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:
•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.
Volume two presents:
•Chapters on aseptic facility design, environmental monitoring, and cleanroom
•A comprehensive chapter on pharmaceutical water systems.
•A discussion of quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing.
•A detailed chapter on processing of parenteral drug products (SVPs and LVPs).
•Presentations on widely used sterilization technologies – steam, gas / chemical, radiation, filtration and dry heat.
•An in-depth chapter on lyophilization.
Volume three presents:
•An in-depth discussion of regulatory requirements, quality assurance,
risk assessment and mitigation, and extractables/leachables.
•Specific chapters on parenteral administrations devices, injection site pain assessment, and parenteral product specifications and stability testing.
•Forward-thinking discussions on the future of parenteral product manufacturing, and siRNA delivery systems.
•New chapters covering recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), and validation of drug product manufacturing process.
All the contributors are pre-eminent scientists in their field and include James Agalloco, James Akers, Scott Aldrich, Gayle Brazeau, Tony Cundell, Michael Dawson, Donna French, Fran DeGrazio, Michael Hageman, Maik Jornitz, Russell Madsen, Ted Meltzer, Dana Morton Guazzo, Terry Munson, Steven Nail, Roger Nosal, Diane Paskiet, Edward Smith, Scott Sutton, Y. John Wang, etc.
1. cGMP Regulations of Parenteral Drugs - Terry E. Munson
2. Risk Assessment and Mitigation in Aseptic Processing - James Agalloco and James Akers
3. Validation of Drug Product Manufacturing Processes: NCEs and NBEs - Karoline Bechtold-Peters
4. Visual Inspection - Maria Toler and Sandeep Nema
5. Advances in Parenteral Injection Devices and Aids - Donna L. French and James J. Collins, Jr.
6. SiRNA Targeting Using Injectable Nano-based Delivery Systems - Lan Feng and Russell J. Mumper
7. Excipients for Parenteral Dosage Forms: Regulatory Considerations and Controls - Sandeep Nema
8. Techniques to Evaluate Damage and Pain on Injection - Gayle A. Brazeau, Jessica Klapa and Pramod Gupta
9. Parenteral Product Specifications and Stability - Michael Bergren
10. Extractables and Leachables - Edward Smith and Dianne M Paskiet
11. Process Analytical Technology and Rapid Microbial Methods - Geert Verdonk and Tony Cundell
12. Quality Assurance - Michael Gorman
13. Application of Quality by Design in CMC Development - Roger Nosal, Tom Garcia, Vince McCurdy, Amit Banerjee, Carol F. Kirchhoff, Satish K. Singh
14. Future of Parenteral Manufacturing - James Agalloco, James Akers, and Russell Madsen
". . .a valuable compilation of the current situation in regulatory issues as well as some of the technical problems associated with parenteral drug production." ---Pharmaceutical Technology (Review of 2nd edn – vol 3)
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.