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- W4289210009 abstract "In oral solid dosage (OSD) forms manufacturing, understanding and characterizing the flowability of pharmaceutical formulations is pivotal since product and process performance directly depend on this property. Therefore, whenever a formulation change occurs during drug development, the impact on powder flowability must be quantified to address any potential effects on the manufacturability or critical quality attributes of the final product. Current industrial practice relies on extensive experimentation to address this problem, resulting into a significant consumption of active pharmaceutical ingredient (API), which is expensive and scarce during the early stages of drug development. In this study, we propose a mixing rule model that can be used to predict the flowability of pharmaceutical blends from the flowability of the individual components. The model is validated with 35 different powder blends consisting of common APIs and excipients used for directly compressed pharmaceutical formulations. Results show that, by measuring the flowability of the pure API and only 6 binary mixtures, the mixing rule model can be used to predict the flowability of directly compressed pharmaceutical blends containing the API without further experiments. For a new pharmaceutical product, the reduction in experimental effort using this modelling approach can translate to ~ 80% reduction of API consumption, depending on the formulated product and the API physical properties." @default.
- W4289210009 created "2022-08-01" @default.
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- W4289210009 date "2022-01-01" @default.
- W4289210009 modified "2023-10-17" @default.
- W4289210009 title "A model-based approach to predict the flowability of directly compressed pharmaceutical blends from individual components" @default.
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- W4289210009 doi "https://doi.org/10.1016/b978-0-323-95879-0.50006-0" @default.
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