4th Edition

Parenteral Medications, Fourth Edition

Edited By Sandeep Nema, John D. Ludwig Copyright 2019
    1144 Pages 350 Color Illustrations
    by CRC Press

    1143 Pages 350 Color Illustrations
    by CRC Press

    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