Characterizing drug product continuous manufacturing residence time distributions of major/minor excipient step changes using near infrared spectroscopy and process parameters
Category
Published on
Abstract
The material residence time distribution in a continuous manufacturing process can be utilized to develop, design and justify the process control strategy. This paper successfully demonstrates using both major and minor formulation component step changes to determine the system response using either Near Infrared Spectroscopy or process parameters. These options provide development flexibility to determine the system's material residence time earlier in the development process and more cost effectively.
Journal
International Journal of Pharmaceutics. Volume 551, 2018, 60-66
DOI
10.1016/j.ijpharm.2018.08.059
Type of publication
Peer-reviewed journal
Affiliations
- Eli Lilly and Company
Article Classification
Research article
Classification Areas
- PAT
- Oral solid dose