Pharmaceutical preparation containing purified fibronectin

Claim 2

An improved lyophilized fibronectin preparation which is readily reconstitutable with sterile water containing on reconstitution: 1-16 mg/ml of at least 95% pure fibronectin; 0.002M to 0.05M of a physiologically acceptable buffer salt selected from the group consisting of sodium citrate, sodium glycinate, sodium phosphate or tris(hydroxymethyl)amino methane; 0.03M to 0.09M of sodium chloride; about 2% to 10% w/v of a carbohydrate selected from the group consisting of glucose, galactose, mannose, sucrose, lactose, maltose, mannitol or sorbitol; wherein the improvement comprises the addition of 0.01% to 0.4% w/v of a pharmaceutically acceptable surface active agent selected from the group consisting of (oxy-1,2-ethanediyl) 20 monododecanoate sorbitan, (oxy-1,2-ethanediyl) 20 monohexadecanoate sorbitan, (oxy-1,2-ethanediyl) 20 monooctadecanoate sorbitan, (oxy-1,2-ethanediyl) 20 mono-9-octadecanoate sorbitan, α[4-(1,1,3,3-tetramethylbutyl)phenyl]-ω-hydroxy(oxy-1,2-ethanediyl) 100 , sodium taurocholate, sodium cholate, sodium deoxycholate, sodium glycocholate and α-hydro-ω-hydroxy(oxyethylene) 7 (oxypropylene) 54 (oxyethylene) 7 .

Claim 3

An improved lyophilized fibronectin preparation which is reconstitutable in 10 minutes with sterile water containing on reconstitution: 1-16 mg/ml of at least 95% pure fibronectin; 0.005M to 0.02M of a physiologically acceptable buffer salt selected from the group consisting of sodium citrate, sodium glycinate, sodium phosphate or tris (hydroxymethyl) amino methane; 0.04M to 0.08M of sodium chloride; about 3% to 7% w/v of a carbohydrate selected from the group consisting of glucose, galactose, mannose, sucrose, lactose, maltose, mannitol or sorbitol; wherein the improvement comprises the addition of: 0.02% to 0.1% w/v of a pharmaceutically acceptable surface active selected from the group consisting of (oxy-1,2-ethanediyl) 20 monododecanoate sorbitan, (oxy-1,2-ethanediyl) 20 monohexadecanoate sorbitan, (oxy-1,2-ethanediyl) 20 monooctadecanoate sorbitan, (oxy-1,2-ethanediyl) 20 mono-9-octadecanoate sorbitan, α[4-(1,1,3,3-tetramethylbutyl)phenyl]-ω-hydroxy(oxy-1,2-ethanediyl) 100 , sodium taurocholate, sodium cholate, sodium deoxycholate, sodium glycocholate and α-hydro-ω-hydroxy(oxyethylene) 7 (oxypropylene) 54 (oxyethylene) 7 .

Claim 4

An improved lyophilized fibronectin preparation which is reconstitutable in 10 minutes with sterile water containing on reconstitution: 1-16 mg/ml of at least 95% pure fibronectin; 0.005M to 0.02M of a physiologically acceptable buffer salt selected from the group consisting of sodium citrate, sodium glycinate, sodium phosphate or tris (hydroxymethyl) amino methane; 0.04M to 0.08M of sodium chloride; about 3% to 7% w/v of a carbohydrate selected from the group consisting of glucose, galactose, mannose, sucrose, lactose, maltose, mannitol or sorbitol; wherein the improvement comprises the addition of: 0.02% to 0.1% w/v of a pharmaceutically acceptable surface active selected from the group consisting of (oxy-1,2-ethanediyl) 20 monododecanoate sorbitan, (oxy-1,2-ethanediyl) 20 monohexadecanoate sorbitan, (oxy-1,2-ethanediyl) 20 monooctadecanoate sorbitan, (oxy-1,2-ethanediyl) 20 mono-9-octadecanoate sorbitan, α[4-(1,1,3,3-tetramethylbutyl)phenyl]-ω-hydroxy(oxy-1,2-ethanediyl) 100 , sodium taurocholate, sodium cholate, sodium deoxycholate, sodium glycocholate and α-hydro-ω-hydroxy(oxyethylene) 7 (oxypropylene) 54 (oxyethylene) 7 .

Claim 5

An improved fibronectin preparation in dosage form which is readily reconstitutable with 50 ml of sterile water containing on reconstitution: 240±35 mg of at least 95% pure fibronectin; 2.5±0.25 gm of sucrose; 0.14±0.015 gm of sodium chloride; 0.025±0.003 gm of sodium citrate; wherein the improvement comprises the addition of: 0.025±0.003 gm of (oxy-1,2-ethanediyl) mono-9-octadecanoate sorbitan.

Claim 6

An improved fibronectin preparation in dosage form which is readily reconstitutable with 50 ml of sterile water containing on reconstitution: 240±35 mg of at least 95% pure fibronectin; 2.5±0.25 gm of sucrose; 0.14±0.015 gm of sodium chloride; 0.025±0.003 gm of sodium citrate; wherein the improvement comprises the addition of: 0.025±0.003 gm of (oxy-1,2-ethanediyl) mono-9-octadecanoate sorbitan.