4th Edition
Parenteral Medications, Fourth Edition
Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration.
Key Features:
- Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms
- Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration
- Includes 13 new chapters and updated chapters throughout
- Contains the contributors of leading researchers in the field of parenteral medications
- Uses full color detailed illustrations, enhancing the learning process
The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements
Preface
Foreword
List of Contributors
1 Parenteral Dosage Forms: Introduction and Historical Perspective
John D Ludwig
2 Parenteral Drug Administration: Routes of Administration and Devices
Himanshu Bhattacharjee, Vivian Loveless, and Laura A Thoma
3 Dosage and Administration Instructions for Parenteral Medications: Stability, Compatibility, Coadministration, and Microbiology
S Kay and D Man
4 Autoinjector and Pen Devices: Combination Product Design and Use
Scott Gibson
5 Preformulation
N Murti Vemuri, Abira Pyne Ramakrishnan
6 Preformulation of New Biological Entities
Riccardo Torosantucci, Vasco Filipe, Jonathan Kingsbury, Atul Saluja, and Yatin Gokarn
7 Clinical Pharmacology of Parenteral Dosage Forms
Anis A Khan and Lorin K Roskos
8 Excipients for Parenteral Use
Sandeep Nema and Ronald J Brendel
9 Drug Solubility and Solubilization
Ching-Chiang Su, Lan Xiao, and Michael J Hageman
10 Formulation Development of Small- and Large-Volume Parenteral Products
Madhav S Kamat and Patrick P DeLuca
11 Formulation of Protein- and Peptide-Based Parenteral Products
Gaozhong Zhu and Pierre O Souillac
12 Biophysical and Biochemical Characterization of Peptide, Protein, and Bioconjugate Products
Tapan K Das and James A Carroll
13 Development of Ophthalmic Formulations
Paramita Sarkar, Martin Coffey, and Mohannad Shawer
14 Formulation Development of Prophylactic and Therapeutic Vaccines
Antu Dey and Manmohan Singh
15 Techniques to Evaluate Damage and Pain on Injection
Srinidi Mohan, Gayle A Brazeau, and Pramod Gupta
16 Design and Delivery of Antibody–Drug Conjugates
Alavattam Sreedhara
17 Unique Chemistry, Manufacturing, and Controls Challenges and Expectations in the Development of Biosimilars
Carol Kirchhoff, Chee-Keng Ng, Arindam Bose, and Beverly Ingram
18 Formulation of Depot Delivery Systems
Christopher A Rhodes and Nikita Malavia
19 Active Nanoparticle Targeting: Current Status and Future Challenges
Siddharth Patel and Janni Mirosevich
20 Cellular Therapeutics: A Novel Modality with Great Therapeutic Potential
Rob Perry and Ron Fedechko
21 Glass Containers for Parenteral Products
Robert Swift, Robert Schaut, Carol Rea Flynn, and Roger Asselta
22 Pharmaceutical Dosage Forms: Parenteral Medications, 4th Edition Elastomeric Closures for Parenterals
Renaud Janssen
23 Plastic Packaging for Parenteral Drug Delivery
Lloyd Waxman, Frances L DeGrazio, and Vinod D Vilivalam
24 Parenteral Product Container-Closure Integrity Testing
Justine Young and Brandon Zurawlow
25 The Management of Extractables and Leachables in Pharmaceutical Products
Edward J Smith and Diane M Paskiet
26 Aseptic Manufacturing Facility Design
Mark Caldwell, Robert Helt, Beth Holden, Francesca McBride, and Kevin Schreier
27 Personnel and Their Impact on Clean room Operations
Jeanne Moldenhauer
28 Preventing Loss of Environmental Control in an Aseptic Processing Facility
Rick Friedman
29 Water Systems for Parenteral Facilities
Joseph Manfredi
30 Industrial Sterilization Technologies: Principles and Overview
Anne F Booth
31 Steam Sterilization
James Agalloco
32 Gas, Vapor, and Liquid Phase Sterilization
James Agalloco
33 Dry-Heat Depyrogenation and Sterilization
Deborah Havlik
34 Radiation Sterilization
Barry P Fairand, Dusan Razem, and Karl Hemmerich
35 Filters and Filtration
Maik W Jornitz
36 Science of Scale for Freeze Drying
Serguei Tchessalov, Sumit Luthra, T N Thompson, and Lisa Graham
37 Quality by Design and Control Strategies for Parenteral Dosage Forms
Vinay Radhakrishnan, Amit Banerjee, and Mansoor A Khan
38 Risk Assessment and Mitigation in Aseptic Processing
James Agalloco and James Akers
39 Sterile Drug Product Process Validation
Walter Manger
40 Visual Inspection
Maria R Toler and Sandeep Nema
41 Cleaning Validation—Lifecycle Approach
Paul L Pluta
42 Freeze-Drying: Principles and Practice
Steven L Nail and Larry A Gatlin
43 Spray Drying of Biotherapeutic Compounds
Alex Langford and Satoshi Ohtake
44 Freezing of Proteins and Cells
Satish K Singh
45 Parenteral Product Specifications and Stability
Michael Bergren and Nanda Subbarao
46 Particulate Matter: Subvisible
D Scott Aldrich
47 Endotoxin Testing
Michael E Dawson
48 The Compendial Sterility Tests
Robert F Guardino and Scott VW Sutton
49 Regulatory Considerations for the Manufacture and Quality Controls for Sterile Products
Ramani R Raghavan
50 Future of Parenteral Manufacturing
James Agalloco, James Akers, and Russell Madsen
Index
Biography
SANDEEP NEMA, PhD, is Executive Director, Biotherapeutics Pharmaceutical Sciences at Pfizer where he is responsible for all pre-proof of concept biologics projects from discovery up to Phase 3. Sandeep earned a PhD in 1992 and since then has been involved with the development of small molecule, vaccine, protein, and cell and gene therapy drugs via parenteral delivery first at Mallinckrodt Medical and then at Pfizer (Searle, Pharmacia). He has been lead formulator for four launched products. Dr. Nema is a Certified Regulatory Affairs Professional and is active in AAPS and PDA, where he regularly teaches courses and organizes symposiums. He is an adjunct professor at the University of Tennessee. In addition, he has served as a Steering Committee Member for the Handbook of Pharmaceutical Excipients.
JOHN D. LUDWIG, PhD, is Senior Vice President, Medicinal Sciences, Worldwide Research and Development at Pfizer, where he is responsible for medicine design, biomedicine design, pharmaceutical sciences, and global clinical supply. Ludwig earned a BS in pharmacy and a PhD in pharmaceutics at the University of Tennessee, Memphis and has held numerous research and development positions at Burroughs Wellcome Co, Searle Inc., Pharmacia Inc., and Pfizer Inc. Dr. Ludwig is active in the American Association of Pharmaceutical Scientists (AAPS) and the Parenteral Drug Association (PDA) Training and Research Institute. He has contributed to the development of three professional training courses and serves regularly as a course instructor at PDA.
This is a worthwhile contribution and it is useful to the intended audience. It is a comprehensive book, covering all of the important issues in this industry. There are other books in this area, but most are written on specific topics that are all covered in this book.
-Lawrence P Carey, Temple University School of Pharmacy