Patent ID: 8071544
Filing Date: 2011-12-06
Classification: A61K,A61P,C07K

Abstract:
1. An hGH pharmaceutical formulation comprising polyelectrolyte complexed crystallized recombinant hGH; a biologically compatible buffer in the pH range of 5.4 to 7.0, selected from the group consisting of triethanolamine, imidazole, glycine, histidine, citrate, acetate, phosphate and tris, or a combination thereof, and one or more additional components selected from the group consisting of a sodium salt having a sodium ion concentration in the range of 60-200 mM, a suspending agent, a chemical stabilizer, a surfactant, and a preservative, wherein the biologically compatible buffer and the one or more additional components are selected from the group consisting of: 10 mM Na Phosphate, 25 mM Tris, 100 mM NaAc, 5% PEG 6000, pH 6.5; 10 mM Na Phosphate, 0.25% Phenol, 150 mM NaCl, 5% PEG 6000, pH 6.0; 10 mM Na Citrate, 0,2% Tween 20, 0.25% Phenol, 150 mM NaCl, pH 6.0; 30 mM Triethanolamine, 100 mM Na Acetate, 5% PEG6000, pH 6.8; 25 mM Triethanolamine, 10 mM Methionine, 100 mM NaCl, 2% PEG3350, pH 6.8; 25 mM imidazole, 100 mM Na Acetate, 5% PEG6000, pH 6.5; 2 mM Na citrate, 8 mM Na phosphate, 120 mM NaCl, 0.3% Phenol, pH 6.0; 10 mM Na Phosphate, 100 mM Glycine, 0.3% phenol, pH 6.0; 10 mM Na Phosphate, 100 mM NaCl, 0.3% phenol, pH 6.0; 10 mM Na Phosphate, 100 mM Na acetate, 5% PEG 6000, pH 6.0; 10 mM Na Phosphate, 100 mM NaCI, 5% PEG 6000, pH 6.0; 10 mM Na Phosphate, 100 mM NaCl, 5% PEG 6000, pH 6.5; 2 mM Na citrate, 8 mM Na phosphate, 120 mM NaCI, 0.3% Phenol pH 5.4; 10 mM Na phosphate, 100 mM NaCl, 10% w/v PEG3350 pH 6.0; 10 mM Na citrate, 80 mM Na Glycine, 10% w/v PEG6000 pH 5.4; and 10 mM Na acetate, 120 mM NaCl, 10% w/v PEG6000 pH 5.6.