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Pharmaceutical Materials Science and Engineering—Mechanical Characterization of Predictive Tools for Rapid Drug Product Development
*Breakfast is not included in the registration fee.
Lunch will be provided on Monday and Tuesday.*
Program
Preliminary Program
Monday, March 4, 2013
7:00 am
Registration
8:15 am–8:30 am
Introduction
8:30 am–noon
Session I, Part A: Fundamental Mechanical Properties of Pharmaceutical Solids
Moderators:
Jian-Xin Li, Ph.D.
DFE Pharma
Ping Gao, Ph.D.
Abbott Laboratories
8:30 am–9:15 am
Basic Principles of Materials Science with Application to Pharmaceutical Materials
Bruno Hancock, Ph.D.
Pfizer Inc.
9:15 am–10:00 am
Predictive Particle Interactions
Steve Beaudoin, Ph.D.
Purdue University
10:00 am–10:30 am
Coffee Break
10:30 am–11:15 am
Particle Engineering for Enhanced Powder Manufacturability
Changquan Calvin Sun, Ph.D.
University of Minnesota
11:15 am–noon
Mechanical Properties of Powders for Compaction and Tableting: An Overview
Gregory Amidon, Ph.D.
University of Michigan
noon–1:30 pm
Lunch and Exhibits
1:30 pm–5:30 pm
Session I, Part B: Fundamental Mechanical Properties of Pharmaceutical Solids
Moderators:
Changquan Calvin Sun, Ph.D.
University of Minnesota
Mukund Yelvigi, Ph.D.
Center for Pharmaceutical Integration, LLC
1:30 pm–2:15 pm
Defining Key Mechanical Properties/Attributes of Drug Product and Assessment with QbD Approach
Ira Buckner, Ph.D.
Duquesne University
2:15 pm–3:00 pm
Single and Bulk Compression of Pharmaceutical Polymer Excipients: Evaluation of Mechanical Properties
Zhibing Zhang, Ph.D.
University of Birmingham, United Kingdom
3:00 pm–3:30 pm
Coffee Break and Exhibits
3:30 pm–4:15 pm
Use of Compaction Simulator and Finite Element Analyses Models for Scale-up of Tableting Process
Alberto Cuitino, Ph.D.
Rutgers University
4:15 pm–5:00 pm
Bilayer Tablets, Challenges, and Issues in Basic Understanding, Testing and Predictive Modeling of Mechanical Integrity
Antonios Zavaliangos, Ph.D.
Drexel University
5:00 pm–5:30 pm
Panel Discussion
5:30 pm-6:30 pm
Reception and Exhibits
Tuesday, March 5, 2013
7:30 am
Registration
8:30 am–noon
Session II: Characterization and Modeling of Powder Flow and Mixing
Moderators:
Sven Stegeman, Ph.D.
Capsugel
Changquan Calvin Sun, Ph.D.
University of Minnesota
8:30 am–9:15 am
A Predictive Framework for the Cohesion Reduction of Fine Pharmaceutical Powders Via Surface Modification
Rajesh Dave, Ph.D.
New Jersey Institute of Technology
9:15 am–10:00 am
Using Material Sparing Segregation Testers for Troubleshooting and Scale Up
Jim Prescott, Ph.D.
Jenike & Johanson
10:00 am–10:30 am
Coffee Break and Exhibits
10:30 am–11:15 am
Review of Numerical Models for Prediction of Content Uniformity from API Particle Size
Brian Rohr, Ph.D.
Bausch & Lomb
11:15 am–noon
Strategy of Assessing Continuous Manufacturing Feasibility Based on Materials Mechanical Properties and Material Sparing Approach
Roland Hohl, Ph.D.
University of Graz, Austria
noon–1:30 pm
Lunch and Exhibits
1:30 pm–5:45 pm
Session III: Mechanical Characterization of Pharmaceutical Solids
Moderators:
Michael Repka, Ph.D.
University of Mississippi
Mukund Yelvigi, Ph.D.
Center for Pharmaceutical Integration, LLC
1:30–2:15 pm
Evaluation of the Effects of Tableting Speed on the Relationships between Compaction Pressure, Tablet Tensile Strength, and Tablet Solid Fraction
John Strong, Ph.D.
Abbott Laboratories
2:15 pm–3:00 pm
The Effect of Water on Mechanical Properties of Pharmaceutical Powders
Changquan Calvin Sun, Ph.D.
University of Minnesota
3:00 pm–3:30 pm
Coffee Break
3:30 pm–4:15 pm
Acoustic Characterization of Pharmaceutical Solid Dosage Forms
Çetin Çetinkaya, Ph.D.
Clarkson University
4:15 pm–5:00 pm
Mechanical Characterization of Crystalline Pharmaceuticals by Nanoindentation: Implications for Milling and Die Compaction
Kyle Ramos, Ph.D.
Las Alamos National Lab
5:00 pm–5:45 pm
Quality by Design: Roles of Material Properties
Lawrence Yu, Ph.D.
U.S. Food and Drug Administration
Wednesday, March 6, 2013
8:30 am–noon
Session IV: Development of Challenging Drug Products and Manufacturing Process
Moderators:
Ping Gao, Ph.D.
Abbott Laboratories
Jian-Xin Li, Ph.D.
DFE Pharma
8:30 am–9:15 am
Role of Feed Frame Lubrication Sensitivity and Particle Fracture on the Mechanical Properties of Pharmaceutical Compacts
Adam Procopio, Ph.D.
Merck & Co., Inc.
9:15 am–10:00 am
Development of Tablet Formulation Based on Amorphous Solid Dispersions/Extrudates with Mechanical Properties Consideration and Case Studies
Mike Repka, Ph.D.
University of Mississippi
10:00 am–10:30 am
Coffee Break
10:30 am–11:15 am
Formulation of Bi-layer Tablets: Developing Empirical Models to Relate Material Properties to Tablet Strength
Otilia Koo, Ph.D.
Bristol-Myers Squibb Company
11:15 am–noon
Tablet Compaction Prediction Success in Industry: Case Studies
Feng Li, Ph.D.
Merck & Co., Inc.