Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge new avenues for regulatory review and allowance to use.

Features:

• Provides guidelines for testing new excipients
• Offers information to ensure that the product ingredients are in compliance with regulatory and quality requirements, and to guarantee the manufacturing and supply chain is in control
• Includes excipient harmonization activities
• Features descriptions on the development and ways of optimal utilization of excipients for the pharmaceutical and biotechnology industries
• Presents multiple case studies for numerous functional excipients

Contents

1. Excipients-Background/Introduction
2. FDA Perspective on Regulation of Excipients
3. Pharmaceutical Excipient Development-A Preclinical Challenge
4. Regulation of Pharmaceutical Excipients
5. Development of Novel Excipients-A Case Study
6. The Use of Food Additive Safety Evaluation Procedures as a Basis for Evaluating the Safety of New Pharmaceutical Excipients
7. Pharmacopoeia Harmonization of Excipients
8. Excipient Interactions
9. Improved Excipient Functionality by Co-Processing
10. A Comparison of Physical and Mechanical Properties of Common Tableting Diluents
11. Excipients for Oral Liquid Formulations
12. Use of Pharmaceutical Excipients in Oral Drug Formulations: Biopharmaceutical Classification System Considerations
13. Excipients for Semisolid Formulations
14. Excipients for Pulmonary Formulations
15. Synergistic Combinations of Penetration Enhancing Excipients and their Discovery by High Throughput Screening
16. Excipient Selection and Criteria for Injectable Dosage Forms
17. Excipients in Biopharmaceutical Products
18. Excipients Used in Vaccines
19. Polymeric Excipients for Controlled Release Applications
20. Emerging Excipients in Parenteral Medications: The New Paradigm
21. Excipient Manufacturing and Good Manufacturing Practices
22. Excipient Quality Assurance: Handling, Sampling and Regulatory Issues
23. Distribution Practices for Excipients

Index

click here to see books • videos • cd-roms of related interest