Sterile drug products : formulation, packaging, manufacturing, and quality / Michael J. Akers

Includes bibliographical references and index.

Introduction, scope, and history of sterile products -- Characteristics of sterile dosage forms -- Types of sterile dosage forms -- Sterile product packaging systems -- Overview of product development -- Formulation components (solvents and solutes) -- Sterile products packaging chemistry -- Formulation and stability of solutions -- Dispersed systems -- Formulation of freeze-dried powders -- Overcoming formulation problems and some case studies -- Overview of sterile product manufacturing -- Contamination control -- Sterile manufacturing facilities

This book is based primarily on courses that I thought on the basic principles of sterile dosage formulation, packaging, manufacturing, and quality control and assurance over a span of 35 years.