Sterile drug products : formulation, packaging, manufacturing, and quality /
Michael J. Akers
- New York : Informa Healthcare, c2010
- ix, 505 pages : illustrations ; 26 cm.
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.