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Application of Process Analytical Technology for Pharmaceutical Coating: Challenges, Pitfalls, and Trends

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Abstract

Coating process is a critical unit operation for manufacturing solid oral dosage forms. For a long time, the coating weight gain has been discerned as the most important, if not only, characteristic describing the coating quality. As the introduction of quality by design (QbD) and advancement of process analytical technology (PAT), nowadays more techniques are available to analyze other quality attributes which have been overlooked but have substantial impacts on the performance of coated products. The techniques that permit rapid and non-destructive measurements are of particular importance to improve process operation and product quality. This article reviews the analytical techniques that have been and potentially could be used as PAT tools for characterizing the quality of pharmaceutical coating product. By identifying the challenges and pitfalls encountered during PAT application, the review aims at fostering the adoption of PAT for paving the way to enhanced quality and efficiency of the coating processes.

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  1. Process analytical technology, Merck & Co., Inc., Rahway, New Jersey, USA

    Hanzhou Feng

  2. Graduate School of Pharmaceutical Sciences, Duquesne University, 600 Forbes Avenue, Pittsburgh, Pennsylvania, USA

    Shikhar Mohan

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  1. Hanzhou Feng
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Feng, H., Mohan, S. Application of Process Analytical Technology for Pharmaceutical Coating: Challenges, Pitfalls, and Trends. AAPS PharmSciTech 21, 179 (2020). https://doi.org/10.1208/s12249-020-01727-8

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