Claims for Patent: 7,857,977

Summary for Patent: 7,857,977

Title:	Packaging of ferric pyrophosphate for dialysis
Abstract:	A stable packaged bicarbonate solution for use in dialysis treatment and for treating anemia, iron deficiency, or reducing the required dose of recombinant erythropoietin to treat anemia includes a bicarbonate solution into which ferric pyrophosphate is dissolved. The amount of ferric pyrophosphate dissolved in the bicarbonate solution is sufficient to provide a therapeutic effect for the treatment of anemia, iron deficiency or to reduce dose of recombinant erythropoietin needed to treat anemia when the bicarbonate solution is combined with other dialysis components to form a dialysate used for dialyzing a patient. The ferric pyrophosphate is stabilized in the bicarbonate solution by holding the solution in a polyolefin container or container liner, such as a high density polyethylene container or liner.
Inventor(s):	Wash; Lori L. (Redford, MI)
Assignee:	Rockwell Medical Technologies, Inc. (Wixom, MI)
Application Number:	11/179,376
Patent Claims:	1. A packaged bicarbonate solution for use in dialysis treatment, comprising: a bicarbonate solution into which ferric pyrophosphate is dissolved in an amount sufficient to provide a therapeutic effect for the treatment of anemia, iron deficiency or to reduce the dose of recombinant erythropoietin needed to treat anemia when the bicarbonate solution is combined with other dialysis components to form a dialysate used for dialysis treatment of a patient; and a polyolefin container or a container having a polyolefin liner, in which the bicarbonate solution is contained, the packaged bicarbonate solution being sufficiently stable to provide a ferric pyrophosphate concentration that remains unchanged for at least 48 hours after preparation. 2. The method of claim 1, wherein the polyolefin container or liner is comprised of high density polyethylene. 3. A process for treating anemia, iron deficiency, or for reducing the dose of recombinant erythropoietin needed to treat anemia, during a dialysis treatment, comprising: preparing a bicarbonate solution suitable for dialysis treatment; dissolving ferric pyrophosphate in the bicarbonate solution in an amount sufficient to provide a therapeutic effect for the treatment of anemia, iron deficiency, or to reduce the dose of recombinant erythropoietin needed to treat anemia, when the bicarbonate solution is combined with other dialysis components to form a dialysate used for dialysis treatment of a patient; storing the bicarbonate solution containing the ferric pyrophosphate in a polyolefin container or in a container having a polyolefin liner, the stored bicarbonate solution being sufficiently stable to provide a ferric pyrophosphate concentration that remains unchanged for at least 48 hours after preparation; combining the bicarbonate solution containing ferric pyrophosphate with a predetermined amount of water and a predetermined dialysis concentrate to form a dialysate; and dialyzing the patient with the dialysate. 4. The process of claim 3, wherein the polyolefin container or liner is comprised of high density polyethylene. 5. The process of claim 3, wherein the iron concentration in the dialysate is from about 2 micrograms per deciliter to about 12 micrograms per deciliter.