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Process Analytical Technology : suivi en temps réel d’une opération d’enrobage et de curing et nouvelles avancées dans la caractérisation du film polymère

Abstract : Implementation of PAT (Process Analytical Technology) approach has recently been promoted by the FDA (Food and Drug Administration) within the pharmaceutical industry. A desired goal of the PAT framework is to enhance understanding and control of the manufacturing process through timely measurements, during processing, to ensure final product quality. Real-time monitoring of a coating operation was performed from in-line Near Infrared (NIR) measurements inside a pan coater. Mass of coating materials, determined by simple and fast weighing but depending on core tablet weight uniformity, and film coating thickness, obtained from accurate and non-destructive Terahertz Pulsed Imaging (TPI) measurements, were used as reference values to calibrate NIR spectral information. In both cases, these two critical quality attributes were predicted with low predictive errors, which were found to be similar. In addition, real-time predictions of drug release from cured tablets were carried out by in-line NIR measurements. The coating operation was successfully stopped when desired dissolution criteria were achieved. A post-coating thermal treatment, known as curing, is generally required to stabilize film coating from aqueous polymer dispersion. Innovative techniques were jointly used to elucidate the underlying mechanisms of film formation along the curing process. This study provided a new insight into the tablet coating structure, highlighting a reduced internal coating porosity, a decrease in water content and showing a better structural rearrangement of polymer chains, with dynamic curing. All investigated techniques confirmed that a stabilized state was reached after a 4 h dynamic curing in comparison with a reference curing carried out in an oven for 24 h. Interestingly even prior to curing, new findings were pointed out, during coated tablets storage, related to the crystallisation and the upward migration of cetyl alcohol, coupled to the downward migration of sodium lauryl sulfate within the coating layer.
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Claire Gendre. Process Analytical Technology : suivi en temps réel d’une opération d’enrobage et de curing et nouvelles avancées dans la caractérisation du film polymère. Médecine humaine et pathologie. Université Paris Sud - Paris XI, 2011. Français. ⟨NNT : 2011PA114836⟩. ⟨tel-00703141⟩

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