Session: QbD in Solid-Liquid Processes (2009 Annual Meeting)

Thursday, November 12, 2009: 12:30 PM

Bayou A (Gaylord Opryland Hotel)

Description:

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.

Sponsor:

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

Chair:

Kostas Saranteas
Email: kostas.saranteas@sepracor.com

Co-Chair:

Michael Pikal
Email: michael.pikal@uconn.edu

12:30 PM

(585a) A QbD Approach to Selection of Materials for Drug Product Packaging and Medical Devices
Arthur J. Shaw III

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

1:45 PM

(585d) On the Optimization of the Cooling Profile in Crystallization Using the Design of Dynamic Experiments Approach
Andrew Hagger, Andrew Fiodalis and Christos Georgakis

2:10 PM

(585e) Quality-by-Design (QbD): Examining the Impact of Process Variables On Particle Size Distribution for a Pharmaceutical Co-Precipitation Process Using Real-Time Lasentec FBRM and PVM Process Monitoring and Design of Experiments (DoE) Approach
Huiquan Wu, Maury White and Mansoor A. Khan

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

See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture