Optical porosimetry by gas in scattering media absorption spectroscopy (GASMAS) applied to roller compaction ribbons

Int J Pharm. 2021 Jan 5:592:120056. doi: 10.1016/j.ijpharm.2020.120056. Epub 2020 Nov 5.

Abstract

Currently, there is a need for new technology for in-line or fast at-line assessment of solid material porosity. One specific gap is a fast technology to be used in connection to roller compaction (RC) manufacturing, where the porosity of the RC ribbons is critical to the manufacturing of tablets of the right tensile strength and disintegration properties. In this paper, the development of an at-line technology for fast, non-destructive assessment of porosity of RC ribbons is reported. The technology is based on a diode laser spectroscopic technique called Gas in scattering media absorption spectroscopy (GASMAS). GASMAS measures the sample voids by laser light, giving the distance through air. The total distance the light travels is measured using time-of-flight spectroscopy (TOFS). The ratio of these measures gives an "optical porosity", which through theory relates to the porosity of the sample. We present a description of the technology, evaluations of measurement robustness and results from an experimental design where roller compactor, roll force, roll gap and formulation were varied. It is concluded that the data from two different pharmaceutical formulations is supported by the same calibration curve, which indicates that optical porosimetry is a general technique for pharmaceutical materials that does not require frequent calibrations.

Keywords: GASMAS; Material analysis; Optical porosity; Ribbon porosity; Roller compaction; Time-of-flight.

MeSH terms

  • Drug Compounding
  • Gases*
  • Porosity
  • Spectrum Analysis
  • Tablets
  • Technology, Pharmaceutical*
  • Tensile Strength

Substances

  • Gases
  • Tablets