Innovative Galenic Formulation of Prussian Blue Tablets: Advancing Pharmaceutical Applications

Background/Objectives: Given the persistent threat of war and nuclear accidents, and the global reliance on marketed Prussian blue capsules manufactured in only a few countries without an openly accessible quantitative formulation, there is a critical need for robust tablet alternatives that ensure stability, scalability, and rapid deployment. This study focuses on the design and development of PB tablets for oral administration as decorporation agents for radioactive and toxic species, particularly for treatment in nuclear and radiological emergencies. Methods: Advanced tableting processes, including direct compression, wet granulation, and dry granulation, were employed to develop innovative Prussian blue tablet formulations and to provide significant flexibility for industrial-scale production. Comprehensive physicochemical and pharmacotechnical characterizations were performed to support the formulation and to ensure both the safety and efficacy of the PB tablets. Stability studies were conducted in accordance with ICH guidelines to evaluate product performance over time and to confirm that quality and performance attributes remained within specification. Results: Among the formulations evaluated, the direct compression (DC5) was recommended for industrial production due to its simplicity, short cycle time, and high throughput. Stability studies up to 18 months confirmed that the PB tablets remained within specification, and the program is ongoing at 24, 36, 48, and 60 months. Conclusions: This research provides a promising advancement in countermeasures for nuclear and radiological incidents by delivering a robust, scalable PB tablet formulation that can be rapidly manufactured and deployed in emergency situations.