Claims for Patent: 4,478,829

Summary for Patent: 4,478,829

Title:	Pharmaceutical preparation containing purified fibronectin
Abstract:	Disclosed are readily reconstitutable lyophilized fibronectin formulations containing fibronectin, a neutral salt, a carbohydrate and a surface active agent.
Inventor(s):	Landaburu; Ricardo H. (Rye Town, NY), Yue; Robert H. (Floral Park, NY), Farb; David L. (LeGrangeville, NY), Violand; Bernard N. (Chesterfield, MO)
Assignee:	Armour Pharmaceutical Company (Tarrytown, NY)
Application Number:	06/595,100
Patent Claims:	1. 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).sub.20 monododecanoate sorbitan, (oxy-1,2-ethanediyl).sub.20 monohexadecanoate sorbitan, (oxy-1,2-ethanediyl).sub.20 monooctadecanoate sorbitan, (oxy-1,2-ethanediyl).sub.20 mono-9-octadecanoate sorbitan, .alpha.[4-(1,1,3,3-tetramethylbutyl)phenyl]-.omega.-hydroxy(oxy-1,2-ethane diyl).sub.100, sodium taurocholate, sodium cholate, sodium deoxycholate, sodium glycocholate and .alpha.-hydro-.omega.-hydroxy(oxyethylene).sub.7 (oxypropylene).sub.54 (oxyethylene).sub.7. 2. 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).sub.20 monododecanoate sorbitan, (oxy-1,2-ethanediyl).sub.20 monohexadecanoate sorbitan, (oxy-1,2-ethanediyl).sub.20 monooctadecanoate sorbitan, (oxy-1,2-ethanediyl).sub.20 mono-9-octadecanoate sorbitan, .alpha.[4-(1,1,3,3-tetramethylbutyl)phenyl]-.omega.-hydroxy(oxy-1,2-ethane diyl).sub.100, sodium taurocholate, sodium cholate, sodium deoxycholate, sodium glycocholate and .alpha.-hydro-.omega.-hydroxy(oxyethylene).sub.7 (oxypropylene).sub.54 (oxyethylene).sub.7. 3. 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.

Details for Patent 4,478,829

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2003-04-28