Pharmaceutical Dosage Forms

Parenteral Medications

Kenneth E. Avis, Herbert Lieberman, Leon Lachman

• Publisher: Routledge
• Year: 2018
• Print ISBN: 9780824790202
• eBook ISBN: 9781351425179
• Topic: Medicine
• Subtopic: Pharmacology

Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials.;With the contributions of leading experts, volume 3 of Pharmaceutical Dosage Forms: Parenteral Medications is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.

Contents of Pharmaceutical Dosage Forms: Parenteral Medications, Second Edition, Revised and Expanded, Volumes 1 and 2

edited by Kenneth E. Avis, Herbert A. Lieberman, and Leon Lachman

VOLUME 1

1.  The Parenteral Dosage Form and Its Historical Development, Kenneth E. Avis

2.  Parenteral Drug Administration: Routes, Precautions, Problems, Complications, and Drug Delivery Systems, Richard J. Duma, Michael J. Akers, and Salvatore J. Turco

3.  Biopharmaceutics of Injectable Medications, Sol Motola

4.  Preformulation Research of Parenteral Medications, Sol Motola and Shreeram N. Agharkar

5.  Formulation of Small Volume Parenterals, Patrick P. DeLuca and James C. Boylan

6.  Formulation of Large Volume Parenterals, Levit J. Demorest and Jeffrey G. Hamilton

7.  Parenteral Products of Peptides and Proteins, Yu-Chang John Wang

8.  Sterile Diagnostics, Leif E. Olsen

9.  Glass Containers for Parenterals, R. Paul Abendroth and Robert N. Clark

10.  Use of Plastics for Parenteral Packaging, John M. Anes, Robert S. Nase, and Charles H. White

11.  Elastomeric Closures for Parenterals, Edward J. Smith and Robert J, Nash

12.  Parenteral Products in Hospital and Home Care Pharmacy Practice, John W. Levchuk

VOLUME 2

1.  The Processing of Small Volume Parenterals and Related Sterile Products
Richard J. Harwood, Joel Benton Portnoff, and Edward William Sunbery

2.  Factors Involved in Manufacturing Large Volume Parenterals
Michael J. Groves, Karen L. Malik, and Nicholas J. Kartinos

3.  Freeze Drying: Principles and Practice
Steven L. Nail and Larry A. Gatlin

4.  Design Considerations for a Parenteral Production Facility
A. Michael Keller and Gary L. Hoffman

5.  Biopharmaceutical Manufacturing Facility Design
Robert Del Ciello

6.  Personnel: The Key Factor in Clean Room Operations
Cecelia J. Luna

7.  Environmental Control in Parenteral Drug Manufacturing
Franco DeVecchi

8.  Industrial Sterilization: A Review of Current Principles and Practices
Frank J. Marino

9.  Development of Ophthalmic Formulations
Krishna M. Bapatla and O. J. Lorenzetti

Index

Contents of Pharmaceutical Dosage Forms: Tablets, Second Edition, Revised and Expanded, Volumes 1-3

edited by Herbert A. Lieberman, Leon Lachman, and Joseph B. Schwartz

VOLUME 1

1.  Preformulation Testing, Deodatt A. Wadke, Abu T. M. Serajuddin, and Harold Jacobson

2.  Tablet Formulation and Design, Garnet E. Peck, George J. Bailey, Vincent E. McCurdy, and Gilbert S, Banker

3.  Compressed Tablets by Wet Granulation, Fred J. Bandelin

4.  Compressed Tablets by Direct Compression, Ralph F. Shangraw

5.  Compression-Coated and Layer Tablets, William C. Gunsel and Robert G. Dusel

6.  Effervescent Tablets, Raymond Mohrle

7.  Special Tablets, James W. Conine and Michael J. Pikal

8.  Chewable Tablets, Robert W. Mendes, Aloysius O. Anaebonam, and Johan B. Daruwala

9.  Medicated Lozenges, David Peters

VOLUME 2

1.  Mixing, Russell J. Lantz, Jr., and Joseph B. Schwartz

2.  Drying, Kurt G. Van Scoik, Michael Zoglio, and Jens T. Carstensen

3.  Size Reduction, Russell J. Lantz, Jr.

4.  Compression, Eugene L. Parrott

5.  Granulation Technology and Tablet Characterization, Roger E. Gordon, Thomas W. Rosanaske, Dale E. Fonner, Neil R. Anderson, and Gilbert S. Banker

