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On-line monitoring of blend uniformity in continuous drug product manufacturing process -The impact of powder flow rate and the choice of spectrometer: Dispersive vs. FT

By Shi, Zhenqi; McGhehey, Kathryn C; Leavesley, Ian M.; Manley, Leo F.

Published on

Abstract

One of the commonly acknowledged issues in continuous manufacturing of drug products is how to provide a representative sampling on flowing powder to assure its blend uniformity. An investigation was conducted to improve understanding on the impact of powder flow rate under different continuous manufacturing conditions and the impact of optical parameters (such as resolution, co-adds, and integration time) on NIR spectral quality with respect to a dispersive and a Fourier transform instrument. A partial least squares (PLS)-based spectral pretreatment was found useful to tackle the impact of different flow rates on NIR spectral signals. Multivariate figures of merit (FOM) were used to evaluate performances across different instruments and optical settings and discover the advantageous selectivity and sensitivity on the Fourier transform than the dispersive instrument regardless of the use of co-adds.

Journal

Journal of Pharmaceutical and Biomedical Analysis. Volume 118, 2016, 259-266

DOI

10.1016/j.jpba.2015.11.005

Type of publication

Peer-reviewed journal

Affiliations

  • Eli Lilly and Company

Article Classification

Research article

Classification Areas

  • PAT
  • Oral solid dose

Tags