US 7,592,004 B2
Stable lyophilized pharmaceutical formulation of IgG antibodies
Elizabet A. Kaisheva, Belmont, Calif. (US); Aleni Flores-Nate, Union City, Calif. (US); and Supriya Gupta, Sunnyvale, Calif. (US)
Assigned to Facet Biotech Corporation, Redwood City, Calif. (US)
Filed on Oct. 14, 2005, as Appl. No. 11/250,835.
Application 11/250835 is a continuation of application No. 10/206469, filed on Jul. 25, 2002, abandoned.
Claims priority of provisional application 60/307878, filed on Jul. 25, 2001.
Prior Publication US 2006/0029599 A1, Feb. 09, 2006
Int. Cl. A61K 39/395 (2006.01)
U.S. Cl. 424—130.1  [424/141.1; 424/144.1] 10 Claims
 
1. A stable lyophilized formulation prepared by lyophilizing an aqueous formulation comprising: about 5-25 mM histidine buffer having a pH from 5.5 to about 6.5, about 0.005%-0.03% polysorbate, about 100-300 mM sucrose, and an IgG antibody wherein said formulation is reconstitutable with a liquid to a solution containing 50 mg/ml to 160 mg/ml IgG antibody within less than 5 minutes, wherein the IgG antibody is daclizumab.