Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common.
This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology:
- Product development, including formulation, packaging, and process development.
- Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control.
- Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form
- Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.
1. Introduction, Scope, and History of Sterile Products
2. Characteristics of Sterile Dosage Forms
3. Types of Sterile Dosage Forms
4. Sterile Product Packaging Systems
5. Overview of Sterile Product Development
6. Formulation Components--Solvents and Solutes
7. Sterile Products Packaging Chemistry
8. Formulation and Stability of Solutions
9. Formulation of Dispersed Systems
10. Formulation of Freeze-Dried Powders
11. Overcoming Formulation Problems
12. Overview of Sterile Product Manufacturing
13. Contamination Control
14. Sterile Manufacturing Facilities
15. Water and Air Quality in Sterile Product Manufacturing
16. Personnel Requirements in Sterile Product Manufacturing
17. Sterilization Methods in Sterile Product Manufacturing
18. Sterile Filtration
19. Sterile Product Filling, Stoppering, and Sealing
20. Freeze-Dry Processing--Lyophilization
21. Aseptic Processing
22. Inspection, Labelling, Secondary Packaging
23. Barrier and Other Advanced Technologies in Aseptic Processing
24. Stability, Storage, and Distribution of Sterile Drug Products
25. Good Manufacturing Practice
26. Quality Assurance and Control
27. Sterility Testing
28. Pyrogens and Pyrogen/Endotoxin Testing
29. Particulate Matter Testing
30. Sterile Package Integrity Testing
31. Administration of Injectable Drug Products
32. Clinical Hazards of Injectable Drug Administration
33. Biopharmaceutical Considerations with Injectable Drug Delivery
Michael J. Akers Ph.D. is Senior Director of Pharmaceutical Research and Development at Baxter and leads the Baxter Lyophilization Center of Excellence in Bloomington, Indiana. Dr. Akers received his B.A. degree from Wabash College and Ph.D. degree in Pharmaceutics from the University of Iowa College of Pharmacy, and has previously been employed at Searle Laboratories, Alcon Laboratories, University of Tennessee, and Eli Lilly and Company. Dr. Akers is active in the Parenteral Drug Association and is a Fellow of the American Association of Pharmaceutical Scientists. He is editor-in-chief of Pharmaceutical Development and Technology, and author or editor of six books, including Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Packaging Integrity Testing, Third Edition, 2002.