Development of a multivariate light-induced fluorescence (LIF) PAT tool for in-line quantitative analysis of pharmaceutical granules in a V-blender

Eur J Pharm Biopharm. 2014 Apr;86(3):524-31. doi: 10.1016/j.ejpb.2013.12.013. Epub 2013 Dec 25.

Abstract

Process analytical technologies (PAT) enable process insight, process control and real-time testing. Light-induced fluorescence (LIF) spectroscopy is especially well suited for low-concentration ingredients as, in many cases, it is the most sensitive probe of the in-line PAT toolbox. This study is aimed at verifying the applicability of a multivariate LIF analyzer to monitor granulated powder blends in industrial settings. Its targets are to: (1) evaluate the critical parameters of powders to obtain robust, precise and accurate concentration predictions and (2) assess technology performance for in-line monitoring of blending operations. Varying dye properties, moisture levels and particle sizes have been shown to have the most significant impact on fluorescence emission. Reliable quantitative models can be obtained by controlling and/or mitigating these factors.

Keywords: Blending; Chemometrics; Light-induced fluorescence (LIF); Mixing; Multivariate analysis; Pharmaceuticals; Powders; Process analytical technology (PAT); Quantitative analysis.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Chemistry, Pharmaceutical / instrumentation
  • Chemistry, Pharmaceutical / methods*
  • Fluorescence
  • Multivariate Analysis
  • Pharmaceutical Preparations / analysis*
  • Pharmaceutical Preparations / chemistry*
  • Spectrometry, Fluorescence / methods*

Substances

  • Pharmaceutical Preparations