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Blend uniformity evaluation during continuous mixing in a twin screw granulator by in-line NIR using a moving F-test

Anal Chim Acta. 2016 Sep 7:935:213-23. doi: 10.1016/j.aca.2016.07.020. Epub 2016 Jul 25.

Abstract

This study focuses on the twin screw granulator of a continuous from-powder-to-tablet production line. Whereas powder dosing into the granulation unit is possible from a container of preblended material, a truly continuous process uses several feeders (each one dosing an individual ingredient) and relies on a continuous blending step prior to granulation. The aim of the current study was to investigate the in-line blending capacity of this twin screw granulator, equipped with conveying elements only. The feasibility of in-line NIR (SentroPAT, Sentronic GmbH, Dresden, Germany) spectroscopy for evaluating the blend uniformity of powders after the granulator was tested. Anhydrous theophylline was used as a tracer molecule and was blended with lactose monohydrate. Theophylline and lactose were both fed from a different feeder into the twin screw granulator barrel. Both homogeneous mixtures and mixing experiments with induced errors were investigated. The in-line spectroscopic analyses showed that the twin screw granulator is a useful tool for in-line blending in different conditions. The blend homogeneity was evaluated by means of a novel statistical method being the moving F-test method in which the variance between two blocks of collected NIR spectra is evaluated. The α- and β-error of the moving F-test are controlled by using the appropriate block size of spectra. The moving F-test method showed to be an appropriate calibration and maintenance free method for blend homogeneity evaluation during continuous mixing.

Keywords: Blend uniformity; Continuous blending; Moving F-test; Near infrared spectroscopy; Process Analytical Technology; α- and β-error control.

MeSH terms

  • Calibration
  • Powders / chemistry
  • Spectroscopy, Near-Infrared / instrumentation
  • Tablets / chemical synthesis
  • Tablets / chemistry
  • Technology, Pharmaceutical* / instrumentation

Substances

  • Powders
  • Tablets