3rd Edition

Pharmaceutical Dosage Forms - Parenteral Medications Volume 1: Formulation and Packaging

Edited By Sandeep Nema, John D. Ludwig Copyright 2010
    422 Pages 90 B/W Illustrations
    by CRC Press

    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 I

    1. Parenteral Dosage Forms: Introduction and Historical Perspectives
    2. John D. Ludwig

    3. Parenteral Drug Administration: Routes of Administration and Devices
    4. Himanshu Bhattacharjee and Laura A. Thoma

    5. Biopharmaceutics and Immunogenicity of Biotherapeutics
    6. Balaji Agoram, Kazuko Sagawa, Ravi M Shanker, and Satish Singh

    7. Preformulation Research of Parenteral Medication
    8. Murti Vemuri

    9. Formulation Development of Small and Large Volume Injections
    10. Madhav Kamat and Patrick P. DeLuca

    11. Solubility and Solubilization
    12. Michael Hageman

    13. Formulation of Depot Delivery Systems
    14. James J. Cunningham, Marc J. Kirchmeier, and Sachin Mittal

    15. Biophysical and Biochemical Characterization of Peptide and Protein Drug Product
    16. Tapan K. Das and James A. Carroll

    17. Formulation of Protein- and Peptide-based Parenteral Products
    18. Gaozhong Zhu and Y. John Wang

    19. Development of Ophthalmic Formulations
    20. Paramita Bandyopadhyay, Martin J. Coffey, and Mohannad Shawer

    21. Glass containers for Parenteral Products
    22. Robert Swift

    23. Plastic Packaging for Parenteral Drug Delivery
    24. Vinod D. Vilivalam and Fran DeGrazio

    25. Elastomeric Closures for Parenterals
    26. Renaud Janssen

    27. Parenteral Product Container-Closure Integrity Testing

              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.