402 Enabling and Advanced Formulations in Drug Product Processing II: Focus on Stability


Description:
These sessions highlight research related to drug product processing for solubility enhancement or other advances in the manufacture of challenging oral formulations. Solubility enhancement includes, but is not limited to, processing of amorphous solid dispersions via spray drying or hot melt extrusion. This session focuses on physical and chemical stability in advanced or enabled formulations.

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


Chair:
Gulsad Kucuk
Boehringer Ingelheim
R&D Pharmaceutical Development
Ridgefield, CT
Email: gulsad.kucuk@boehringer-ingelheim.com

Co-Chair:
John Peragine
Principal Technical Investigator
Bristol-Myers Squibb
Global Manufacturing and Supply
1 Squibb Drive
New Brunswick, NJ
08903
Email: john.peragine@bms.com


Papers:
402a
In Situ Studies of Phase Separation in Amorphous Solid Dispersions (ASDs) Using the QCM-D
Mark A. Isbell, imperial college london; Geoff G. Z. Zhang, AbbVie Inc.; Jerry Y. Y. Heng, Imperial College London
402b
Mathematical Models for the Stability of Atropisomer-Forming Drug Substance in a Spray-Dried Dispersion Formulation
Jose Tabora, Bristol Myers Squibb; Thomas M. Razler, Bristol Myers Squibb; Brian He, Bristol Myers Squibb
402c
Study of Nimesulide Recrystallization Kinetics By Particle Sizing, Microscopy, and Raman
Tim E. Alcacio, Vertex Pharmaceuticals; Gregor Hsiao, Blaze Metrics LLC
402d
Revealing Polymorphic Phase Transformations in Polymer-Based Hot Melt Extrusion Processes
Jose Hernandez Espinell, Crystallization Design Institute; Vilmali Lopez-Mejias, Crystallization Design Institute; Torsten Stelzer, Crystallization Design Institute
402e
Development of a Tablet Manufacturing Line Via Hot-Melt Extrusion and Strand Pelletization
Theresa R. Hörmann, European Consortium for Continuous Pharmaceutical Manufacturing (ECCPM); Otto Scheibelhofer, Research Center Pharmaceutical Engineering GmbH; Jakob Rehrl, European Consortium for Continuous Pharmaceutical Manufacturing (ECCPM); Adrian Funke, Bayer Pharma AG; Amrit Paudel, European Consortium for Continuous Pharmaceutical Manufacturing (ECCPM); Johannes G. Khinast, Graz University of Technology
402f
Exploring Mesoporous Supports As a Means to Separate Physical Property Control from Crystallization
Christopher S. Polster, Eli Lilly and Company; Justin Burt, Eli Lilly and Company; Jeremy Merritt, Eli Lilly and Company; Mark Polizzi, Eli Lilly and Co; Dale E. Greenwood, Eli Lilly and Co; Aktham Aburub, Eli Lilly and Co
402g
Generation of Stable Nanobubbles Following Reconstitution of Lyophilized Protein Formulations: Effects of Excipient Structure on Nanobubble Formation
Jared Snell, University of Colorado Boulder; Theodore W. Randolph, University of Colorado
Abstract Submissions Closed
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum
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