Aqueous stable preserved pharmaceutical compositions of erythropoietin

摘要

A pharmaceutical formulation comprises a pH buffering agent, a stabilizing amount of human serum albumin, a stabilizing amount of an amino acid, an antimicrobial quantity of cresol and erythropoietin and optionally an tonicity agent. Also described are formulations comprising either 10000, 25000 or 40000 IU erythropoietin, 6.25mg or 5mg human serum albumin, 2.91mg or 2.33mg sodium phosphate monobasic dihydrate, 11.19mg or 8.95 sodium phosphate dibasic dodecahydrate, 50mg or 40mg glycine, 7.50mg or 6.0 mg m-cresol adjusted to 2.5ml with water and a urea-free, non-lyophilized pharmacuetical formulation comprising 2000, 4000, 10000 or 40000 IU erythropoietin, 4.38mg sodium chloride, 1.16mg sodium phosphate monobasic dihydrate, 2.23mg sodium phosphate dibasic, 5mg glycine, 0.30mg Polysorabte 80 adjusted to 1ml with water