Comparison Between Pure Component Modeling Approaches for Monitoring Pharmaceutical Powder Blends with Near-Infrared Spectroscopy in Continuous Manufacturing Schemes.

Autor: Rish AJ; Duquesne University Graduate School for Pharmaceutical Sciences, Pittsburgh, PA, 15282, USA.; Duquesne Center for Pharmaceutical Technology, Duquesne University, 600 Forbes Ave, Pittsburgh, PA, 15282, USA., Henson SR; Duquesne University Graduate School for Pharmaceutical Sciences, Pittsburgh, PA, 15282, USA.; Duquesne Center for Pharmaceutical Technology, Duquesne University, 600 Forbes Ave, Pittsburgh, PA, 15282, USA., Alam MA; Worldwide Research and Development, Pfizer Inc., Groton, CT, 06340, USA., Liu Y; Worldwide Research and Development, Pfizer Inc., Groton, CT, 06340, USA., Drennen JK; Duquesne University Graduate School for Pharmaceutical Sciences, Pittsburgh, PA, 15282, USA.; Duquesne Center for Pharmaceutical Technology, Duquesne University, 600 Forbes Ave, Pittsburgh, PA, 15282, USA., Anderson CA; Duquesne University Graduate School for Pharmaceutical Sciences, Pittsburgh, PA, 15282, USA. andersonca@duq.edu.; Duquesne Center for Pharmaceutical Technology, Duquesne University, 600 Forbes Ave, Pittsburgh, PA, 15282, USA. andersonca@duq.edu.
Jazyk: angličtina
Zdroj: The AAPS journal [AAPS J] 2022 Jul 12; Vol. 24 (4), pp. 82. Date of Electronic Publication: 2022 Jul 12.
DOI: 10.1208/s12248-022-00725-x
Abstrakt: Near-infrared (NIR) spectroscopy has become an important process analytical technology (PAT) for monitoring and implementing control in continuous manufacturing (CM) schemes. However, NIR requires complex multivariate models to properly extract the relevant information and the traditional model of choice, partial least squares, can be unfavorable on account of its high material and time investments for generating calibrations. To account for this, pure component-based approaches have been gaining attention due to their higher flexibility and ease of development. In the present study, the application of two pure component approaches, classical least squares (CLS) models and iterative optimization technology (IOT) algorithms, to pharmaceutical powder blends in a continuous feed frame was considered. The approaches were compared from both a model performance and practical implementation perspective. IOT were found to demonstrate superior performance in predicting drug content compared to CLS. The practical implementation of each modelling approach was also given consideration.
(© 2022. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.)
Databáze: MEDLINE
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