Pharmaceutical Manufacturing Handbook : Production and Processes

by Editor: Shayne Cox Gad (IBS, Raleigh, North Carolina)

• ISBN13: 9780470259801
• ISBN10: 0470259809
• Format: eBook
• Copyright: 2008-03-01
• Publisher: Wiley-Interscience

Summary

This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Table of Contents

Contributors

Preface

MANUFACTURING SPECIALTIES

Biotechnology-Derived Drug Product Development

Regulatory Considerations in Approval on Follow-On Protein Drug Products

Radiopharmaceutical Manufacturing

ASEPTIC PROCESSING

Sterile Product Manufacturing

FACILITY

From Pilot Plant to Manufacturing: Effect of Scale-Up on Operation of Jacketed Reactors

Packaging and Labeling

Clean-Facility Design, Construction, and Maintenance Issues

NORMAL DOSAGE FORMS

Solid Dosage Forms

Semisolid Dosages: Ointments, Creams, and Gels

Liquid Dosage Forms

NEW DOSAGE FORMS

Controlled-Release Dosage Forms

Progress in the Design of Biodegradable Polymer-Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein

Liposomes and Drug Delivery

Biodegradable Nanoparticles

Recombinant Saccharomyces cerevisiae as New Drug Delivery System to Gut: In Vitro Validation and Oral Formulation (Stéphanie Blanquet and Monique Alric

Nasal Delivery of Peptide and Nonpeptide Drugs

Nasal Powder Drug Delivery

Aerosol Drug Delivery

Ocular Drug Delivery

Microemulsions as Drug Delivery Systems

Transdermal Drug Delivery

Vaginal Drug Delivery (José das Neves, Maria Helena Amaral, and Maria Fernanda Bahia

TABLET PRODUCTION

Pharmaceutical Preformulation: Physicochemical Properties of Excipients and Powers and Tablet Characterization (Beom-Jin Lee

Role of Preformulation in Discovery and Development: Pharmaceutics of Solid Dosage Forms

Tablet Design

Tablet Production Systems

Controlled Release of Drugs from Tablet Coatings

Tablet Compression

Effects of Grinding in Pharmaceutical Tablet Production

Oral Extended-Release Formulations

ROLE OF NANOTECHNOLOGY

Cyclodextrin-Based Nanomaterials in Pharmaceutical Field

Nanotechnology in Pharmaceutical Manufacturing

Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety

Oil-in-Water Nanosized Emulsions: Medical Applications

Index

Table of Contents provided by Publisher. All Rights Reserved.