Entirely updating and expanding the First Edition of these well-received references, Disperse Systems • Volume 3 completes the series by providing detailed information on specialized products, such as emulsions, liposomes, polymers, and polymeric pharmaceutical excipients.

This reference explains the requirements for conducting clinical research and obtaining marketing approval for new drug products—furnishing a current, comprehensive review of U.S. drug regulations!

Written by over 25 international experts, Disperse Systems • Volume 3 offers completely new information on

• Techniques for preparing polymeric nanoparticles and physicochemical methods of characterization
• The importance of nanoparticles of poly(lactic acid) and poly(lactic-co-glycolic acid) used in sustained release parenteral formulations and drug targeting products
• The properties and applications of aqueous polymeric dispersions
• The scale-up of dispersed parenteral drug dosage forms, including discussions of freeze drying, solvent removal, material compatibilities, equipment cleanliness, and sterilization
• The scientific, regulatory, and toxicological aspects of polymers commonly used in disperse systems
• The validation of disperse system products
• And more!

Contains over 1350 bibliographic citations, tables, drawings, photographs, and equations.

Contents

1. Specialized Dispersed System
   Specialized Pharmaceutical Emulsions
   Liposomes
   Polymeric Dispersions as Drug Carriers
   Aqueous Polymer Dispersions as Film Formers
   Biodegradable Nanoparticles of Poly(lactic acid) and Poly(lactic-co-glycolic acid) for Parenteral Administration
   Aqueous Polymeric Dispersions
   Polymeric Pharmaceutical Excipients

2. Equipment, Processing, Quality Assurance, Validation, Regulation
   A Practical Guide to Equipment Selection and Operating Techniques
   Scale-Up to Manufacturing
   Scale-Up of Dispersed Parenteral Dosage Form
   Quality Assurance
   Validation of Disperse Systems
   Drug Regulatory Affairs

Index

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