About the Book
Pharmaceutical Dosage Forms: Parenteral Medications explores the administration of medications through other than the enteral route. First published in 1984 (as two volumes) and then last revised in 1993, this three-volume set presents the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration.
Volume 1 (Formulation and Packaging) presents a historical perspective of injectable drug therapy. It discusses common routes of administration and biopharmaceutics of NCEs and NBEs. It examines the preformulation and formulation of small and large molecules, including ophthalmic dosage forms. The book also presents a range of parenteral primary packaging options—including glass and plastic containers and elastomeric closures—and discusses container-closure integrity. This edition includes chapters on solubility and solubilization, formulation of depot delivery systems, and biophysical/biochemical characterization of proteins.
Volume 2 (Facility Design, Sterilization and Processing) explores aseptic facility design, environmental monitoring, and cleanroom operations. It discusses pharmaceutical water systems and quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing. The book contains a detailed discussion on the processing of parenteral drug products (SVPs and LVPs) as well as widely used sterilization technologies such as steam, gas/chemical, radiation, filtration, and dry heat. It also examines lyophilization.
Volume 3 (Regulations, Validation and the Future) provides an in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables. It explores parenteral administrations devices, injection site pain assessment, parenteral product specifications, and stability testing. It also discusses and the future of parenteral product manufacturing and siRNA delivery systems. The book covers recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), as well as validation of drug product manufacturing process.
Each individual volume is also available separately.
Table of Contents:
Volume I Parenteral Dosage Forms: Introduction and Historical Perspectives John D. Ludwig Parenteral Drug Administration: Routes of Administration and Devices Himanshu Bhattacharjee and Laura A. Thoma Biopharmaceutics and Immunogenicity of Biotherapeutics Balaji Agoram, Kazuko Sagawa, Ravi M Shanker, and Satish Singh Preformulation Research of Parenteral Medication Murti Vemuri Formulation Development of Small and Large Volume Injections Madhav Kamat and Patrick P. DeLuca Solubility and Solubilization Michael Hageman Formulation of Depot Delivery Systems James J. Cunningham, Marc J. Kirchmeier, and Sachin Mittal Biophysical and Biochemical Characterization of Peptide and Protein Drug Product Tapan K. Das and James A. Carroll Formulation of Protein- and Peptide-based Parenteral Products Gaozhong Zhu and Y. John Wang Development of Ophthalmic Formulations Paramita Bandyopadhyay, Martin J. Coffey, and Mohannad Shawer Glass containers for Parenteral Products Robert Swift Plastic Packaging for Parenteral Drug Delivery Vinod D. Vilivalam and Fran DeGrazio Elastomeric Closures for Parenterals Renaud Janssen Parenteral Product Container-Closure Integrity Testing Dana Morton Guazzo Volume 2: Asceptic Manufacturing Facility Design Mark Caldwell, Bob Helt, Beth Holden, Francesca McBride, and Kevin Schreier Personnel and their impact on Cleanroom Operations Jeanne Moldenhauer The Fundamentals of an Environmental Control Program William H. Miele Water Systems for Parenteral Facilities J. Manfredi Particulate Matter: Sub-Visible D. Scott Aldrich Endotoxin Testing Michael E. Dawson The Compendial Sterility Tests Scott VW Sutton Industrial Sterilization Technologies: Principles and Overview Anne F. Booth Steam Sterilization James Agalloco Gas, Vapor and Liquid Chemical Sterilization James Agalloco Dry Heat Depyrogenation and Sterilization Deborah Havlik and Kevin Trupp Radiation Sterilization Barry P. Fairand and Dusan Razem Filters and Filtration Maik W. Jornitz and Theodore H. Meltzer Processing of Small Volume Parenterals (SVPs) and Large Volume Parenterals (LVPs) Donald A. Eisenhauer, Christine Martin, Roland Schmidt, and Steven G. Schultz Freeze Drying: Principles and Practice Steven L. Nail and Larry A. Gatlin Volume 3: CGMP Regulations of Parenteral Drugs Terry E. Munson Risk Assessment and Mitigation in Aseptic Processing James Agalloco and James Akers Validation of Drug Product Manufacturing Processes: NCEs and NBEs Karoline Bechtold-Peters Visual Inspection Maria Toler and Sandeep Nema Advances in Parenteral Injection Devices and Aids Donna L. French and James J. Collins, Jr. SiRNA Targeting Using Injectable Nano-based Delivery Systems Lan Feng and Russell J. Mumper Excipients for Parenteral Dosage Forms: Regulatory Considerations and Controls Sandeep Nema Techniques to Evaluate Damage and Pain on Injection Gayle A. Brazeau, Jessica Klapa and Pramod Gupta Parenteral Product Specifications and Stability Michael Bergren Extractables and Leachables Edward Smith and Dianne M. Paskiet Process Analytical Technology and Rapid Microbial Methods Geert Verdonk and Tony Cundell Quality Assurance Michael Gorman Application of Quality by Design in CMC Development Roger Nosal, Tom Garcia, Vince McCurdy, Amit Banerjee, Carol F. Kirchhoff, Satish K. Singh Future of Parenteral Manufacturing James Agalloco, James Akers, and Russell Madsen
About the Author :
Sandeep Nema Ph.D. is Executive Director, Pharmaceutical R&D, BioTherapeutics Pharmaceutical Sciences at Pfizer in St. Louis. Since graduating in 1992 with his doctorate, Dr. Nema has been involved with the development of small molecule and protein drugs via parenteral delivery, first at Mallinckrodt Medical and then at Pfizer (Searle, Pharmacia), and has led the formulation of four launched products. He is active in the American Association of Pharmaceutical Scientists (AAPS) and the Parenteral Drug Association (PDA), where he has chaired several meetings and focus groups. Dr. Nema holds an adjunct faculty appointment at the University of Tennessee. John D. Ludwig Ph.D. is Vice President, Business Strategy, Operations, and Clinical Supply Planning, BioTherapeutics Pharmaceutical Sciences at Pfizer, and Site Director for the company's St. Louis Laboratories. Dr. Ludwig received a B.S. degree in Pharmacy and Ph.D. degree in Pharmaceutics from the University of Tennessee, Memphis and has held numerous research and development positions at Burroughs Wellcome Co, Searle, Inc., Pharmacia, Inc., and Pfizer. He is active in the American Association of Pharmaceutical Scientists (AAPS) and the Parenteral Drug Association (PDA) Training and Research Institute, where he has contributed to developing professional training courses and has regularly served as an instructor.
