To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new excipients to be developed and approved continues to increase. 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. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.
Excipients-Background/Introduction. FDA Perspective on Regulation of Excipients. Pharmaceutical Excipient Development-A Preclinical Challenge. Regulation of Pharmaceutical Excipients. Development of Novel Excipients-A Case Study. The Use of Food Additive Safety Evaluation Procedures as a Basis for Evaluating the Safety of New Pharmaceutical Excipients. Pharmacopoeia Harmonization of Excipients. Excipient Interactions. Improved Excipient Functionality by Co-Processing. A Comparison of Physical and Mechanical Properties of Common Tableting Diluents. Excipients for Oral Liquid Formulations. Use of Pharmaceutical Excipients in Oral Drug Formulations: Biopharmaceutical Classification System Considerations. Excipients for Semisolid Formulations. Excipients for Pulmonary Formulations. Synergistic Combinations of Penetration Enhancing Excipients and their Discovery by High Throughput Screening. Excipient Selection and Criteria for Injectable Dosage Forms. Excipients in Biopharmaceutical Products. Excipients Used in Vaccines. Polymeric Excipients for Controlled Release Applications. Emerging Excipients in Parenteral Medications: The New Paradigm. Excipient Manufacturing and Good Manufacturing Practices. Excipient Quality Assurance: Handling, Sampling and Regulatory Issues. Distribution Practices for Excipients.