Innovative Galenic Formulation of Prussian Blue Tablets: Advancing Pharmaceutical Applications

Area of Science:

• Pharmaceutical Sciences
• Radiological Health
• Materials Science

Background:

• Global reliance on limited Prussian blue (PB) capsule sources necessitates alternative formulations.
• Nuclear accidents and warfare present persistent threats requiring rapid countermeasures.
• Lack of accessible quantitative formulations for existing PB products highlights a critical need.

Purpose of the Study:

• To design and develop stable, scalable Prussian blue (PB) tablets for oral administration.
• To create a robust formulation for decorporation of radioactive and toxic elements.
• To ensure rapid deployment capabilities for nuclear and radiological emergencies.

Main Methods:

• Utilized direct compression, wet granulation, and dry granulation for tablet development.
• Conducted comprehensive physicochemical and pharmacotechnical characterizations.
• Performed stability studies adhering to ICH guidelines.

Main Results:

• The direct compression formulation (DC5) was identified as optimal for industrial production.
• DC5 offers simplicity, short cycle times, and high throughput.
• Stability studies up to 18 months confirmed PB tablets remain within specifications.

Conclusions:

• Developed a robust and scalable Prussian blue (PB) tablet formulation.
• The PB tablets represent a significant advancement in nuclear and radiological emergency countermeasures.
• The formulation enables rapid manufacturing and deployment for critical situations.