Pharmaceutical Dosage Forms - Parenteral Medications
Volume 1: Formulation and Packaging
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.
Table of Contents
- Parenteral Dosage Forms: Introduction and Historical Perspectives
- Parenteral Drug Administration: Routes of Administration and Devices
- Biopharmaceutics and Immunogenicity of Biotherapeutics
- Preformulation Research of Parenteral Medication
- Formulation Development of Small and Large Volume Injections
- Solubility and Solubilization
- Formulation of Depot Delivery Systems
- Biophysical and Biochemical Characterization of Peptide and Protein Drug Product
- Formulation of Protein- and Peptide-based Parenteral Products
- Development of Ophthalmic Formulations
- Glass containers for Parenteral Products
- Plastic Packaging for Parenteral Drug Delivery
- Elastomeric Closures for Parenterals
- Parenteral Product Container-Closure Integrity Testing
John D. Ludwig
Himanshu Bhattacharjee and Laura A. Thoma
Balaji Agoram, Kazuko Sagawa, Ravi M Shanker, and Satish Singh
Madhav Kamat and Patrick P. DeLuca
James J. Cunningham, Marc J. Kirchmeier, and Sachin Mittal
Tapan K. Das and James A. Carroll
Gaozhong Zhu and Y. John Wang
Paramita Bandyopadhyay, Martin J. Coffey, and Mohannad Shawer
Vinod D. Vilivalam and Fran DeGrazio
Dana Morton Guazzo
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.