Solid soluble ferric pyrophosphate formulations, kits, and methods using the same
A solid particulate formulation comprising soluble ferric pyrophosphate and a sachet comprising the solid particulate formulation of soluble ferric pyrophosphate for adding to a dialysis solution are provided. Improved methods of administering soluble ferric pyrophosphate comprising the solid particulate formulations and kits comprising the solid particulate formulation and a dialysis concentrate formulation are also disclosed.
1. A solid particulate formulation of soluble ferric pyrophosphate citrate chelate comprising milled soluble ferric pyrophosphate wherein 90% of the particles have a particle size between 1 μm and 50 μm.
2. The solid particulate formulation of claim 1 , wherein the soluble ferric pyrophosphate citrate chelate has an angle of repose less than 45 degrees.
3. The solid particulate formulation of claim 1 that is stable in aqueous solution at ambient temperature for at least 24 months.
4. The solid particulate formulation of claim 1 , wherein the soluble ferric pyrophosphate citrate chelate comprises iron in an amount of 7% to 11% by weight, citrate in an amount of at least 14%, and pyrophosphate in an amount of at least 10%.
5. The solid particulate formulation of claim 1 , comprising iron in an amount from 7.5-9.0% by weight, citrate in an amount from 15-22% by weight, pyrophosphate in an amount from 15-22% by weight, phosphate in an amount less than 2%, sodium in an amount from 18-25% by weight, and sulfate in an amount from 20-35% by weight.
6. The solid particulate formulation of claim 1 , comprising iron in an amount from 9-14% by weight, citrate in an amount from 30-60% by weight, pyrophosphate in an amount from 5-20% by weight, sodium in an amount from 1-15% by weight, and essentially no sulfate.
7. The solid particulate formulation of claim 1 , comprising a compound having structure (I):
8. The solid particulate formulation of claim 1 , wherein the soluble ferric pyrophosphate citrate chelate has an angle of repose less than 42 degrees.
9. The solid particulate formulation of claim 1 , wherein 90% of the particles have a particle size between 3 μm and 40 μm.
10. The solid particulate formulation of claim 1 , wherein 90% of the particles have a particle size between 10 μm and 30 μm.
11. The solid particulate formulation of claim 1 , wherein 90% of the particles have a particle size between 1 μm and 25 μm.
12. A sachet comprising the solid particulate formulation of claim 1 .
13. The sachet of claim 12 , comprising a dose of soluble ferric pyrophosphate citrate chelate that will result in a final iron concentration of 110 μg/L or 2 μM in a dialysate to be administered to a patient receiving hemodialysis.
14. A kit comprising the solid particulate formulation of claim 1 and a dialysis concentrate formulation in a solid or liquid form.
15. The kit of claim 14 , wherein the dialysis concentrate formulation is a solid form.
16. The kit of claim 14 , wherein the dialysis concentrate formulation is a liquid form.
17. The kit of claim 14 , wherein the dialysis concentrate formulation is an acid.
18. The kit of claim 14 , wherein the dialysis concentrate formulation is a base.
19. A composition comprising particles of a soluble ferric pyrophosphate citrate chelate, comprising 90% of the particles having a particle size between 1 μm and 50 μm.
20. The composition of claim 19 , wherein the soluble ferric pyrophosphate citrate chelate has an angle of repose less than 45 degrees.
21. The composition of claim 19 , wherein the soluble ferric pyrophosphate citrate chelate has an angle of repose less than 42 degrees.
22. The composition of claim 19 , wherein the soluble ferric pyrophosphate citrate chelate comprises iron in an amount of 7% to 11% by weight, citrate in an amount of at least 14%, and pyrophosphate in an amount of at least 10%.
23. The composition of claim 19 , comprising iron in an amount from 7.5-9.0% by weight, citrate in an amount from 15-22% by weight, pyrophosphate in an amount from 15-22% by weight, phosphate in an amount less than 2%, sodium in an amount from 18-25% by weight, and sulfate in an amount from 20-35% by weight.
24. The composition of claim 19 , comprising iron in an amount from 9-14% by weight, citrate in an amount from 30-60% by weight, pyrophosphate in an amount from 5-20% by weight, sodium in an amount from 1-15% by weight, and essentially no sulfate.