Pharmaceutical Manufacturing Handbook Production and Processes

PHARMACEUTICAL MANUFACTURING HANDBOOK Production and Processes......Page 3
CONTRIBUTORS......Page 7
CONTENTS......Page 11
PREFACE......Page 15
SECTION 1 MANUFACTURING SPECIALTIES......Page 17
1.1 Biotechnology-Derived Drug Product Development......Page 19
1.2 Regulatory Considerations in Approval on Follow-On Protein Drug Products......Page 49
1.3 Radiopharmaceutical Manufacturing......Page 75
SECTION 2 ASEPTIC PROCESSING......Page 113
2.1 Sterile Product Manufacturing......Page 115
SECTION 3 FACILITY......Page 153
3.1 From Pilot Plant to Manufacturing: Effect of Scale-Up on Operation of Jacketed Reactors......Page 155
3.2 Packaging and Labeling......Page 175
3.3 Clean-Facility Design, Construction, and Maintenance Issues......Page 217
SECTION 4 NORMAL DOSAGE FORMS......Page 249
4.1 Solid Dosage Forms......Page 251
4.2 Semisolid Dosages: Ointments, Creams, and Gels......Page 283
4.3 Liquid Dosage Forms......Page 329
SECTION 5 NEW DOSAGE FORMS......Page 361
5.1 Controlled-Release Dosage Forms......Page 363
5.2 Progress in the Design of Biodegradable Polymer-Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein......Page 409
5.3 Liposomes and Drug Delivery......Page 459
5.4 Biodegradable Nanoparticles......Page 551
5.5 Recombinant Saccharomyces cerevisiae as New Drug Delivery System to Gut: In Vitro Validation and Oral Formulation......Page 581
5.6 Nasal Delivery of Peptide and Nonpeptide Drugs......Page 607
5.7 Nasal Powder Drug Delivery......Page 667
5.8 Aerosol Drug Delivery......Page 699
5.9 Ocular Drug Delivery......Page 745
5.10 Microemulsions as Drug Delivery Systems......Page 785
5.11 Transdermal Drug Delivery......Page 809
5.12 Vaginal Drug Delivery......Page 825
SECTION 6 TABLET PRODUCTION......Page 895
6.1 Pharmaceutical Preformulation: Physicochemical Properties of Excipients and Powers and Tablet Characterization......Page 897
6.2 Role of Preformulation in Development of Solid Dosage Forms......Page 949
6.3 Tablet Design......Page 993
6.4 Tablet Production Systems......Page 1069
6.5 Controlled Release of Drugs from Tablet Coatings......Page 1115
6.6 Tablet Compression......Page 1149
6.7 Effects of Grinding in Pharmaceutical Tablet Production......Page 1181
6.8 Oral Extended-Release Formulations......Page 1207
SECTION 7 ROLE OF NANOTECHNOLOGY......Page 1239
7.1 Cyclodextrin-Based Nanomaterials in Pharmaceutical Field......Page 1241
7.2 Nanotechnology in Pharmaceutical Manufacturing......Page 1265
7.3 Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety......Page 1305
7.4 Oil-in-Water Nanosized Emulsions: Medical Applications......Page 1343
INDEX......Page 1383