671 Materials Science in Pharmaceutical Process Development I


Description:
Material science understanding is a key factor to consider in drug substance and drug product process development. The material properties for the API, excipients, and intermediates can influence the process and product performance. This session focuses on the application of material science to guide drug substance and drug product development. Of particular interest is work related to elucidate key material attributes impacting process and product performance as well as the application of the novel material property tool or data to gain further process understanding.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Co-Sponsor(s):
Pharmaceuticals (15B)


Chair:
Jason Mustakis
Pfizer Inc.
Pfizer Global Research & Development
Groton, CT
06340
Email: Jason.Mustakis@pfizer.com

Co-Chair:
Lei Zhu
Merck & Co.
Rahway, NJ
Email: lei.zhu2@merck.com


Papers:
Wettability of Pharmaceutical Powders of Different Particle Size By Droplet Penetration Technique
Yu Han, Rutgers University; Zhanjie Liu, Rutgers University; Sara Moghtadernejad, Rutgers University; Fernando Muzzio, Rutgers University; Gerardo Callegari, Rutgers University; German Drazer, Rutgers University
Investigation of Microsphere Strength for Spray Drying Applications By Means of Acoustic Levitation
Manuel Kreimer, Research Center Pharmaceutical Engineering; Isabella Aigner, Research Center Pharmaceutical Engineering; Stephan Sacher, Research Center Pharmaceutical Engineering GmbH; Markus Krumme, Novartis Pharma AG; Thomas Mannschott, Novartis Pharma AG; Peter van der Wel, Hosokawa Micron B.V.; Albert Kaptein, Hosokawa Micron B.V.; Hartmuth Schröttner, Graz University of Technology; Günter Brenn, Graz University of Technology (TUG); Johannes G. Khinast, Research Center Pharmaceutical Engineering GmbH
Nanostructural Interfaces of Additives on the API Surfaces Influencing Process Performance
Sajan K. Chatarla, Western Michigan University; Tijana Rajh, Argonne National Laboratory; Elena Rozhkova, Argonne National Laboratory; Kalyana Pingali, Western Michigan University
Rational Strategies for Physical Characterization of Amorphous Solid Dispersions during Drug Product Development and Manufacture
Stephen L. Conway, Merck & Co., Inc.; Kenneth Rosenberg, Merck & Co., Inc.; Itzia Arroyo, Merck & Co., Inc; Andrew Gmitter, Merck & Co., Inc.; Julianne Farabaugh, Merck & Co., Inc.; Cindy Starbuck, Merck & Co., Inc.
Investigation of Compression Induced Amorphization of Crystalline API
Lei Zhu, Merck & Co.; Chengbin Huang, University of Wisconsin-Madison; Gerard Klinzing, Merck & Co.; Adam Procopio, Merck & Co.; Fengyuan Yang, Merck & Co.; Jie Ren, Merck & Co.; Rubi Burlage, Merck & Co.; Anthony Leone, Merck & Co.; Lawrence Rosen, Merck & Co.; Yongchao Su, Merck & Co.
Abstract Submissions Closed