644 Novel Excipients in Formulation Design and Drug Delivery

Thursday, November 19, 2020: 8:00 AM - 9:00 AM
Pharmaceutical Discovery, Development and Manufacturing Forum (26) (PreRecorded+)

Description:
This session focuses on the importance of excipients in drug product performance. Selection and evaluation of excipients plays a critical role in determining stability, processability, and bioavailability of pharmaceutical drug products. Submissions may include novel evaluation of existing excipients or the introduction and evaluation of novel excipients and capsules for drug product.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Chair:
Satheesh Podaralla Email: satheesh.podaralla@fda.hhs.gov
Co-Chair:
Parind Desai Email: parind.m.desai@gsk.com


(644a) Next Generation Lipid-Based Excipients: Overcoming the Challenges of Spray Drying Applications on the Development of Inhalable Lipid-Microparticles
Carolina Corzo, Agnes Fuchsbichler, Ɖana Crvenjak, Sebastian Reyer, Dirk Lochmann, Andreas Zimmer and Sharareh Salar-Behzadi


(644b) Comparative Evaluation of Dissolution Behavior and Bioequivalence of Various Capsules
Jin Zhao, Amie Gehris, Thomas Watson, Laura McReady, Tom Breshamer, Bahi Mahesan, Elizabeth Tocce, Yeli Zhang, Paul Zajac and Michael Baumann


(644c) Development of High-Solids, Quick-Set Pharmaceutical Tablet Coatings.
Thomas H. Kalantar, Mladen Ladika, Hui Shao, Stacey L. Dean, J. Keith Harris, Paul J. Sheskey, Karen Coppens, Karen M. Balwinski and Debora L. Holbrook


(644d) Advanced Structure-Function of Lipid-Based Excipients
Sharareh Salar-Behzadi, Carolina Corzo, Andreas Zimmer, Dirk Lochmann and Sebastian Reyer


(644e) Influence of External Lubricants and the Environmental Conditions on the Puncturing Properties of Gelatin and HPMC Capsules for Inhalation
Thomas Wutscher, Milica Stanković-Brandl, Sarah Zellnitz, Mirjam Kobler, Francesca Buttini, Veronica Chierici, Laura Andrade Benítez, Verónica Daza Fernández, Alberto Mercandelli, Stefano Biserni, Susana Ecenarro Probst, Laura Canalejas and Amrit Paudel


(644f) Formulation, Stability, and Scalability of Fast-Releasing Lumefantrine Nanoparticles for the Treatment of Malaria
Madeleine Armstrong, Jie Feng, Chester E. Markwalter, Chang Tian, Kurt D. Ristroph, Leon Z. Wang, Jiankai Yang, Hui Du, Huizhuan Lin, Fengjiao He, Shuhong Jiang, Santipharp Panmai, Hanu Ramachandruni, Yingyue Zhang, Simon A. McManus, Kai Gong, Claire White, Aditya Rawal and Robert K. Prud’homme
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