Data fusion strategies for performance improvement of a Process Analytical Technology platform consisting of four instruments: An electrospinning case study.

Journal: International journal of pharmaceutics
PMID: 31252149

Abstract

The aim of this work was to develop a PAT platform consisting of four complementary instruments for the characterization of electrospun amorphous solid dispersions with meloxicam. The investigated methods, namely NIR spectroscopy, Raman spectroscopy, Colorimetry and Image analysis were tested and compared considering the ability to quantify the active pharmaceutical ingredient and to detect production errors reflected in inhomogeneous deposition of fibers. Based on individual performance the calculated RMSEP values ranged between 0.654% and 2.292%. Mid-level data fusion consisting of data compression through latent variables and application of ANN for regression purposes proved efficient, yielding an RMSEP value of 0.153%. Under these conditions the model could be validated accordingly on the full calibration range. The complementarity of the PAT tools, demonstrated from the perspective of captured variability and outlier detection ability, contributed to model performance enhancement through data fusion. To the best of the author's knowledge, this is the first application of data fusion in the field of PAT for efficient handling of big-analytical-data provided by high-throughput instruments.

Authors

  • Tibor Casian
    Department of Pharmaceutical Technology and Biopharmacy, "Iuliu Hatieganu" University of Medicine and Pharmacy, 400012 Cluj-Napoca, Romania. Electronic address: casian.tibor@umfcluj.ro.
  • Attila Farkas
    Department of Organic Chemistry and Technology, Budapest University of Technology and Economics, H-1111 Budapest, Hungary.
  • Kinga Ilyés
    Department of Pharmaceutical Technology and Biopharmacy, "Iuliu Hatieganu" University of Medicine and Pharmacy, 400012 Cluj-Napoca, Romania.
  • Balázs Démuth
    Department of Organic Chemistry and Technology, Budapest University of Technology and Economics, H-1111 Budapest, Hungary.
  • Enikő Borbás
    Department of Organic Chemistry and Technology, Budapest University of Technology and Economics, H-1111 Budapest, Hungary.
  • Lajos Madarász
    Department of Organic Chemistry and Technology, Budapest University of Technology and Economics, H-1111 Budapest, Hungary.
  • Zsolt Rapi
    Department of Organic Chemistry and Technology, Budapest University of Technology and Economics, H-1111 Budapest, Hungary.
  • Balázs Farkas
    Department of Organic Chemistry and Technology, Budapest University of Technology and Economics, H-1111 Budapest, Hungary.
  • Attila Balogh
    Department of Organic Chemistry and Technology, Budapest University of Technology and Economics, H-1111 Budapest, Hungary.
  • András Domokos
    Department of Organic Chemistry and Technology, Budapest University of Technology and Economics, H-1111 Budapest, Hungary.
  • György Marosi
    Department of Organic Chemistry and Technology, Budapest University of Technology and Economics, H-1111 Budapest, Hungary.
  • Ioan Tomută
    Department of Pharmaceutical Technology and Biopharmacy, "Iuliu Hatieganu" University of Medicine and Pharmacy, 400012 Cluj-Napoca, Romania.
  • Zsombor Kristóf Nagy
    Department of Organic Chemistry and Technology, Faculty of Chemical Technology and Biotechnology, Budapest University of Technology and Economics, Műegyetem rkp. 3., H-1111 Budapest, Hungary.

Keywords

External Resources

Popular Topics
Recent Journals