486 Bio and Pharmaceutical Formulation & Process Design

Wednesday, November 19, 2014: 12:30 PM
203 (Hilton Atlanta)
Description:
This session covers the formulation process development of both biologics and small molecule drug products. Papers are invited, but not limited to techniques involved in oral, parenteral, transmucosal and transdermal delivery systems. Topics of interest include best practices in early development formulation optimization (stability, manufacturability, and bioavailability) and scale-up to commercial manufacturing , innovative ways of reducing development cycle time, and interesting case studies that highlight the impact of good formulation and process design to solve challenging problems. Priority will be given to submissions that show scale-up experience and demonstrate Quality by Design principles for various solid and liquid dosage forms and processing methods.

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

Chair:
Co-chairs:
Padma Narayan
Email: PNarayan@dow.com

Yali Zhang
Email: yali.zhang@boehringer-ingelheim.com


12:30 PM
(486a) Crystallinity Detection Methods for Polymer-Stabilized Solid Dispersion Formulations
Stephen L. Conway, Eugene Park, Itzia Arroyo, Jun-Hong Chou, Rory Sargeant and Kenneth Rosenberg

12:55 PM

1:20 PM
(486c) Screening Microneedle Formulations for Influenza Vaccine Stabilization
Matt Mistilis, Andreas S. Bommarius and Mark Prausnitz

1:45 PM
(486d) Tablet Press Weight Control Model
Leo Manley, Bernard M. McGarvey and Genevieve Sullivan

2:10 PM
(486e) Quality-By-Design Evaluation of an Immediate Release Tablet Platform
Joseph Kushner IV, Beth A. Langdon, Fasheng Li, Gautam R. Ranade, Daniel Song, Anil Kane, Ian Hicks, Lalji Kathiria and Kam Agarwal

2:35 PM
(486f) Excipient-Process Interactions and Their Effects on Tablet Compaction and Film Coating
Preetanshu Pandey, Shruti Gour, Dilbir Bindra, Jade Trinh, David Buckley and Sherif Badawy