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Sampling optimization for blend monitoring of a low dose formulation in a tablet press feed frame using spatially resolved near-infrared spectroscopy

By Román-Ospino, Andrés; Baranwal, Yukteshwar; Li, Jingzhe; Vargas, Jenny; Igne, Benoît; Bate, Simon; Brouckaert, Davinia; Chauchard, Fabien; Hausner, Douglas; Ramachandran, Rohit; Singh, Ravendra; Muzzio, Fernando

Published on CMKC

Abstract

In-line measurements of low dose blends in the feed frame of a tablet press were performed for API concentration levels as low as 0.10% w/w. The proposed methodology utilizes the advanced sampling capabilities of a Spatially Resolved Near-Infrared (SR-NIR) probe to develop Partial Least-Squares calibration models. The fast acquisition speed of multipoint spectra allowed the evaluation of different numbers of co-adds and feed frame paddle speeds to establish the optimum conditions of data collection to predict low potency blends. The interaction of the feed frame paddles with the SR-NIR probe was captured with high resolution and allowed the implementation of a spectral data selection criterion to remove the effect of the paddles from the calibration and testing process. The method demonstrated accuracy and robustness when predicting drug concentrations across different feed frame paddle speeds.

Journal

International Journal of Pharmaceutics. Volume 602, 2021, 120594

DOI

10.1016/j.ijpharm.2021.120594

Type of publication

Peer-reviewed journal

Affiliations

  • Rutgers, The State University of New Jersey
  • GlaxoSmithKline
  • Indatech

Article Classification

Research article

Classification Areas

  • PAT
  • Oral solid dose

Tags