Claims for Patent: 7,592,004

Summary for Patent: 7,592,004

Title:	Stable lyophilized pharmaceutical formulation of IgG antibodies
Abstract:	This invention is directed to a stable lyophilized pharmaceutical formulation prepared by lyophilizing an aqueous formulation comprising a high concentration, e.g. 50 mg/ml or more, of an IgG antibody in about 5-25 mM histidine buffer having pH from about 5.5 to about 6.5, about 0.005%-0.03% polysorbate, sucrose, and optionally serine, and/or mannitol. This lyophilized formulation is stable at room temperature for at least 6 months, and preferably 1 year. This lyophilized formulation has a short reconstitution time of less than 2 minutes, and is suitable for parenteral administration such as intravenous, intramuscular, intraperitoneal, or subcutaneous injection. This invention is exemplified by the anti-IL2 receptor antibody.
Inventor(s):	Kaisheva; Elizabet A. (Belmont, CA), Flores-Nate; Aleni (Union City, CA), Gupta; Supriya (Sunnyvale, CA)
Assignee:	Facet Biotech Corporation (Redwood City, CA)
Application Number:	11/250,835
Patent 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. 2. The stable lyophilized formulation according to claim 1, wherein said sucrose concentration is about 100-200 mM. 3. The stable lyophilized formulation according to claim 1, wherein said formulation is stable at about 22-28.degree. C. for at least 3 months. 4. The stabilized lyophilized formulation according to claim 1, wherein said formulation is stable at about 2-8.degree. C. for at least 1 year. 5. The stable lyophilized formulation according to claim 1, wherein said formulation is suitable for subcutaneous injection. 6. The stable lyophilized formulation according to claim 1, wherein the composition is isotonic. 7. The stable lyophulized formulation according to claim 1, wherein the histidine concentration is 10-20 mM. 8. The stable lyophilized formulation according to claim 1, wherein the aqueous formulation comprises 20 mM histidine buffer, pH 6.0, 0.0 15% polysorbate, and 117 mM'1 sucrose and the daclizumab is at a concentration of 50-80 mg/ml. 9. The stable lyophilized formulation according to claim 1, wherein the aqueous formulation comprises 20 mM histidine buffer, pH 6.0, 0.025% polysorbate, and 190 mM sucrose and the daclizumab is at a concentration of 80 mg/ml. 10. 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 100 mg/ml IgG antibody in less than two minutes, wherein the IgG antibody is daclizumab.

Details for Patent 7,592,004

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749	12/10/1997		2021-07-25
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/27/2016		2021-07-25
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/26/2017		2021-07-25