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

ISBN-13: 9781420086430 / Angielski / Twarda / 2009 / 422 str.

Sandeep Nema; John D. Ludwig

Opis

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.

Spis treści

Volume I

1. Parenteral Dosage Forms: Introduction and Historical Perspectives

John D. Ludwig

2. Parenteral Drug Administration: Routes of Administration and Devices

Himanshu Bhattacharjee and Laura A. Thoma

3. Biopharmaceutics and Immunogenicity of Biotherapeutics

Balaji Agoram, Kazuko Sagawa, Ravi M Shanker, and Satish Singh

4. Preformulation Research of Parenteral Medication

Murti Vemuri

5. Formulation Development of Small and Large Volume Injections

Madhav Kamat and Patrick P. DeLuca

6. Solubility and Solubilization

Michael Hageman

7. Formulation of Depot Delivery Systems

James J. Cunningham, Marc J. Kirchmeier, and Sachin Mittal

8. Biophysical and Biochemical Characterization of Peptide and Protein Drug Product

Tapan K. Das and James A. Carroll

9. Formulation of Protein- and Peptide-based Parenteral Products

Gaozhong Zhu and Y. John Wang

10. Development of Ophthalmic Formulations

Paramita Bandyopadhyay, Martin J. Coffey, and Mohannad Shawer

11. Glass containers for Parenteral Products

Robert Swift

12. Plastic Packaging for Parenteral Drug Delivery

Vinod D. Vilivalam and Fran DeGrazio

13. Elastomeric Closures for Parenterals

Renaud Janssen

14. Parenteral Product Container-Closure Integrity Testing

          Dana Morton Guazzo