Patent ID: 6320029
Filing Date: 2001-11-20
Classification: A61K,Y10S

Abstract:
A method of delivering a plasma protein to a mammal in need thereof, said method comprising the steps of:(a) preparing a stable (at least 30 days at 37.degree. C.) liquid formulation of at least one plasma protein selected from the group consisting of: (i) a stable aqueous liquid formulation of at least one plasma protein, (ii) a stable non-aqueous liquid formulation of at least one plasma protein, and (iii) a stable mixed aqueous and non-aqueous liquid formulation of at least one plasma protein;(b) incorporating said stable liquid formulation of at least one plasma protein into a continuous administration system; and(c) introducing said continuous administration system into amammal in need of said plasma protein,wherein said plasma protein is delivered from said continuous administration system into said mammal, andwherein said stable aqueous liquid formulation of at least one plasma protein is selected from the group consisting of:(i) a stable aqueous liquid formulation comprising: (a) a plasma protein; (b) a pH buffering compound; (c) a source of calcium ions; (d) an osmotic modulating agent in a concentration of 1-500 mM; and (e) water;(ii) a stable aqueous liquid formulation comprising: (a) aplasma protein; (b) a pH buffering compound; (c) calcium chloride in a concentration of 0. 1-40 mM; (d) an osmotic modulating agent; and (e) water; and(iii) a stable aqueous liquid formulation comprising: (a) a plasma protein; (b) a pH buffering compound in a concentration of 0.1-100 mM; (c) a source of calcium ions; (d) an osmotic modulating agent; and (e) water, andwherein said stable non-aqueous liquid formulation comprises: (a) a plasma protein; and (b) a non-aqueous liquid, and contains substantially no water, andwherein said stable mixed aqueous and non-aqueous liquid formulation of a plasma protein comprises: (a) a plasma protein; (b) a non-aqueous liquid selected from the group consisting of: glycerol, dimethyl sulfoxide (DM SO), ethylene glycol, diethylene glycol, triethylene glycol, PEG 200, PEG 300, PEG 400, dipropylene glycol, tripropylene glycol, PPG 425, PPG 725, PPG 1000, PPG 2000, PPG 3000 and PPG 4000; and (c) water.