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

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.