720 Materials Science in Pharmaceutical Process Development II


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:
How Crystal Specifications Influence Pharmaceutical Tablets?
Nastaran Ghazi, Rutgers University; Zhanjie Liu, Rutgers University; Zhiwei Cao, Rutgers University; Chinmay Bhat, Rutgers University; San Kiang, Rutgers University; Alberto Cuitino, Rutgers University
Using a Focused Beam Reflectance Measurement (FBRM) Probe to Characterize Tablet Disintegration Behavior As a Function of Drug Product Processing Conditions
Catherine Metzler, Vertex Pharmaceuticals; Michael Waldo, Vertex Pharmaceuticals; Joseph W. Bullard, Vertex Pharmaceuticals; Katie McCarty, Vertex Pharmaceuticals; Martha Do, Auburn University
Finding a Surrogate Material to an Expensive API By Applying a Multivariate Analysis on a Material Database
M. Sebastian Escotet-Espinoza, Rutgers, The State University of New Jersey; Gerardo Callegari, Rutgers University; Marianthi Ierapetritou, Rutgers, The State University of New Jersey; Fernando Muzzio, Rutgers University
Statistical Evaluation of Modeling Approaches of Drug Release Profiles for HPMC Matrix Tablets
Wenzhao Yang, The Dow Chemical Company; Jin Zhao, The Dow Chemical Co.; Jaime Curtis-Fisk, The Dow Chemical Co; Karen Balwinski, The Dow Chemical Co.; True Rogers, The Dow Chemical Company; Shrikant Khot, The Dow Chemical Co.
Multivariate Data Analysis of Raw Material Properties from Pharmaceutical Powders for Predicting Compaction Behavior Using Finite Element Method
Jens Dhondt, Ghent University; Ashish Kumar, Janssen Pharmaceutica, Johnson & Johnson; Bernd Van Snick, Ghent University; Johny Bertels, Janssen Pharmaceutica, Johnson & Johnson; Didier Klingeleers, Janssen Pharmaceutica, Johnson & Johnson; Chris Vervaet, Ghent University; Thomas De Beer, Ghent University
Simulation of Particle Dissolution Using the Phase Field Approach
Dominik Sleziona, TU Dortmund; David R. Ely, Ivy Tech Community College; Markus Thommes, TU Dortmund University
Optimization of a Low-Dose Dosator Capsule Filling Process for Dry Powder Inhalation (DPI) Applications Using in-Line PAT Approaches
Sandra Stranzinger, Graz University of Technology; Eva Faulhammer, Research Center Pharmaceutical Engineering (RCPE); Otto Scheibelhofer, Research Center Pharmaceutical Engineering (RCPE); Vittorio Calzolari, MG2; Stefano Biserni, MG2; Amrit Paudel, Research Center Pharmaceutical Engineering (RCPE) GmbH; Johannes G. Khinast, Graz University of Technology
Abstract Submissions Closed