A non-destructive method for quality control of the pellet distribution within a MUPS tablet by terahertz pulsed imaging

Eur J Pharm Sci. 2018 Jan 1:111:549-555. doi: 10.1016/j.ejps.2017.10.029. Epub 2017 Oct 19.

Abstract

Terahertz pulsed imaging (TPI) was applied to analyse the inner structure of multiple unit pellet system (MUPS) tablets. MUPS tablets containing different amounts of theophylline pellets coated with Eudragit® NE 30 D and with microcrystalline cellulose (MCC) as cushioning agent were analysed. The tablets were imaged by TPI and the results were compared to X-ray microtomography. The terahertz pulse beam propagates through the tablets and is back-reflected at the interface between the MCC matrix and the coated pellets within the tablet causing a peak in the terahertz waveform. Cross-section images of the tablets were extracted at different depths and parallel to the tablet faces from 3D terahertz data to visualise the surface-near structure of the MUPS tablets. The images of the surface-near structure of the MUPS tablets were compared to X-ray microtomography images at the same depths. The surface-near structure could be clearly resolved by TPI at depths between 24 and 152μm below the tablet surface. An increasing amount of pellets within the MUPS tablets appears to slightly decrease the detectability of the pellets within the tablets by TPI. TPI was shown to be a non-destructive method for the detection of pellets within the tablets and could resolve structures thicker than 30μm. In conclusion, a proof-of-concept was provided for TPI as a method of quality control for MUPS tablets.

Keywords: 3D mapping; MUPS tablets; Pellet distribution analysis; Quality control; Spectroscopy; Terahertz pulsed imaging.

MeSH terms

  • Bronchodilator Agents / chemistry*
  • Drug Implants / chemistry*
  • Tablets
  • Terahertz Imaging*
  • Theophylline / chemistry*
  • X-Ray Microtomography

Substances

  • Bronchodilator Agents
  • Drug Implants
  • Tablets
  • Theophylline