In-line Raman spectroscopic monitoring and feedback control of a continuous twin-screw pharmaceutical powder blending and tableting process

Brigitta Nagy, Attila Farkas, Martin Gyürkés, Szofia Komaromy-Hiller, Balázs Démuth, Bence Szabó, Dávid Nusser, Enikő Borbás, G. Marosi, Zsombor Kristóf Nagy

Research output: Article

27 Citations (Scopus)

Abstract

The integration of Process Analytical Technology (PAT) initiative into the continuous production of pharmaceuticals is indispensable for reliable production. The present paper reports the implementation of in-line Raman spectroscopy in a continuous blending and tableting process of a three-component model pharmaceutical system, containing caffeine as model active pharmaceutical ingredient (API), glucose as model excipient and magnesium stearate as lubricant. The real-time analysis of API content, blend homogeneity, and tablet content uniformity was performed using a Partial Least Squares (PLS) quantitative method. The in-line Raman spectroscopic monitoring showed that the continuous blender was capable of producing blends with high homogeneity, and technological malfunctions can be detected by the proposed PAT method. The Raman spectroscopy-based feedback control of the API feeder was also established, creating a ‘Process Analytically Controlled Technology’ (PACT), which guarantees the required API content in the produced blend. This is, to the best of the authors’ knowledge, the first ever application of Raman-spectroscopy in continuous blending and the first Raman-based feedback control in the formulation technology of solid pharmaceuticals.

Original languageEnglish
Pages (from-to)21-29
Number of pages9
JournalInternational Journal of Pharmaceutics
Volume530
Issue number1-2
DOIs
Publication statusPublished - szept. 15 2017

Fingerprint

Powders
Raman Spectrum Analysis
Pharmaceutical Preparations
Technology
Pharmaceutical Technology
Lubricants
Excipients
Caffeine
Least-Squares Analysis
Tablets
Glucose

ASJC Scopus subject areas

  • Pharmaceutical Science

Cite this

In-line Raman spectroscopic monitoring and feedback control of a continuous twin-screw pharmaceutical powder blending and tableting process. / Nagy, Brigitta; Farkas, Attila; Gyürkés, Martin; Komaromy-Hiller, Szofia; Démuth, Balázs; Szabó, Bence; Nusser, Dávid; Borbás, Enikő; Marosi, G.; Nagy, Zsombor Kristóf.

In: International Journal of Pharmaceutics, Vol. 530, No. 1-2, 15.09.2017, p. 21-29.

Research output: Article

Nagy, Brigitta ; Farkas, Attila ; Gyürkés, Martin ; Komaromy-Hiller, Szofia ; Démuth, Balázs ; Szabó, Bence ; Nusser, Dávid ; Borbás, Enikő ; Marosi, G. ; Nagy, Zsombor Kristóf. / In-line Raman spectroscopic monitoring and feedback control of a continuous twin-screw pharmaceutical powder blending and tableting process. In: International Journal of Pharmaceutics. 2017 ; Vol. 530, No. 1-2. pp. 21-29.
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