Critical review on the role of excipient properties in pharmaceutical powder-to-tablet continuous manufacturing
ABSTRACT
Introduction: The pharmaceutical industry is gradually changing batch-wise manufacturing processes to continuous manufacturing processes, due to the advantages it has to offer. The final product quality and process efficiency of continuous manufacturing processes is among others impacted by the properties of the raw materials. Existing knowledge on the role of raw material properties in batch processing is however not directly transferable to continuous processes, due to the inherent differences between batch and continuous processes.
Article highlights
- Continuous processes are inherently different from batch processes.
- Knowledge on the role of raw material properties in batch processing is not directly transferable to continuous processes.
- Prior knowledge of physical chemical material properties can provide indications of how the powder will behave during processing and can support the optimal selection of equipment design and tooling.
- Excipient innovations that support the implementation of continuous processes include a good feedable lubricant, regulatory-wise accepted customized co-processed excipients, cleaning excipients, and improved insights in data, consistency, and modeling.
- Fast wetting kinetics and fast drying of excipients can help to achieve higher throughputs in twin screw granulation processes.
Areas covered: A review is performed to evaluate the role of excipient properties for different unit operations used in continuous manufacturing processes. Unit operations that will be discussed include feeding, blending, granulation, final blending, and compression.
Expert opinion: Although the potency of continuous manufacturing is widely recognized, full utilization still requires a number of challenges to be addressed effectively. An expert opinion will be provided that discusses those challenges and potential solutions to overcome those challenges. The provided overview can serve as a framework for the pharmaceutical industry to push ahead process optimization and formulation development for continuous manufacturing processes.
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Pauline H. M. Janssen, Sara Fathollahi, Bastiaan H. J. Dickhoff & Henderik W. Frijlink (12 Aug 2024): Critical review on the role of excipient properties in pharmaceutical powder-to-tablet continuous manufacturing, Expert Opinion on Drug Delivery, DOI: 10.1080/17425247.2024.2384698
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