Parenteral Medications, Fourth Edition: 4th Edition (Hardback) book cover

Parenteral Medications, Fourth Edition

4th Edition

Edited by Sandeep Nema, John D. Ludwig

CRC Press

1,125 pages | 350 Color Illus.

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Hardback: 9781498719148
pub: 2019-08-14
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Description

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

Reviews

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

Table of Contents

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

About the Editors

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.

Subject Categories

BISAC Subject Codes/Headings:
BUS070130
BUSINESS & ECONOMICS / Industries / Pharmaceutical & Biotechnology
MED071000
MEDICAL / Pharmacology
MED072000
MEDICAL / Pharmacy
SCI013000
SCIENCE / Chemistry / General
TEC009010
TECHNOLOGY & ENGINEERING / Chemical & Biochemical