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Characterizing drug product continuous manufacturing residence time distributions of major/minor excipient step changes using near infrared spectroscopy and process parameters

By Shi, Zhenqi; Manley, Leo

Published on CMKC

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

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