Stable aqueous formulation for growth hormone
AssigneeSandoz Ltd.
InventorsBernt Pragl, Sabine Fuertinger
Life of this patent
Estimating the term…
Abstract
The present invention is related to a pharmaceutically acceptable aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein, wherein the concentration ratio between the biopharmaceutical protein and the neutral salt is in the range of ≥0.7 and ≤5.
Claims20
A pharmaceutically acceptable aqueous formulation comprising a neutral salt, a phosphate buffer, a non-ionic surfactant, a preservative, and recombinant human growth hormone (hGH), wherein hGH is the only biopharmaceutical protein in the formulation, wherein the neutral salt is sodium chloride, and wherein the ratio of the concentration of recombinant hGH to the concentration of the neutral salt is from 1.2:1 to 2.0:1.
A pharmaceutically acceptable aqueous formulation comprising:
- (a) sodium chloride in a concentration ranging from 2 mg/mL to 20 mg/mL;
- (b) a phosphate buffer;
- (c) a non-ionic surfactant selected from Poloxamer 188, Pluronic F-68, and Polysorbate 20 in a concentration ranging from 2 mg/mL to 3 mg/mL;
- (d) a preservative selected from phenol and benzyl alcohol in a concentration ranging from 0.11 mg/mL to 3 mg/mL;
- and
- (e) recombinant human growth hormone (hGH) in a concentration ranging from 2 mg/mL to 20 mg/mL,
- wherein the ratio of the concentration of recombinant hGH to the concentration of sodium chloride is of from 1.2:1 to 2.0:1, and
- wherein hGH is the only biopharmaceutical protein in the formulation.
A pharmaceutically acceptable aqueous formulation consisting of:
- (a) sodium chloride;
- (b) a phosphate buffer;
- (c) Poloxamer 188;
- (d) phenol;
- and
- (e) recombinant hGH,
- wherein the ratio of the concentration of recombinant hGH to the concentration of sodium chloride is from 1.2:1 to 2.0:1.
Dependencies are inferred from the claim text.