Roller compaction is a key unit operation in a dry granulation line for pharmaceutical tablet manufacturing. However, determining the optimal settings for a roller compactor (RC) typically requires extensive material-consuming experimental campaigns. This amount of material, in particular if active pharmaceutical ingredients are involved, may not be available during development phases, or may be very expensive. For this reason, a compactor simulator (CS) is usually employed to emulate the behaviour of compacted powders at a much smaller scale, with significant savings of materials, time, and money. However, the experimental conditions at which a CS shall be run to obtain a product with assigned specifications are different from those required to obtain the same product from a full-scale RC. How to find these conditions is an open issue. In this study, historical data from both CS and RC experiments are used to develop a transfer methodology that allows the experimenter to obtain optimal RC setup from the CS experimental results solely. The developed correlation, which has been applied to six different pharmaceutical powder blends, successfully captures the differences between the two equipment scales. Implementing this transfer methodology can result in reliable prediction of RC machine settings, thus enabling significant resource, time and money savings.

Roller compaction is a key unit operation in a dry granulation line for pharmaceutical tablet manufacturing. However, determining the optimal settings for a roller compactor (RC) typically requires extensive material-consuming experimental campaigns. This amount of material, in particular if active pharmaceutical ingredients are involved, may not be available during development phases, or may be very expensive. For this reason, a compactor simulator (CS) is usually employed to emulate the behaviour of compacted powders at a much smaller scale, with significant savings of materials, time, and money. However, the experimental conditions at which a CS shall be run to obtain a product with assigned specifications are different from those required to obtain the same product from a full-scale RC. How to find these conditions is an open issue. In this study, historical data from both CS and RC experiments are used to develop a transfer methodology that allows the experimenter to obtain optimal RC setup from the CS experimental results solely. The developed correlation, which has been applied to six different pharmaceutical powder blends, successfully captures the differences between the two equipment scales. Implementing this transfer methodology can result in reliable prediction of RC machine settings, thus enabling significant resource, time and money savings.

Accelerating pharmaceutical tablet development by transfer of compaction equipment across types and scales

BECCARO, LUCA
2022/2023

Abstract

Roller compaction is a key unit operation in a dry granulation line for pharmaceutical tablet manufacturing. However, determining the optimal settings for a roller compactor (RC) typically requires extensive material-consuming experimental campaigns. This amount of material, in particular if active pharmaceutical ingredients are involved, may not be available during development phases, or may be very expensive. For this reason, a compactor simulator (CS) is usually employed to emulate the behaviour of compacted powders at a much smaller scale, with significant savings of materials, time, and money. However, the experimental conditions at which a CS shall be run to obtain a product with assigned specifications are different from those required to obtain the same product from a full-scale RC. How to find these conditions is an open issue. In this study, historical data from both CS and RC experiments are used to develop a transfer methodology that allows the experimenter to obtain optimal RC setup from the CS experimental results solely. The developed correlation, which has been applied to six different pharmaceutical powder blends, successfully captures the differences between the two equipment scales. Implementing this transfer methodology can result in reliable prediction of RC machine settings, thus enabling significant resource, time and money savings.
2022
Accelerating pharmaceutical tablet development by transfer of compaction equipment across types and scales
Roller compaction is a key unit operation in a dry granulation line for pharmaceutical tablet manufacturing. However, determining the optimal settings for a roller compactor (RC) typically requires extensive material-consuming experimental campaigns. This amount of material, in particular if active pharmaceutical ingredients are involved, may not be available during development phases, or may be very expensive. For this reason, a compactor simulator (CS) is usually employed to emulate the behaviour of compacted powders at a much smaller scale, with significant savings of materials, time, and money. However, the experimental conditions at which a CS shall be run to obtain a product with assigned specifications are different from those required to obtain the same product from a full-scale RC. How to find these conditions is an open issue. In this study, historical data from both CS and RC experiments are used to develop a transfer methodology that allows the experimenter to obtain optimal RC setup from the CS experimental results solely. The developed correlation, which has been applied to six different pharmaceutical powder blends, successfully captures the differences between the two equipment scales. Implementing this transfer methodology can result in reliable prediction of RC machine settings, thus enabling significant resource, time and money savings.
Roller compaction
Dry granulation
Compactor simulator
Pharmaceutical
Modeling
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.12608/50942