QbD in Solid-Liquid Processes

Thursday, November 12, 2009: 12:30 PM
Bayou A (Gaylord Opryland Hotel)

This session covers QbD consideration for processes involving a solid suspended in a liquid phase. Crystallization and parenteral products are the main focus of this session. Contributions of interest are those involving process considerations and modeling, in-situ characterization of the product or incoming material selection.

Topical I: Comprehensive Quality by Design to Develop and Manufacture Pharmaceutical Products

Kostas Saranteas
Email: kostas.saranteas@sepracor.com

Michael Pikal
Email: michael.pikal@uconn.edu

12:55 PM
(585b) Application of Modeling to Scale-up Liquid Mixing Processes
Venkat R. Koganti, Fred Carroll, Richard Ferraina, Mark Berry, Robert Leasure, Jeffrey Gaudio, Yang Liu, Kenneth Norris, Bryan Braxton, WIlliam Petre, Yogesh Waghmare and Rick Falk

1:20 PM
(585c) Application of Quality by Design Principles to Development of Freeze-Dried Parenteral Dosage Forms
Linas Mockus, Michael Pikal, Nancy Harper, Prabir K. Basu, Steven Nail, Nathan Pease, Mansoor A. Khan and Tim Paul

2:35 PM
(585f) The in Situ Analysis and Characterization of the Coprecipitation of a Model Drug and Polymer
Juandria V. Williams, Rakhi B. Shah, Huiquan Wu and Mansoor A. Khan