Feeding of particle-based materials in continuous solid dosage manufacturing: a material science perspective

•Continuous processing represents new challenges in pharmaceutical material science.•Critique of key process steps such as feeding on product quality has increased.•Batch dispensing and continuous feeding are fundamentally different processes.•Rational approach based on predictive science is key to...

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Bibliographic Details
Published in:Drug discovery today Vol. 25; no. 4; pp. 800 - 806
Main Authors: Hsiao, Wen-Kai, Hörmann, Theresa R., Toson, Peter, Paudel, Amrit, Ghiotti, Patrizia, Stauffer, Fanny, Bauer, Finn, Lakio, Satu, Behrend, Olaf, Maurer, Reto, Holman, James, Khinast, Johannes
Format: Journal Article
Language:English
Published: England Elsevier Ltd 01-04-2020
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Summary:•Continuous processing represents new challenges in pharmaceutical material science.•Critique of key process steps such as feeding on product quality has increased.•Batch dispensing and continuous feeding are fundamentally different processes.•Rational approach based on predictive science is key to optimize continuous feeding. The pharmaceutical industry today is experiencing a paradigm shift from batch to continuous manufacturing, which promises greater flexibility to target diverse populations, as well as more-consistent product quality to ensure best efficacy. However, shifting to continuous processing means that even basic process steps, such as feeding, can become unexpected but are crucially important. In this review, we will present the fundamental differences between dispensing (batch) and feeding (continuous) and how they impact the formulation design space. We will further outline our rational development approach, applicable to continuous unit operations in general, which includes standardized material and process characterization, as well as predictive modeling based on advanced, multidomain simulation tools.
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ISSN:1359-6446
1878-5832
DOI:10.1016/j.drudis.2020.01.013