Real-time release testing of in vitro dissolution and blend uniformity in a continuous powder blending process by NIR spectroscopy and machine vision

Mészáros, Lilla Alexandra and Gyürkés, Martin and Varga, Emese and Tacsi, Kornélia and Honti, Barbara and Borbás, Enikő and Farkas, Attila and Nagy, Zsombor Kristóf and Nagy, Brigitta (2024) Real-time release testing of in vitro dissolution and blend uniformity in a continuous powder blending process by NIR spectroscopy and machine vision. EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, 201. ISSN 0939-6411

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Abstract

Continuous manufacturing is gaining increasing interest in the pharmaceutical industry, also requiring real-time and non-destructive quality monitoring. Multiple studies have already addressed the possibility of surrogate in vitro dissolution testing, but the utilization has rarely been demonstrated in real-time. Therefore, in this work, the in-line applicability of an artificial intelligence-based dissolution surrogate model is developed the first time. NIR spectroscopy-based partial least squares regression and artificial neural networks were developed and tested in-line and at-line to assess the blend uniformity and dissolution of encapsulated acetylsalicylic acid (ASA) – microcrystalline cellulose (MCC) powder blends in a continuous blending process. The studied blend is related to a previously published end-to-end manufacturing line, where the varying size of the ASA crystals obtained from a continuous crystallization significantly affected the dissolution of the final product. The in-line monitoring was suitable for detecting the variations in the ASA content and dissolution caused by the feeding of ASA with different particle sizes, and the at-line predictions agreed well with the measured validation dissolution curves (f2 = 80.5). The results were further validated using machine vision-based particle size analysis. Consequently, this work could contribute to the advancement of RTRT in continuous end-to-end processes. © 2024 The Author(s)

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