Spectroscopic characterization of tablet properties in a continuous powder blending and tableting process

Brigitta Nagy, Attila Farkas, Krisztina Magyar, Balázs Démuth, Zsombor Kristóf Nagy, G. Marosi

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

By the advent of continuous pharmaceutical manufacturing, fast and accurate characterization of product quality has become of a major interest. Although it also promotes the real-time release testing approach, so far mainly content uniformity studies were performed by near-infrared (NIR) spectroscopy. This paper proposes the simultaneous application of NIR and Raman spectroscopy to nondestructively analyze the critical quality attributes of continuously produced tablets in a real-time release testing procedure. A face-centered composite design was applied to determine the impact of lubrication and compression force on the properties of a tablet formulation containing caffeine, glucose-monohydrate and magnesium stearate and to provide a systematic comparison of the applicability of spectroscopic methods. Quantitative methods were developed to evaluate different lubrication approaches in a continuous blending and tableting line. The simultaneous application of NIR and Raman spectroscopy revealed that NIR spectroscopy is more suitable to follow the changes of compression force, while Raman spectroscopy could be successfully applied for the detection of overlubrication. The presented approach can be a part of a comprehensive real-time release strategy, where NIR and Raman spectroscopy provide complementary information about multiple critical quality attributes, such as content uniformity, tablet hardness, friability and dissolution.

Original languageEnglish
Pages (from-to)10-19
Number of pages10
JournalEuropean Journal of Pharmaceutical Sciences
Volume123
DOIs
Publication statusPublished - Oct 15 2018

Keywords

  • Continuous blending
  • Lubrication
  • NIR spectroscopy
  • Process analytical technology
  • Raman spectroscopy
  • Real-time release testing
  • Tablet compression

ASJC Scopus subject areas

  • Pharmaceutical Science

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