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This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
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Autorenporträt
SHAYNE COX GAD, PhD, DABT, ATS, is the Principal of Gad Consulting Services. Dr. Gad has more than thirty years of experience as a toxicologist, statistical consultant, manager, and general consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is the author of twenty-nine books and numerous papers, presentations, and other publications.
Inhaltsangabe
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 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 -Gr i 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 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 6.3 Tablet Design 977 Eddy Castellanos Gil, Isidoro Caraballo, and Bernard Bataille 6.4 Tablet Production Systems 1053 Katharina M. Picker-Freyer 6.5 Controlled Release of Drugs from Tablet Coatings 1099 Sacide Alsoy Altinkaya 6.6 Tablet Compression 1133 Helton M. M. Santos and João J. M. S. Sousa 6.7 Effects of Grinding in Pharmaceutical Tablet Production 1165 Gavin Andrews, David Jones, Hui Zhai, Osama Abu Diak, and Gavin Walker 6.8 Oral Extended-Release Formulations 1191 Anette Larsson, Susanna Abrahmsén-Alami, and Anne Juppo Section 7 Role of Nanotechnology 1223 7.1 Cyclodextrin-Based Nanomaterials in Pharmaceutical Field 1225 Erem Bilensoy and A. Attila Hincal 7.2 Nanotechnology in Pharmaceutical Manufacturing 1249 Yiguang Jin 7.3 Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety 1289 D. F. Chowdhury 7.4 Oil-in-Water Nanosized Emulsions: Medical Applications 1327 Shunmugaperumal Tamilvanan Index 1367
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 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 -Gr i 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 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 6.3 Tablet Design 977 Eddy Castellanos Gil, Isidoro Caraballo, and Bernard Bataille 6.4 Tablet Production Systems 1053 Katharina M. Picker-Freyer 6.5 Controlled Release of Drugs from Tablet Coatings 1099 Sacide Alsoy Altinkaya 6.6 Tablet Compression 1133 Helton M. M. Santos and João J. M. S. Sousa 6.7 Effects of Grinding in Pharmaceutical Tablet Production 1165 Gavin Andrews, David Jones, Hui Zhai, Osama Abu Diak, and Gavin Walker 6.8 Oral Extended-Release Formulations 1191 Anette Larsson, Susanna Abrahmsén-Alami, and Anne Juppo Section 7 Role of Nanotechnology 1223 7.1 Cyclodextrin-Based Nanomaterials in Pharmaceutical Field 1225 Erem Bilensoy and A. Attila Hincal 7.2 Nanotechnology in Pharmaceutical Manufacturing 1249 Yiguang Jin 7.3 Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety 1289 D. F. Chowdhury 7.4 Oil-in-Water Nanosized Emulsions: Medical Applications 1327 Shunmugaperumal Tamilvanan Index 1367
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