Volume one provides:
- An 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.
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
". . .Every chapter has been revised and updated to keep pace with advances in science and technology. The editors did a good job of systematically organizing the contents of the text into three volumes. . .The first volume deals with performultion, formulation, and product development. . . .well illustrated with photographs, diagrams, and flow charts. . .The contributing authors. . .have impressive credentials and their views and experiences enhance the value of the book. . .strongly recommend[ed]. . .for both students and professionals, both in academics and in industry." ---BioPharm (Review of 2nd edn – vol 1)
"This book forms part of a 3-volume set which is a standard reference work for the formulation and manufacture of parenteral dosage forms. . . . . .coverage. . .is very comprehensive. . . . . .The entire series is probably the best source for information of the disparate multidisciplinary area we call pharmaceutics, and is essential reading for all in this area. " ---Journal of Pharmacy and Pharmacology (Review of 2nd edn – vol 1)
". . .Every chapter has been revised and updated to keep pace with advances in science and technology. The editors did a good job of systematically organizing the contents of the text into three volumes. . .The first volume deals with performultion, formulation, and product development. . . .well illustrated with photographs, diagrams, and flow charts. . .The contributing authors. . .have impressive credentials and their views and experiences enhance the value of the book. . .strongly recommend[ed]. . .for both students and professionals, both in academics and in industry. " ---BioPharm (Review of 2nd edn – vol 1)
Sandeep is Executive Director, Pharmaceutical R&D, Global Biologics in St. Louis where he is responsible for Formulation Development of biotherapeutics with a focus on vaccines and oligonucleotides. In this role he manages projects from discovery support, formulation development, scale-up, and validation through regulatory filings.
Sandeep is a Certified Regulatory Affairs Professional. He is active in AAPS and PDA where he has served as Chairman, Arden House Conference on “Parenteral Products: Integrating Science, Innovation and Patient Needs” (2002); Co-Chair, AAPS/FDA/USP workshop on ‘Future Direction in Aseptic Processing’, (2003); and past Chair of Sterile Product Focus group. He is also an adjunct faculty at University of Tennessee. Sandeep was a Steering Committee Member for the Handbook of Pharmaceutical Excipients.
Sandeep received his PhD in 1992 and since then 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). He has been lead formulator for four launched products.
John began his career with Burroughs Wellcome Co. in 1989 as a pharmaceutical formulator and worked on a variety of dosage forms including liquid and lyophilized parenterals, topical creams and ointments, and oral liquids. He joined Searle, Inc. in Skokie, IL in 1995 responsible for parenteral product formulation and process development, clinical manufacturing, technology transfer/validation, and the R&D microbiology function. In 2001 he transferred to Chesterfield, MO as Site Leader for the Bioprocess and Formulation Technology organization (Pharmacia, Inc.). Following the Pfizer acquisition in 2003, John led the combined Pharmaceutical and Analytical R&D line for Pfizer Global Biologics and from 2007-2009 the Analytical R&D organization. He currently leads the Business Strategy, Operations, and Clinical Supply Planning function, and serves as Site Director for Pfizer St. Louis Laboratories.
John is active in the American Association of Pharmaceutical Scientists and the Parenteral Drug Association (PDA) Training and Research Institute. He has contributed to developing three professional training courses and serves regularly as a course instructor for PDA.
John's research interests include parenteral container/closure integrity evaluation and protein stabilization and processing.
Dr. Ludwig received a B.S. degree in Pharmacy and Ph.D. degree in Pharmaceutics from the University of Tennessee, Memphis. He lives in Wildwood, MO with his wife Sue and their three children.