Impact of Raw Material Properties on Solid Dosage Form Processes
A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".
Deadline for manuscript submissions: 5 July 2024 | Viewed by 1466
Special Issue Editors
Interests: pharmaceutical technology; continuous manufacturing; 3D printing; additive manufacturing; pellets; twin-screw granulation; direct compression; material science
Special Issues, Collections and Topics in MDPI journals
Special Issue Information
Dear Colleagues,
The interlink between raw material properties and drug product performance has been a growing research topic in the last few years. Advances in the definition of a manufacturing classification system allowed rationalizing drug product process selection based on raw material properties. Such initiatives, however, rely on powder characterizations predictive of the behaviour of the powder during manufacturing at the pilot or commercial scale. It also implies that the raw material properties driving the process are well identified and that the desired ranges have been defined. Hence, it is key to understand the impact of the raw materials’ properties for each unit of operation as well as the integrated manufacturing process. Based on this knowledge, it becomes possible to design raw materials with the desired properties in order to make it amenable for a preferred process (e.g., a greener process) to improve the drug product process robustness and the drug product quality. Finally, there will always be a natural variability in the raw materials’ physical properties. New approaches are being developed to understand batch-to-batch variability and define critical material attributes for a specific product.
This Special Issue aims to approach this complex topic in a transversal way, allowing a comprehensible view of the current landscape.
Prof. Dr. Valérie Vanhoorne
Dr. Fanny Stauffer
Guest Editors
Manuscript Submission Information
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Keywords
- pharmaceutical technology
- material science
- powder
- drug product process development
- quality-by-design
