti

4.3 Liquid Dosage Forms 313

Maria V. Rubio-Bonilla, Roberto Londono, and Arcesio Rubio

SECTION 5 NEW DOSAGE FORMS 345

5.1 Controlled-Release Dosage Forms 347

Anil Kumar Anal

5.2 Progress in the Design of Biodegradable Polymer-Based

Microspheres for Parenteral Controlled Delivery of Therapeutic

Peptide/Protein 393

Shunmugaperumal Tamilvanan

5.3 Liposomes and Drug Delivery 443

Sophia G. Antimisiaris, Paraskevi Kallinteri, and Dimitrios G. Fatouros

5.4 Biodegradable Nanoparticles 535

Sudhir S. Chakravarthi and Dennis H. Robinson

5.5 Recombinant Saccharomyces cerevisiae as New Drug Delivery

System to Gut: In Vitro Validation and Oral Formulation 565

Stéphanie Blanquet and Monique Alric

5.6 Nasal Delivery of Peptide and Nonpeptide Drugs 591

Chandan Thomas and Fakhrul Ahsan

5.7 Nasal Powder Drug Delivery 651

Jelena Filipovi-Gri and Anita Hafner

5.8 Aerosol Drug Delivery 683

Michael Hindle

5.9 Ocular Drug Delivery 729

Ilva D. Rupenthal and Raid G. Alany

5.10 Microemulsions as Drug Delivery Systems 769

Raid G. Alany and Jingyuan Wen

CONTENTS xi

5.11 Transdermal Drug Delivery 793

C. Scott Asbill and Gary W. Bumgarner

5.12 Vaginal Drug Delivery 809

José das Neves, Maria Helena Amaral, and Maria Fernanda Bahia

SECTION 6 TABLET PRODUCTION 879

6.1 Pharmaceutical Preformulation: Physicochemical Properties of

Excipients and Powers and Tablet Characterization 881

Beom-Jin Lee

6.2 Role of Preformulation in Development of Solid Dosage Forms 933

Omathanu P. Perumal and Satheesh K. Podaralla

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