6.  Bioavailability in Tablet Technology, Solomon A. Stavchansky and James W. McGinity

7.  Pharmaceutical Tablet Compression Tooling, George F. Loeffler and Glen C. Ebey

VOLUME 3

1.  Principles of Improved Tablet Production System Design, Garnet E. Peck, Neil R. Anderson, and Gilbert S. Banker

2.  Coating of Pharmaceutical Solid-Dosage Forms, Stuart C. Porter and Charles H. Bruno

3.  Particle-Coating Methods, Dale E. Wurster

4.  Sustained Drug Release from Tablets and Particles through Coating, Rong-Kun Chang and Joseph R. Robinson

5.  Pharmaceutical Pilot Plant, Charles I. Jarowski

6.  Tablet Production, Robert J. Connelly, Frank A. Berstler, and David Coffin-Beach

7.  The Essentials of Process Validation, Robert A. Nash

8.  Stability Kinetics, Samir A. Hanna

9.  Quality Assurance, Samir A. Hanna

Contents of Pharmaceutical Dosage Forms: Disperse Systems, Volumes 1 and 2

edited by Herbert A. Lieberman, Martin M. Rieger, and Gilbert S. Banker

VOLUME 1

1. Introduction, Norman Weiner

2. Theory of Suspensions, Michael J. Falkowicz

3. Theory of Emulsions, Stig E. Friberg, Lisa B. Goldsmith, and Martha L. Hilton

4. Theory of Colloids, John Vanderhoff and Mohamed S. El-Aasser

5. Pharmaceutical Suspensions, Robert A. Nash

6. Pharmaceutical Emulsions, Bernard Idson

7. Specialized Pharmaceutical Emulsions, Morton Rosoff

8. Surfactants, Martin M. Rieger

9. Rneology of Dispersed Systems, Donald E. Deem

10. Experimental Design, Modeling, and Optimization Strategies for Product and Process Development, Robert M. Franz, Jeffrey E. Browne, and Allen R. Lewis

VOLUME 2

1. A Practical Guide to Equipment Selection and Operating Techniques
Roy R. Scott

2. Preservation of Dispersed Systems
Harun Takruri and Claude B. Anger

3. Bioavailability of Disperse Dosage Forms
Ronald D. Schoenwald and Douglas R. Flanagan

4. Viscosity-Imparting Agents in Disperse Systems
Joel L. Zatz, Joseph J. Berry, and Daniel A. Alderman

5. Antacids and Clay Products
Richard J. Harwood, Joseph R. Luber, and Edward W. Sunbery

6. Oral Aqueous Suspensions
Clyde M. Ofner III, Roger L. Schnaare, and Joseph B. Schwartz

7. Topical Suspensions
Hridaya N. Bha...

Table of contents

• Cover
• Half Title
• Title Page
• Copyright Page
• Table of Contents
• Preface
• Contributors
• Contents of Pharmaceutical Dosage Forms: Parenteral Medications, Volumes 1 and 2
• Contents of Pharmaceutical Dosage Forms: Tablets, Volumes 1–3
• Contents of Pharmaceutical Dosage Forms: Disperse Systems, Volumes 1 and 2
• 1. Quality Assurance
• 2. Records and Reports
• 3. Particulate Matter
• 4. Validation of Sterilization Processes and Sterile Products
• 5. Federal Regulation of Parenterals
• 6. Systematic Audits of Parenteral Drug Good Manufacturing Practices
• 7. Medical Devices: Design, Manufacture, and Quality Control
• 8. Quality Assurance for Medical Devices
• 9. Regulatory and GMP Considerations for Medical Devices
• Index