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Regulatory Considerations on the Use of Lipid Excipients in Oral and Parenteral Drug Products
Wednesday, November 14
2:00 pm – 4:30 pm
Symposium
ACPE #073-999-07-568-L04
Lipid excipients due to their versatility and biocompatibility play a crucial role in drug delivery and targeting. Their function in the formulation include, enhancing drug stability, solubility and bioavailability either by improving drug permeability or through drug efflux inhibition. Since lipids, like other excipients, enhance several attributes of the overall efficacy and safety of a drug product during storage or use, their consistency in desired product specifications and regulatory status need to be assured. This becomes particularly important for parenteral administration and several emerging lipid excipients are at various stages of clinical development. This symposium will focus on regulatory considerations in the use of lipid excipients for oral and parenteral drug administration. An overview on the classification and function of lipid excipients in oral and parenteral lipid products will be presented first, followed by a regulatory talk on the excipient qualification process and criteria for pharmaceutical development. Biopharmaceutical aspects of lipid excipients in reference to drug solubility, permeability and efflux inhibition will then be addressed and case studies will be presented. Emerging lipid excipients in parenteral drug delivery systems and products will be the subject of the last talk along with representative case studies. The need for streamlining procedures and developing consistent guidelines to expedite regulatory approval of novel excipients will be highlighted throughout the symposium.
Moderators
Panayiotis P. Constantinides, Ph.D.
Biopharmaceutical & Drug Delivery Consulting, LLC
Mei-Ling Chen, Ph.D.
U.S. Food and Drug Administration
Classification and Function of Oral and Parenteral Lipid Excipients
Robert Strickley, Ph.D.
Gilead Sciences, Inc.
Lipid Excipient Qualification for Pharmaceutical Development: A Regulatory Perspective
Arthur B. Shaw, Ph.D.
U.S. Food and Drug Administration
Biopharmaceutical Aspects of Oral Lipid Excipients for Class II and Class III Compounds
Leslie Z. Benet, Ph.D.
University of California, San Francisco
Emerging Lipid Excipients in Parenteral Drug Products
Atul Khare, Ph.D.
Baxter Healthcare Corporation