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Pharmaceutical Dosage Forms - Parenteral Medications. Edition No. 3
Informa Healthcare, August 2010, Pages: 500
This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals.
First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations.
Volume one presents:
- A historical perspective of injectable drug therapy, common routes of administration, and biopharmaceutics of NCEs and NBEs.
- An in-depth discussion on the preformulation and formulation of small and large molecules, including ophthalmic dosage forms.
- A presentation of parenteral primary packaging options - glass and plastic containers, as well as elastomeric closures.
- A definitive chapter on container-closure integrity.
- New chapters on solubility and solubilization, formulation of depot delivery systems and biophysical/biochemical characterization of proteins.
Volume two presents:
- Chapters on aseptic facility design, environmental monitoring, and cleanroom operations.
- A comprehensive chapter on pharmaceutical water systems.
- A discussion of quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing.
- A detailed chapter on processing of parenteral drug products (SVPs and LVPs).
- Presentations on widely used sterilization technologies – steam, gas / chemical, radiation, filtration and dry heat.
- An in-depth chapter on lyophilization.
Volume three presents:
- An in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables.
- Specific chapters on parenteral administrations devices, injection site pain assessment, and parenteral product specifications and stability testing.
- Forward-thinking discussions on the future of parenteral product manufacturing, and siRNA delivery systems.
- New chapters covering recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), and validation of drug product manufacturing process.
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
Formulation Development of Small and Large Volume Injections
Madhav Kamat and Patrick P. DeLuca
Solubility and Solubilization
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
Plastic Packaging for Parenteral Drug Delivery
Vinod D. Vilivalam and Fran DeGrazio
Elastomeric Closures for Parenterals
Parenteral Product Container-Closure Integrity Testing
Dana Morton Guazzo
Asceptic Manufacturing Facility Design
Mark Caldwell, Bob Helt, Beth Holden, Francesca McBride, and Kevin Schreier
Personnel and their impact on Cleanroom Operations
The Fundamentals of an Environmental Control Program
William H. Miele
Water Systems for Parenteral Facilities
Particulate Matter: Sub-Visible
D. Scott Aldrich
Michael E. Dawson
The Compendial Sterility Tests
Scott VW Sutton
Industrial Sterilization Technologies: Principles and Overview
Anne F. Booth
Gas, Vapor and Liquid Chemical Sterilization
Dry Heat Depyrogenation and Sterilization
Deborah Havlik and Kevin Trupp
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
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
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
Techniques to Evaluate Damage and Pain on Injection
Gayle A. Brazeau, Jessica Klapa and Pramod Gupta
Parenteral Product Specifications and Stability
Extractables and Leachables
Edward Smith and Dianne M. Paskiet
Process Analytical Technology and Rapid Microbial Methods
Geert Verdonk and Tony Cundell
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
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.