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|Abstract:||The invention relates to aqueous pharmaceutical formulations comprising human growth hormone, histidine, poloxamer, phenol, and mannitol.|
|Inventor(s):||Bjorn; Soren (Lyngby, DK), Sorensen; Hans Holmegaard (Virum, DK), Langballe; Peter (Charlottenlund, DK), Larsen; Silke Moller (Charlottenlund, DK), Ebbehoj; Kristen (N.ae butted.rum, DK), Hansen; Birthe Lykkegaard (V.ae butted.rlose, DK)|
|Assignee:||Novo Nordisk Health Care AG (Zurich, CH)|
1. An aqueous pharmaceutical formulation comprising a) about 1 mg/ml to about 15 mg/ml of human growth hormone (hGH), b) histidine in an amount of about 0.05-about 0.5
mg per mg hGH, c) Poloxamer 188 in an amount of about 0.1-about 2 mg per mg hGH, d) mannitol in an isotonicity conferring amount, and e) phenol in an amount that confers a preservative effect, wherein the formulation has a pH 6.0-6.2, and wherein the hGH
is dissolved in said formulation.
2. The formulation of claim 1, wherein the formulation has a pH of about 6.1.
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