Pharmaceutical Dosage Forms: Parenteral Medications, Third Edition. 3 Volume Set (3RD ed.)

Biographical Note:

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.

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.