The application of Near-Infrared Spatially Resolved Spectroscopy in scope of achieving continuous real-time quality monitoring and control of tablets with challenging dimensions

In scope of achieving real-time release of tablets, quality attributes need to be monitored and controlled through Process Analytical Technology tools such as near-infrared spectroscopy (NIRS). The authors evaluated the suitability of NIR-Spatially Resolved Spectroscopy (NIR-SRS) for continuous real-time monitoring and control of content uniformity, hardness and homogeneity of tablets with challenging dimensions. A novel user-friendly research and development inspection unit was used as standalone equipment for the analysis of small oblong tablets with deep-cut break lines. A total of 66 tablets varying in hardness and Active Pharmaceutical Ingredient (API) content were inspected, with each tablet being analysed five times and measurements repeated on three different days.

Partial Least Squares (PLS) models were developed to assess content uniformity and hardness, of which the former showed higher accuracy. The authors attempted to visualize tablet homogeneity through NIR-SRS spectra by regressing all spectra obtained during a single measurement using a content uniformity PLS model. The NIR-SRS probe demonstrated its potential towards real-time release testing through its ability to quickly monitor content uniformity, hardness and visualize homogeneity, even for tablets with challenging dimensions.

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Materials

Tablets were supplied by UCB Pharma, containing API_P (UCB Pharma, Braine l’Alleud, Belgium) as active pharmaceutical ingredient (API) in a model formulation. The model formulation consisted of lactose monohydrate (Pharmatose 200M, DFE Pharma, Goch, Germany), microcrystalline cellulose (Avicel PH102, FMC biopolymer, Philadelphia, USA), Hypromellose 2910 (Methocel E3, Colorcon, Dartford, England), croscarmellose sodium (Ac-Di-Sol SD711, FMC Biopolymer, Philadelphia, USA) and magnesium stearate

A. De Man, J.-S. Uyttersprot, P.-F. Chavez, F. Vandenbroucke, F. Bovart, T. De Beer, The application of Near-Infrared Spatially Resolved Spectroscopy in scope of achieving continuous real-time quality monitoring and control of tablets with challenging dimensions, International Journal of Pharmaceutics, 2023, 123064, ISSN 0378-5173, https://doi.org/10.1016/j.ijpharm.2023.123064.

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