Erythropoietin solution formulation

1. A stable phosphate-buffered pharmaceutical formulation of erythropoietin containing tris-(hydroxymethyl)-aminomethane as stabilizer, whereby the formulation does not contain amino acids or human serum albumin, further wherein the pH of the formulation ranges from 5.9 to 6.8.

2. A stable pharmaceutical formulation of claim 1 comprising:

a) as a pH buffering agent a sodium phosphate buffer,

b) as stabilizer tris-(hydroxymethyl)-aminomethane in an amount of 10 to 200 mM, and

c) a pharmaceutical quantity of erythropoietin.

3. The formulation of claim 2 which comprises NaCl in an amount of 20-150 mM.

4. The formulation according to claim 3 wherein the amount of NaCl ranges from 50 to 100 mM.

5. The formulation of claim 2 wherein the pH buffering agent has the formula Na x H y PO 4 wherein x is 1 or 2 and y is 1 or 2 and the sum of x and y is 3 whereby the pH buffering agent is present in the pharmaceutical formulation in a range of 5 mM to 50 mM.

6. The formulation of claim 1 which is an aqueous formulation.

7. The formulation of claim 1 wherein the tris-(hydroxymethyl)-aminomethane is present in an amount of 20 to 100 mM.

8. The formulation of claim 1 which contains also a non-ionic detergent in an amount ranging from 0.005 to 0.1 % w/v.

9. The formulation of claim 8 wherein the non-ionic detergent is a polysorbate.

10. The formulation according to claim 9 wherein the polysorbate is not produced from materials derived from animals and wherein the content of peroxide is lower than 1.00 μmol/g.

11. The formulation of claim 9 , wherein the non-ionic detergent is Tween 20 or Tween 80.

12. The formulation according to claim 1 which comprises further ethylenediaminetetraacetic acid in an amount of 0.1 to 0.5 mM.

13. The formulation of claim 1 , wherein the pH ranges from 6.2 to 6.6.