Pharmaceutical manufacturing handbook : production and processes (2008)

CONTRIBUTORS. PREFACE. SECTION 1 MANUFACTURING SPECIALTIES. 1.1 Biotechnology-Derived Drug Product Development ( 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 ( Erin Oliver, Stephen M. Carl, Kenneth R. Morris, Gerald W. Becker, and Gregory T. Knipp ). 1.3 Radiopharmaceutical Manufacturing ( Brit S. Farstad and Ivan Penuelas ). SECTION 2 ASEPTIC PROCESSING. 2.1 Sterile Product Manufacturing ( James Agalloco and James Akers ). SECTION 3 FACILITY. 3.1 From Pilot Plant to Manufacturing: Effect of Scale-Up on Operation of Jacketed Reactors ( B. Wayne Bequette ). 3.2 Packaging and Labeling ( Maria Ines Rocha Miritello Santoro and Anil Kumar Singh ). 3.3 Clean-Facility Design, Construction, and Maintenance Issues ( Raymond K. Schneider ). SECTION 4 NORMAL DOSAGE FORMS. 4.1 Solid Dosage Forms ( Barbara R. Conway ). 4.2 Semisolid Dosages: Ointments, Creams, and Gels ( Ravichandran Mahalingam, Xiaoling Li, and Bhaskara R. Jasti ). 4.3 Liquid Dosage Forms ( Maria V. Rubio-Bonilla ). SECTION 5 NEW DOSAGE FORMS. 5.1 Controlled-Release Dosage Forms ( Anil Kumar Anal ). 5.2 Progress in the Design of Biodegradable Polymer-Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein ( Shunmugaperumal Tamilvanan ). 5.3 Liposomes and Drug Delivery ( Sophia G. Antimisiaris, Paraskevi Kallinteri, and Dimitrios G. Fatouros ). 5.4 Biodegradable Nanoparticles ( 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 ( Stephanie Blanquet and Monique Alric ). 5.6 Nasal Delivery of Peptide and Nonpeptide Drugs ( Chandan Thomas and Fakhrul Ahsan ). 5.7 Nasal Powder Drug Delivery ( Jelena Filipovic-Grcic and Anita Hafner ). 5.8 Aerosol Drug Delivery ( Michael Hindle ). 5.9 Ocular Drug Delivery ( Ilva D. Rupenthal and Raid G. Alany ). 5.10 Microemulsions as Drug Delivery Systems ( Raid G. Alany and Jingyuan Wen ). 5.11 Transdermal Drug Delivery ( C. Scott Asbill and Gary W. Bumgarner ). 5.12 Vaginal Drug Delivery ( Jose das Neves, Maria Helena Amaral, and Maria Fernanda Bahia ). SECTION 6 TABLET PRODUCTION. 6.1 Pharmaceutical Preformulation: Physicochemical Properties of Excipients and Powers and Tablet Characterization ( Beom-Jin Lee ). 6.2 Role of Preformulation in Discovery and Development: Pharmaceutics of Solid Dosage Forms ( Omathanu P. Perumal and Satheesh K. Podaralla ). 6.3 Tablet Design ( Eddy Castellanos Gil, Isidoro Caraballo, and Bernard Bataille ). 6.4 Tablet Production Systems ( Katharina M. Picker-Freyer ). 6.5 Controlled Release of Drugs from Tablet Coatings ( Sacide Alsoy Altinkaya ). 6.6 Tablet Compression ( Helton M. M. Santos and Joao J. M. S. Sousa ). 6.7 Effects of Grinding in Pharmaceutical Tablet Production ( Gavin Andrews, David Jones, Zhai Hui, Osama Abu Diak, and Gavin Walker ). 6.8 Oral Extended-Release Formulations ( Anette Larsson, Susanna Abrahmsen-Alami, and Anne Juppo ). SECTION 7 ROLE OF NANOTECHNOLOGY. 7.1 Cyclodextrin-Based Nanomaterials in Pharmaceutical Field ( Erem Bilensoy and A. Attila Hincal ). 7.2 Nanotechnology in Pharmaceutical Manufacturing ( Yiguang Jin ). 7.3 Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety ( Faz Chowdhury ). 7.4 Oil-in-Water Nanosized Emulsions: Medical Applications ( Shunmugaperumal Tamilvanan ). INDEX.