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Functionality Testing of Excipients
Monday, November 12
8:00 am – 10:00 am
Roundtable
ACPE #073-999-07-511-L04
The design of robust formulations requires that we understand the excipients, API and process and how they interact. Understanding the properties and limitations of excipients in pharmaceutical drug product development is as important as the drug characterization in design and development of the product. This is because, excipients although known as ‘inactive ingredients’, can interact with active pharmaceutical ingredients in many ways to affect the in-vitro and in-vivo performance of the product. Failure to properly understand the raw materials and processes, their variability and how they interact can lead to loss of product (possibly including market withdrawal), unnecessary multiplicity of prototype formulations, inadvertent changes in physicochemical properties (stability, solubility, dissolution profile) and inability to obtain a successful drug registration. Excipient functionality testing has been proposed as a means of improving our understanding of how excipients influence the manufacture and subsequent performance of drug products. The roundtable will examine the options available for both excipient manufacturers and excipient users including how such tests should be incorporated into specifications.
ModeratorS
Moji C. Adeyeye, Ph.D.
Duquesne University
Chris Moreton, Ph.D.
Idenix Pharmaceuticals
Drug-excipient Interaction and Characterization
Moji C. Adeyeye, Ph.D.
Duquesne University
Excipient Functionality: Specifications and Monographs
Chris Moreton, Ph.D.
Idenix Pharmaceuticals
Excipient Functionality; an IPEC-Americas Perspective
Dave Schoneker, Ph.D.
Colorcon, Inc.