Taiwanese company Panion & BF Biotech has been awarded a US patent on high-grade ferric citrate that could be used as an active pharmaceutical ingredient for the treatment of iron deficiency diseases, renal failure and elevated blood phosphate, reports Phil Taylor.
While ferric citrate is already available on the market as a source of iron for food products, its use as a pharmaceutical has been limited by the quality of ingredient available.
Current methods of production involve syntheses with multiple steps, each of which impart a degree of variability in the composition of the resulting product, with variations in the proportions of iron and citrate and varying amounts of hydrate.
Panion's new patent covers a process that makes ferric citrate in three steps or less, which makes the product's final composition much easier to control, with more reproducible ratios between the iron and citrate components.
The process involves mixing solid citric acid and a solid ferric salt - preferably ferric chloride, ferric sulfate or ferric nitrate - adding alcohol to the mixture, and then filtering the mixture to obtain solid pharmaceutical-grade ferric citrate.
The patent also covers formulations of the ingredient suitable for use in the treatment of diseases in humans, as well as animals, and the use of the pharmaceutical-grade product in foods.
Panion makes pharmaceuticals, cosmetics and consumer healthcare products which are marketed in the Far East, as well as supplying ingredients. It holds a Drug Master File in the US for its pharma-grade ferric citrate, and manufactures it at a plant in Vancouver, Canada.